| Oct 6, 2000 | Solvay celebrating its 50 years expertise in influenza prevention |
| Oct 3, 2000 | Solvay establishes itself in the South American pharmaceutical market by acquiring the Brazilian company Sintofarma |
| Sept 29, 2000 | Solvay celebrating 100 years of pancreatic enzyme substitution |
| Sept 22, 2000 | SOLVAY Joins EURONEXT 100 |
| July 12, 2000 | Fluvoxamine recognized as first line therapy for depression in Japan |
| June 8, 2000 | Opening Automated Molecular Assembly Plant Solvay Pharmaceuticals Weesp |
| March 23, 2000 | SOLVAY GROUP confirms excellent 1999 net consolidated results of 423 million EUR, increases the 1999 net dividend by 6.5% |
| Feb 29, 2000 | SOLVAY Group: approval by U.S. FDA for AndroGelTM, First Gel to Treat Male Testosterone Deficiency |
| Jan 17, 2000 | India: * Main shareholders of Duphar-Interfran Ltd. jointly announce restructuring plans * Set up of a new company: Solvay Pharma India Ltd. |
| Jan 5, 2000 | DURAMED Pharmaceuticals completes stock sale to SOLVAY Pharmaceuticals |
| Nov 9, 1999 | New antihypertensive medication survey reveals that nearly 19 million hypertensive patients may have significant drug-tolerability problems |
| Oct 19, 1999 | Solvay pharmaceuticals exercises option to purchase DURAMED Pharmaceuticals common stock |
| Oct 18, 1999 | Antihypertensive TEVETEN® (eprosartan mesylate) tablets is now available in the U.S. |
| Oct 7, 1999 | Solvay pharmaceuticals, Inc. introduces ACEON® (perindopril erbumine) tablets to U.S. market |
| Oct 6, 1999 | DURAMED Pharmaceuticals and SOLVAY Pharmaceuticals announce alliance in the USA |
| Sep 29, 1999 | Prestigious SOLVAY Pharmaceuticals menopause prize goes to research on HRT and Stroke |
| Sep 21, 1999 | Fluvoxamine: helping patients recover after trauma |
| Jul 20, 1999 | SOLVAY Pharmaceuticals, Inc. acquisition of UNIMED Pharmaceuticals,Inc |
| Jun 14, 1999 | SOLVAY Group announces agreement to acquire UNIMED Pharmaceuticals, Inc to strengthen its marketing presence among U.S. primary care physicians |
| May 11, 1999 | SOLVAY acquires TEVETEN®, an innovative cardiovascular drug, for world-wide marketing |
| May 5, 1999 | SOLVAY Pharmaceuticals, Inc. enters cardiovascular market acquires U.S. rights to ACEON® (perindopril erbumine) for hypertension |
| Apr 16, 1999 | BERNA and SOLVAY Pharmaceuticals collaborate in influenza vaccines |
| Apr 16, 1999 | Novel vaccine approaches for the control of infectious diseases such as AIDS, hepatitis B and influenza |
| Apr 7, 1999 | Solvay group: LUVOX® and DEPROMEL®, first innovative mental health drug(SSRI), approved for Japanese market |
| Mar 30, 1999 | Microsurgical developments pvc-rat reduces use of live rats drastically |
INFLUENZA VACCINATION MOVES FROM RISK PATIENTS TO HEALTHY WORKING P0PULATION
Today at a symposium on the Solvay Pharmaceuticals site in Weesp the company celebrated its 50 years expertise in the prevention of influenza. Influenza is still a highly contagious disease, every year causing thousands of deaths worldwide, many cases of hospitalization, and loss of production through absenteeism. During major epidemics, the attack rate of influenza may range from 5% – 20% in the community, disrupting many activities.
Over the last few years vaccination programs have intensified in many countries for the so-called risk groups: particularly the elderly, people with chronic medical conditions, etc. For instance in The Netherlands the vaccination rate for these at risk patients is 77%. But in many countries less than half of the risk patients is actually vaccinated.
Recently the economic impact of the disease has become increasingly visible. New studies have indicated that influenza vaccination programs for other people, for instance the working population, have a positive effect on society. Vaccination of working adults leads to reduced absenteeism and therefore to cost savings. Nowadays it is in the limelight to discuss whether it is appropriate to expand vaccination programs to all working adults.
During the symposium many speakers gave a presentation on this interesting topic. Prof. D. Fedson (author of many key influenza publications) spoke about the cost-effectiveness of vaccinating healthy working adults. He indicated that influenza-like illnesses generally lead to a work loss of 2.8 days and a loss of effectiveness at work of 4.6 days. He distinguished between direct costs: cost of vaccination, medical care for side effects, and medical care averted, and indirect costs: ie. work loss for vaccination, work loss for side effects, and work loss averted. His conclusion was that vaccination of healthy working adults is associated with substantial health economic benefits.
Mr J Guest ( director of the Health Economics Agency Catalyst) presented a newly developed model which will help employers to determine the economic consequences (positive or negative) of implementing vaccination programmes for their employees in their own organization.
Mr J. Piercy (director of the Health Economics Agency Adelphi) presented a cost-effectiveness study of the various influenza prevention strategies in the UK, France, and Germany. He found that a vaccination programme for the high risk groups in the UK with a 65% coverage rate could save 58,000 life years. Similar results were found for the elderly population in the UK and for both the high risk and elderly populations in France.
Prof. dr. A. Osterhaus, Director of the Dutch National Influenza Center, memorized the long-standing relationship between his institute and Solvay Pharmaceuticals during the past 50 years. He also spoke about the potential threat for pandemics and the importance of introducing an alternative production method with the cell-culture technique. Presently influenza vaccines are still produced with the use of chicken eggs. In case of a pandemic threat the huge dependence on chicken eggs reduces the flexibility to produce enough quantities of vaccine for the population in time. He mentioned that the cell culture technique developed by Solvay Pharmaceuticals offers an exciting potential. This technique is currently under evaluation with the European regulatory authorities to obtain a marketing license in Europe.
Influvac® is the vaccine of Solvay Pharmaceuticals that was first launched on the Dutch market in 1950. Today it is sold in more than 35 countries all over the world. Influvac® is the number 9 product of Solvay Pharmaceuticals.
Solvay Pharmaceuticals is a group op pharmaceutical companies which focuses, apart from immunology, on four therapeutic areas: cardiology, psychiatry, gastroenterology, and women’s health. Solvay Pharmaceuticals is a member of the Solvay Group of chemical and pharmaceutical companies based in Brussels (Belgium). Solvay employs about 33,000 people in 50 countries. Its 1999 turnover worldwide was EUR 7.9 billion from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals. Solvay SA is listed among the top hundred European companies of the Euronext 100 index.
For more information please contact:
Puck Bossert, Pharmaceuticals Communications, Solvay Pharmaceuticals, Weesp. Telephone: + 31-(0) 294-477242. , mobile: +6-53-165942.
SOLVAY ESTABLISHES ITSELF IN THE SOUTH AMERICAN PHARMACEUTICAL MARKET BY ACQUIRING THE BRAZILIAN COMPANY SINTOFARMA
Solvay (Brussels, Belgium) has acquired the pharmaceutical company Sintofarma in Sao Paulo, Brazil. The acquisition marks Solvay’s penetration in the Brazilian pharmaceutical market and is in line with Solvay Pharmaceuticals’ growth strategy for Mercosur.
Sintofarma, with net sales in 1999 around 25 MUSD, ranks number 41 in the list of pharmaceutical companies in Brazil. The company was until now privately owned and has been mainly active in the therapeutic classes gynecology and gastroenterology. Sintofarma has been in existence since 1948 and employs almost 400 people including a substantial sales force covering the whole of Brazil. The acquisition of Sintofarma fits the main therapeutic areas of Solvay Pharmaceuticals, i.e. gynecology, gastroenterology, cardiology, and mental health. Up to now Solvay Pharmaceuticals had only been indirectly active in Brazil.
Mr Jürgen Ernst, General Manager Solvay Pharmaceuticals, says: “We are happy with this start in Brazil as it enables us to penetrate the South American pharmaceutical market. We can now effectively market our leading pharmaceutical products. I am convinced this acquisition will enhance our future growth”.
The political and economic stabilization in Brazil as well as a recently enforced patent law have contributed to this acquisition of Sintofarma. Brazil is the eighth largest pharmaceutical market in the world (6.2 billion USD in 1999) and has a population of around 165 million.
The acquisition gives Solvay Pharmaceuticals the opportunity to launch its cardiology product Teveten® in Brazil, as well as various other products that have already been registered there, i.e. Duspatal®, Creon®, Serc®, and Duphalac®.
Solvay Pharmaceuticals is a group of pharmaceutical companies which focuses on four therapeutic areas: cardiology, psychiatry, gastroenterology, and women’s health. Solvay Pharmaceuticals is a member of the Solvay Group of chemical and pharmaceutical companies based in Brussels (Belgium). Solvay employs about 33,000 people in 50 countries. Its 1999 turnover worldwide was EUR 7.9 billion from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals. Solvay SA is listed among the top hundred European companies of the Euronext 100 index.
For further information please contact:
| Puck Bossert Pharmaceuticals Communications Solvay Pharmaceuticals, Weesp telephone: +31-(0)294-477242 Fax: +31-(0)294-477112 E-mail: puck.bossert@solvay.com Internet: solvaypharmaceuticals.com |
Martial Tardy Corporate Press Officer SOLVAY S.A. Headquarters Tel: 32/2/509.60.16 Fax: 32/2/509.72.40 E-mail: martial.tardy@solvay.com Internet: www.solvay.com |
SOLVAY CELEBRATING 100 YEARS OF PANCREATIC ENZYME SUBSTITUTION
CREON® NOW PREFERRED PRODUCT WORLDWIDE FOR TREATING PANCREATIC EXOCRINE INSUFFICIENCY Today at a symposium at the Expo in Hanover Solvay Pharmaceuticals celebrates its 100 years expertise in creating pancreatic enzyme substitution. When the function of the pancreas is disrupted patients suffer from insufficient digestive enzymes so that their food is not properly digested and their bodies are unable to absorb the valuable substances and nutrients in the food. Already in 1900 two young scientists discovered that Pankreon® could be manufactured. It was the first medicine for pancreatic enzyme replacement, recognized as effectively by the medical profession. What started out as Pankreon® has now become the Creon® product range used for the treatment of pancreatic exocrine insufficiency, associated with several underlying conditions, including cystic fibrosis, chronic pancreatitis, and pancreatic surgery.
Creon®’s galenic form was revolutionized relatively recently in its 100 years’ history. In contrast to former preparations impressive technological advances established by Solvay Pharmaceuticals now guarantee standardized contents of high quality enzymes in the form of enteric coated minimicrospheres, said Dr M. A. Rudmann, Head of International Medical Information at Solvay Pharmaceuticals. This major breakthrough ensures maintenance of enzyme activity until the capsules have reached the small intestine where they are most needed. This improvement of Creon® is particularly beneficial to cystic fibrosis patients as the extent of their pancreas insufficiency is severe. Substantial clinical improvement has also been demonstrated in patients with chronic pancreatitis and after surgical intervention.
Prof.dr. M. Götz, Head of the Department of Pediatric and Adolescent Medicine Wilhelminenspital in Vienna (Austria) announced today that Creon® with its enteric coated minimicrospheres has become the preferred product worldwide wherever cystic fibrosis is being treated.
Cystic fibrosis is a worldwide multiorgan disease affecting 1:2500 newborn infants. It is indeed the most frequent inheritable disease in Europe. The main characteristics are failure to thrive caused by pancreatic insufficiency and chronic bacterial pulmonary infections. Median life expectancy has improved vastly over the last decades and is close to 30 years old in Europe. “Adult patient numbers are increasing throughout the world. Without any doubt these impressive advances are largely attributable to modern pancreatic supplementations in conjunction with aggressive antibacterial strategies”, said Prof. Götz.
Dr. C.D. Johnson, Reader in Surgery and Honorary Consultant Surgeon at the University of Southhampton (UK) spoke about “Progress in Pancreatic Surgery”. He explained that pancreatic surgery has developed from the first successful attempts at pancreatic resection a hundred years ago through a pattern of extension as technical advances made surgery safer. Surgeons became more adventurous but later a phase of re-evaluation started with a more realistic appraisal of the effectiveness and disadvantages of surgical treatment. This pattern has run in parallel in the treatment of pancreatic cancer, acute pancreatitis and chronic pancreatitis. Not only advances in surgery have been made, also in medicine (pancreatic enzyme supplements like Creon®), in anesthesia and intensive care, as well as in nutritional support.
Phillip P. Toskes, professor of medicine at the University of Florida College of Medicine in Gainesville talked about future treatment options. Epidemiological and clinical data have to be generated to investigate the benefit of pancreatic enzyme substitution in diseases associated with an exocrine insufficiency like diabetes mellitus, inflammatory bowel disease or irritable bowel syndrome. Although, around 95% of all patients with a pancreatic exocrine insufficiency are adequately treated and controlled with the current modern preparations, possible alternatives to porcine pancreatin are investigated for future therapy. These include gastric lipase and microbial enzymes and should further improve symtom control of poor or non-responders or help patients who will not take medicine derived from pigs due to religious reasons.
