For Cambridge, Massachusetts–based Genzyme, the fourth largest independent US biotech firm and the biggest in market value in the biotech-rich Boston area, joining Sanofi provides both a lucrative exit and a way to end a period of headache and controversy. In the past two years, Genzyme has experienced repeated serious biologics manufacturing problems, leading to censure by the US Food and Drug Administration (FDA; Nat. Biotechnol. 28, 388, 2010) and calls from activist shareholders for its longtime CEO, Henri Termeer, to step down. As a result of the buyout, Paris-based Sanofi will own Genzyme's prized franchise in enzyme replacement therapy (ERT), a fast-growing biologics portfolio that can help Sanofi plug looming revenue shortfalls resulting from loss of patent protection on three of its main products: Plavix (clopidogrel), Lovenox (enoxaparin) and Taxotere (docetaxel). Sanofi also gains a potential blockbuster product for multiple sclerosis (MS).
One major sticking point in the takeover negotiations, which began in late July 2010 after Sanofi presented an unsolicited $17.5 billion cash offer to Genzyme management, was the value assigned to Genzyme's MS compound Lemtrada (alemtuzumab). This humanized IgG1 monoclonal antibody (mAb), which binds CD52 on the surface of lymphocytes, is approved as a leukemia drug under the name of Campath. In MS, it has blockbuster potential but faces competition, notably from Basel-based Novartis's oral MS medication, Gilenya (fingolimod), launched late last year (Nat. Biotechnol. 28, 1135, 2010). Also, Genzyme's Cambridge neighbor, Biogen Idec, recently received CE Mark in Europe and has filed in the US for a label change to its MS humanized mAb Tysabri (natalizumab) to include use of a diagnostic to stratify patients at risk for progressive multifocal leukoencephalopathy, which could expand that drug's use. Genzyme's Lemtrada, a once-a-year injection that ablates T and B cells, also raises concerns over potential side effects.
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