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Roche's Primary Progressive MS Drug Positive in Phase III

Roche Holding AGRHHBY announced encouraging results from a randomized, double-blind, global multi-centre phase III study (ORATORIO) on ocrelizumab for the treatment of patients suffering from primary progressive multiple sclerosis (PPMS). The study met its primary endpoint.

In this study, ocrelizumab significantly lowered the progression of clinical disability in patients, as measured by the Expanded Disability Status Scale, which sustained for at least 12 weeks compared to placebo. The incidence of adverse and seriously adverse events in the ocrelizumab arm was similar to that observed in the placebo arm.

Roche intends to present top-line data from the ORATORIO study at the European Committee for Treatment and Research in Multiple Sclerosis on Oct 10, 2015.

We remind investors that in Jun 2015, the company announced the successful completion of two pivotal studies (OPERA I and OPERA II) on ocrelizumab versus Pfizer Inc. PFE /Merck KGaA's MKGAF Rebif for the treatment of relapsing MS. Both studies met their primary and major secondary endpoints.

Roche is looking to submit data from the OPERA I and II studies along with that from the ORATORIO study to regulatory authorities of different countries in early 2016.

According to the Multiple Sclerosis International Federation and National Institutes of Health-National Institute of Neurological Disorders and Stroke, MS is estimated to affect 2.3 million people across the world. Moreover, almost one in 10 people affected by MS are diagnosed with the primary progressive form of the disease. According to the press release by Roche, no drug has yet gained regulatory approval for the treatment of PPMS. The company believes that ocrelizumab is the first candidate to demonstrate a clinically meaningful and statistically significant effect on the progression of disease in patients suffering from PPMS.

In this scenario, positive results from the ORATORIO study are highly encouraging. We believe that Roche stands the chance to gain a large market for its PPMS products, if successfully developed and approved.

Investors may note that Tecfidera, Aubagio and Gilenya are some of the treatments approved for the relapsing forms of MS. In Dec 2014, Novartis NVS announced that its phase III INFORMS study for PPMS failed to show a significant difference between Gilenya and placebo on a combination of disability measures.

Roche carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Eli Lilly and Company LLY , carrying a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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