Genentech Announces New OCREVUS (Ocrelizumab) Data on Long-Term Disability Benefits in Primary Progressive Multiple Sclerosis and Initiation of Two Global Studies in Progressive MS

Genentech Announces New OCREVUS (Ocrelizumab) Data on Long-Term Disability Benefits in Primary Progressive Multiple Sclerosis and Initiation of Two Global Studies in Progressive MS

• OCREVUS may delay the need for a wheelchair by seven years for people with primary progressive multiple sclerosis (PPMS)
• Longer-term efficacy and safety data are consistent with OCREVUS’ favorable benefit-risk profile for both PPMS and relapsing MS (RMS)
• Two new Phase IIIb studies for OCREVUS in progressive MS will use novel endpoints to evaluate upper-limb function and disability progression
• FLOODLIGHT Open, a study that uses smartphone-based technology to monitor MS disease progression, is now enrolling in the United States
• OCREVUS approved in more than 60 countries, with 50,000 patients treated globally to date

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new OCREVUS^® (ocrelizumab) data will be presented at the 4^th Congress of the European Academy of Neurology (EAN) from June 16-19 in Lisbon, Portugal. The new Phase III data analyses show OCREVUS may provide meaningful disability benefits such as delay in the need for a wheelchair for people with primary progressive multiple sclerosis (PPMS). Genentech continues its commitment to people with progressive forms of MS by initiating two new global Phase IIIb studies that will evaluate the efficacy of OCREVUS in a broad range of people with progressive forms of MS.

In a new exploratory analysis from the extended control period of the Phase III ORATORIO study in PPMS, OCREVUS may significantly delay the time to need a wheelchair by seven years, as measured by the length of time until a person reaches Expanded Disability Status Scale seven or greater (EDSS≥7) using 24-week confirmed disability progression (CDP). People treated with OCREVUS had a 46 percent reduction in the risk of progressing to a wheelchair compared to the placebo-treated group (6.2 percent vs. 9.8 percent risk, respectively, p=0.022). When these results were extended (extrapolated) to calculate the median time-to-wheelchair, the data suggest OCREVUS treatment may delay the need for a wheelchair by seven years (19.2 years for OCREVUS vs. 12.1 years for placebo).

“To a person living with primary progressive MS, for whom disability accumulates twice as fast as in relapsing MS, seven more years without the need for a wheelchair could extend the time they can live independently in their home, continue working or looking after their families,” said Helmut Butzkueven, Professor and Chair of MS and Neuroimmunology Research at Central Clinical School, Monash University, Head of MS and Neuroimmunology Service at Alfred Health and Director of MS Service at Eastern Health. “The data at EAN show the significant impact that OCREVUS, the first disease-modifying medicine for PPMS approved in more than 60 countries around the world, can have on people with MS with the greatest unmet need.”

Additionally, the analysis showed that the placebo-treated patient population studied in ORATORIO had similar disability progression rates to an untreated real-world PPMS population. The extrapolated median time to wheelchair (EDSS≥7) for placebo-treated people in the ORATORIO study was 12.1 years compared to 12.4 years for people with PPMS in the real-world MSBase registry.

Longer-term safety data presented at EAN representing 3,778 RMS and PPMS patients and 9,474 patient years of exposure to OCREVUS, across all OCREVUS clinical trials, remain consistent with the medicine’s favorable benefit-risk profile. As of June 2018, over 50,000 people have been treated globally with OCREVUS.

In parallel to EAN and following the success of Genentech’s first MS Forum in 2017, Genentech will be hosting a live MS Forum: ‘Maintaining Independence in Progressive Multiple Sclerosis’ on Monday, June 18, 4:00 – 5:00 p.m. CEST. Registration can be made here: http://livestream.videum.com/roche/ms/.

Follow Genentech on Twitter via @Genentech and keep up to date with EAN 2018 news and updates by using the hashtag #EAN2018.

OCREVUS is now approved in over 60 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union. Marketing applications are currently under review in more than 20 countries across the world.

FLOODLIGHT Open now enrolling in the U.S.