Solvay Pharmaceuticals, today the biggest manufacturer in the world of pancreatic enzymes, will continue its Research & Development programs for a further improvement of its Creon® product range. Together with leading academic institutions and universities we will continue to develop further improvement of the presentation forms or with non-animal derived enzymes such as fungal or microbial enzymes.
Solvay Pharmaceuticals is a group of pharmaceutical companies which focuses on four therapeutic areas: cardiology, psychiatry, gastro-enterology, and women’s health. Solvay Pharmaceuticals is a member of the Solvay Group of chemical and pharmaceutical companies based in Brussels (Belgium). Solvay employs about 33,000 people in 46 countries. Its 1999 turnover worldwide was EUR 7,9 billion from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals.
For more information please contact:
Mrs. drs. Puck Bossert, Manager Communications Solvay Pharmaceuticals, Weesp, the Netherlands, telephone: +31-294-477469, or mobile: +31-6-53-165942.
SOLVAY Joins EURONEXT 100
SOLVAY SA will be listed among the top hundred European companies of the EURONEXT 100 index, whose composition was unveiled today in Paris. Euronext is being created through the merger of the Paris, Amsterdam and Brussels stock markets.
SOLVAY, a BEL 20 blue chip company, is one of the nine Belgian companies that were integrated into Euronext 100 -and is ranking in 69th position within the new European index .
Building up a significant business in pharmaceuticals and focusing on cost leadership in strong core businesses in the chemicals and plastics sectors, SOLVAY has developed into a “hybrid” pharmaceuticals and chemicals company.
The listing in EURONEXT 100 Index will increase the visibility of SOLVAY shares as well as their accessibility to foreign financial investors.
“Euronext is a very good initiative”, said Aloïs Michielsen, Chairman of the Executive Committee, SOLVAY SA. “Having as a reference market an entity much larger than the Belgian stock market is a positive development”, Aloïs Michielsen said.
SOLVAY is an international pharmaceutical and chemical group headquartered in Brussels. It employs about 33,000 people in 50 countries. In 1999, its consolidated sales amounted to EUR 7.9 billion, generated by its four sectors of activity: Pharmaceuticals, Chemicals, Plastics and Processing.
FLUVOXAMINE RECOGNIZED AS FIRST LINE THERAPY FOR DEPRESSION IN JAPAN
ECONOMIC BURDEN OF DEPRESSION ON SOCIETY CAN BE REDUCED BY SUCCESSFUL TREATMENT Brussels, 12 July 2000.
At a press conference held today during the 22nd CINP Congress in Brussels (Belgium) two interesting subjects were discussed. Prof. Yoshio Hirayasu from the Kyorin University School of Medicine in Tokyo, Japan gave a presentation on the mental health developments in Japan now that the first Selective Serotonin Reuptake Inhibitor (fluvoxamine) has been successfully introduced in Japan. He announced that fluvoxamine has become recognized as the first line therapy for depression. He also indicated that since the launch of this first SSRI to enter the Japanese market public attention given to depression has increased considerably as well as the Japanese population of depressed patients.
Prof. Koen Demyttenaere from Leuven University in Belgium focused on “Health Economics of Depression”. He made clear that depression is a chronic, recurrent illness that exerts a large social, medical and economic impact on society. Successful treatment can be expected to reduce the overall costs of depression to the individual and to society at large. Demyttenaere indicated that in measuring the economic costs of depression both the direct total healthcare costs and indirect costs should be taken into account. Direct costs such as the costs of medication, hospital, community care are only a smaller part of the costs of depression. Indirect costs such as the lost resources due to mortality (suicide) or due to morbidity (absenteeism, lost productivity, unemployment, cost of social support, etc.) are much higher and often overlooked.
For more information please contact:
Mrs. drs. Puck Bossert, Manager Communications Solvay Pharmaceuticals, Weesp, the Netherlands, telephone: +31-294-477469, or by e-mail : puck.bossert@solvay.com
Opening Automated Molecular Assembly Plant Solvay Pharmaceuticals Weesp
On Tuesday, June 13, 2000, 10.00 a.m., Drs. E.A.A.M. Koopmans, Chief Executive Officer of Solvay Pharmaceuticals B.V. officially opens a new and innovative automated combinatorial chemistry production unit at the premises of Solvay Pharmaceuticals B.V. in Weesp, The Netherlands. This combinatorial chemistry production unit, the Automated Molecular Assembly Plant (AMAP), is a revolutionary development in combinatorial chemistry and is unique in Europe.
The AMAP has a capacity of producing approx. 35.000 single compounds in library-format per year, based on solution chemistry techniques. In comparison with the classical method of synthesizing molecules, the AMAP-technology allows an exponential increase in the number of compounds which can be synthesized. The products, being delivered in 96-well plates, are ready for High Throughput Screening (HTS).
The AMAP-technology, developed by Solvay’s alliance partner Arqule Inc., is based on a modular system with manual transport between the modules. Each of the modules deals with a fundamental handling within the synthetic chemistry process. Examples are modules dealing with compound dissolution, compound distribution, reaction setup, solvent evaporation, liquid-liquid extraction, filtration, replication and quality control.
Solvay Pharmaceuticals is an internationally oriented pharmaceutical company which core activities consist of discovering, developing and manufacturing medicines for human use. Solvay Pharmaceuticals is part of the Pharmaceuticals Sector of the Solvay group, a chemical and pharmaceutical company with operations in 50 countries. Solvay employs 33,000 people and in 1999 generated a turnover of Euro 7,9 billion.
Weesp, May 31, 2000
COPYRIGHT, 2000, Solvay S.A.
Updated June 8, 2000. Made by Qwentès
SOLVAY GROUP
confirms excellent 1999 net consolidated results of 423 million EUR, increases the 1999 net dividend by 6.5%
Results
The Solvay Group confirms its preliminary consolidated 1999 results, which were announced on February 9, 2000, showing net earnings before extraordinary items of 423 million EUR, an increase of 12% over the 1998 figure of 377 million EUR. As net extraordinary items were negligible, the Group’s net earnings amounted to 423 million EUR for 1999, compared to 378 million EUR for 1998.
Consolidated results (1)
| Millions of EUR |
1998 |
1999 |
|
Sales |
7 451 |
7 869 |
|
Operating income |
596 |
610 |
|
Financial results |
-41 |
-14 |
|
Income before extraordinary items (before tax) |
555 |
596 |
|
Extraordinary items (before tax) |
-49 |
-19 |
|
Income before tax |
506 |
577 |
|
Net income |
378 |
423 |
(1) Consolidated in accordance with the Belgian Royal Degree of January 16, 1999
Net income of the Group’s mother company, SOLVAY S.A., reached 468 million EUR in 1999, compared to 189 million EUR in 1998. This increase reflects significant steps (internal transfers of shareholdings and creation of subsidiaries) taken to improve the efficiency of the asset’s management, which generated capital gains of 264 million EUR. It is proposed that these gains be transferred to reserves. The net profit (compared to that of 1998, which was 188 million EUR) amounted to 194 million EUR in 1999.
|
– SOLVAY S.A. – (millions of EUR) |
1998 |
1999 |
|
Net income for the year |
189 |
468 |
|
Transfers to untaxed reserves |
-1 |
-10 |
|
Net earnings available for distribution |
188 |
458 |
|
Capital gains on internal transfers of interests, |
– |
-264 |
|
Comparable net profit |
188 |
194 |
Dividends
The Board of Directors has decided to recommend to the General Shareholders’ Meeting of June 5, 2000 the payment of a net dividend of 1.65 EUR per share, an increase from the 1998 net dividend that will equal 0.10 EUR. The 1999 dividend represents a gross distribution by SOLVAY S.A. of 185 million EUR. Taking into account the interim dividend paid on January 13, 2000 (0.25 EUR per share), the balance (1.40 EUR per share) will be paid on June 14, 2000.
Performance per share
Net income per share before extraordinary items in 1999 amounted to 5.08 EUR, an increase of 16% compared to 1998 (4.38 EUR). Net income per share in 1999 was also 5.08 EUR, compared to 4.45 EUR in 1998 (+14%). Minority interests suffered a loss of five million EUR in 1999 (compared to net income of three million EUR in 1998), which reflects the negative results of Solvay Indupa in Argentina for such period.
|
Performances per share (Solvay share in Group’s earnings) |
EUR/SHARE |
|
|
1998 |
1999 |
|
|
Net current earnings |
4.38 |
5.08 |
|
Net income |
4.45 |
5.08 |
|
Gross dividend Net dividend |
2.07 1.55 |
2.20 1.65 |
|
Number of shares (000) |
84 206 |
84 314 |
Extension of the stock option plan and proposal of coverage through a share buy back program
The Board of Directors has also decided to recommend to the Extraordinary Meeting of Shareholders to be held on June 5, 2000 a statutory decision which would allow Solvay to buy back its own shares. Such decision is recommended in order to cover the stock option plan recently extended to about 300 executives of the Solvay Group worldwide. This share buy back program would involve in average 500 000 Solvay shares on a yearly basis.
Consolidated balance sheet after distribution : key-figures
| (Millions of EUR) | 1998 | 1999 |
| Fixed assets | 4 540 | 5 133 |
| Working capital | 939 | 1 116 |
| Shareholders’ equity
Incl. Minority interests |
3 293
246 |
3 670
253 |
| Net Debt | 565 | 956 |
The Group balance sheet is extremely solid. Net Debt to Equity Ratio went from 17% in 1998 to 26% at the end of 1999, reflecting significant ongoing investments during the last year.
Return on Equity (ROE) for 1999 remained stable at 11.5%.
The external auditor gave an unqualified opinion on the 1999 annual consolidated financial statements and confirmed that the accounting information contained in this release accurately reflects such consolidated financial statements.
Key dates:
| End of March 2000: Annual report on the Internet | |
| June 5, 2000: Annual Shareholders Meeting | |
| July 27, 2000: Announcement of the results for the first half of 2000 |
For further information please contact :
SOLVAY S.A. Headquarters
Corporate Communications and Investor Relations
Tel : 32/2/509.60.16
Fax : 32/2/509.72.40
E-mail : dominique.clerbois@solvay.com
SOLVAY Group : approval by U.S. FDA for AndroGelTM, First Gel to Treat Male Testosterone Deficiency
The Solvay Group today announced that its wholly owned subsidiary, Unimed Pharmaceuticals, Inc. obtained approval by the U.S. Food and Drug Administration (FDA) for AndroGelTM 1% (testosterone gel) (C-III). The approval makes AndroGelTM the first-ever testosterone replacement gel to be approved by the FDA for replacement therapy in men for conditions associated with low testosterone. Low testosterone, also known as hypogonadism, affects approximately four to five million American men. The condition is linked with diminished interest in sex, impotence, reduced lean body mass, decreased bone density and lowered mood and energy levels. AndroGelTM will be available with a prescription in pharmacies throughout the United States by mid-summer.
AndroGelTM is a unique, clear, colorless topical gel which provides an easy, effective, invisible alternative to painful deep muscle injections and potentially irritating patches. AndroGelTM is the only FDA approved testosterone replacement therapy available in gel form. It provides men with a safe and easy-to-use treatment that can be applied at home.
Though the hypogonadism market is limited, this is the first steps for Solvay Pharmaceuticals into the male hormone therapeutic area. Solvay Pharmaceuticals Inc. has already an extensive presence on the women’s health market with Prometrium®, Cenestin®, Estratab® and Estratest®, these last 3 products being jointly promoted with Duramed Pharmaceuticals Inc. This US FDA backing for AndrogelTM clearly confirms the strategic interest of Unimed acquired by Solvay in June 1999.
This approval fosters the Solvay Group strategy to grow faster in pharmaceuticals, in particular in the US. In 1999, excellent growth in pharmaceuticals sales and earnings were recorded worldwide (+16%) and a series of very successful steps were executed, e.g. : acquisition and launch of 2 anti-hypertensives, launch of the first and only SSRI in Japan, doubling of US sales force, etc.. All Solvay therapeutic areas recorded sales growth in 1999, with turnover in women’s health products showing a strong increase of 24%.
Solvay Pharmaceuticals, Inc. of Marietta, Georgia (USA), is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women’s health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium. Solvay employs some 33,000 people in 46 countries. Its 1999 turnover worlwide was 7.9 billion EUR.
For full prescribing information, physicians and patients may visit www.Unimed.com or call 1-877-463-7645
For further information please contact: Dominique Clerbois
Head of Corporate Communications and Investor Relations
SOLVAY S.A. Headquarters
Tel: + 32/2/509.60.16
Fax:+ 32/2/509.72.40
E-mail : dominique.clerbois@solvay.com Karen Carlisle
Director, Government & Public Affairs
Solvay Pharmaceuticals Inc
Tel: 1/770/578-5581
E-mail : karen.carlisle@solvay.com Marissa Weber
Edelman Worldwide
Tel: 1/312/240-2841
E-mail : marissa_weber@edelman.com Shelly Wilt
Edelman Worldwide
Tel: 1/312/240-2839
E-mail : shelly_wilt@edelman.com
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India: Set up of a new company: Solvay Pharma India Ltd.
