Sunday, Oct 15, 2017

Genentech to Present New Ocrevus (Ocrelizumab) Efficacy & Safety Data in Relapsing and Primary Progressive Forms of Multiple Sclerosis at ECTRIMS

• Largest body of OCREVUS data presented at a congress to date to reinforce favorable benefit-risk profile and advance clinical understanding of disease progression

South San Francisco, CA -- October 15, 2017 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data on OCREVUS^® (ocrelizumab) in people with relapsing and primary progressive forms of multiple sclerosis (MS) will be presented during the 7th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) – Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting in Paris, France, October 25-28. Eighteen abstracts, including two platform presentations, have been accepted and will be shared during the congress. The data will explore new and existing measures of disease progression, show the effect of OCREVUS on visual outcomes and reinforce its favorable benefit-risk profile.

Research into two newly emerging MS endpoints will be presented, which may help clinicians more closely monitor underlying signs of disease activity that often lead to disability. These data include a post-hoc analysis of the OPERA I and OPERA II studies that show the impact of OCREVUS in people with relapsing MS (RMS) who experience Progression Independent of Relapse Activity (PIRA), a composite measure examining underlying disease activity independent of any influence of acute relapses. Additionally, in a platform presentation, researchers for the first time will share a new method using conventional brain MRI to automatically detect and characterize Slowly Evolving Lesions (SELs), which may represent a biomarker of chronic disease activity in the brain, versus the acute disease activity in MS lesions.

“The data presented at ECTRIMS – ACTRIMS demonstrate the commitment of our scientists and research partners to advance understanding of MS progression through ongoing analyses of the OCREVUS Phase III clinical trials,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “With our studies of two new potential markers of underlying disease activity and their impact on disease progression, we hope to bring new tools to the MS community to better understand and manage the disease.”

In line with this goal, Genentech will also present new data from its FLOODLIGHT clinical trial program investigating sensor-based outcomes from a series of active neurological tests and passive monitoring made possible by the use of a smartphone. The technology enables a continuous stream of precise, real-world MS disease progression data to be collected and analyzed using dedicated algorithms and machine learning.

Among other notable data from Genentech at ECTRIMS – ACTRIMS are results from the extended controlled period of the Phase III ORATORIO study in primary progressive MS (PPMS), which will show the impact of OCREVUS on sustained reduction in confirmed disability progression. Data from open-label extension periods will also show a safety profile consistent with that seen in controlled treatment periods.

Investigators will present the following oral and poster presentations:

Abstract Title	Abstract Number (type), Presentation Date, Time
Ocrelizumab Reduces Disability Progression Independent of Relapse Activity in Patients with Relapsing Multiple Sclerosis	P654 (poster), Thursday, October 26, 3:30 p.m. CET
Ocrelizumab Does Not Modulate Peripheral T Cell Functionality or Prevalence in a Small Subset of Relapsing MS Patients Enrolled in OPERA I, a Phase III Double-blind, Double-dummy Interferon Beta-1a-controlled Study	P659 (poster), Thursday, October 26, 3:30 p.m. CET
T-cell Population Changes and Serious Infection Rates in the Controlled Periods of the Pivotal Phase III Trials of Ocrelizumab in Multiple Sclerosis	P668 (poster), Thursday, October 26, 3:30 p.m. CET
Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients with Relapsing and Primary Progressive Multiple Sclerosis	P676 (poster), Thursday, October 26, 3:30 p.m. CET
Incidence Rates of Malignancies in Patients with Multiple Sclerosis in Clinical Trials and Epidemiological Studies	P686 (poster), Thursday, October 26, 3:30 p.m. CET
Subgroup Analyses of Annualized Relapse Rates in Patients with Relapsing Multiple Sclerosis Who Received Ocrelizumab or Interferon Beta-1a in the Phase III OPERA I and OPERA II Studies	P687 (poster), Thursday, October 26, 3:30 p.m. CET
Subgroup Analyses of No Evidence of Disease Activity in Patients with Relapsing Multiple Sclerosis Who Received Ocrelizumab or Interferon Beta-1a in the Phase III OPERA I and OPERA II Studies	P688 (poster), Thursday, October 26, 3:30 p.m. CET
Effect of Ocrelizumab on B and T Cell Immune Repertoires in Patients with Relapsing Multiple Sclerosis	P693 (poster), Thursday, October 26, 3:30 p.m. CET
An Update on Pregnancy Outcomes Following Ocrelizumab Treatment in Patients with Multiple Sclerosis and Other Autoimmune Diseases	P710 (poster), Thursday, October 26, 3:30 p.m. CET
Association of Brain Volume Loss and NEDA Outcomes in Patients with Relapsing Multiple Sclerosis in the OPERA I and OPERA II Studies	P774 (poster), Thursday, October 26, 3:30 p.m. CET
Detection and Characterization of Slowly Evolving Lesions in Multiple Sclerosis Using Conventional Brain MRI	186 (platform), Friday, October 27, 9:15 a.m. CET
Effect of Ocrelizumab vs that of Interferon Beta-1a on Visual Outcomes in Patients with Relapsing Multiple Sclerosis in the OPERA Studies	192 (platform), Friday, October 27, 9:27 a.m. CET
Interim Analysis from FLOODLIGHT: A Prospective Pilot Study to Evaluate the Feasibility of Conducting Remote Patient Monitoring with the Use of Digital Technology in Patients with Multiple Sclerosis	P1226 (poster), Friday, October 27, 3:30 p.m. CET
Sustained and Durable Reduction in Confirmed Disability Progression in Patients with Primary Progressive Multiple Sclerosis Receiving Ocrelizumab: Findings from the Phase III ORATORIO Study Extended Control Period	P1234 (poster), Friday, October 27, 3:30 p.m. CET
Effect of Ocrelizumab on Upper Limb Function in Patients with Primary Progressive Multiple Sclerosis in the ORATORIO Study	P1236 (poster), Friday, October 27, 3:30 p.m. CET
Infusion-Related Reactions with Ocrelizumab in Phase III Studies	(e-poster)
CSF Cell Signature and Biomarkers of Neuroinflammation and Neurodegeneration in MS: Preliminary Results of the OBOE Study	(e-poster)
Activities of Daily Living, Work Productivity and Reliance on Caregiver in Patients with Primary Progressive Multiple Sclerosis	(e-poster)

Full session details and data presentation listings for the 2017 Joint ECTRIMS – ACTRIMS Meeting can be found on the meeting website: https://www.ectrims-congress.eu/2017.html .

Additionally, Genentech is sponsoring two symposia, including “Beyond the Lightbulb: Exploring the Known Unknown” on Thursday, October 26 at 1:00 p.m. CET in Hall B and “Turning the Lights On: Seeing is Believing” on Friday, October 27 at 6:00 p.m. CET in Hall B.

OCREVUS has been approved for use in countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia and Switzerland. Marketing applications for OCREVUS are currently under review in over 50 countries across the world.

Follow Genentech on Twitter via @Genentech and keep up to date with Joint ECTRIMS – ACTRIMS Meeting news and updates by using the hashtag #MSParis2017.

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 or 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.

 

###