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Title: Sabril Recognised as an Innovative Product for Epilepsy
URL: http://www.pslgroup.com/dg/8CC2.htm
Doctor's Guide
May 16, 1996


MONTREAL, May 16, 1996 -- The Prix Galien Canada Award for Innovative Product has been awarded to Hoechst Marion Roussel Canada for Sabril, its anti-epileptic drug which brings new hope to epilepsy sufferers.

"Sabril is an important advance in the treatment of epilepsy," said Prix Galien jury member Dr. Serge Carriere, Vice-President, Clinical Research, of Phoenix International. "It is easy to use and effective in reducing seizures in patients who are not helped by existing drug therapies. Furthermore, it has been proven safe for adults and children, with minimal adverse effects and no significant interactions with other anti-epileptic drugs. We see it as a substantial improvement over currently available drug therapy, as well as an ideal add-on therapy to other medication."

"Altogether," Dr. Carriere concluded, "Sabril is a sterling example of pharmaceutical progress."

Sabril is the trade name for the molecule Vigabatrin, discovered in the company's research laboratories in France in 1977. The long process of development and approval has been completed, and the product has been available in Canada since 1994, when the Patent Medicine Price Review Board approved it as a Category II drug - a breakthrough product or substantial improvement over existing products. It was one of only three products introduced in Canada that year to receive that classification.

About one per cent of the Canadian population will be classified as epileptic at some time in their lives. Many patients obtain complete control with other anti-epileptic drugs, although there are side effects ranging from nausea to anemia. However, some 30% of patients with epilepsy are not helped by these medications. This has a profound effect on their mortality and morbidity, as well as their employability and quality of life.

Sabril has been proven effective among half of epilepsy sufferers who have not responded to other medication, reducing seizures by 50% on average and dramatically improving their condition, with minimal adverse effects. In fact, some patients using Sabril reported an improvement in their mental functioning. The drug is also expected to emerge as the first line of treatment for infantile spasms.

Hoechst Marion Roussel Canada, as part of the worldwide team that has developed Sabril, conducted a number of clinical studies to determine the drug's efficacy and safety. This included a study by Canadian epileptologists of 111 patients at 10 sites across the country, a pediatric study of 53 patients at 14 sites to evaluate Sabril's safety and efficacy in children, and a multi-centre trial by 20 investigators currently under way to compare Sabril's safety and efficacy with that of existing drug treatments for earlier treatment phases of epileptic patients.

The Company's health economists also performed a study to determine the impact of Sabril's use on the overall cost of treating epilepsy in Quebec. With effects such as a reduction in the use of emergency services and less hospitalization, a net cost reduction in the range of $3 million to $10 million per year was projected.

"Sabril represents the kind of innovative research that we foster at Hoechst Marion Roussel Canada," said Company President Gerald P. (Jerry) Belle. "It is a rationally designed drug which fulfils currently unmet needs, in this case better quality of life and greater longevity for epileptic patients. At the same time, Sabril actually covers the cost of treating epilepsy for these patients, providing potentially significant cost savings to the health-care system."

The Prix Galien was established in Canada in 1994. Created in France in 1970 to promote and foster drug research, it has spread to many other countries over the years, as its prestige has increased correspondingly. It is open to all Canadian pharmaceutical companies, as well as to all Canadian researchers involved in pharmaceutical research.

"The Prix Galien owes its credibility and prestige to the quality of the jury members, who are independent, objective, and well-recognized in their fields," said Dr. Jacques Gagne, Chairman of the Canadian Prix Galien. "As a result, the Prix Galien has become the official recognition of excellence in the field of pharmaceuticals."

Hoechst Marion Roussel Canada is a leading pharmaceutical health management company committed to providing its partners with sensible and innovative health care solutions. These solutions, the result of the discovery, development, manufacturing and commercialization of pharmaceutical products and services, are designed to extend and enhance human lives. Hoechst Marion Roussel Canada, a member of the Hoechst Group, is based in Laval, Quebec.

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