Biotech Values

[DewDiligence]

Roche/BIIB—Ocrelizumab bested Rebif in two phase-3 trials in relapsing MS:

http://finance.yahoo.com/news/genentech-ocrelizumab-significantly-reduced-both-050000511.html

Treatment with ocrelizumab significantly reduced the annualized relapse rate (ARR) over a two-year period compared with interferon beta-1a, the primary endpoint in both studies. Ocrelizumab also significantly reduced the progression of clinical disability compared with interferon beta-1a, as measured by the Expanded Disability Status Scale (EDSS).

Additionally, treatment with ocrelizumab led to a significant reduction in the number of lesions in the brain (areas of disease activity) compared with interferon beta-1a, as measured by MRI.

It would have been more illuminating if the comparator drug in these trials had been Tecfidera, Gilenya, Aubagio, or Lemtrada—rather than Rebif. (Blinding could have been achieved via use of matching placebos even if the comparator drug had been oral.)

Ocrelizumab is dosed only twice per year by injection. Results from an additional phase-3 trial in PPMS are expected in 2015, and BLA/MAA submissions in RMS are expected in 1Q16.

Roche owns worldwide commercial rights to Ocrelizumab, but it will pay BIIB a substantial royalty on US sales as a consequence of the settlement of litigation pertaining to the longstanding CD20 (Rituxan) partnership between the companies.