Roche Holdings Ltd. (RHHBY) reported positive data from a mid-stage trial on ocrelizumab, which is also the second set of data that the company reported within a week. The candidate is being studied to treat patients suffering from relapsing-remitting multiple sclerosis (RRMS).
The study showed that a significant reduction in disease activity was maintained through 96 weeks, similar to the previously-reported 24 weeks.
Results demonstrated that none of the patients who were dosed 600 mg of ocrelizumab developed a new or enlarging brain lesion (as measured by MRI), during the 24-96 week treatment period. Further, the annualized relapse rate (ARR), the rate of clinical attacks or flare-ups per patient-year, was less than 0.2 attacks per patient per year across the 96-week period. The data also showed that two-thirds of the patients who completed the study in the 600 mg group were free of any disease activity (as measured by MRI, relapses or neurological progression) over the 96-week treatment period.
We note that Roche has commenced patient enrollment for a late-stage program (Orchestra) of ocrelizumab. The phase III program consists of two studies – one in patients with RRMS (Opera I and II) and the other in patients with primary progressive MS (Oratorio).
Ocrelizumab is being developed by Roche in collaboration with Biogen Idec (BIIB). According to the agreement Roche is responsible for the development and commercialization of ocrelizumab, while Biogen will receive tiered, double-digit royalties on the US sales of the drug.
On approval, ocrelizumab will face competition from Biogen’s Avastin, Novartis’ (NVS) Extavia, among others.
In the short run, we have a Zacks #3 Rank (Hold rating) on Roche.