SOLVAY PHARMACEUTICALS (Netherlands) and Mr D. Vasant Kumar, the two principal promoters of DUPHAR-INTERFRAN Ltd. (DIL), have jointly announced a “Scheme of Arrangement” to restructure the businesses subject to the approvals of the shareholders and of various statutory authorities governing such a transaction. Under the Scheme of Arrangement, the two principal promoters of Duphar-Interfran Ltd. (sales : about EUR 15 million for 1999) propose to split the company in two parts: a pharmaceutical business is to be taken on by SOLVAY PHARMA INDIA Ltd, a new pharmaceutical company, and a chemical business, this latter remaining with Duphar-Interfran Ltd. Every shareholder will receive, free of cost, in addition to shares held in Duphar-Interfran Ltd. two equity shares of Solvay Pharma India Ltd. for every one share held in Duphar-Interfran Ltd.. Both companies will be listed on Stock Exchange in Bombay. Following the split, the two promoters will exchange their respective shareholdings in the two companies. This will result in Solvay holding 60.5% in Solvay Pharma India Ltd. and Mr Vasant Kumar, holding 60.5% in Duphar-Interfran Ltd (whose name will be changed later on). This restructuring of Duphar-Interfran Ltd. into two separate companies enables the two principal promoters to take the lead in developing business strategies for their respective companies: · Solvay Pharma India Ltd. will market pharmaceutical products like Duphaston ® Duvalidan ®, Vertin ®, and Colospa ®. Mr Dick Buisman, future Managing Director of Solvay Pharma’s operations in India says: “We are happy with this restructuring as we can redefine the strategy for our pharmaceutical products and give it a new thrust. Solvay has been involved in DIL for almost three decades. This gives us confidence to take this new step. The majority stake will enable Solvay Pharma India Ltd. to further strengthen our brands, building on the worldwide experience of the global Solvay group to which we belong”. · Mr Vasant Kumar said the “restructuring is in line with Duphar-Interfran Ltd.’s strategy of moving away consciously from a manufacturing company to a marketing enterprise. This move will enable us to consolidate and enhance our core competency in chemicals, enabling us to increase shareholder value. We will also be looking at strategic acquisitions in the IT sector for future growth.” Solvay Pharmaceuticals is a group of pharmaceutical companies which focus on four therapeutic areas: cardiology, psychiatry, gastro-enterology and women’s health. Solvay Pharmaceuticals is member of the SOLVAY GROUP of chemical and pharmaceutical companies based in Brussels (Belgium). Solvay employs about 33,000 people in 46 countries. Its 1998 turnover worldwide was EUR 7.5 billion from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals. For further information, please contact:
SOLVAY S.A. Headquarters
Dominique Clerbois
Head of Corporate Communications and Investor Relations
Tel: + 32 2 509.60.16
Fax:+ 32 2 509.72.40 E-mail : DUPHAR-INTERFRAN Mr D. Vasant Kumar
Fax : 0091 22 836 4713
E-mail:Vasant@dil.net SOLVAY PHARMA INDIA Ltd. Dick Buisman
E-mail: dick.buisman@dil.net
DURAMED PHARMACEUTICALS COMPLETES STOCK SALE TO SOLVAY PHARMACEUTICALS
Transaction Completes Solvay Pharmaceuticals 3 Million Share Purchase
CINCINNATI, December 30, 1999 — Duramed Pharmaceuticals, Inc.
(Nasdaq: DRMD) today announced that Solvay Pharmaceuticals, Inc. has completed its planned purchase of an additional 1,333,334 shares of Duramed common stock at $9.00 per share. The purchase, completed under the option granted October 6, 1999, brings Solvay Pharmaceuticals’ total position in Duramed to 3 million shares, or 11.5 percent of the total 26,129,422 shares outstanding. In conjunction with the sale, Duramed has agreed to create an additional director position on Duramed’s board of directors to be designated by Solvay Pharmaceuticals no later than at the time of the Annual Shareholders’ Meeting 2000. Duramed was advised by Banc of America Securities LLC on the agreements, including the stock purchase transactions, between Solvay Pharmaceuticals and Duramed.
Duramed Chairman and Chief Executive Officer E. Thomas Arington, commented, “Solvay Pharmaceuticals’ substantial ownership position is a measure of the strong working relationship between our two companies. Our alliance has already meant more expansive, more visible market coverage for both Duramed and Solvay Pharmaceuticals women’s health products.”
On October 6, 1999, Duramed and Solvay Pharmaceuticals announced an alliance to jointly promote three of the companies’ hormone products in the United States: Duramed Pharmaceuticals’ CENESTIN® (synthetic conjugated estrogens, A) Tablets and Solvay Pharmaceuticals’ ESTRATEST®/ESTRATEST® H.S. Tablets1 (esterified estrogens and methyltestosterone) and PROMETRIUM® (progesterone) Capsules2.
Solvay Pharmaceuticals President and Chief Executive Officer David A. Dodd, said, “Our investment in Duramed goes hand in hand with the value of the alliance in enhancing our franchise in women’s health, increasing the value of our efforts in the obstetric and gynecological offices and further demonstrating our strong commitment to the U.S. women’s healthcare market. Duramed Pharmaceuticals is an excellent strategic partner due to its demonstrated success in bringing new products to the market and its shared commitment to women’s health care, as evidenced by its investment in developing hormone products and technology.”
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., based in Marietta, Ga., is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women’s health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium. The Group’s members employ some 33,000 people in 46 countries. Its 1998 revenue worldwide was 7.5 billion EUR ($8.7 billion) from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals. Additional information about the Group can be found on the World Wide Web at http://www.solvay.com .
About Duramed Pharmaceuticals, Inc.
Duramed Pharmaceuticals, Inc. develops, manufactures and markets prescription drug products. The company’s business strategy emphasizes products with attractive market opportunities and potentially limited competition due to technological barriers to entry, focusing on women’s health and the hormone replacement therapy market.
On March 24, 1999, the U.S. Food and Drug Administration (FDA) approved Duramed’s first branded product, CENESTIN® (synthetic conjugated estrogens, A) Tablets, for the treatment of moderate-to-severe vasomotor symptoms. The company is undertaking a clinical program to evaluate CENESTIN in additional tablet strengths and for the prevention of osteoporosis. One important element of these clinical trials – the bone marker study — is complete. Preliminary results are favorable and clearly show a reduction in bone markers, which indicates a bone preservation effect. The company anticipates beginning the full osteoporosis clinical study in 2000 to confirm the beneficial results indicated by the bone marker study.
The company’s stock is traded on Nasdaq using the symbol DRMD. Additional information about the company can be found on the World Wide Web at http://www.duramed.com and http://www.cenestin.com .
1. Estratest is a trademark of Solvay Pharmaceuticals.
2. Prometrium is a trademark of Solvay Pharmaceuticals.
Like all estrogen drug products, CENESTIN®, and ESTRATEST®/ESTRATEST® H.S. Brand Tablets should not be used in women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women with an intact uterus. The most common adverse events reported in clinical experience with CENESTIN included headache, insomnia, asthenia, nervousness, paresthesia, and depression. The most common adverse events reported with ESTRATEST®/ESTRATEST® H.S. Brand Tablets include those typical of estrogen therapy (such as breast tenderness, headache, nausea, edema and abdominal pain) and of androgen treatment (including hair loss, acne and hirsutism). Common side effects of PROMETRIUM® Capsules are breast tenderness, dizziness, abdominal bloating, and vaginal discharge. For additional information on CENESTIN®, ESTRATEST® Brand Tablets or PROMETRIUM® Capsules, please see full prescribing information.
The Securities and Exchange Commission (SEC) encourages companies to disclose forward-looking information so that investors can better understand a company’s future prospects and make informed investment decisions. Due to changing market conditions, product competition, the nature of product development and regulatory approval processes, the achievement of forward-looking statements contained in this press release are subject to risks and uncertainties. For further details and a discussion of these risks and uncertainties, see Duramed’s SEC filings, including its annual report on Form 1O-K/A.
NEW ANTIHYPERTENSIVE MEDICATION SURVEY REVEALS THAT NEARLY 19 MILLION HYPERTENSIVE PATIENTS MAY HAVE SIGNIFICANT DRUG-TOLERABILITY PROBLEMS
Study Also Shows That One-Third of Hypertensives Have Uncontrolled, Elevated Systolic Blood Pressure
ATLANTA, Nov. 9, 1999 – Today, a national antihypertensive medication survey released in a symposium sponsored by the Association of Black Cardiologists, Inc. (ABC), revealed that nearly four out of every 10 patients (38 percent) being treated for high blood pressure may stop taking their medication due to drug tolerability problems. The survey also found that 95 percent of patients believe that their blood pressure is under control, yet 35 percent of these patients reported elevated or uncontrolled systolic blood pressure above 140 mm Hg, suggesting that elevated systolic blood pressure — the leading cause of cardiovascular morbidity and mortality — is misunderstood among patients.
“This survey highlights the extent of the tolerability problem in hypertension, which is widespread among all patient populations, and underscores the need for the medical community to continue searching for pharmacological alternatives,” says Dr. Frank James, President of the Association of Black Cardiologists, Inc. “Surprisingly, the survey also presents some new challenges in treating high blood pressure, because the findings show that elevated systolic blood pressure is not being controlled to the recommended levels.”
The survey, released by ABC, demonstrates that among patients being treated for hypertension, 36 percent have changed medications at least once because of the severity of side effects. Also, 13 percent of respondents stated that their current medication dosage had to be adjusted, at least once, because of adverse events. The most commonly reported side effects were fatigue (22%), and dizziness (21%). African American respondents were significantly more likely to experience the side effects of headache, potassium loss and weakness compared to Caucasian respondents.
The survey also finds that younger patients (ages 25-54) are significantly more likely than their older counterparts (age 55 and up) to characterize side effects as having a significant impact on their life.
The ABC survey confirms recent trends from the Third National Health and Nutrition Examination Survey (NHANES-III) that demonstrate a downward trend in hypertension awareness, treatment, and control among patients. Phase 2 of the NHANES (1991-1994) revealed that among high blood pressure patients, there is a decrease in awareness of hypertension (68 percent in 1994 vs. 73 percent in 1991). Similarly, treatment rates have declined from 65 percent in 1991 to 54 percent in 1994 and high blood pressure control (achieving target measurements within the normal range) has declined from 29 percent in 1991 to 27 percent in 1994.
Isolated Systolic Hypertension on The Rise
The survey reports that on average, 30 percent of patients have been diagnosed with isolated systolic hypertension (ISH), per physician practice. ISH — a condition that exists when the systolic pressure is higher than 140 mm Hg with a diastolic pressure that is less than 90 mm Hg — is the most common form of high blood pressure in older Americans. ISH affects more than three million people over the age of 60.
More than half of physicians surveyed (52.5 percent) believe that controlling systolic pressure is the most important goal in treating elderly hypertensives. Conversely, nearly 20 percent believe that diastolic control is the most important goal of therapy.
The ABC survey also found that 44 percent of African Americans vs. 31 percent of Caucasians reported systolic readings > 140 mm Hg. Similarly nearly 40 percent of the diabetic patient population reported a reading above 140 mm Hg.
“Systolic blood pressure is a major predictor of cardiovascular diseases and this survey underscores the need to do a better job at controlling systolic blood pressure in key patient groups,” says Dr. Domenic Sica, chairman of Clinical Pharmacology and Hypertension at the Medical College of Virginia of Virginia Commonwealth University. “Clearly, these new results also indicate a greater need to educate patients on what constitutes elevated hypertension, including systolic blood pressure.”
A study conducted in 1991, called the Systolic Hypertension in the Elderly Program (SHEP), reported a significant reduction in stroke and coronary events with successful lowering of systolic blood pressure to below 140 mm Hg through drug therapy. SHEP proved that ISH is not a normal part of the aging process, but a strong indicator of increased cardiovascular risk.
Tolerability Problems Include Drug-Drug Interactions
The physician component of the survey also confirmed that the tolerability problem extends beyond side effects. Seventy-five percent of treating physicians reported that drug-drug interactions are a common problem with their patients. Conversely, 88 percent of respondents in the patient arm of the study stated that they had little drug-drug interaction problems.
“Physicians are very concerned about drug-drug interactions, while patients are generally not aware of the significant problems that concomitant drug regimens can create,” added Dr. James. “The ABC survey reinforces that the tolerability problem extends beyond common side effects or adverse reactions in the hypertensive patient.”
