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Case Title:

Biogen IDEC: Troubles with Tysabri

Publication Year : 2005

Authors: Rekha Ravindran. C, Bindu Kannan

Industry: Health Care

Region:USA

Case Code: IPD0040B

Teaching Note: Not Available

Structured Assignment: Not Available

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Abstract:
In 2003, Biogen IDEC was formed by the merger of Biogen NV and IDEC Pharmaceuticals Corporation (IDEC). It became the world’s third largest bio-pharmaceutical company after the merger. In 2003, IDEC merged with Biogen to form Biogen IDEC. Biogen IDEC had a revised product line, resulting from the synergies of both the companies. (Exhibit-1I). In 2004, Biogen IDEC submitted for FDA approval, a new drug, Tysabri, which was to be used for the treatment of multiple sclerosis. By mid February 2005, Biogen IDEC ran into trouble, when two of the patients, who were part of the clinical trials of Tysabri, developed a very rare brain disease, Progressive Multifocal Leukoencephalopathy (PML). Despite all the roadblocks, Biogen IDEC had high hopes of getting Tysabri back into the market by 2005 end. Biogen IDEC faced the risk of patent expiry, by 2011, for its blockbuster drug, Avonex. In April 2005, Biogen IDEC released a two year clinical study report on Tysabri, which reaffirmed the positive effects of the previously reported one year data of clinical trials. Biogen IDEC planned to continue the safety probe till 2005 end. Based on those reports, the company planned to submit a request to FDA about resumption of Tysabri sales. But industry experts believed that if Tysabri came back, its prescriptions could be restricted to patients who did not respond to any other existing drugs available for MS.

Pedagogical Objectives:

  • To discuss the perils of accelerated drug approvals
  • How Biogen would re-launch Tysabri in the market, and what would be the market reaction
  • How Biogen would face the patent expiry of its block buster drug, Avonex.

Keywords : Tysabri; Biogen IDEC; FDA; Bio-pharmaceutical industry; Accelerated approval; Innovation Management Case Study; Block buster drug; Side effects of drug; Drug withdrawl; Avonex; MS patients; Clinical trials; PML; Multiple sclerosis; Alternative multiple Clinical trials; PML; Alternative multiple sclerosis drugs

Contents:

  • The U.S Bio- pharmaceutical industry
  • Biogen IDEC- A profile
    • Biogen NV
    • IDEC

    • Multiple sclerosis (MS)
    • Tysabri
    • Shift in fortunes
    • The Challenges Ahead

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