Biotech company Biogen Idec (BIIB) and Swiss pharmaceutical giant Roche recently suffered a setback with one of their pipeline candidates, ocrelizumab, due to safety related issues.
Biogen and Roche announced that they have suspended treatment of rheumatoid arthritis (RA) patients based on a recommendation issued by an independent Data and Safety Monitoring Board (DSMB).
Concerns regarding the safety of the drug were raised in October 2009, when a safety review of ocrelizumab in RA and lupus nephritis (LN) studies showed an imbalance in opportunistic infections in patients being treated with the candidate. At that time, the companies halted re-dosing in several ongoing phase III studies.
The recent review conducted by the DSMB indicates that the safety risk outweighs the benefits of the drug in the specific patient populations. Serious and opportunistic infections, some which may be fatal, were observed.
A detailed analysis of all the clinical data on ocrelizumab will be conducted to help determine the future development path for the candidate in the treatment of RA. Meanwhile, a phase II study which is evaluating ocrelizumab for Relapsing Remitting Multiple Sclerosis (RRMS) is ongoing.
The suspension of development of ocrelizumab and uncertainty regarding future development plans for the candidate is disappointing for both Roche and Biogen. Ocrelizumab is a second-generation Rituxan product, which could have hit the market in the 2011/2012 timeframe if developed successfully. Even if ocrelizumab eventually gains approval, safety concerns could limit the commercial potential of the drug.
We currently have a Neutral recommendation on Biogen. Key products Avonex and Tysabri, continue to contribute significantly to sales, and we expect Biogen to maintain its leading position in the multiple sclerosis market.
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