In addition to their hypertension treatments, the research revealed that most hypertensive patients take 2 or more additional medications. Forty-six percent take 2-3 other medications while 36 percent take 3-5 other medications. Because of this drug-drug prevalence, 95 percent of physicians reported that the method of elimination is an important consideration in their selection of anti-hypertensive medication. Most drugs are either eliminated through the liver or
the kidney. Those that have a dual elimination process are often preferred because they lower the likelihood of toxicity if one or the other organ is functionally impaired.
Rating Antihypertensive Medications
Combination therapy is the most common treatment regimen. Physicians who were surveyed indicated that, on average, 39 percent of their patients receive combination therapy. The most commonly prescribed class of medication is the ACE inhibitors (prescribed to 31 percent of patients). ARBs are the least commonly prescribed treatment class (prescribed to 11 percent of patients). However, cardiologists are more likely to prescribe ARBs than general practitioners (14% vs. 9% respectively).
Most physicians surveyed reported having to switch a patient’s medication at least once to address efficacy. According to the survey, diuretics (46.5 percent) are the most likely to be changed because of efficacy problems, followed by beta blockers (21.8 percent), calcium channel blockers (15.8 percent), ACE inhibitors (9.9 percent) and ARBs (5.9 percent).
Interestingly, almost one quarter of the physicians believe that ARBs are the most likely medication to be stopped because of adverse events or side effects. However, these same physicians reported the fewest efficacy problems and lowest level of drug interactions with ARBs.
According to Dr. Sica this is not necessarily a contradiction. “ARBs are a relatively new classification of hypertensive drugs,” says Sica. “Many physicians have not used them long enough to understand them. If an adverse event occurs when patients are being treated with a new drug, physicians will likely assume it is caused by the new treatment even if the reaction is unrelated. However, numerous clinical studies have showed us that ARBs have a tolerability profile similar to or better than placebo; therefore, it is necessary to translate this knowledge into clinical practice.”
Physicians also indicated the percentage of patients in their practice that experience the most common and specific side effect in conjunction in each drug class :
– Of patients treated with beta-blockers, the average percentage of patients having fatigue as a side effect is 34 percent.
– Of patients treated with diuretics, the average percentage of patients experiencing electrolyte imbalance as a side effect is 30 percent.
– Of patients treated with calcium channel blockers, the average percentage of patients having edema as a side effect is 26 percent.
– Of patients treated with ACE inhibitors, the average percentage of patients having cough as a side effect is 21 percent.
– Of patients treated with ARBs, the average percentage of patients having cramping as a side effect is 7 percent.
The Study
The study was comprised of two audiences, patients and physicians, and utilized two key research methods, qualitative and quantitative, with each audience. The patient research consisted of a small-scale, telephone-based, qualitative study with 20 clinically diagnosed, hypertensive patients. Findings from the qualitative research were used to design a more in-depth telephone questionnaire. Three hundred fourteen (314) patients completed the telephone questionnaire. The survey gathered information from 314 patients for a margin of error on the overall findings of +/- 5.5 percent at the 95 percent confidence interval.
The physician audience primarily consisted of primary care physicians and cardiologists. Again, a two-phase research approach was utilized. The qualitative research consisted of 12 telephone interviews with physicians. Following the completion of the qualitative research, a structured questionnaire was conducted among 101 physicians representing five physician groups (cardiology, internal medicine, family/general practice, nephrology and geriatrics).
The study was funded by a grant from Unimed Pharmaceuticals, a Solvay Pharmaceuticals, Inc. company. The study was conducted by the independent research firm, Berrier & Associates, in October, 1999.
The Association of Black Cardiologists is a not-for-profit 501(c) 3 volunteer organization of more than 600 African-American cardiologists and medical professionals that is fully accredited by the Accreditation Council for Continuing Medical Education (ACCME). ABC was founded by Dr. Richard Allen Williams and sixteen other cardiologists in 1974. ABC emerged out of a need for health providers, particularly those who provide cardiovascular care to African-Americans, to coalesce as a group to promote primary prevention, quality of life and culturally sensitive clinical management of cardiovascular diseases. According to Dr. Williams, “The Association of Black Cardiologists was created because children deserve to know their grandparents.”
For information, contact:
Jennifer Saltz
Principal PR
(404) 898-1729
Lynda Woodworth
Principal PR
(212) 537-8078
SOLVAY PHARMACEUTICALS EXERCISES OPTION TO PURCHASE DURAMED PHARMACEUTICALS COMMON STOCK
CINCINNATI, October 19, 1999 — Duramed Pharmaceuticals, Inc. (Nasdaq:DRMD) today announced that it has been notified that Solvay Pharmaceuticals, Inc. is exercising the option granted October 6, 1999, and intends to purchase the maximum number of 3,000000 shares of Duramed common stock at $9.00 per share made available under the option, subject to certain conditions. On or before October 22, 1999, Solvay Pharmaceuticals will purchase 1,666,666 shares of Duramed common stock. Duramed expects to satisfy the conditions of that purchase.
Purchase of the remaining 1,333,334 shares available under the option is subject to additional conditions, including: satisfactory completion of all applicable regulatory requirements, including Hart-Scott-Rodino antitrust review; the future creation of an additional director position on Duramed’s board of directors to be designated by Solvay Pharmaceuticals; and, final approval by the Solvay America, Inc. board of directors.
The sale of 1,666,666 shares of newly issued stock will increase Duramed’s total fully diluted shares outstanding to approximately 29 million. The closing market price of Duramed common stock on October 18, 1999 was $8 11/16 per share.
Duramed Pharmaceuticals and Solvay Pharmaceuticals In Product Promotion Alliance
On October 6, 1999, the companies announced an alliance to jointly promote three of the companies’ hormone products in the United States: Duramed Pharmaceuticals’ CENESTIN® (synthetic conjugated estrogens, A) Tablets and Solvay Pharmaceuticals’ ESTRATEST®/ESTRATEST® H.S. Tablets (esterified estrogens and methyltestosterone) and PROMETRIUM® (progesterone) Capsules.
On October 11, 1999, a combined national sales force of more than 300 Duramed Pharmaceuticals and Solvay Pharmaceuticals sales representatives began promoting the alliance products to obstetricians and gynecologists across the United States. Solvay Pharmaceuticals’ resources also include teams of regional marketing managers, field trainers, medical liaison teams and a medical advisory committee comprised of leading women’s health physicians.
CENESTIN is designated as the primary product in the Duramed/Solvay Pharmaceuticals alliance while the Solvay Pharmaceuticals products will address additional important therapeutic requirements in women’s health. All three products are expected to benefit from the broadened exposure in the marketplace. Under the terms of the alliance, Duramed Pharmaceuticals, Inc. and Solvay Pharmaceuticals, Inc. will retain all revenue from their respective products.
CENESTIN® was approved by the U.S. Food and Drug Administration (FDA) in March 1999. CENESTIN offers millions of women and their physicians a new, appealing plant-derived synthetic conjugated estrogens product with a slow-release formulation. Solvay Pharmaceuticals is a leader in the women’s health market. Its products, ESTRATEST®/ESTRATEST® H.S. Brand Tablets and PROMETRIUM® Capsules will complement CENESTIN in the pharmaceutical sales effort.
About Solvay Pharmaceuticals, Inc. Solvay Pharmaceuticals, Inc., based in Marietta, Ga., is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women’s health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium. The Group’s members employ some 33,000 people in 46 countries. Its 1998 revenue worldwide was 7.5 billion EUR ($8.7 billion) from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals. Additional information about the Group can be found on the World Wide Web at http://www.solvay.com
About Duramed Pharmaceuticals, Inc. Duramed Pharmaceuticals develops, manufactures and markets prescription drug products. The company’s business strategy emphasizes products with attractive market opportunities and potentially limited competition due to technological barriers to entry, focusing on women’s health and the hormone replacement therapy market.
On March 24, 1999, the U.S. Food and Drug Administration (FDA) approved the company’s first branded product, CenestinÒ (synthetic conjugated estrogens, A) Tablets, for the treatment of moderate-to-severe vasomotor symptoms. The company is undertaking a clinical program to evaluate Cenestin in additional tablet strengths and for the prevention of osteoporosis. One important element of these clinical trials – the bone marker study — is complete. Preliminary results are favorable and clearly show a reduction in bone markers, which indicates a bone preservation effect. In addition, in the cardiovascular evaluation, a positive lipid profile was found. The company anticipates beginning the full osteoporosis clinical study in 2000 to confirm the beneficial results indicated by the bone marker study. Further, Duramed anticipates receiving approval for the 1.25 mg tablet strength of Cenestin by December 1999 and approval for the 0.3 mg tablet strength in mid-2000.
The company’s stock is traded on Nasdaq using the symbol DRMD. Additional information about the company can be found on the World Wide Web at www.duramed.com.
###
Like all estrogen drug products, CENESTIN®, and ESTRATEST®/ESTRATEST® H.S. Brand Tablets should not be used in women with known or suspected pregnancy, breast cancer, or estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, or thromboembolic disorders. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women with an intact uterus. The most common adverse events reported in clinical experience with CENESTIN included headache, insomnia, asthenia, nervousness, paresthesia, and depression. The most common adverse events reported with ESTRATEST®/ESTRATEST® H.S. Brand Tablets include those typical of estrogen therapy (such as breast tenderness, headache, nausea, edema and abdominal pain) and of androgen treatment (including hair loss, acne and hirsutism). Common side effects of PROMETRIUM® Capsules are breast tenderness, dizziness, abdominal bloating, and vaginal discharge. For additional information on CENESTIN®, ESTRATEST® Brand Tablets or PROMETRIUM® Capsules, please see full prescribing information.
The Securities and Exchange Commission (SEC) encourages companies to disclose forward-looking information so that investors can better understand a company’s future prospects and make informed investment decisions. Due to changing market conditions, product competition, the nature of product development and regulatory approval processes, the achievement of forward-looking statements contained in this press release are subject to risks and uncertainties. For further details and a discussion of these risks and uncertainties, see Duramed’s SEC filings, including its annual report on Form 1O-K/A. Back to top
ANTIHYPERTENSIVE TEVETEN® (EPROSARTAN MESYLATE) TABLETS IS NOW AVAILABLE IN THE U.S.
(October 18, 1999, Chicago, IL) Unimed Pharmaceuticals Inc., a Solvay Pharmaceuticals, Inc. company, announced today that TEVETEN® Tablets is now available in U.S. pharmacies for the treatment of hypertension in all levels of severity. TEVETEN® is the latest member of the newest class of antihypertensive drugs – angiotensin II receptor blockers (ARBs). TEVETEN® is an efficacious and well-tolerated antihypertensive medication providing effective 24-hour control of high blood pressure with once-daily dosing, regardless of patient age or gender.1 TEVETEN® has been available in Germany, Ireland, Denmark, Finland, Sweden, The Netherlands and Portugal and was evaluated in more than 3,300 patients and healthy volunteers in worldwide clinical trials.2
“TEVETEN® promises to be an effective treatment for all levels of severity for a wide range of patients, including the elderly, patients with diabetes, patients with renal impairment, and African American patients,” says Dr. Domenic Sica, Medical College of Virginia of Virginia Commonwealth University.
In May of 1999, Solvay S.A. acquired the worldwide rights to market, manufacture and further develop TEVETEN® from SmithKline Beecham. Chicago-based, Unimed Pharmaceuticals, Inc., a wholly-owned subsidiary of Solvay Pharmaceuticals Inc., will market and further develop TEVETEN® in the United States. Unimed Pharmaceuticals will provide competitive resources and the appropriate detailing capacity to successfully compete in the antihypertensive market and fully leverage the excellent profile of TEVETEN®.
“TEVETEN® is an important addition to Unimed’s portfolio. We expect TEVETEN® to become one of the leading ARBs and antihypertensive medications in the U.S.,” says Robert Dudley, CEO, Unimed Pharmaceuticals. “Our resources have been allocated to make this a successful market roll-out for both the patients and prescribing physicians.”
Clinical Efficacy and Tolerability of TEVETEN®
Extensive studies have demonstrated TEVETEN®’s efficacy and tolerability profile. In summary:
•TEVETEN® produced favorable decreases in, both, sitting diastolic blood pressure and systolic blood pressure, with greater response than enalapril, the leading angiotensin-converting enzyme inhibitor, in patients with mild to moderate hypertension.3 •TEVETEN® clinical trials have demonstrated a side effect profile similar to placebo and is not generally associated with the dry cough commonly associated with ACE inhibitors.4 •TEVETEN® may be used in combination with selected antihypertensive drugs.5,6 •TEVETEN® is not metabolized by the cytochrome P450 isoenzyme system; therefore, the potential for drug-drug interactions with agents metabolized via this enzyme system is significantly reduced. 8 •TEVETEN® is effective and well-tolerated in elderly patients.9 •TEVETEN® requires no initial dosing adjustment for elderly or hepatic-impaired patients or those with renal impairment. 10
The recommended starting dose of TEVETEN® is 600 mg daily, which may be increased up to 800 mg daily depending upon the patient’s blood pressure response.11
TEVETEN® related adverse events were of mild or moderate severity. The overall incidence of adverse experiences and the incidences of specific adverse events reported with TEVETEN® were similar to placebo and were similar in patients regardless of age, gender, or race.
