Media Release

Basel, 29 March 2017

FDA approves Roche's OCREVUS™ (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis

First and only approved disease-modifying therapy for primary progressive form of multiple sclerosis (PPMS) – one of the most disabling forms of multiple sclerosis (MS)

An important new treatment option for people with relapsing forms of MS (RMS) demonstrating superior efficacy on the three major markers of disease activity compared with Rebif®

A favourable benefit-risk profile demonstrated in three large Phase III studies with a diverse patient population, including those early in the disease

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The majority of people with MS have a relapsing form or primary progressive MS at diagnosis.1

"The FDA's approval of OCREVUS is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B-cell targeted therapy", said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "Until now, no FDA-approved treatment has been available to the primary progressive MS community, and some people with relapsing forms of MS continue to experience disease activity and disability progression despite available therapies. We believe OCREVUS, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine."

In two identical RMS Phase III studies (OPERA I & OPERAII), OCREVUS demonstrated superior efficacy on the three major markers of disease activity by reducing relapses per year by nearly half, slowing the worsening of disability and significantly reducing MRI lesions compared with Rebif® (high-dose interferon beta-1a) over the two-year controlled treatment period. A similar proportion of patients in the OCREVUS group experienced serious adverse events and serious infections compared with patients in the high-dose interferon beta-1a group in the RMS studies.

In a separate PPMS Phase III study (ORATORIO), OCREVUS was the first and only treatment to significantly slow disability progression and reduce signs of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years. A similar proportion of patients in the OCREVUS group experienced adverse events and serious adverse events compared with patients in the placebo group in the PPMS study.

The most common side effects associated with OCREVUS in all Phase III studies were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity. Results from these three Phase III studies were recently published in the 19 January 2017 issue of the New England Journal of Medicine (NEJM).2

"This is an exciting day for everyone touched by MS, a disease that strikes in the prime of a person's life when she or he may be starting a career or family", said June Halper, MSN, APN-C, MSCN, FAAN, Chief Executive Officer at the Consortium for MS Centers. "We have eagerly awaited the FDA approval of OCREVUS because it not only offers a new, highly efficacious treatment option for people with relapsing multiple sclerosis, but it is also the first disease-modifying therapy indicated for primary progressive multiple sclerosis, a highly disabling type of this chronic disease. For many people living with MS, this FDA approval is a source of hope."

The OCREVUS Marketing Authorisation Application (MAA) has also been validated by the European Medicines Agency (EMA) and is currently under review.

About OCREVUS (ocrelizumab)

OCREVUS is a humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved.

OCREVUS is administered by intravenous infusion every six months. The first dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.

About the OPERA I and OPERA II studies in relapsing forms of MS

OPERA I and OPERA II are