South San Francisco, CA April 16, 2018 Genentech Press Release
- Breadth of data will reinforce efficacy and safety of OCREVUS in relapsing and primary progressive multiple sclerosis and demonstrate its benefits in slowing disability progression, including new cognitive and biomarker results
- Important research in Alzheimer’s disease, Huntington’s disease, Spinal muscular atrophy and Duchenne muscular dystrophy will highlight the strength of Genentech’s neuroscience pipeline
SOUTH SAN FRANCISCO, CA — 2018-04-15 00:00:00
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data on its approved and investigational medicines for neurological conditions will be presented during the 70th American Academy of Neurology (AAN) Annual Meeting from April 21-27 in Los Angeles, California. These data will reinforce the efficacy and safety of OCREVUS® (ocrelizumab) and expand the clinical understanding of disability progression in multiple sclerosis (MS). They will also represent investigational research from the Genentech neuroscience pipeline in Alzheimer’s disease, Huntington’s disease, Spinal muscular atrophy (SMA) and Duchenne muscular dystrophy (DMD).
“Our neuroscience pipeline is one of the deepest and most diverse in the industry, spanning both common and rare neurological conditions with the greatest unmet need,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “OCREVUS is now approved in over 55 countries with more than 40,000 people treated. We remain committed to continuing our research and development to understand MS progression further and help those living with MS and their physicians.”
OCREVUS data will show significant and sustained efficacy as well as benefits in cognition in people with relapsing MS (RMS). The early impact of OCREVUS on biomarkers of inflammation and neurodegeneration in people with RMS will be shared for the first time through the OBOE (Ocrelizumab Biomarker Outcome Evaluation) study.
Additional notable MS presentations include updated safety analyses for OCREVUS, which will further inform and reinforce its continued favorable benefit-risk profile. New data from the FLOODLIGHT pilot study, which support mobile technology as a complement to in-clinic testing to provide a more complete and real-time picture of a patient’s underlying disease activity, will also be presented.
Encouraging data from other investigational medicines in Genentech’s neuroscience pipeline will also be presented:
- Alzheimer’s disease is an important area of focus for Genentech. Four presentations on investigational anti-amyloid beta antibodies crenezumab and gantenerumab show promise in Genentech’s Alzheimer’s disease pipeline, and the findings have informed the design for both the CREAD and GRADUATE pivotal Phase III trial programs, respectively. In a platform session, data on gantenerumab will be presented showing a significant reduction in brain amyloid beta plaques with a higher dosing regimen (1200 mg) in two Phase III, open label extension studies. Data from these two studies guided the dose and titration regimen selection for the recently initiated Phase III GRADUATE pivotal program investigating gantenerumab for the treatment of early Alzheimer’s disease. Two posters on crenezumab will be presented; one will focus on preclinical data and will discuss its proposed mechanism of action, including data supporting its preferential binding to neurotoxic amyloid beta oligomers. A second poster will describe the results from a safety, tolerability and pharmacokinetics Phase Ib study in doses up to 120 mg. Data from this study were used to determine an optimal dose now used in the ongoing CREAD pivotal program investigating crenezumab for the treatment of early Alzheimer’s disease.
- Data from a Phase I/IIa multiple-ascending dose study of RG6042 (formerly known as IONIS HTTRx) in Huntington’s disease will be presented in a plenary session. These data will highlight the safety and tolerability of this investigational medicine over four monthly doses, demonstrate dose-dependent lowering of the mutant huntingtin protein (mHTT), and show additional exploratory analyses from this first-in-human study. These results for RG6042 are the first data demonstrating lowering of mHTT, the disease-causing protein in people with Huntington’s disease.
- The SMA presentations include late-breaking interim data on the increase in survival of motor neuron (SMN) protein levels following treatment with RG7916 in infants with Type 1 SMA. SMA, the leading genetic cause of mortality in infants and toddlers, is a rare neuromuscular disease caused by a deficiency of SMN protein. RG7916 is an investigational oral SMN2 splicing modifier being developed in collaboration with PTC Therapeutics, Inc. and the SMA Foundation.