TEVETEN®, like other drugs that act directly on the renin-angiotensin system, can cause injury and even death to the developing fetus when it is used during the second and third trimesters of pregnancy. When pregnancy is detected, TEVETEN® should be discontinued as soon as possible.12
In May 1999, the FDA approved TEVETEN® for once-daily dosing. TEVETEN® was developed using state-of-the-art methodology and is currently indicated for the treatment of hypertension in all levels of severity. A fixed combination of TEVETEN® with a diuretic is also in late stage development.
Unimed Pharmaceuticals, a wholly-owned subsidiary of Solvay Pharmaceuticals, Inc., focuses on drugs with multiple indications in the therapeutic areas of hypertension, endocrinology, urology, HIV and other infectious diseases. Unimed Pharmaceuticals is home to more than 70 employees with expertise in ethical drug development, marketing and sales.
Solvay Pharmaceuticals, Inc. of Marietta, GA, is a research-based pharmaceutical company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women’s health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.
Lynda Woodworth
Principal PR
+1 212-537-8181
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1. Weber M. Clinical efficacy of eprosartan. Pharmacotherapy 1999;19(4 Pt 2):95S-101S
2. Unimed data on-file
3. Gavras I, Gavras H. “Effects of eprosartan versus enalapril in hypertensive patients on the renin-angiotensin-aldosterone system and safety parameters: results from a 26-week, double-blind, multicentre study. Eprosartan Multinational Study Group. Curr Med Res Opin 1999; 15(1):15-24.
4. Hedner T, Himmelmann A, for the Eprosartan Multinational Study Group. The efficacy and tolerance of one and two daily doses of eprosartan in essential hypertension. J Hypertens 1999;17(1):129-136.
5. Study RSD-100WH3/1 (050). A long-term (two-year), open-label, multicenter study of once daily oral SK&F 108566-J (Eprosartan Mesylate) in patients with essential hypertension.
6. Study RSD-100VP/1 (052). A long-term, open-label, multicenter, multi-country extension study of once daily oral SK&F 108566 (Eprosartan) in patients with essential hypertension who have completed a clinical trial with eprosartan.
7. Ilson B, Kazierad DJ, Freed M. Overview of the clinical pharmacology of eprosartan, a novel angiotensin II receptor antagonist. Poster presented at American Society of Hypertension Thirteenth Scientific Meeting, New York, New York. May 13-16, 1998. Am J Hypertension 1998; 11(4pt 2): 108A, E050 abstract.
8. Ilson B. Drug interaction studies with eprosartan, a novel angiotensin II receptor antagonist. Poster presented at American Society of Hypertension Thirteenth Scientific Meeting, New York, New York. May 13-16, 1998. American Journal of Hypertension 1998; 11(4pt 2):108A, E051 abstract.
9. Argenziano L, Fratta L, et al. Effect of eprosartan and enalapril in the treatment of elderly hypertensive patients: Subgroup analysis of a 26-week, double-blind, multicentre study. Curr Med Res Opin 1999; 15(1):9-14.
10. TEVETEN Product Insert on File
11. Gradman AH, Gray J, et al. Assessment of once-daily eprosartan an angiotensin II antagonist, in patients with systemic hypertension. Eprosartan Study Group. Clin Ther 1999 Mar; 21(3):442-53.
12. TEVETEN Product Insert on File
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SOLVAY PHARMACEUTICALS, INC. INTRODUCES
ACEON® (perindopril erbumine) TABLETS TO U.S. MARKET
One Tablet, 24-Hour Control of Hypertension
Marietta, GA, Oct. 6, 1999 – ACEON® (pronounced ace-e-on) Tablets, a once-daily medication for the treatment of essential hypertension, is now available in the United States, Solvay Pharmaceuticals, Inc., announced today.
An important addition to the antihypertensive armamentarium in the United States, perindopril already is a leading antihypertensive therapy in Europe.1 It was first marketed in France ten years ago as Coversyl®, and will be launched in the United States as ACEON® Tablets. Based on extensive clinical experience, ACEON® Tablets has been shown to be effective and well-tolerated.
In clinical studies in more than 3400 hypertensive patients, perindopril was proven to provide continuous 24-hour blood pressure control throughout the entire dosing interval with a single daily dose. In a pivotal clinical study, perindopril demonstrated approximately equivalent blood pressure reduction at 6 and 24 hours after administration. (2)
According to the Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNCVI), therapies that provide continuous 24-hour efficacy with a single daily dose are the optimal treatment choice. Twenty-four hour coverage offers protection against sudden increases of blood pressure after waking from overnight sleep.(3)
“We all experience normal increases and decreases in blood pressure throughout the day,” says Michael Weber, MD, chairman, department of medicine, The Brookdale University Hospital and Medical Center, and investigator for perindopril. “For example, when we wake from sleep each morning, most people experience a sudden rise in blood pressure. For the hypertensive patient, this could be a concern if their medication doesn’t provide full 24-hour coverage.
“Now with perindopril (ACEON® Tablets), we have another well-tolerated treatment option that provides the continuous 24-hour blood pressure effect needed to protect patients during those early morning hours, ” continues Dr. Weber.
Hypertension in the United States
As many as 50 million Americans have hypertension, according to the American Heart Association. Blood pressure is the result of two forces. One is created by the heart as it pushes blood into the arteries and through the circulatory system; the other is the force of the arteries as they resist blood flow. Elevated blood pressure indicates that the heart is working harder than normal, putting it and the arteries under a greater strain.(4)
Healthy arteries have an elastic quality that allows them to expand and contract in response to the pressure of the blood as it is pushed from the heart through the arteries. The risk of hypertension increases as elasticity decreases due to age and other risk factors. (5)
ACEON® Tablets is the first antihypertensive therapy in its class with product labeling describing an increase in compliance (elasticity) of large arteries in patients, consistent with the results of animal studies. This suggests a direct effect on the arterial smooth (elastic) muscle, which plays a major role in regulating blood pressure. (2) This is a new and evolving area of research that is attracting a great deal of interest from researchers and clinicians.
“Even with the many effective antihypertensive therapies available in the U.S., we have not reduced the incidence of cardiovascular disease as much as we should have,” explains Joel Neutel, M.D., chief of the division of clinical pharmacology and hypertension at the Veterans Affairs Medical Center, Long Beach, CA. “Since no two patients with high blood pressure are alike, the more safe and efficacious therapies that we have to treat this disease, the more effective we can be in controlling hypertension in the individual patient.”
ACEON® (perindopril erbumine) Tablets is a member of the class of drugs called angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors act to reduce blood pressure by interfering with the conversion of angiotensin I to the artery-constricting angiotension II. Blocking the production of angiotensin II results in arterial vasodilation and an accompanying reduction in blood pressure.6 As a therapeutic category, ACE inhibitors account for 37.5 percent of the total antihypertension prescriptions in the U.S.(7)
Marketing and Availability
Recognizing the U.S. potential for such a widely used and established antihypertensive, Solvay Pharmaceuticals has now licensed ACEON® Tablets and will market it nationwide. The introduction of ACEON® Tablets marks Solvay Pharmaceuticals’ entry into the U.S. cardiovascular market. Perindopril was approved by the U.S. Food and Drug Administration in December 1993, and is currently available in 113 countries. (1)
“We are pleased to enter the U.S. cardiovascular market with such a promising hypertension therapy that has been used so successfully in other countries,” said David A. Dodd, President and CEO of Solvay Pharmaceuticals, Inc. “This new antihypertensive therapy is the first of several cardiovascular products that Solvay Pharmaceuticals will bring to the U.S. market.”
Dosage and Administration
In patients with essential hypertension including the elderly, the recommended initial dose of ACEON® (perindopril erbumine) Tablets is 4 mg once a day. The usual maintenance dose range is 4 to 8 mg, administered as a single daily dose. In hypertensive patients with minimally impaired kidney function, the initial dose should be 2mg per day and increased up to 8 mg per day until blood pressure control is achieved. ACEON® Tablets may also be administered in two divided doses.(2)
In patients with congestive heart failure, with or without associated renal insufficiency, ACE inhibitors may cause excessive hypotension, and may be associated with ologuria or azotemia, and rarely with acute renal failure and death. In patients with ischemic heart disease or cerebrovascular disease, such an excessive fall in blood pressure could result in a myocardial infarction or a cerebrovascular accident. (2)
Common Side Effects and Other Important Information
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected ACEON® Tablets should be discontinued as soon as possible. See the package insert for WARNINGS: Fetal/Neonatal Morbidity and Mortality. (2)
ACEON® Tablets is contraindicated in patients known to be hypersensitive to this product or to any other ACE inhibitor, as well as those with a history of angioedema related to previous treatment with an ACE inhibitor. (2)
In clinical trials, cough was the most frequent adverse event possibly or probably related to treatment occurring in 6% of patients treated with ACEON® (perindopril erbumine) Tablets compared to 1.8% in patients receiving placebo. Other commonly reported side effects included: proteinuria, palpitation, sinusitis, viral infections, dyspepsia, fever, upper extremity pain, and hypertonia. (2)
Like other ACE inhibitors, ACEON® Tablets can cause symptomatic hypotension. ACEON® Tablets has been associated with hypotension in 0.3 % of uncomplicated hypertensive patients in the U.S. placebo-controlled trials. Symptomatic hypotension associated with the use of ACE inhibitors is more likely to occur in patients who have been volume and/or salt-depleted, therefore, these conditions should be corrected before initiating therapy with ACEON® Tablets. (2)
Adjusted doses of ACEON® Tablets may be used safely in hypertensive patients with minimal renal impairment, type 1 diabetes mellitus, and congestive heart failure. In controlled trials, ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks. Also, black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to nonblacks. (2)
Another ACE inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients but more frequently in patients with renal impairment, especially patients with a collagen vascular disease such as lupus erythematosus or scleroderma. Available data are insufficient to show whether ACEON® Tablets cause agranulocytosis at similar rates. (2)
Solvay Pharmaceuticals, Inc., of Marietta, Ga., is a research-based pharmaceutical company, active in the therapeutic areas of cardiology, women’s health, gastroenterology and mental health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.
Please see accompanying package insert for other important safety and prescribing information.
References
1. Data on file, Solvay Pharmaceuticals, Inc.
2. Solvay Pharmaceuticals, Inc. ACEON® Tablets. Product labeling information. Rev. April 1999.
3. National Institutes of Health. The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. NIH Publication No. 98-4080. November 1997; 23.
4. American Heart Association. Blood Pressure.
(http://www/americanheart.org/Heart_and_Stroke_A_Z_Guide/bp.html).
(http://www/americanheart.org/Heart_and_Stroke_A_Z_Guide/hbps.html). (http://www/americanheart.org/Heart_and_Stroke_A_Z_Guide/hbp.html).
5. Van Bortel LM, et al. Disparate Effects of Antihypertensive Drugs on Large Artery Distensibility and Compliance in Hypertension. The American Journal of Cardiology 1995; 46E.
6. The Bantam Medical Dictionary (second revised edition). Bantam Books. New York. 1994; 3.
7. Scott Levin data, 1999.
DURAMED PHARMACEUTICALS AND SOLVAY PHARMACEUTICALS ANNOUNCE ALLIANCE IN THE USA
CINCINNATI, OH and MARIETTA, GA (October 6, 1999) — Duramed Pharmaceuticals, Inc. (Nasdaq:DRMD) and Solvay Pharmaceuticals, Inc. today announced an alliance to jointly promote in the US three of the companies’ hormone products: Duramed Pharmaceuticals’ CENESTIN(tm) (synthetic conjugated estrogens, A) Tablets and Solvay Pharmaceuticals’ ESTRATEST®/ESTRATEST® H.S. Tablets (esterified estrogens and methyltestosterone) and PROMETRIUM® (progesterone) Capsules.
Promotion Efforts Planned for October
A combined national sales force of more than 300 Duramed Pharmaceuticals and Solvay Pharmaceuticals sales representatives will begin Oct. 11, 1999 to promote the alliance products to obstetricians and gynecologists across the United States. Solvay Pharmaceuticals’ resources also include teams of regional marketing managers, field trainers, medical liaison teams and a medical advisory committee comprised of leading women’s health physicians.
“This alliance means more expansive, more visible market coverage for both Duramed and Solvay Pharmaceuticals women’s health products, starting with Duramed Pharmaceuticals’ CENESTIN(tm),” said Duramed Pharmaceuticals Chairman and Chief Executive Officer E. Thomas Arington. He added, “We have been extremely pleased with the physician/patient response to CENESTIN(tm) since our marketing efforts began in mid-summer. We believe, however, that Solvay Pharmaceuticals’ demonstrated strength in this marketplace makes it a perfect ally for Duramed Pharmaceuticals.”
