Bristol-Myers Squibb GmbH & Co. KGaA

Novartis and Bristol-Myers Squibb Announce Strategic Alliance for Zelmac(TM) Collaboration Includes Two Bristol-Myers Squibb Biologics Being Developed In Transplantation and Auto-Immune Disease

    Basel, Switzerland and Princeton, N.J. (ots-PRNewswire) -

    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(TM) (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(TM) (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 finalize 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 maintains the option to participate in each other's development and commercialization activities within these fields.

    "These new compounds hold the promise of helping patients tolerate their transplant without life-long use of immunosuppression," said Thomas Ebeling, CEO of Novartis Pharma AG. "This would represent a significant scientific breakthrough in the field of transplantation and improve significantly the quality of life of transplant patients. We are pleased by the prospect of continuing to provide important and innovative products to this critically important field of medicine."

    "Bristol-Myers Squibb has been excited about the potential of CTLA 4Ig and LEA 29Y, two powerful immune modulators, since their discovery in our labs," said Peter R. Dolan, President, Bristol-Myers Squibb. "We look forward to having an equally enthusiastic partner who will help us bring these medications to people in need. Importantly, the co-development of these compounds fits perfectly with the strategic expansion of our biologics program and this collaboration with Novartis is a giant step in that direction."

    The foregoing press release, and the attached Background Information, contain forward-looking statements that can be identified by terminology such as "anticipates," "preliminary", "potential," "believe," "will deliver," "expect," "intended," "should," promise," "attempt," "hope" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. In particular, management's expectations could be affected by, among other things, uncertainties relating to clinical trials and product development; unexpected regulatory delays or government regulation generally; uncertainties associated with action dependent on governmental agencies; the company's ability to obtain or maintain patent and other proprietary intellectual property protection; and competition in general.

    Additional risk factors are discussed in Exhibit 99 to the Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended 31 December 1999.

    About Novartis

    Novartis is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group (including Agribusiness) achieved sales of CHF 32.5 billion (USD 21.6 billion) and invested more than CHF 4.2 billion (USD 2.8 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82 500 people and operates in over 140 countries around the world. The Group plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the fourth quarter of 2000.

    About Bristol-Myers Squibb

    Bristol-Myers Squibb is a USD 20 billion diversified global health and personal care company whose mission is to extend and enhance human life. With an R&D budget of nearly USD 2 billion in 1999, the Company is a leading maker of innovative therapies for cardiovascular, metabolic, and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is also a leading maker in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. In addition, Bristol-Myers Squibb recently announced plans to divest both the Clairol and Zimmer businesses.

    BACKGROUND INFORMATION

    About Zelmac(TM)

    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.

    About Irritable Bowel Syndrome (IBS)

    IBS is a condition associated with the digestive system. In short, it involves hypersensitivity and altered motility of the gastrointestinal tract. Symptoms vary, but the hallmark symptoms of IBS are abdominal pain/discomfort, bloating and symptoms associated with altered bowel function, such as constipation, diarrhea or an alternating pattern of the two. Secondary symptoms associated with IBS include passing of mucous with stools, tiredness, depression, anxiety and irritability.

    Prevalence of IBS

    IBS is a surprisingly prevalent condition among the world population -- surprising because public awareness of the condition is so low despite the widespread nature of the disorder. Up to 20 percent of the world's population is affected by IBS, and of those people who suffer from the condition, approximately 70 percent are estimated to be female. In the US, 25 million people have a form of IBS that includes three major symptoms: abdominal pain, bloating and altered bowel function. Also in the US, IBS accounts for four percent of all primary care physician visits and it is the second most common reason for sick days next to the common cold. Approximately 33 million people in the top-five European countries are affected by the condition.

    About the Zelmac Submission Process

    A new drug application for Zelmac was submitted to the US Food and Drug Administration (FDA) in February 2000, and in April, it was granted priority review. Priority review status is granted by the FDA to products that are considered a potential therapeutic advance over existing therapies or where none exists. On 26 June, the FDA's Gastrointestinal Advisory Committee recommended approval for Zelmac for the treatment of abdominal pain/discomfort and constipation in women with IBS.

    In August, Novartis received an approvable letter from the FDA for Zelmac. In that letter, the FDA requested additional clinical data. Preliminary data from this recently completed clinical study of 1500 females treated with Zelmac confirm safety and efficacy of the drug for the treatment of abdominal pain/discomfort and constipation in women with IBS. Novartis anticipates providing additional details of this study upon submission of the data to regulatory authorities later this year.

    A regulatory submission for Zelmac is also currently under review by the European Medicine Evaluation Agency (EMEA) and many other health authorities worldwide. The submissions are based on data from clinical studies involving 2500+ patients in 15 countries. Novartis believes that the data show that Zelmac provides patients with relief from certain key symptoms of IBS, such as abdominal pain and discomfort and constipation. Zelmac was also found to be well-tolerated with side effects comparable to placebo. Diarrhea was the only notable adverse event that was reported more often in Zelmac treatment groups (12% vs. 5% on placebo). Diarrhea is an expected pharmacodynamic effect of the drug and only 1.6% of patients discontinued treatment as a result of it.

ots Original Text Service: Bristol-Myers Squibb Company Internet: http://recherche.newsaktuell.de

Contact: Novartis Press Office, +41-61-324-2200, or Tracy Furey, +1-609-252-3208, or Deborah Mechaneck, +44 1 895 628 936 both of Bristol-Myers Squibb Company

Original-Content von: Bristol-Myers Squibb GmbH & Co. KGaA, übermittelt durch news aktuell

Weitere Meldungen: Bristol-Myers Squibb GmbH & Co. KGaA

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