Genentech to Present New Data in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder at MSVirtual2020

• New data further reinforce Ocrevus (ocrelizumab) as a highly effective treatment option offering a favorable and consistent benefit:risk profile, with high treatment persistence and adherence
• Initiation of Phase IIIb Ocrevus higher dose clinical trial program and Phase IV study evaluating Ocrevus in minority populations
• Initiation of Phase III clinical trial program for fenebrutinib, an investigational medicine designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, which may offer novel approach to suppress disease activity and slow disease progression in MS
• New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with Enspryng (satralizumab-mwge), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD)

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) data will be presented at MSVirtual2020, the 8th Joint Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) - European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Meeting from September 11 – 13, 2020.

“While conditions of the nervous system are some of the most complex to understand and treat, we are committed to following the science to reduce relapses in NMOSD and slow and eventually stop disease progression in MS,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “From the success of our first-in-class B cell MS therapy Ocrevus, we are poised to continue advancing the science in MS with our new investigational BTK inhibitor fenebrutinib, and in NMOSD with the recent FDA approval of Enspryng.”

Multiple Sclerosis (MS)

New analyses from the two-year open-label Phase IIIb CASTING study will show patients with relapsing-remitting MS (RRMS) who experienced a prior suboptimal response to one or more disease-modifying therapies (DMTs) achieved a high rate of no evidence of disease activity (NEDA) after switching to Ocrevus. Other data to be presented will show high treatment persistence and strong adherence for patients treated with Ocrevus compared to other DMTs in real-world settings. Additionally, new longer-term safety data will reinforce the consistently favorable benefit:risk profile of Ocrevus.

We are exploring potential optimization of Ocrevus, our first-in-class B cell therapy, in a large Phase IIIb clinical trial program to evaluate the impact of higher dose Ocrevus on reducing disability progression in relapsing MS (RMS) and primary progressive MS (PPMS). This decision was based on a post-hoc analyses from the pivotal RMS and PPMS studies presented at the American Academy of Neurology Annual Meeting 2019, which showed higher Ocrevus exposure was associated with lower B-cell levels and with less disability progression, without any associated impact on safety.

Genentech is also deeply committed to addressing barriers to clinical trial participation and advancing inclusive research. The study design of the recently initiated CHIMES (CHaracterization of ocrelizumab In Minorities with multiplE Sclerosis) trial, an open-label, multi-center Phase IV study evaluating disease activity and neurological biomarkers in African-American and Hispanic- and Latinx-American people with RMS treated with Ocrevus, will be presented.

Genentech’s commitment to potentially slow or stop disease progression continues with the Phase III clinical trial program initiation of fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor in RMS and PPMS. Fenebrutinib is designed to be a highly selective small molecule and is the only reversible non-covalent BTK inhibitor currently in Phase III development in MS.

Neuromyelitis Optica Spectrum Disorder (NMOSD)

New data show Enspryng lowered relapse severity in people with NMOSD in double-blind periods of SAkura Phase III studies. Pooled data from SAkura open-label extension (OLE) studies also showed Enspryng significantly reduced risk of relapse, further reinforcing the findings from the double-blind period. Preventing relapses, the most severe of which cause cumulative, irreversible neurological damage and disability, is the primary goal for NMOSD disease management.

On August 14, Enspryng was approved by the U.S. Food and Drug Administration (FDA) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive NMOSD, a rare disabling neurological disorder often mistaken for MS. Enspryng can be self-administered every four weeks by a person living with NMOSD or a caregiver, after an initial loading dose and following training by a healthcare provider.

Until recently, people living with NMOSD did not have medicines specifically tested and designed to treat the condition. Many people with NMOSD remain misdiagnosed and untreated.

New data from the double-blind and OLE trials continue to build on one of the largest pivotal clinical trial programs undertaken for this rare neurological disease, further demonstrating Enspryng’s sustained efficacy and favorable safety profile in adults with NMOSD.

Follow Genentech on Twitter via @Genentech and keep up to date with MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting news and updates by using the hashtag #MSVIRTUAL2020.

A full list of Genentech presentations can be found at: https://cslide.ctimeetingtech.com/msdc2020/attendee/confcal/session

Presentations at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting include:

About Ocrevus^® (ocrelizumab)

Ocrevus is the first and only therapy approved for both RMS (including clinically isolated syndrome, RRMS and active, or relapsing, SPMS) and PPMS, with dosing every six months. 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 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, suggesting that 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.

Important Safety Information

What is Ocrevus?

Ocrevus is a prescription medicine used to treat:

• Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
• Primary progressive MS, in adults.

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

Who should not receive Ocrevus?

Do not receive Ocrevus if you have an active hepatitis B virus (HBV) infection.

Do not receive Ocrevus if you have had a life threatening allergic reaction to Ocrevus. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past.

What is the most important information I should know about Ocrevus?

Ocrevus can cause serious side effects, including:

• Infusion reactions: Ocrevus can cause infusion reactions that can be serious and require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of Ocrevus for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms:
  • itchy skin
  • rash
  • hives
  • tiredness
  • coughing or wheezing
  • trouble breathing
  • throat irritation or pain
  • feeling faint
  • fever
  • redness on your face (flushing)
  • nausea
  • headache
  • swelling of the throat
  • dizziness
  • shortness of breath
  • fatigue
  • fast heartbeat

These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion.

If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.