CENESTIN(tm) is designated as the primary product in the Duramed/Solvay Pharmaceuticals alliance while the Solvay Pharmaceuticals products will address additional important therapeutic requirements in women’s health. All three products are expected to benefit from the broadened exposure in the marketplace. Under the terms of the co-promotion alliance, Duramed Pharmaceuticals, Inc. and Solvay Pharmaceuticals, Inc. will retain all revenue from their respective products.
David A. Dodd, President and Chief Executive Officer, Solvay Pharmaceuticals, said, “We see this alliance enhancing our franchise in women’s health, increasing the value of our efforts in the obstetric and gynecological offices and further demonstrating our strong commitment to the U.S. women’s healthcare market. Duramed Pharmaceuticals is an excellent strategic partner due to its demonstrated success in bringing new products to the market and its shared commitment to women’s health care, as evidenced by its investment in developing hormone products and technology.”
CENESTIN(tm) was approved by the U.S. Food and Drug Administration (FDA) in March 1999. CENESTIN offers millions of women and their physicians a new, appealing plant-derived synthetic conjugated estrogens product with a slow-release formulation. Solvay Pharmaceuticals is a leader in the women’s health market. Its products, ESTRATEST® Brand Tablets and PROMETRIUM® Capsules will complement CENESTIN(tm) in the pharmaceutical sales effort.
Solvay Pharmaceuticals Granted Equity Option in Duram ed
Duramed has given Solvay Pharmaceuticals an option to purchase a minimum of 1,666,666 shares and a maximum of 3,000000 shares of common stock of Duramed at a price of $9.00 per share. The closing price of Duramed common stock on October 5, 1999 was $7 1/16 per share. If completed, the sale of the minimum number of 1,666,666 shares will be closed by the end of October. The sale of any additional shares is expected to be closed by the end of the year.
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., based in Marietta, Ga., is a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women’s health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium. The Group’s members employ some 33,000 people in 46 countries. Its 1998 revenue worldwide was 7.5 billion EUR ($8.7 billion) from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals.
About Duramed Pharmaceuticals, Inc.
Duramed Pharmaceuticals, Inc. develops, manufactures and markets prescription drug products. The company’s business strategy emphasizes products with attractive market opportunities and potentially limited competition due to technological barriers to entry, focusing on women’s health and the hormone replacement therapy market.
The company’s stock is traded on Nasdaq using the symbol DRMD. Additional information about the company can be found on the World Wide Web at http://www.duramed.com.
SOLVAY S.A. Headquarters
Mrs Dominique Clerbois
Head of Corporate Communications and Investor Relations
Tel : 32/2/509.60.16
Fax : 32/2/509.72.40
E-mail : dominique.clerbois@solvay.com
SOLVAY PHARMACEUTICALS, INC.
Karen Carlisle
Tel: (770) 578-5581
E.mail: karen.carlisle@solvay.com
DURAMED PHARMACEUTICALS, INC.
Investor relations:
(513) 731-9900
DURAMED PHARMACEUTICALS, INC.
MEDIA INQUIRIES
Ellen Knight or Ursula Miller
Dan Pinger Public Relations Inc.
(513) 564-0700
PRESTIGIOUS SOLVAY PHARMACEUTICALS MENOPAUSE PRIZE GOES TO RESEARCH ON HRT AND STROKE
A leading European Union researcher into the menopause has been awarded the prestigious Solvay Pharmaceuticals Menopause Prize, jointly awarded by the European Association of Gynaecologists and Obstetricians (EAGO) and Solvay Pharmaceuticals, one of the world’s leading companies in women’s health. The event took place at the XIV EAGO Congress in Granada, Spain.
The 1999 winner of the Solvay Pharmaceuticals Menopauze Prize is Anette Tønnes Pedersen, MD, Ph.D of the Department of Obstetrics and Gynaecology, Hvidovre Hospital, University of Copenhagen, Denmark.
The Prize of Dfl. 25,000 is awarded every two years to the researcher, scientist or physician from any EU country for original research which, in the opinion of the judges, makes an outstanding contribution toward scientific understanding of the menopause or related issues.
Dr. Pedersen’s prize-winning Abstract entitled “Hormone Replacement Therapy and Risk of Stroke” found that HRT had no impact on the risk of non-fatal haemorrhagic or thromboembolic stroke. While evidence of a protective effect of postmenopausal hormone replacement therapy (HRT) on the primary prevention of cardiovascular disease has been compelling, the effect of HRT on the risk of cerebrovascular diseases has sofar remained controversial.
Dr. Pedersen said: “The question of whether or not to start HRT is of key importance among many peri- and postmenopausal women.
Any uncertainty in the form of unresolved issues about HRT will inevitably influence their decisions and may affect compliance.
We needed conclusive evidence on the impact of oestrogen and combined oestrogen-progestogen replacement therapy on haemorrhagic as well as thromboembolic strokes.
We found – most importantly – that the current use of sex steroids in the form of postmenopausal HRT had no negative effect on risks in this key area of women’s health.”
Stroke is a major contributor to long-term disability, and the third leading cause of death among postmenopausal women in developed countries, after coronary heart disease and cancer.
“Dr. Pedersen’s research has made an important contribution to our understanding of this key field and was outstanding in its trial design and execution. Its scientific excellence must give us considerable confidence in the validity of its findings.
Women considering HRT or currently receiving combined therapy will be reassured by Dr Pedersen’s conclusions”, said Professor Ulmsten, the Chairman of the International Scientific Committee of the Solvay Pharmaceuticals Menopause Prize.
Dr. Pedersen’s study is the largest ever conducted on HRT and the risk of stroke. The study included 1,422 stroke cases. The population-based study design allowed the accurate estimate of absolute incidence of non-fatal stroke events. No significant impact was found of either former use, current use of unopposed oestrogens or current use of combined regimens on the risk of subarachnoid haemorrhage, intracerebral haemorrhage or thromboembolic stroke.
However, an approximately twofold, significantly increased risk of transient ischaemic attacks (TIA) was seen among women previously receiving HRT and among current users of unopposed oestrogens. No association between current use of combined hormones and TIA was shown.
Solvay Pharmaceuticals is a sector of the Belgian chemical-pharmaceutical concern Solvay SA, dedicated to optimal patient health management, providing products and undertaking innovative research in the core areas of psychiatry, cardiology (heart and vascular diseases), gastro-enterology (stomach and intestinal complaints) and gynaecology (women’s health).
For more information please contact:
Mrs. Drs. Cilia Linssen, Communications Manager, Pharmaceuticals Communications,
Solvay Pharmaceuticals
Telephone +31-294-477483, mobile +31-6-51247876.
The widespread fear among women1 that all hormone replacement therapy (HRT) use will lead inevitably to weight gain is unfounded, according to a growing body of research evidence, presented at the XIV EAGO Congress in Granada, Spain.
At the onset of the menopause, women who do not take HRT show an increase in total mass. Additional fat deposits appear, especially in the abdominal region, a phenomenon known as central obesity. This localised increase in body fat in post- menopausal women is believed to be an important risk factor for the development of cardiovascular disease.
Fear of weight gain is a major factor affecting women’s compliance with HRT. Yet there is a compelling body of evidence to suggest that this fear is unfounded, at least not for every type of HRT.
THE EVIDENCE
In the Postmenopausal Estrogen/Progestin Intervention Trial (PEPI-trial) of 875 women, the weight increase in the placebo group was higher than in any of the 4 HRT groups. The average weight gain in the treatment groups was less than 1 kg within 3 years.
HRT AND DECREASED WEIGHT – THE USE OF FEMOSTON®
A recent randomised study of 100 postmenopausal women found significant differences in weight, following HRT or placebo treatment. 26 women were given placebo, while the remainder was randomised to one of three treatment groups: those given tibolone 2.5 mg/day (28 women); those given oral estradiol 2mg/day plus sequential dydrogesterone 10 mg/day Femoston® for 14 of 28 days per cycle (26 women), or those given a transdermal estradiol patch releasing 50 microgram/day in addition to oral sequential dydrogesterone 10mg/day for 14 out of 28 days per cycle (20 women).
In the orally treated group given Femoston®, the expected increase in additional body fat mass reverted, which led to a stable – or reduced – body weight. This means that women taking Femoston® actually lose weight.
By contrast, the study found that untreated post-menopausal women in the placebo group showed a mean gain of fat mass of 3.6 kg in a two-year period.
Women taking the HRT treatment Femoston® had a mean fat mass reduction of 1.2 kg in contrast to both transdermal estradiol and tibolone (Livial®, a product with oestrogenic, progestogenic and androgenic effects). The body weight of women using the transdermal patch increased by 2 %. (2)
WEIGHT GAIN AND COMPLIANCE – REDUCING HRT’S BENEFIT
HRT offers its most beneficial effect: relieving climacteric symptoms, prevention of osteoporosis and decreasing cardiovascular risk in the long term over a period of several years. However, only 3 women in every 10 who are prescribed HRT continue treatment for more than 3 years.(3) It has been estimated that as many as 20% of women stop HRT because of weight gain. (3)
WEIGHT GAIN AND THE MENOPAUSE
Women’s concerns about postmenopausal weight gain are justified – but a causal link to HRT is not. However, weight gain is undesirable for a number of reasons. There is an established link between body fat distribution (a waist-to-hip ratio of more than 0.85, for example) as well as being overweight, and the risk of developing cardiovascular disease.(4) These factors may be either directly linked to cardiovascular disease (5), or indirectly linked.
FEMOSTON®: NO NEGATIVE IMPACT ON WEIGHT
The undesirability of post menopausal weight gain is well founded – but the fear that all HRT contributes to weight gain is not.
Two clinical studies with Femoston® have shown that the shift to central obesity was prevented during one or two years’ treatment respectively 2,6 Femoston® may even lead to weight loss, while conferring all the benefits of HRT.
The combination of healthy diet, regular exercise and HRT can offer postmenopausal women an opportunity to enhance their all-round health, and with it their future quality of life.
Femoston® was developed and is marketed by Solvay Pharmaceuticals. Solvay Pharmaceuticals is a sector of the Belgian chemical-pharmaceutical concern Solvay SA, dedicated to optimal patient health management, providing products and undertaking innovative research in the core areas of psychiatry, cardiology (heart and vascular diseases), gastro-enterology (stomach and intestinal complaints) and gynaecology (women’s health).
References
1 Poll results by SOFRES (2000 questionnaires – weight gain ranked second in HRT concerns after hormones themselves)
2 Hänggi W. et al. Differential impact of conventional oral or transdermal hormone replacement therapy or tibolone on body composition in postmenopausal women. Clin. Endocrinol. 1998;1840:691-699
3 Van Seumeren I. Weight gain and hormone replacement therapy: are women’s fears justified? Maturitas, in press.
4 Lapidus L. et al. Distribution of adipose tissue and risk of cardiovascular disease and death: a 12-year follow-up of participants in the population study of women in Gothenburg, Sweden. Brit. Med. J. 1984; 289: 1257-1261
5 Donahue R.P. et al. Central obesity and coronary heart disease. Lancet 1987; 821-824
6 Van der Mooren M.J. et al. A two-year study on the beneficial effects of 17ß-oestradiol dygesterone therapy on serum lipoproteins and Lp(a) in post-menopausal women: no additional unfavorable effects of dydrogesterone. Eur. J. Obstet. Gynecol. Reprod. Biol. 1993;52:117-123
For more information please contact:
Mrs. Drs. Cilia Linssen, Communications Manager, Pharmaceuticals Communications,
Solvay Pharmaceuticals
Telephone +31-294-477483, mobile +31-6-51247876
FLUVOXAMINE: HELPING PATIENTS RECOVER AFTER TRAUMA
Post-traumatic stress disorder (PTSD) is a relatively common problem that affects not only the patient, but also their family and friends. There is mounting evidence that drugs such as fluvoxamine, one of the class of drugs known as the selective serotonin reuptake inhibitors (or SSRIs), may help these patients recover.
Fluvoxamine – the background
* The SSRI fluvoxamine has been used world-wide for a number of years for the treatment of depression and a range of anxiety disorders such as obsessive-compulsive disorder, panic disorder and social anxiety disorder. More than 35,000 patients world-wide have been entered in clinical studies.
* It is a safe drug. It has no potential for abuse and has less sexual side-effects than the other SSRIs.
Serotonin and PTSD
* There is mounting evidence that the neurotransmitter known as serotonin is involved in PTSD.
* Fluvoxamine has a selective effect on the reuptake of serotonin in neurones in the brain.
* This suggests that fluvoxamine will be useful in alleviating the disturbing irritability, aggression and arousal symptoms of PTSD.
Fluvoxamine – promising effects in PTSD
* To date, three studies have investigated the effects of fluvoxamine in patients with PTSD (both civilians and war veterans).
* All the evidence shows that fluvoxamine clearly improves symptoms of intrusion, avoidance and arousal.
* Fluvoxamine also improves other psychiatric disorders, such as depression and panic disorder, that are commonly seen in PTSD patients.
* Fluvoxamine is safe in patients with PTSD.
Thus, fluvoxamine may help patients to cope with the devastating symptoms of PTSD.
