Biotech company, Biogen Idec (BIIB) and Swiss pharmaceutical giant Roche (RHHBY) recently announced that they have decided to discontinue the development of pipeline candidate ocrelizumab for the treatment of rheumatoid arthritis (RA).
The decision was based on a detailed analysis of safety and efficacy data from the candidates’ RA program, which included four phase III studies. Biogen and Roche arrived at the conclusion that the overall benefit-to-risk profile of ocrelizumab for RA was not favorable considering current treatment options.
While a disappointment, the discontinuation of the development of ocrelizumab for RA indication does not come as a surprise. In March, Biogen and Roche suspended treatment of rheumatoid arthritis patients with ocrelizumab 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 had halted re-dosing in several phase III studies.
The review conducted by the DSMB indicated that the safety risk outweighed the benefits of the drug in the specific patient populations. Serious and opportunistic infections, some which may be fatal, were observed.
The discontinuation of development of ocrelizumab 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.
However, Biogen and Roche are continuing with the development of ocrelizumab for relapsing remitting multiple sclerosis (RRMS). A phase II study that is evaluating ocrelizumab for this indication is ongoing. Data from this study will be presented at the ECTRIMS conference later this year.
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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