• Infection:
  • Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Tell your healthcare provider if you 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 you have received your last dose of Ocrevus. If you have an active infection, your healthcare provider should delay your treatment with Ocrevus until your infection is gone.
  • Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with Ocrevus treatment in clinical trials, PML may happen with Ocrevus. PML is a rare brain infection that usually leads to death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include problems with thinking, balance, eyesight, weakness on 1 side of your body, strength, or using your arms or legs.
  • Hepatitis B virus (HBV) reactivation: Before starting treatment with Ocrevus, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have 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. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Ocrevus.
  • Weakened immune system: Ocrevus taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Before receiving Ocrevus, tell your healthcare provider about all of your medical conditions, including if you:

• have ever taken, take, or plan to take medicines that affect your 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.
  • You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Ocrevus. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Ocrevus and until your healthcare provider tells you that your immune system is no longer weakened.
  • When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Ocrevus. If you would like to receive any ‘non-live’ (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with Ocrevus, talk to your healthcare provider.
  • If you are pregnant or planning to become pregnant talk to your doctor about vaccinations for your baby, as some precautions may be needed.
• are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Ocrevus will harm your unborn baby. You should use birth control (contraception) during treatment with Ocrevus and for 6 months after your last infusion of Ocrevus.
• are breastfeeding or plan to breastfeed. It is not known if Ocrevus passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Ocrevus.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of Ocrevus?

Ocrevus may cause serious side effects, including:

• Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider’s instructions 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For more information, go to http://www.Ocrevus.com or call 1-844-627-3887.

For additional safety information, please see the full Prescribing Information and Medication Guide.

About Enspryng™ (satralizumab-mwge)

Enspryng, which was designed by Chugai, a member of the Roche Group, is a humanized monoclonal antibody that targets IL-6 receptor activity. The cytokine IL-6 is believed to be a key driver in NMOSD, triggering the inflammation cascade and leading to damage and disability. Enspryng was designed using novel recycling antibody technology, which compared to conventional technology, allows for longer duration of the antibody and subcutaneous dosing every four weeks.

Positive Phase III results for Enspryng, as both monotherapy and used concurrently with baseline immunosuppressant therapy, suggest that IL-6 inhibition is an effective therapeutic approach for NMOSD. The Phase III clinical development program for Enspryng includes two studies: SAkuraStar and SAkuraSky.

Enspryng is approved in the U.S., Canada, Japan and Switzerland. Applications are under review with numerous regulators, including in the EU and China.

Enspryng has been designated as an orphan drug in the U.S., Europe and Japan. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018.

What is Enspryng?

Enspryng is a prescription medicine used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive.

It is not known if Enspryng is safe and effective in children.

Important Safety Information

Patients should not take Enspryng if they:

• are allergic to satralizumab-mwge or any of the ingredients in Enspryng
• have an active hepatitis B infection
• have active or untreated inactive (latent) tuberculosis (TB)

Enspryng may cause serious side effects including:

• Infections. Enspryng can increase risk of serious infections some of which can be life-threatening. Patients should speak with their healthcare provider if they are being treated for an infection and call right away if there are signs of an infection, with or without a fever, such as:
  • chills, feeling tired, muscle aches, cough that will not go away or a sore throat
  • skin redness, swelling, tenderness, pain or sores on the body
  • diarrhea, belly pain, or feeling sick
  • burning when urinating or urinating more often than usual

A healthcare provider will check for infection and treat it if needed before starting or continuing to take Enspryng

• A healthcare provider should test for hepatitis and TB before initiating Enspryng
• All required vaccinations should be completed before starting Enspryng. People using Enspryng should not be given ‘live’ or ‘live-attenuated’ vaccines. ‘Live’ or ‘live-attenuated’ vaccines should be given at least 4 weeks before a patient starts Enspryng. A healthcare provider may recommend that a patient receive a ‘non-live’ (inactivated) vaccine, such as some of the seasonal flu vaccines. If a patient plans to get a ‘non-live’ (inactivated) vaccine it should be given, whenever possible, at least 2 weeks before starting Enspryng
  • Increased liver enzymes. A healthcare provider should order blood tests to check patient liver enzymes before and while taking Enspryng. A healthcare provider will dictate how often these blood tests are needed. Patients should complete all follow-up blood tests as ordered by a healthcare provider. A healthcare provider may wait to start Enspryng if liver enzymes are increased
  • Low neutrophil count. Enspryng can cause a decrease in neutrophil counts in the blood. Neutrophils are white blood cells that help the body fight off bacterial infections. A healthcare provider should order blood tests to check neutrophil counts while a patient is taking Enspryng.
  • Serious allergic reactions that may be life-threatening have happened with other medicines like Enspryng. Patients should call their healthcare provider right away if they have any of these symptoms of an allergic reaction:
    • shortness of breath or trouble breathing
    • swelling of lips, face, or tongue
    • dizziness or feeling faint
    • moderate or severe stomach (abdominal) pain or vomiting
    • chest pain

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

• have or think they have an infection
• have liver problems
• have ever had hepatitis B or are a carrier of the hepatitis B virus
• have had or have been in contact with someone with TB
• have had a recent vaccination or are scheduled to receive any vaccination
• are pregnant, think they might be pregnant, or plan to become pregnant. It is not known if Enspryng will harm one’s unborn baby
• are breastfeeding or plan to breastfeed. It is not known if Enspryng passes into breast milk. Patients should speak with their healthcare provider about the best way to feed one’s baby while on treatment with Enspryng

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

The most common side effects of Enspryng include:

• sore throat, runny nose (nasopharyngitis)
• headache
• upper respiratory tract infection
• rash
• fatigue
• nausea
• extremity pain
• inflammation of the stomach lining
• joint pain

For more information about the risk and benefit profile of Enspryng, patients should ask their healthcare provider.

Patients may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at 1-888-835-2555.

Please see the full Prescribing Information for additional Important Safety Information.

About Genentech in neuroscience

Neuroscience is a major focus of research and development at Genentech and Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, stroke, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism spectrum disorder. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

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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