SOLVAY PHARMACEUTICALS, INC. ACQUISITION OF UNIMED PHARMACEUTICALS, INC.
At midnight Monday, July 19, Solvay Pharmaceuticals acquired more than 95 percent of the shares of Unimed Pharmaceuticals. This is an outstanding result and it means the closing on the acquisition will occur immediately (read press release of June 14). By tomorrow afternoon, Unimed will be a wholly owned subsidiary of Solvay Pharmaceuticals. This acquisition is a key step in the Solvay Group’s strategy to rapidly expand its pharmaceutical business in the U.S.
As I mentioned to you in a recent communication, Unimed will be responsible for marketing its existing products, as well as TEVETEN® Tablets. Unimed also will be responsible for the regulatory, manufacturing, quality, and development aspects of its existing products, TEVETEN® Tablets, and development products. In some situations, both organizations will share services, such as marketing research studies or other initiatives.
This is an exciting time for Solvay Pharmaceuticals and we should all take pride in the fact that we are part of a growing enterprise..
David A. Dodd
President and CEO
Solvay Pharmaceuticals, Inc.
SOLVAY GROUP ANNOUNCES AGREEMENT TO ACQUIRE UNIMED PHARMACEUTICALS, INC. TO STRENGHTEN ITS MARKETING PRESENCE AMONG U.S. PRIMARY CARE PHYSICIANS.
As part of the Solvay Group’s strategy of growing faster in pharmaceuticals, Solvay Pharmaceuticals, Inc, has entered into an agreement with Unimed Pharmaceuticals, Inc. (Nasdaq: UMED) to acquire all outstanding Unimed shares.
Terms of the agreement call for the shareholders of Unimed Pharmaceuticals to receive $12.00 in cash for each share of Unimed’s common stock held by them. The net value of the planned transaction is about $123 million. The offer is subject to certain conditions including a minimum tender.
Commenting on the acquisition, Aloïs Michielsen, CEO of Solvay Group said, “Unimed fits very well with the strategic objective of broadening our presence in the U.S. pharmaceutical business. This acquisition will contribute to our plan to rapidly increase the total number of our U.S. sales representation from 450 at the end of 1998 to over 1,000 people in year 2000, selling existing drugs from Solvay Pharmaceuticals and Unimed Pharmaceuticals as well as products recently acquired by Solvay Pharmaceuticals.”
Jürgen Ernst, President of Solvay’s world-wide Pharmaceuticals activities added, “Indeed, in order to quickly and effectively maximize sales potential for both ACEON® Tablets and TEVETEN® Tablets, the two anti-hypertensive drugs acquired by Solvay in May 1999, Solvay Pharmaceuticals will sell ACEON® through its own primary care sales force. However, TEVETEN® Tablets will be sold by Unimed representatives, whose current number will be increased very significantly. Unimed also will strengthen Solvay’s current portfolio of Hormone Replacement Therapies (HRT) by including male HRT and providing an early entrée into the emerging area of andropause.”
Unimed Pharmaceuticals is an emerging Chicago-area pharmaceutical company. The company focuses on drugs that have multiple indications and fall within the therapeutic areas of endocrinology, urology, HIV and other infectious diseases.
The Solvay Group is an international chemical and pharmaceutical group based in Brussels, Belgium. Its members employ some 33,000 people in 46 countries. Its 1998 turnover worldwide was 7.5 billion EUR ($8.7 billion) from four operating sectors: Chemicals, Plastics, Processing, and Pharmaceuticals. Solvay Pharmaceuticals, Inc., a member of the Solvay Group, is a research-based pharmaceutical company active in the therapeutic areas of cardiology, women’s health, gastroenterology and mental health.
For further information, please contact :
SOLVAY S.A.
Dominique Clerbois
Head of Corporate Communications and Investor Relations
Tel. : +32-2-509.60.16
E-mail: dominique.clerbois@solvay.com
Solvay Pharmaceuticals, Inc.
Jeff Linton,
Vice President
Law, Government x Public Affairs
Tel: 770-578-5739 E-mail: jeff.linton@solvay.com
SOLVAY ACQUIRES TEVETEN®, AN INNOVATIVE CARDIOVASCULAR DRUG, FOR WORLD-WIDE MARKETING
Solvay announces today that it is acquiring Teveten®, a new oral antihypertensive from SmithKline Beecham for world-wide marketing, manufacturing and further development.
Teveten® has been developed by SmithKline Beecham (SB) up to registration, according to state-of-the-art standards. Teveten® is already on the market in Germany, Ireland, Denmark, Finland, Sweden, The Netherlands and Portugal. It is registered in Europe and the US. A fixed combination of Teveten® with a diuretic is also in a late stage of development.
Solvay will assume current marketing activities of SB and will execute a fully fledged product launch in new territories. Solvay will provide competitive resources and the appropriate detailing capacity to successfully compete in this cardiovascular antihypertensive segment and to fully exploit the excellent profile of Teveten® in the market.
Teveten® (eprosartan mesylate) is an angiotensin-II-receptor antagonist, and belongs to the newest class of drugs available for the treatment of hypertension. Teveten® is indicated for use either alone or in combination with other antihypertensives.
Jürgen Ernst, Solvay Pharmaceuticals president said: »This is an important business opportunity in line with the Solvay group strategy to increase its presence in Pharmaceuticals.» We expect Teveten® to become one of our top pharmaceutical products, and to contribute significantly to our global marketing and sales activities. The world-wide market for hypertension is estimated to be 10 billion US dollar, and therefore it is one of the most interesting areas for pharmaceutical marketing.»
SmithKline Beecham decided to divest Teveten® to concentrate efforts on other strategically important products. J.P. Garnier, C.O.O. of SB said: »We are in a very fortunate position and we have to make choices. Teveten® is an excellent product and we are very pleased that Solvay Pharmaceuticals will be able to give it the attention it deserves.»
Uncontrolled hypertension is a major cardiovascular risk factor. It can cause progressive damage to the heart and the vascular system, leading to stroke, heart failure, myocardial infarction, and kidney disease. Cardiovascular diseases are the leading cause of death in the western world. The hypertension market is one of the largest single pharmaceutical markets world-wide.
Solvay Pharmaceuticals is a research-based innovative group of companies with products and research in the areas of cardiology, psychiatry, gastro-enterology and women’s health. The group has a strong presence in Europe, and is growing rapidly in the US and Asia. Solvay Pharmaceuticals is part of the global chemical and pharmaceutical concern Solvay SA, headquartered in Brussels, Belgium. Solvay S.A. is present in 46 countries with about 33,000 employees. Its consolidated sales in 1998 reached EUR 7,5 billion (USD 8,7 billion), generated by four sectors of activity: chemicals, plastics, processing and pharmaceuticals.
For further information, please contact:
Dominique Clerbois
Head of Corporate Communication and Investor Relations
SOLVAY S.A. Headquarters
Tel : 32 2 509 60 16
dominique.clerbois@solvay.com
Puck Bossert
Solvay Pharmaceuticals B.V.
Tel : 31/653/16.59.42
Cilia Linssen
Solvay Pharmaceuticals B.V.
Tel : 31/651.24.78.76
Karen Carlisle
Solvay Pharmaceuticals, Inc.
Tel : 1 770 578 5581
SOLVAY PHARMACEUTICALS, INC. ENTERS CARDIOVASCULAR MARKET ACQUIRES U.S. RIGHTS TO ACEON® (PERINDOPRIL ERBUMINE) TABLETS FOR HYPERTENSION
Solvay Pharmaceuticals, Inc., today announced its entry into the U.S. cardiovascular market with ACEON® (perindopril erbumine) Tablets. This once-daily angiotensin converting enzyme (ACE) inhibitor therapy, indicated for the treatment of essential hypertension, is a major ACE inhibitor product in many markets throughout the world, and marks Solvay Pharmaceuticals’ entry into the highly competitive U.S. cardiovascular arena.
»We are pleased to have obtained this innovative antihypertensive product to initiate our cardiology portfolio in the U.S.», said Solvay Pharmaceuticals President and CEO David A. Dodd. »We expect ACEON® Tablets to contribute significantly to our aggressive marketing and sales plans for our newly established primary care sales force.» Mr. Dodd added »ACEON® Tablets will be available by prescription in the U.S. later this year.»
In clinical studies with hypertensive patients, ACEON® Tablets was proven to provide true 24-hour blood pressure control accompanied by an improvement in arterial elasticity, leading to improved arterial blood flow. Arterial elasticity reflects the ability of the artery to respond to pressure. The role of arterial elasticity as a marker for a variety of vascular diseases is a subject of increasing study and interest.
»ACEON® Tablets offers a potential clinical advantage available in no other antihypertensive therapy,» said Jay N. Cohn, M.D., Professor of Medicine, University of Minnesota Medical School, Minneapolis, Minn. »Studies with ACEON® Tablets have demonstrated its ability to improve arterial elasticity, which is an indicator doctors should be concerned about in patients with high blood pressure,» he explained. Dr. Cohn is a leading investigator of arterial elasticity and the emerging understanding of its clinical benefits in the treatment of hypertension.
ACE Inhibitors’ Mechanism of Action
As many as 50 million Americans have hypertension, according to the American Heart Association. Hypertension, commonly known as high blood pressure, occurs when the force of blood against the walls of the arteries is greater than normal. Hypertension is often characterized by increased resistance from the vessels that carry blood throughout the body and/or the amount of blood the heart has to pump. Hypertension is a major risk factor for coronary heart disease and stroke.
ACE inhibitors act to reduce elevated blood pressure by interfering with the action of the angiotensin converting enzyme that converts inactive angiotensin I to the artery constrictor angiotensin II. Blocking the production of the angiotensin II results in arterial vasodilation and an accompanying reduction in blood pressure. As a therapeutic category, ACE inhibitors account for 28 percent of the antihypertensive market in the U.S.
Marketing x Availability
COVERSYL® (perindopril erbumine), to be marketed as ACEON® Tablets in the U.S., was first brought to market in France in 1989, and is currently available worldwide. Now the mainstay of hypertension therapy in 113 countries, product experience includes well over 73 million patient-months. ACEON® Tablets is approved by the U.S. Food and Drug Administration. Due to the product’s overwhelming success worldwide and increasing demand by U.S. physicians, Solvay Pharmaceuticals has now licensed the drug and will make it available in this country.
»We look forward to bringing ACEON® Tablets to market in the U.S. to help fill the need for an effective antihypertensive therapy that may also improve arterial elasticity,» said Mr. Dodd.
ACEON® Tablets will be marketed and distributed nationwide by Solvay Pharmaceuticals, Inc., of Marietta, Ga., a research-based pharmaceuticals company, active in the therapeutic areas of cardiology, women’s health, gastroenterology and mental health. It is a member of the worldwide Solvay Pharmaceuticals Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium. Solvay employs about 33,000 people in 46 countries. In 1998, its turnover was EUR 7.5 billion (USD 8.7 billion) resulting from four sectors of activity: Chemicals, Plastics, Processing and Pharmaceuticals.
For further information, please contact:
Dominique Clerbois
SOLVAY S.A.
Head of Corporate Communication and Investor Relations
Tel: 32/2/509.60.16
dominique.clerbois@solvay.com Karen Carlisle
Solvay Pharmaceuticals, Inc.
Tel : 1 770 578 5581
Karen Reina
Ruder Finn Healthcare
1 212 593 6313
BERNA AND SOLVAY PHARMACEUTICALS COLLABORATE IN INFLUENZA VACCINES
Berna and Solvay Pharmaceuticals collaborate in influenza vaccines SOLVAY Pharmaceuticals and BERNA, the Swiss Serum and Vaccine Institute Berne, have recently signed a license and distribution agreement in the field of human influenza. Both companies are marketing influenza vaccines, are engaged in the development of new influenza vaccines, and have new manufacturing techniques and processes.
BERNA has developed a new adjuvanted influenza vaccine, using the virosome technology, currently sold in Switzerland and Italy under the trademark Inflexal Berna® V. SOLVAY Pharmaceuticals has extensive manufacturing capabilities and is working on a new manufacturing process, in which BERNA is interested. The signed agreement which does not touch the independence of the two companies concerns marketing, manufacturing and research activities in influenza vaccines.
As a licensee of BERNA, SOLVAY Pharmaceuticals will receive the right to manufacture and sell the virosomal influenza vaccine under its own trademark in an agreed territory. BERNA will have rights to sell under its own brand SOLVAY’s subunit vaccine in a defined territory.
SOLVAY Pharmaceuticals is working on a new manufacturing process, making use of cell culture for influenza virus multiplication. SOLVAY Pharmaceuticals and BERNA intend to jointly develop this cell-culture process for influenza. Under the agreement, the two companies will also share expertise in the development of new vaccines for preventing influenza.
Dr Laurenz Grünenfelder, Director of BERNA, says : “We are happy to work together with SOLVAY Pharmaceuticals and its very successful business operations to maximise the global availability of the virosomal influenza vaccine.”
