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Apr 8, 2013

BMS Shores Up R&D after Trial Failure, Plavix Patent Loss

  • Bristol-Myers Squibb yesterday named Francis Cuss as executive vp and chief scientific officer effective July 1, as the pharma giant moved to shore up an R&D effort set back by the costly failure of a hepatitis C candidate and the looming loss of Plavix revenue to the patent cliff.

    Dr. Cuss will succeed current CSO Elliott Sigal, M.D., Ph.D., who the company said was retiring after nine years in the position, and two years on the company’s board of directors. Dr. Cuss joined BMS in 2003 as senior vp, drug discovery, adding responsibility three years later for discovery medicine and clinical pharmacology. Before joining BMS, Dr. Cuss spent 14 years at Schering-Plough and three years at Glaxo, holding positions of increasing responsibility in discovery, clinical research, and medical affairs in the U.S. and Europe.

    In a statement, BMS credited Dr. Cuss with successfully integrating Adnexus, Medarex, and ZymoGenetics into BMS’ research organization over the past decade, as well as with having “driven innovation in the research operating model, processes and governance,” and being recognized for industry leadership “based on cycle time, success rates and costs, having increased discovery output while maintaining a flat operating budget.”

    BMS hopes these skills will strengthen its R&D operation. It stumbled last year when hep C candidate BMS-986094 (094) failed a Phase IIb study that was suspended after a heart failure death in one of 30 patients receiving the highest daily dose, 200 mg, in combination with BMS’ daclatasvir, another hep C candidate.

    BMS took a $1.8 billion noncash impairment charge in the third quarter of 2012 reflecting the failure of ‘094, and is looking to settle $500 million in claims made in lawsuits against the company by trial patients and families of patients. ‘094 was earlier known as INX-189 when it was the lead drug candidate of Inhibitex. BMS acquired Inhibitex last year for $2.5 billion, with the goal of bringing a successful hepatitis C drug to market.

    R&D fared much better, however, in successfully developing the anticancer drug Yervoy® (ipilimumab), approved by FDA in 2011 for late-stage metastatic melanoma, and Eliquis®, which won agency approval late last year to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

    BMS envisions the new drugs and others like Forxiga as a “string of pearls” or linchpins of its future portfolio as the company looks to replace revenue lost since patent protection for Plavix ended in May 2012. Worldwide net sales of the drug all but collapsed last year to $49 million, from $1.672 billion in 2011. BMS will announce first-quarter 2013 results on April 25.

    Forxiga, approved in Europe for type 2 diabetes, was co-developed and co-commercialized with AstraZeneca. BMS’ announcement also credited Dr. Cuss with playing a key role in bringing the company’s pipeline successes to market, particularly in hepatitis C and PD-1.

    Days before naming Dr. Cuss as CSO, BMS announced a pair of key R&D moves. On Friday, BMS and Vertex Pharmaceuticals said they will team up to conduct Phase II studies of a once-daily combination therapy designed to fight hepatitis C by wedding BMS’ investigational NS5A replication complex inhibitor daclatasvir to Vertex' investigational nucleotide analogue hep C virus (HCV) polymerase inhibitor VX-135.

    Earlier last week, BMS confirmed it will shut down the San Diego operations it acquired last summer when it bought diabetes drug pioneer Amylin Pharmaceuticals, saying the shutdown would improve BMS’ efficiency and eliminate redundant jobs. About 420 staffers work for BMS in San Diego. An as-yet unknown number will be considered for relocation; the rest will be laid off.


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