Bristol-Myers Squibb will not pursue approval of vinflunine in bladder cancer - the lead indication for the novel cytotoxic - after reviewing research, the company said during its Oct. 25 third quarter earnings call.

Bristol and partner Pierre Fabre "are currently reviewing the clinical development plan and are evaluating the ongoing research programs" for the late-stage oncologic, Chief Scientific Officer Elliott Sigal noted.

"The company remains in discussions with the FDA regarding vinflunine," Bristol added in a news release. However, "Based on FDA feedback, the company does not expect to file a New Drug Application for the treatment of bladder cancer."

Bladder cancer was intended as the lead indication for vinflunine, but the company also is studying the therapy in non-small cell lung cancer and breast cancer.

The announcement comes on the heels of FDA approval of another Bristol cancer drug, Ixempra (ixabepilone), for treatment of advanced breast cancer in patients who have failed prior therapy, such as anthracyclines, taxanes and capecitabine (¹ Also see "Bristol’s Breast Cancer Treatment Ixempra Gets FDA Nod" - Pink Sheet, 16 October, 2007.).

Ixabepilone was also approved in combination with capecitabine for the treatment of patients with breast cancer resistant to an anthracycline or a taxane.

Development of vinflunine and Ixempra are part of Bristol's strategy to recapture its leadership in oncology by focusing on novel cytotoxic agents.

While the company declined to offer more details on the plans for vinflunine, it played up the potential for further development of Ixempra.

"We think this is very important to have a novel cytotoxic that will be backbone chemotherapy and backbone to new targeted agents, and we're expanding into biologics, other targets of hormone therapy and immunotherapy," Sigal stated.

Bristol's net sales jumped 22 percent to $5.1 billion in the third quarter, including a three percent favorable foreign currency impact.

The increase was mainly driven by Plavix (clopidogrel) sales, which soared 99 percent, including a 2 percent favorable foreign exchange impact, to $1.25 billion, versus $630 million in the same period in 2006. The comparison to the third quarter of 2006 reflects the adverse impact of Apotex's generic clopidogrel, which had sales estimated to be in the range of $525 million to $600 million.

-Brooke McManus (b.mcmanus@elsevier.com)

Bristol Halts Development Of Vinflunine In Bladder Cancer

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