FLOODLIGHT Open is a new global study using Roche and Genentech’s proprietary FLOODLIGHT mobile technology to collect and monitor anonymized patient data to help gain a better understanding of MS disease progression. The FLOODLIGHT mobile technology assesses sensor-based outcomes from a series of active neurological tests and passive monitoring through the use of patients’ smartphones. An ongoing pilot study, most recently presented at the 2018 American Academy of Neurology Annual Meeting, supports the FLOODLIGHT mobile technology as a potential complement to in-clinic testing that may provide a more complete and consistent picture of a patient’s underlying disease activity and its effect on disability progression. FLOODLIGHT Open is an observational, open access study aimed to enroll 10,000 people globally, including people with relapsing and progressive forms of MS, within five years. Data will be available through an open access database that is accessible to the entire MS research community. For more information on the FLOODLIGHT Open study and how to enroll, visit http://www.floodlightopen.com.

New progressive MS studies initiating in 2018

Many people with progressive MS eventually transition into a wheelchair, which means that maintaining the ability to use their hands and arms is important, especially in later stages of the disease. To advance the clinical understanding of MS progression and the importance of maintaining upper-limb function in people with progressive MS, Genentech will be initiating two new Phase IIIb studies of OCREVUS in 2018.

A first-of-its-kind study, ORATORIO-HAND, will evaluate the long-term safety and efficacy of OCREVUS in people with PPMS later in their disease course (with an EDSS score three to eight) and the Nine-Hole Peg Test (9-HPT) — a measure of arm, wrist and hand function — will be used as the primary efficacy outcome. A key secondary endpoint is 12-week CDP. This multi-center, randomized, placebo-controlled, double-blind study is planned to start before the end of 2018 and will enroll approximately 1,000 people with PPMS.

“Addressing the needs of people with progressive MS, who are typically more advanced in their disease course, is one of the major frontiers in MS research. Around a third of people living with progressive MS may already be confined to a wheelchair, so maintaining hand and arm function is essential for them to stay independent and lead active lives,” said lead trial investigator Gavin Giovannoni, Professor of Neurology at Barts and The London School of Medicine and Dentistry, Queen Mary University of London. “For a number of years, through our #ThinkHand campaign, we have been urging industry to conduct a study looking at upper limb function in people with advanced MS. We’re pleased that in collaboration with Roche and Genentech, we will conduct a clinical trial that uses hand function as a primary outcome for the first time.”

The second study, named CONSONANCE, will evaluate the efficacy of OCREVUS in the complete spectrum of progressive MS (PPMS and secondary progressive MS (SPMS)). The CONSONANCE study will measure the long-term effectiveness of OCREVUS in progressive MS with novel composite disability endpoints, including No Evidence of Progression (NEP) and No Evidence of Progression or Active Disease (NEPAD), in addition to a wide range of patient-relevant measures and advanced MRI outcomes. The four-year, Phase IIIb study is currently enrolling 600 people with PPMS or SPMS (in a 1:1 ratio) from across 26 countries. The study will also explore whether technology-enabled, continuous sensor-based and self-administered measures may detect changes in disability progression earlier than conventional clinical measures.

Genentech presentations at EAN 2018

Leading investigators will present the following oral and poster presentations at EAN 2018:

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

OPERA I and OPERA II are Phase III, randomized, double-blind, double-dummy, global multi-center studies evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS. In these studies, relapsing MS (RMS) was defined as relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) with relapses. 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.

About the ORATORIO study in primary progressive MS

ORATORIO is a Phase III, randomized, double-blind, global multi-center study evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 people with primary progressive MS (PPMS). The blinded treatment period of the ORATORIO study continued until all patients had received at least 120 weeks of either OCREVUS or placebo and a predefined number of confirmed disability progression (CDP) events was reached overall in the study. 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.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic disease that affects an estimated 400,000 people in the U.S., for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults.

Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85 percent of people with MS are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive MS (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of MS (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15 percent of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS, there have been no FDA approved treatments for PPMS.

People with all forms of MS experience disease activity – inflammation in the nervous system and permanent loss of nerve cells in the brain – even when their clinical symptoms aren’t apparent or don’t appear to be getting worse. An important goal of treating MS is to reduce disease activity as soon as possible to slow how quickly a person’s disability progresses. Despite available disease-modifying treatments (DMTs), some people with RMS continue to experience disease activity and disability progression.