- Results from a Phase Ib/II study of the investigational adnectin fusion protein RG6206 in young male adolescents with DMD will also be presented. These data will highlight the myostatin suppression levels achieved and its potential effect in increasing lean body mass volume.
Investigators will present the following plenary, platform and poster presentations:
|Medicine||Abstract Title||Abstract Number (type), Presentation Date, Time|
|OCREVUS (ocrelizumab)||Brain MRI Activity and Atrophy Measures in Patients Receiving Continuous Ocrelizumab or Switching from Interferon Beta-1a to Ocrelizumab Therapy in the Open-label Extension Period of the Phase III Trials of Ocrelizumab in Patients with Relapsing Multiple Sclerosis||S6.002 (platform), Sunday, April 22, 1:12 – 1:24 p.m. PDT|
|Annualized Relapse Rate and Confirmed Disability Progression in Patients Receiving Continuous Ocrelizumab or Switching from Interferon Beta-1a to Ocrelizumab Therapy in the Open-label Extension Period of the Phase III Trials of Ocrelizumab in Patients with Relapsing Multiple Sclerosis||P1.366 (poster), Sunday, April 22, 11:30 a.m. – 5:30 p.m. PDT|
|Confirmed Disability Progression in Different Subgroups of Patients with Relapsing Multiple Sclerosis Who Received Ocrelizumab or Interferon Beta-1a in the Phase III OPERA I and OPERA II Studies||P1.371 (poster), Sunday, April 22, 11:30 a.m. – 5:30 p.m. PDT|
|Establishment of Optimal Bioanalytical Parameters for Measuring Neurofilament Light Chain (Nf-L) in Multiple Sclerosis (MS) Subjects from Clinical Trial Cohorts||P1.413 (poster), Sunday, April 22, 11:30 a.m. – 5:30 p.m. PDT|
|Impact of Ocrelizumab on Cognition in Patients at Increased Risk of Progressive Disease||P1.420 (poster), Sunday, April 22, 11:30 a.m. – 5:30 p.m. PDT|
|Interim Analysis of the OBOE (Ocrelizumab Biomarker Outcome Evaluation) Study in Multiple Sclerosis (MS)||S24.002 (platform), Tuesday, April 24, 3:42 – 3:54 p.m. PDT|
|Ocrelizumab May Reduce Tissue Damage in Chronic Active Lesions as Measured by Change in T1 Hypo-intensity of Slowly Evolving Lesions in Patients with Primary Progressive Multiple Sclerosis||P3.376 (poster), Tuesday, April 24, 11:30 a.m. – 7:00 p.m. PDT|
|Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients with Relapsing and Primary Progressive Multiple Sclerosis||S36.001 (platform), Wednesday, April 25, 3:30 – 3:42 p.m. PDT|
|Effect of Ocrelizumab on Vaccine Responses in Patients with Multiple Sclerosis||S36.002 (platform), Wednesday, April 25, 3:42 – 3:54 p.m. PDT|
|FLOODLIGHT: Remote Self-monitoring is Accepted by Patients and Provides Meaningful, Continuous Sensor-based Outcomes Consistent with and Augmenting Conventional In-clinic Measures||P4.382 (poster), Wednesday, April 25, 11:30 a.m. – 7:00 p.m. PDT|
|Design of the Ocrelizumab Pregnancy Registry to Assess Maternal, Fetal and Infant Outcomes in Women with Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy||P4.367 (poster), Wednesday, April 25, 11:30 a.m. – 7:00 p.m. PDT|
|Design of a Multi-source Post-marketing Study to Evaluate Pregnancy and Infant Outcomes in Women with Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy||P4.372 (poster), Wednesday, April 25, 11:30 a.m. – 7:00 p.m. PDT|
|Time to Cognitive Worsening in Patients with Relapsing Multiple Sclerosis in Ocrelizumab Phase III Trials||S44.005 (platform), Thursday, April 26, 4:18 – 4:30 p.m. PDT|
