Tuesday, Apr 18, 2017

Genentech to Present New Data at AAN Reinforcing Efficacy And Safety of Newly FDA Approved Ocrevus (Ocrelizumab) in Two Types of Multiple Sclerosis

Data presentations will include platform sessions and posters across relapsing multiple sclerosis and primary progressive multiple sclerosis

South San Francisco, CA -- April 18, 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 forms of multiple sclerosis (RMS) and primary progressive MS (PPMS) will be presented during the 69th American Academy of Neurology (AAN) Annual Meeting from April 22-28 in Boston, Massachusetts.

Data presented across three platform sessions will describe the rapid benefit of OCREVUS in RMS patients in the first eight weeks of treatment and its effect on fatigue in PPMS patients. Efficacy and safety data from the open-label extension study will also be presented, as well as the effect of OCREVUS on active disease and progression in PPMS.

“OCREVUS is the only disease-modifying therapy approved by the FDA for people with primary progressive MS and offers people with relapsing MS a new treatment option with a favorable benefit-risk profile,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The data being presented at AAN will demonstrate how rapidly OCREVUS controls disease activity and reduces brain MRI lesions in people with early RMS, both of which are important goals of treatment.”

Leading investigators will present the following oral and poster presentations:

Abstract Title

Abstract Number (type), Presentation Date, Time

Rapid Onset of Ocrelizumab Suppression of Brain MRI Activity in Relapsing-Remitting Multiple Sclerosis

S12.008 (oral), Monday, April 24, 2:24 p.m. EDT

Multimodal Evoked Potentials in Primary Progressive MS: A Potential Biomarker for Prognosis and Course

P2.350 (poster), Monday, April 24, 5:00 p.m. EDT

Rapidity of Onset of Ocrelizumab Clinical Efficacy in Relapsing Multiple Sclerosis

S31.002 (oral), Wednesday, April 26, 1:12 p.m. EDT

Preliminary Results of the OPERA I and OPERA II Open-Label Extension Study

S31.004 (oral), Wednesday, April 26, 1:36 p.m. EDT

The Association Between Confirmed Disability Progression and Patient-reported Fatigue in PPMS Patients in the ORATORIO study

S33.006 (oral), Wednesday, April 26, 4:30 p.m. EDT

No Evidence of Disease Activity on Ocrelizumab Treatment in Patients With Early Relapsing Multiple Sclerosis: Pooled Analysis of the Phase III OPERA Studies

P4.391 (poster), Wednesday, April 26, 5:30 p.m. EDT

Evaluation of No Evidence of Progression or Active Disease (NEPAD) in Patients with Primary Progressive Multiple Sclerosis in the ORATORIO Trial

P4.384 (poster), Wednesday, April 26, 5:30 p.m. EDT

Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients with Relapsing and Primary Progressive Multiple Sclerosis

P5.407 (poster), Thursday, April 27, 5:30 p.m. EDT

Effects of Ocrelizumab on Neurofilament Light Chain and Other Biomarkers of Neuroinflammation and Neurodegeneration in MS: OBOE Study Design

P6.337 (poster), Friday, April 28, 4:00 p.m. EDT

Efficacy of Ocrelizumab on Brain MRI Outcomes in Patients with Early Relapsing Multiple Sclerosis: Pooled Analysis of the OPERA Studies

P6.338 (poster), Friday, April 28, 4:00 p.m. EDT

Advanced Myelin-related MRI Measures in Relapsing Multiple Sclerosis Patients Treated with Ocrelizumab or Interferon Beta-1a Over 96 Weeks

P6.371 (poster), Friday, April 28, 4:00 p.m. EDT

Full session details and data presentation listings for the 2017 AAN Annual Meeting can be found at the meeting website: https://www.aan.com/conferences/2017-annual-meeting/ .

OCREVUS received approval from the U.S. Food and Drug Administration (FDA) on March 28, 2017 for the treatment of adult patients with relapsing or primary progressive forms of MS.

Follow Genentech on Twitter via @Genentech and keep up to date with AAN 2017 Annual Meeting news and updates by using the hashtag #AANAM.

About OCREVUS (ocrelizumab)

OCREVUS is a humanized 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.

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 41 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.

All trademarks used or mentioned in this release are protected by law.

 

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