About OCREVUS® (ocrelizumab)

OCREVUS is a humanized monoclonal antibody designed to 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 multiple sclerosis (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 initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.

OCREVUS U.S. Indication

OCREVUS is a prescription medicine used to treat adults with relapsing or primary progressive forms of multiple sclerosis.

It is not known if OCREVUS is safe or effective in children.

Important Safety Information

Who should not receive OCREVUS?

Do not receive OCREVUS if you are a patient that has an active hepatitis B virus (HBV) infection. Do not receive OCREVUS if you are a patient that has had a life threatening allergic reaction to OCREVUS. Patients should tell their healthcare provider if they have had an allergic reaction to OCREVUS or any of its ingredients in the past.

What is the most important information about OCREVUS?

OCREVUS can cause serious side effects, including:

• Infusion Reaction: OCREVUS can cause infusion reactions that can be serious and require a patient to be hospitalized. A patient will be monitored during the infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Patients should tell their healthcare provider or nurse if they get any of these symptoms: itchy skin, rash, hives, tiredness, coughing or wheezing, trouble breathing, throat irritation or pain, feeling faint, fever, redness on the face (flushing), nausea, headache, swelling of the throat, dizziness, shortness of breath, fatigue, fast heart beat.
  
  These infusion reactions can happen for up to 24 hours after the infusion. It is important that patients call their healthcare provider right away if they get any of the signs or symptoms listed above after each infusion. If a patient gets infusion reactions, the healthcare provider may need to stop or slow down the rate of the infusion.

• Infection: OCREVUS increases a patient’s risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Patients should tell their healthcare provider if they have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or signs of herpes (such as cold sores, shingles, or genital sores). These signs can happen during treatment or after a patient has received their last dose of OCREVUS. If a patient has an active infection, their healthcare provider should delay treatment with OCREVUS until the infection is gone.
• Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with OCREVUS treatment, PML may happen with OCREVUS. PML is a rare brain infection that usually leads to death or severe disability. Patients should tell their healthcare provider right away if they have any new or worsening neurologic signs or symptoms. These may include problems with thinking, balance, eyesight, weakness on one side of the body, strength, or using arms or legs.
• Hepatitis B virus (HBV) reactivation: Before starting treatment with OCREVUS, a patient’s healthcare provider will do blood tests to check for hepatitis B viral infection. If a patient has ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with OCREVUS. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. A healthcare provider will monitor a patient if they are at risk for hepatitis B virus reactivation during treatment and after they stop receiving OCREVUS.
• Weakened immune system: OCREVUS taken before or after other medicines that weaken the immune system could increase a patient’s risk of getting infections.

Before receiving OCREVUS, patients should tell their healthcare provider about all of their medical conditions, including if they:

• have ever taken, take, or plan to take medicines that affect the immune system, or other treatments for MS.
• have ever had hepatitis B or are a carrier of the hepatitis B virus.
• have had a recent vaccination or are scheduled to receive any vaccinations. A patient should receive any required vaccines at least 6 weeks before they start treatment with OCREVUS. A patient should not receive certain vaccines (called ‘live’ or ‘live attenuated’ vaccines) while being treated with OCREVUS and until their healthcare provider tells them that their immune system is no longer weakened;
• are pregnant, think that they might be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm an unborn baby. Patients should use birth control (contraception) during treatment with OCREVUS and for 6 months after the last infusion of OCREVUS;
• are breastfeeding or plan to breastfeed. It is not known if OCREVUS passes into the breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if the patient takes OCREVUS.

What are possible side effects of OCREVUS?

OCREVUS may cause serious side effects, including:

• Risk of cancers (malignancies) including breast cancer. Patients should follow their healthcare provider’s recommendations about standard screening guidelines for breast cancer.

Most common side effects include infusion reactions and infections.

These are not all the possible side effects of OCREVUS.

Patients should call their doctor for medical advice about side effects. Patients may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch . Patients may also report side effects to Genentech at (888) 835-2555.

For additional safety information, please see the OCREVUS full Prescribing Information and Medication Guide. For more information, go to http://www.OCREVUS.com or call 1-844-627-3887.

About Genentech in neuroscience

Neuroscience is a major focus of research and development at Genentech and Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com .

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