Genentech to Present New Ocrevus (ocrelizumab) Data in Multiple Sclerosis and Continued Research Into Neuromyelitis Optica Spectrum Disorder at ECTRIMS 2022

– Ocrevus data will show significant benefit on slowing disease activity and progression in patients with treatment-naïve early-stage relapsing-remitting multiple sclerosis (RRMS) –

– Largest pregnancy safety data across anti-CD20 medicines for Ocrevus in multiple sclerosis (MS) –

– Nine-year safety data for Ocrevus reinforces its favorable benefit-risk profile –

– New research demonstrates impact of misdiagnosis and delay of starting treatment in neuromyelitis optica spectrum disorder (NMOSD) –

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new Ocrevus^® (ocrelizumab) data and continued research into neuromyelitis optica spectrum disorder (NMOSD) will be presented at the 38^th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from October 26-28, 2022. These data include 35 abstracts, highlighting disease activity and progression results in early-stage relapsing-remitting multiple sclerosis (RRMS), pregnancy outcomes from more than 2,000 women with MS and long-term safety data for Ocrevus, as well as global NMOSD data exploring impact of delayed treatment, clinical characterization of disease severity and stability, and accurate identification of people living with NMOSD through healthcare claims-based algorithms. Finally, the design of a Phase III study evaluating the efficacy and safety of satralizumab in Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD), a rare, chronic and debilitating autoimmune disease primarily affecting the optic nerve, brain and spinal cord, will be presented.

“Our aim is to enable people living with MS and NMOSD to maintain life to the fullest. With over 250,000 people treated with Ocrevus, we continue to see significant reductions in MS disease progression balanced with favorable safety,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are also focused on remaining unmet needs – such as earlier diagnosis and treatment – which is critical to ensure patients are receiving the most appropriate treatment.”

Multiple sclerosis (MS)

Genentech will present 29 MS abstracts, including data from a two-year interim analysis of treatment-naïve, early-stage patients with RRMS from the open label Phase IIIb ENSEMBLE study that will show the positive impact on disease activity and progression when newly diagnosed patients are treated with Ocrevus, and outcomes from the largest cumulative pregnancy dataset for an anti-CD20 MS medicine in more than 2,000 women treated with Ocrevus. Long-term data from all Ocrevus clinical trials in relapsing MS (RMS) and primary progressive MS (PPMS) over nine years will reinforce the consistently favorable benefit-risk profile of Ocrevus.

Neuromyelitis optica spectrum disorder (NMOSD)

Genentech will present five NMOSD abstracts, including the development and testing of a healthcare claims-based algorithm to identify people living with NMOSD. Misdiagnosis of NMOSD is common and associated with a delay in initiating maintenance therapy. This was highlighted in a study looking to develop a clearer understanding of patient characteristics, relapse severity and other drivers of treatment choice.

The development of validated consensus statements on AQP4-IgG seropositive NMOSD management will also be presented with a focus on treatment recommendations including satralizumab; these statements aim to optimize patient outcomes through informed treatment decision making. The characterization of disease severity and stability in NMOSD will also be presented, with the aim of integrating these in worldwide NMOSD clinical practice.

Genentech will also present the study design from a Phase III study that will evaluate the efficacy and safety of satralizumab in MOGAD.

Follow Genentech on Twitter via @Genentech and keep up to date with ECTRIMS 2022 news and updates by using the hashtag #ECTRIMS2022.

About Ocrevus^® (ocrelizumab)

Ocrevus is the first and only therapy approved for both RMS (including RRMS and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the United States) and PPMS. 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.

Indications and 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 and 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: Infusion reactions are a common side effect of Ocrevus, which can be serious and may 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 heart beat

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. Infections are a common side effect, which can be serious. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away. Signs of herpes include cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of Ocrevus. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus until your infection is gone.
  • 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.
    
    
• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability, and has been reported with Ocrevus. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:
  • thinking
  • eyesight
  • strength
  • balance
  • weakness on 1 side of your body
  • using your arms or legs

• Decreased immunoglobulins: Ocrevus may cause a decrease in some types of immunoglobulins. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

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 have a baby and you received Ocrevus during your pregnancy, it is important to tell your baby’s healthcare provider about receiving Ocrevus so they can decide when your baby should be vaccinated.
• 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. Talk with your healthcare provider about what birth control method is right for you during this time.
  • Pregnancy Registry. There is a pregnancy registry for women who take Ocrevus during pregnancy. If you become pregnant while receiving Ocrevus, tell your healthcare provider right away. Talk to your healthcare provider about registering with the Ocrevus Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Your healthcare provider can enroll you in this registry by calling 1-833-872-4370 or visiting http://www.ocrevuspregnancyregistry.com.
• 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.
• Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as:
  • Diarrhea (loose stools) or more frequent bowel movements than usual
  • Stools that are black, tarry, sticky or have blood or mucus
  • Severe stomach-area (abdomen) pain or tenderness

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. You may also report side effects to Genentech at (888) 835-2555.

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^TM (satralizumab-mwge)

Enspryng, which was designed by Chugai, a member of the Roche Group, is a humanized monoclonal antibody that targets interleukin-6 (IL-6) receptor activity. The cytokine IL-6 is believed to be a key driver in NMOSD disease processes, triggering the inflammation cascade and leading to damage and disability. Enspryng was designed using novel recycling antibody technology. When compared to conventional antibodies, Enspryng’s recycling antibody technology enables the medicine to remain in the bloodstream for a longer period of time and bind repeatedly to its target (the IL-6 receptor) - maximally sustaining IL-6 suppression in a chronic disease like NMOSD and enabling subcutaneous dosing every four weeks.

Positive Phase III results for Enspryng, as both monotherapy and in combination with baseline immunosuppressive therapy, suggest that IL-6 inhibition is an effective therapeutic approach for people with NMOSD who are AQP4-IgG seropositive. The Phase III clinical development program for Enspryng includes two studies: SAkuraStar and SAkuraSky.

Enspryng is currently approved in 63 countries, including the United States, Canada, Japan, South Korea and the European Union.

Enspryng has been designated as an orphan drug in the United States, Europe, Japan and Russia. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018, which is given to treatments that may demonstrate substantial improvement over other available options.

Indications and 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 ground-breaking 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, Alzheimer’s disease, Parkinson’s disease 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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