New Data for Genentech’s Ocrevus Show That After 10 Years of Treatment 77% of People With Relapsing Multiple Sclerosis Were Free From Disability Progression and 92% Continue to Walk Unaided

– 10-year efficacy data highlight Ocrevus’ impact on preventing disability progression and maintaining mobility in both relapsing and progressive forms of multiple sclerosis (MS) –

– 10-year safety data from over 6,000 patients continue to reinforce consistent long-term safety profile of Ocrevus –

– More than 3,200 women with MS treated with Ocrevus reported no increased risk in adverse pregnancy and infant outcomes with real-world analyses showing low risk of relapse during and after pregnancy –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new clinical and real-world data for Ocrevus^® (ocrelizumab) demonstrating its role in continuing to transform care for people living with relapsing or primary progressive multiple sclerosis (RMS or PPMS) presented at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis). Ocrevus is the first and only disease-modifying treatment (DMT) in MS to benefit both people with RMS and PPMS and now has 10 years of follow-up data from its three Phase III trials.

“Ocrevus is the first B-cell therapy approved for RMS and PPMS and it’s remarkable to see that after 10 years of treatment, a great majority of RMS patients remain free from disease progression,” said Stephen Hauser, M.D., chair of the Scientific Steering Committee of the OPERA studies and director of the Weill Institute for Neurosciences at the University of California, San Francisco. “These results signify that people with both RMS and PPMS have more years to spend their days living independently without the need for walking aids or wheelchairs.”

10-year disability outcomes from Phase III Ocrevus open-label extension (OLE) trials

After 10 years of continuous Ocrevus treatment, 77% of patients with RMS were free from disability progression based on 48-week confirmed disability progression (CDP) events and 92% of patients were still walking unassisted. In patients with PPMS, 36% were free from disability progression based on 48-week CDP events and 80% of those patients treated continuously with Ocrevus over 10 years were still able to walk. These long-term data reinforce the critical importance of early treatment in preserving function across the MS spectrum, showing a lower risk of reaching disability events in patients with RMS and PPMS who initiated Ocrevus treatment earlier (initiating at the start of the double-blind studies vs. the start of the OLEs).

10-year safety profile of Ocrevus

New safety data from 6,155 patients with 28,269 patient-years of exposure to Ocrevus across 12 clinical trials further support the medicine’s favorable benefit-risk profile, which has remained consistent over 10 years. The risk characteristics of Ocrevus in the all-exposure population (RMS and PPMS) remained consistent with the characteristics observed during the controlled treatment periods. Serious infections and malignancy rates remain within the range reported for patients with MS in real-world registries. Longer exposure to Ocrevus did not lead to an increased risk of serious infections regardless of the immunoglobulin G (IgG) status of the patients (normal levels or levels below the lower limit of normal). No new or unexpected safety signals were seen in patients treated with Ocrevus in ongoing clinical trials.

Real-world analyses on pregnancy & infant outcomes and postpartum relapses

Family planning is an essential aspect in the care of women living with MS, many of whom are of child-bearing age. Genentech safety data from 3,253 cumulative pregnancies in women with MS do not suggest an increased risk of adverse pregnancy or infant outcomes in women with MS treated with Ocrevus. Outcomes were known for 1,145 prospectively reported pregnancies and 512 of these had in utero exposure to Ocrevus. Respective outcomes from these two groups were: 83.6% and 84.2% live births (1.3% and 1.6% with major congenital anomalies); 1.2% and 0.8% ectopic pregnancy; 5.1% and 7.4% elective terminations; 10.0% and 7.4% spontaneous abortions; <0.1% and 0.2% still birth. In utero exposure to Ocrevus did not increase the risk of adverse pregnancy or infant outcomes compared with the epidemiological background of both the MS and general populations.

“Some women affected by MS may be thinking about starting a family, so it is important to understand how their treatment prior to pregnancy may impact them and their unborn child,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “With more than 300,000 people treated globally and 30 ongoing trials, we continue to accrue robust evidence for how Ocrevus may benefit many underrepresented groups including pregnant women.”

Furthermore, a real-world analysis from the international MSBase registry based on data from 1,722 women living with MS receiving different DMTs suggests that women who conceived during Ocrevus treatment or soon after their last dose are at low risk for relapse during pregnancy and postpartum. During pregnancy, the annualized relapse rate (ARR) was 0.00 for women previously treated with Ocrevus vs. 0.05 to 0.32 for other DMTs. The postpartum ARR was 0.09 for women treated with Ocrevus vs. 0.10 to 0.74 for other DMTs. Genentech is committed to generating further data on family planning priorities by assessing pregnancy and infant outcomes including infant B-cell levels through routine pharmacovigilance activities, post-marketing commitments and two ongoing Phase IV studies, MINORE (placental transfer and infant outcomes) and SOPRANINO (breastmilk transfer and infant outcomes).

More than 300,000 people with MS have been treated with Ocrevus globally. Ocrevus is approved in more than 100 countries across North America, South America, the Middle East, Eastern Europe, Asia, Australia, Switzerland, the United Kingdom and the EU.

Genentech is committed to advancing innovative clinical research programs to broaden the scientific understanding of MS, further reducing disability worsening in RMS and PPMS and improve treatment experiences for those living with the disease. There are more than 30 ongoing Ocrevus clinical trials designed to help us better understand MS and its progression.

About Ocrevus

Ocrevus is the first and only therapy approved for both relapsing forms of MS (RMS) (including relapsing-remitting MS [RRMS] and active, or relapsing secondary progressive MS [SPMS]), in addition to clinically isolated syndrome [CIS] in the U.S.) and primary progressive MS (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.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic disease that affects more than 2.8 million people worldwide. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (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.

People with all forms of MS experience disease progression – permanent loss of nerve cells in the central nervous system – from the beginning of their disease even if their clinical symptoms aren’t apparent or don’t appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with MS, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating MS is to slow, stop and ideally prevent disease activity and progression as early as possible.

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% 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% of people with MS are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus, there had been no FDA-approved treatments for PPMS.

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 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: 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.

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

Please see additional Important Safety Information throughout and click here for the full Prescribing Information and Medication Guide.

About Genentech in Neuroscience

Neuroscience is a major focus of research and development at Genentech. 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 MS, spinal muscular atrophy (SMA), neuromyelitis optica spectrum disorder (NMOSD), Alzheimer’s, Huntington’s, Parkinson’s, acute ischemic stroke, Duchenne muscular dystrophy and Angelman syndrome. 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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