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BMS abandons Pierre Fabre bladder cancer drug

BMS and Pierre Fabre Medicament terminate their license agreement for the development of metastatic bladder cancer chemotherapy agent, vinflunine

US-based Bristol-Myers Squibb and France-headquartered Pierre Fabre Medicament have terminated their license agreement for the development of metastatic bladder cancer chemotherapy agent, vinflunine.

The treatement was developed by Pierre Fabre Medicament and licensed to BMS in 2004 for specific territories.

A review of the clinical development programme and the recent decision not to file a new drug application (NDA) for bladder cancer in the US prompted the decision. Both companies have jointly decided that all rights licensed to BMS for the treatment will be returned to Pierre Fabre Medicament.

P Hurteloup, general manager of Pierre Fabre Medicament Oncology Division, said: "In the EU, Pierre Fabre Medicament intends to continue discussions with regulatory authorities and plan to file for the registration of vinflunine for bladder cancer in Q1 FY08. We also are considering a range of further development options, including pursuing the product on a worldwide basis for the treatment of a number of cancers."

Low growth in EU bladder cancer market
An October 2007 Frost & Sullivan report said that the lack of successful treatments was depressing the EU bladder cancer market.

No new drugs have entered the EU market over the past two decades, which has limited the scope for newer and more effective bladder cancer therapeutics. Research results remain disappointing. The report said that the market racked up revenue of USD 128.3m in 2006 and estimates it could increase to USD 163.2m in 2013.

Products in the pipeline for bladder cancer, however, are unlikely to dramatically change the competitive landscape over the long term, as they do not offer substantial improvement or change compared with existing treatments.

The EU bladder cancer market is likely to be considerably impacted from 2013 onwards, when monoclonal antibody treatments, such as GlaxoSmithKline's (GSK) Tykerb (lapatinib) are likely to be filed for this indication.

30th September 2008

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