Novartis and Bristol-Myers Squibb announce strategic alliance for Zelmac

Collaboration includes two Bristol-Myers Squibb biologics being developed in transplantation and auto-immune disease

20-Oct-2000

Basel/Princeton, 18 October 2000 -- Novartis AG (NYSE: NVS) and Bristol-Myers Squibb Company (NYSE: BMY) today announced a strategic alliance. Novartis also revealed that its preliminary analysis of data from a recently completed clinical study of 1500 women treated with Zelmac (tegaserod) confirm safety and efficacy of the drug for the treatment of abdominal pain/discomfort and constipation in women with irritable bowel syndrome (IBS). Novartis expects to provide additional details of this study upon submission of the data to regulatory authorities later this year.

The companies signed an agreement (excluding Japan) to co-develop and co-promote Zelmac™ (tegaserod), Novartis' new investigational drug treatment for women with certain symptoms associated with IBS, currently filed with regulatory authorities worldwide.

The alliance also provides for a collaboration between the companies in the development of two Bristol-Myers Squibb immune-modulating compounds (CTLA 4Ig and LEA 29Y) in the transplantation and auto-immune areas.

Large Scale Professional and Consumer Education Campaign to be Initiated The co-development and co-promotion of Zelmac will bring new hope to millions of people around the world with IBS. The combined Novartis and Bristol-Myers Squibb field force effort will focus on establishing Zelmac's therapeutic value among physicians so they can better serve a large segment of currently unsatisfied IBS patients. Both companies plan to mount large-scale professional and consumer education programs to better define IBS and its symptoms, and to increase awareness of IBS as an important women's public health issue.

"Major global partnerships of this kind will play an increasingly important role in the future of our industry. The additional commercial power gained with Bristol-Myers Squibb's strong presence in the key US market will accelerate our efforts to bring Zelmac to millions of suffering patients who will benefit from this novel therapy," said Daniel Vasella, Chairman and CEO of Novartis.

"This important partnership with Novartis is evidence of our sharpened focus on the medicines business and our related strategies to drive growth and extend our reach into new therapeutic areas," said Charles A. Heimbold, Jr., Chairman and CEO of Bristol-Myers Squibb. "We are pleased to be collaborating with Novartis and to apply our collective strengths to the successful launch of Zelmac and its potential to address a pressing medical need."

The term of the Zelmac collaboration will run to the end of the patent term for the drug in all countries of the alliance. Bristol-Myers Squibb will collaborate with Novartis in further developing Zelmac for potential future indications in the treatment of upper and lower gastrointestinal tract disorders, including gastro-esophogeal reflux disease (GERD), chronic constipation, and functional dyspepsia.

Zelmac belongs to a new chemical class of compounds which selectively target and act on 5-HT4 receptors present throughout the gastrointestinal (GI) tract. These serotonin receptors appear to play a key role in GI motility and may be involved in pain perception. By acting on the 5-HT4 receptor pathway, Zelmac may improve GI function by relieving abdominal pain and constipation in certain IBS patients.

Transplantation/Autoimmune Disease Collaboration The companies also announced their intended collaboration in connection with two novel Bristol-Myers Squibb immunosuppressants, CTLA 4Ig and LEA 29Y. The parties have signed an agreement in principle and will now seek to finalise details by the first quarter of 2001. Both molecules are in the early development phases targeting potential indications in transplantation and auto-immune diseases such as rheumatoid arthritis and multiple sclerosis. Novartis and Bristol-Myers Squibb expect that the compounds will be developed for transplantation indications by Novartis, and for auto-immune indications by Bristol-Myers Squibb. Each company

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