Mr Bart Kwist, SOLVAY Pharmaceuticals’ Manager of Global Business Development, says: “This is a good deal for SOLVAY Pharmaceuticals and BERNA since it allows both companies to develop and launch new influenza vaccines.”
BERNA, the Swiss Serum and Vaccine Institute Berne, was founded in Berne, Switzerland in 1898 and is specialised in the development, manufacturing and marketing of vaccines and serums. In the field of vaccine research and development, BERNA enjoys a leading position world-wide. Its business derives from sales of immunobiologicals and plasma derivatives. BERNA’s sales network is covering the world.
SOLVAY is an international chemical and pharmaceutical group, headquartered in Brussels, and directly present in 46 countries with more than 33,000 employees. Its consolidated sales in 1998 reached EUR 7.5 billion (USD 8.7 billion), generated by four sectors of activity: Chemicals, Plastics, Processing, and Pharmaceuticals. Solvay Pharmaceuticals is active in the discovery and marketing of ethical pharmaceutical products.
For more information please contact:
BERNA, Mr. Peter Wiesli, Chairman and CEO, telephone 0041-31-9806209.
Solvay Pharmaceuticals, Mrs Puck Bossert, +31-294-477469
Solvay Pharmaceuticals, Mr. Klaus Weidner, telephone + 49-511-8573457
NOVEL VACCINE APPROACHES FOR THE CONTROL OF INFECTIOUS DISEASES SUCH AS AIDS, HEPATITIS B AND INFLUENZA
Press Release from Symposium
“European Perspective in the Control of Infectious Diseases”
On 16 April 1999, at an international scientific symposium in Malta hosted by Professor Albert Osterhaus, professor of Virology at the Erasmus University in Rotterdam (The Netherlands), new developments in vaccine research were presented to combat important infectious diseases such as AIDS, hepatitis B and influenza.
Today the European population still faces a high person-to-person transmission of certain human infectious diseases. For influenza and hepatitis B, vaccines are available but their utilisation in Europe varies greatly. With regard to influenza vaccination it is known that at most 50% of “high-risk” patients receive yearly vaccination. “High-risk” patients include subjects aged 65 and over, and persons with underlying conditions like heart disease, lung disease and diabetes. These people have the greatest risk to suffer from complications caused by influenza which can lead to hospitalisation or even death.
For hepatitis B a need for increased vaccine usage has been recognised by public health authorities. Vaccination can prevent chronic hepatitis B infection, chronic liver disease, and hepatocellular carcinoma (HCC). However, the strategy of specifically targeting high-risk subjects has failed to prevent about half of total cases which occur in persons with no identifiable risk. Therefore hepatitis B vaccination has been or will be included in the routine vaccination schedule of many European countries.
Groups with high risk for contracting hepatitis B include healthcare workers, clients and staff of institutions for the mentally retarded, haemodialysis patients, homosexually active men and heterosexually active persons with multiple sexual partners, and users of illicit injectable drugs.
Apart from the need for increased vaccine usage to reduce the spread of infectious diseases, scientists have realised in recent years that novel technologies can improve vaccine efficacy and may enable the production of vaccines against new infectious diseases, e.g. AIDS. At the same time, some of these modern technologies may lead to the development of therapeutic vaccines.
In Malta, key European scientists discussed their projects in progress investigating the potential advantages of new and improved vaccines. The meeting was started by the renowned scientists Professor Maurice Hilleman (USA) and Professor Geoffrey Schild (UK), who gave fascinating overviews on the history of vaccines and on future prospects, respectively.
Various researchers discussed their experiences with the virosome technology, one of the most promising candidate adjuvants for the future. As was presented by Dr. Jan Wilschut (NL) and Dr. Reinhard Glück (CH), vaccines using Immunopotentiating, reconstituted Influenza Virosomes (IRIV) as a delivery vehicle have been found to induce an improved immune response. In humans, licensed IRIV-based vaccines containing hepatitis A and influenza antigens have been shown to possess enhanced immunogenicity compared to other vaccines. Further research on the use of this new adjuvant in other fields of vaccinology was advocated.
Professor Luc Montagnier (France), chairman of the World Foundation of AIDS
Research and Prevention, and discoverer of the Human Immunodeficiency Virus type 1 (HIV-1), and Professor Osterhaus held presentations on HIV vaccine developments. It was explained that the control of the HIV virus would ideally require specific mucosal immunity to protect the genital region through which transmission frequently occurs. Therefore a vaccine that stimulated a disseminated mucosal and systemic protective immune response would be extremely useful.
Professor Montagnier indicated that a nasal spray with a virosome-Nef vaccine has shown promising results. Professor Osterhaus presented data on the reasons why Rev and Tat may also be important candidates to be included in a future HIV vaccine.
Professor Jörg Reimann (Germany) and Professor Yezechel Barenholz (Israel) held presentations on the design of vaccines against chronic hepatitis B virus (HBV) infection in preclinical models. It was indicated that a specific cellular immune response to HBV-encoded proteins rather than viral factors seem to be decisive in determining the outcome of HBV infection. Among other things, they are now studying the therapeutic value of CHO-protein- or DNA-based HBV vaccines, including virosomes, in animal models.
Professor Pietro Crovari (Italy) and Professor John Oxford (UK) concluded the day with presentations on novel trends in influenza vaccination. Prof. Crovari presented exciting results of the use of a virosomal influenza vaccine in humans given via the intranasal route.
Prof. Oxford described the progress that has been made over the last 50 years, stating that there is now clear evidence of vaccine efficacy in preventing hospitalisation and death due to influenza. He expected that in the coming years many new developments in influenza vaccines can be expected. Finally he indicated that, statistically speaking, a future influenza pandemic may not be far away. The global influenza outbreaks in 1918, 1957 and 1968 caused intense social and medical disruption. Influenza vaccines have made a unique contribution to the health and security of the population and the recent scientific developments will undoubtedly enhance this trend. However, Oxford hoped that the expectations of society to be protected against infectious diseases would result in increased investments in quality scientific and medical research into influenza vaccines.
The scientific symposium was sponsored by BERNA, Swiss Serum and Vaccine Institute Bern (Switzerland), specialised in the research, manufacturing and marketing of immunobiologicals, and Solvay Pharmaceuticals, a division of the chemical and pharmaceutical group Solvay SA, with headquarters in Brussels (Belgium), which is active in the research, manufacturing and marketing of pharmaceutical products.
For more information, please contact:
Professor Albert Osterhaus, Institute of Virology, Erasmus University, Rotterdam, The Netherlands, telephone +31-(0)10-4088066, fax +31-(0)10-4089485
SOLVAY GROUP: LUVOX® AND DEPROMEL®, FIRST INNOVATIVE MENTAL HEALTH DRUG (SSRI), APPROVED FOR JAPANESE MARKET
On the 7th April 1999 the Japanese Ministry of Health and Welfare approved Luvox® and Depromel® (both brand names contain the active ingredient: fluvoxamine) for marketing in Japan. Luvox® (Solvay’s international brand) is approved for depression and obsessive-compulsive disorders (OCD) in more than 75 countries. It is an innovative mental health drug developed and manufactured by Solvay. It is the first Selective Serotonin Re-uptake Inhibitor (SSRI) to enter the Japanese market. Luvox® is safe and effective in depression and OCD and has less side effects than traditional anti-depressants. Being an SSRI, it inhibits the re-uptake of serotonin, a substance in the brain that plays an important role in mental health disorders like depression and OCD.
In Japan this innovative mental health drug has been co-developed by Solvay-Meiji and Meiji Seika. Solvay-Meiji is a joint venture of Solvay SA and Meiji Seika. Introduction nationwide is foreseen for June 1999, under the trademark LUVOX® by Fujisawa and Solvay Seiyaku (the Japanese fully owned subsidiary of Solvay Pharmaceuticals) as well as under the trademark DEPROMEL® by Meiji Seika.
Experts believe that depression is underrecognized in Japan. Today this market is around USD 140 million, but it is expected to grow. Like in many other countries mental illness is often considered to be profoundly stigmatizing, not just to patients but also to their families. Depression and obsessive-compulsive disorders are complicated diagnoses to make with many patients going unrecognized.
In the last decade the introduction of SSRI’s as antidepressant drugs has had a major impact on the treatment of depression. The antidepressant market in the USA has grown approximately 10-fold and the European antidepressant market has grown approximately 4-fold during this period. This growth can be explained by improvements in the diagnosis of depression, the ease and efficacy of SSRI treatment, and an increase in the duration of the treatment.
Worldwide Luvox® was also the first SSRI to enter other markets, starting with Switzerland in 1983. Since then worldwide use of LUVOX® exceeds 19 million patients. In addition a detailed database of safety information on more than 38,000 patients participating in clinical trials is available. The drug is marketed in 75 countries.
Solvay Pharmaceuticals is a sector of the Belgian chemical-pharmaceutical concern Solvay SA, dedicated to optimal patient health management, providing products and undertaking innovative research in the core areas of psychiatry, cardiology (heart and vascular diseases), gastro-enterology (stomach and intestinal complaints) and gynaecology (women’s health).
Solvay SA is an international chemical and pharmaceutical group, headquartered in Brussels, present in 46 countries with more than 33,000 employees. Its consolidated sales in 1998 reached EUR 7,5 billion (USD 8.7 billion), generated by four sectors of activity: Chemicals, Plastics, Processing, and Pharmaceuticals.
For further information:
Solvay Pharmaceuticals : R. Bickerstaffe (tel: 31 653 380 122) , P. Bossert (tel: 31 653 165 942)
Solvay Corporate Communications: 32 2 509 60 16
MICROSURGICAL DEVELOPMENTS PVC-RAT REDUCES USE OF LIVE RATS DRASTICALLY
Today the Microsurgical Developments PVC-rat (MD PVC-rat) has been officially launched in The Netherlands with the first one being handed over to Mr. Joop van der Reijden, former Minister of Health and presently Chairman of the Dutch television organization Veronica. This Microsurgical Developments PVC-rat is a true-to-life rat model made from a special Solvay PVC. It is a practical device developed for students, micro-surgeons, biotechnicians and other researchers to train basic microsurgical techniques. By making use of this MD PVC-rat the use of live laboratory animals can now be drastically reduced.
Scientists can practice a total of 25 different operation techniques on this MD PVC-rat, including button and suture techniques to attach blood vessels to each other, and transplantation of organs such as kidney and heart. Training in microsurgical techniques is by tradition live animal-based. The number of animals needed in the initial training phases may be very high due to the complexity of the surgery and anaesthesia used. Many techniques need to be practised and mastered and many live animals may be sacrificed during this learning phase. A great deal of laboratory animals can now be spared thanks to the launch of the MD PVC-rat. This model of a life-sized rat is currently produced for MD at a cost of Dlf. 350,– thanks to the sponsorship of Solvay. It is expected that this year a few hundred examples will be sold by the Microsurgical Developments Foundation to research institutes around the world.
Microsurgical Developments (MD) is a Dutch not-for-profit foundation that was established at the end of the 1980s, with as primary objective to replace, reduce and refine animal experiments in biomedical sciences. Over the years MD has developed various teaching materials such as the “Manual of Microsurgery on the Laboratory Rat”, and a set of videotapes accompanying this manual, and now the PVC-rat.
The MD PVC-rat was initiated with a grant from the Dutch Platform for Alternatives for Animal experiments. This platform was inaugurated in the 1980s with among others the active support of the Dutch government, a few phamaceutical companies in The Netherlands, and various animal protection organizations.
Today the launch and marketing of the rat is supported by the Solvay Group, Solvay Plastics (supplier of the special PVC used) and Solvay Pharmaceuticals.
Solvay Pharmaceuticals is one of the top 50 pharmaceutical companies in the world. It has a strong presence in Europe, and is rapidly expanding in the US, Asia, Central and Eastern Europe. The core activities of Solvay Pharmaceuticals consist of discovering, developing, and producing drugs for humans in the fields of psychiatry (mental illness), gastro-enterology (stomach and intestinal complaints), gynaecology (women’s health), and cardiology (heart and vascular diseases).
Solvay Pharmaceuticals deals carefully and caringly with laboratory animals and animal experiments. The company has high standards for this, and these are laid down in a special Company Policy, that strives to continuously replace, reduce, and refine live animal use. While animal experiments are only considered for research into the prevention or cure of human diseases, the company guarantees good housing, supervision, and care for all laboratory animals. In recent years Solvay Pharmaceuticals has achieved an 80% reduction in total animal use.
Solvay Pharmaceuticals and Solvay Plastics are divisions of the international chemical and pharmaceutical group Solvay SA, headquartered in Brussels, present in 46 countries with more than 33,000 employees. Its consolidated sales in 1998 reached EUR 7,5 billion (USD 8,7 billion) generated by four sectors of activity: Chemicals, Plastics, Processing, and Pharmaceuticals.
For more information please contact:
Mrs. Drs. Puck Bossert, Manager Communications, International Pharmaceuticals Communications, Solvay Pharmaceuticals
Telephone +31-294-477469, mobile +31-6-53-165942.