|Routine Laboratory Measures in the Controlled-treatment Period of Phase III Ocrelizumab Trials in Relapsing and Progressive Multiple Sclerosis||P5.425 (poster), Thursday, April 26, 11:30 a.m. – 7:00 p.m. PDT|
|Baseline Characteristics of the CHORDS Study Population: A Phase III Trial to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with RRMS who had Disease Activity with Prior Disease-modifying Therapies||P6.370 (poster), Friday, April 27, 11:30 a.m. – 5:30 p.m. PDT|
|Real-world Experience with Ocrelizumab||P6.356 (poster), Friday, April 27, 11:30 a.m. – 5:30 p.m. PDT|
|Crenezumab||Characterization of the Selective In Vivo and In Vitro Binding Properties of Crenezumab: Insights into Crenezumab’s Unique Mechanism of Action||P6.174 (poster), Friday, April 27, 11:30 a.m. – 5:30 p.m. PDT|
|Safety, Tolerability and Pharmacokinetics of Crenezumab in Mild-to-Moderate AD Patients Treated with Escalating Doses for up to 32.3 Months||P6.182 (poster) Friday, April 27, 11:30 a.m. – 5:30 p.m. PDT|
|Gantenerumab||Higher Dose Gantenerumab Leads to Significant Reduction in Amyloid Plaque Burden – Results for the Marguerite and Scarlet Road Open Label Extension Studies||S2.005 (platform), Sunday, April 22, 1:48 – 2:00 p.m. PDT|
|Optimizing the Gantenerumab Phase 3 Dosing Regimen Through PK/PD Modeling and Clinical Trial Simulations||P6.179 (poster), Friday, April 27, 11:30 a.m. – 5:30 p.m. PDT|
|RG7916||RG7916 Significantly Increases SMN Protein in SMA Type 1 Babies||004 (Emerging Science platform), Tuesday, April 24, 5:54 p.m. PDT|
|Updated Pharmacodynamic and Safety Data from SUNFISH Part 1, a Study Evaluating the Oral SMN2 Splicing Modifier RG7916 in Patients with Type 2 or 3 Spinal Muscular Atrophy||P4.453 (poster), Wednesday, April 25, 11:30 a.m. – 7:00 p.m. PDT|
|Preliminary Evidence for Pharmacodynamics Effects of RG7916 in JEWELFISH, a Study in Patients with Spinal Muscular Atrophy Who Previously Participated in a Study with Another SMN2-Splicing Targeting Therapy||S46.003 (platform), Thursday, April 26, 3:54 – 4:06 p.m. PDT|
|Relationship Between Central and Peripheral SMN Protein Increase Upon Treatment with RO7034067 (RG7916)||S46.007 (platform), Thursday, April 26, 4:42 – 4:54 p.m. PDT|
|Olesoxime||A Long-term, Open-label Follow-up Study of Olesoxime in Patients with Type 2 or Non-ambulatory Type 3 Spinal Muscular Atrophy Who Participated in a Placebo-controlled Phase 2 Trial||S46.002 (platform), Thursday, April 26, 3:42– 3:54 p.m. PDT|
|Effects of IONIS-HTTRx in Patients with Early Huntington’s Disease, Results of the First HTT-lowering Drug Trial||CT.002 (plenary session), Tuesday, April 24, 9:15 – 9:27 a.m. PDT|
|RG6206||A Randomized, Placebo-controlled, Double-blind, Phase 1b/2 Study of the Novel Anti-myostatin Adnectin RG6206 (BMS-986089) in Ambulatory Boys with Duchenne Muscular Dystrophy||P5.431 (poster), Thursday, April 26, 11:30 a.m. to 7:00 p.m. PDT|
Full session details and data presentation listings for the 2018 AAN Annual Meeting can be found at the meeting website: https://www.aan.com/
OCREVUS is now approved in over 55 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union. Marketing applications are currently under review in more than 20 countries across the world.
Follow Genentech on Twitter via @Genentech and keep up to date with AAN 2018 Annual Meeting news and updates by using the hashtag #AANAM.
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.
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.