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Sunday, Jun 5, 2016

Phase III Study Shows Genentech’s Actemra® (tocilizumab) Maintained Steroid-Free Remission in People with Giant Cell Arteritis (GCA)

  • The Phase III study, the largest clinical trial ever conducted in GCA, met its primary and key secondary endpoints
  • There have been no new treatments for GCA in more than 50 years
  • Results will be shared with the U.S. Food and Drug Administration (FDA) with the goal of bringing a new treatment to people with GCA

South San Francisco, CA -- June 5, 2016 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III study known as GiACTA, which evaluated Actemra® (tocilizumab) in people with giant cell arteritis (GCA). The study met its primary and key secondary endpoints, showing Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six or 12-month steroid-only regimen in people with newly diagnosed and relapsing GCA. No new safety signals were observed with Actemra in the study at the time of this analysis. Adverse events were similar to those seen in previous Actemra clinical studies.

GCA is a serious condition where arteries, commonly in the head but also the aorta and its branches, become inflamed.1 This inflammation can lead to persistent and severe headaches, scalp tenderness and jaw and arm pain. It is difficult to diagnose and if left untreated, GCA may lead to blindness, stroke or aortic aneurysms.1 Vision problems occur in approximately 30 percent of people with GCA,2 and about 15 percent experience permanent vision loss.3

"These results are encouraging for patients with this rare disease, for which there have been no new treatments in more than 50 years," said Sandra Horning, M.D., Chief Medical Officer and head of Global Product Development. "Currently, long-term high-dose steroids are the mainstay treatment for GCA but they can cause their own serious adverse effects. If approved, Actemra will provide an important new alternative to long-term steroid use for people with GCA."

Approximately 80 percent of people with GCA who are exposed to long-term steroid use experience steroid-related side effects such as cataracts, diabetes, fractures, and hypertension.4 Reducing the use of steroids in this patient group is an important goal for physicians and people living with GCA.

About the GiACTA Study

GiACTA (NCT01791153) is a Phase III, global, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Actemra as a novel treatment for GCA. It is the largest clinical trial ever conducted in GCA and the first to use blinded, variable-dose, variable-duration steroid regimens. The multicenter study was conducted in 251 patients across 76 sites in 14 countries. The study's primary and key secondary endpoints were evaluated at 52 weeks.

GiACTA data will be submitted for presentation at an upcoming medical conference and to the FDA for approval consideration.

About Giant Cell Arteritis

The occurrence of GCA has been estimated at over 200 per 100,000 persons in the U.S. over the age of 50and is two to three times more likely to affect women.1 GCA is often difficult to diagnose due to the wide and variable spectrum of signs and symptoms. With no new treatments for the condition in more than 50 years, people are limited to high-dose steroid treatment that generally fails to cure GCA or induce long-term steroid-free remissions.

About Actemra

Actemra is the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. In addition, Actemra is also used as an IV formulation for patients with active polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA) two years of age and older.

Actemra is intended for use under the guidance of a healthcare practitioner.

Important Safety Information

Actemra can cause serious side effects. Actemra changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections.

Actemra can cause other serious side effects. These include:

  • stomach tears
  • changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels
  • an increased risk of certain cancers by changing the way a patient’s immune system works
  • hepatitis B infection
  • serious allergic reactions, including death. These may happen with Actemra infusions or injections, even if they did not occur with an earlier infusion or injection.
  • nervous system problems

Patients should tell their doctor if they are allergic to Actemra or if they have had a bad reaction to Actemra previously.

Common side effects in patients with RA treated with Actemra:

Patients must tell their doctor if they have these or any other side effect that bothers them or does not go away:

  • Upper respiratory tract infections (like common cold and sinus infections)
  • Headache
  • Increased blood pressure (also called hypertension)
  • Injection site reactions

Common side effects in patients with PJIA or SJIA treated with Actemra:

  • Upper respiratory tract infections (like common cold and sinus infections)
  • Headache
  • Diarrhea

Actemra & pregnancy:

Patients must tell their doctor if they are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. The patient and their doctor should decide if the patient will take Actemra or breast-feed. Patients should not do both. If a patient is pregnant and taking Actemra, they must join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or http://www.FDA.gov/medwatch. Call Genentech at 1-888-835-2555.

Please visit http://www.actemra.com for the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information or call 1-800-ACTEMRA (228-3672).

Actemra is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland and Australia.

About Genentech

Founded 40 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.

References

1 Bhat S, et al. Giant cell arteritis. Midlife and Beyond, GM. Rheumatology 2010; 071-079.

2 Eamonn M, et al. Polymyalgia Rheumatica and Giant Cell Arteritis, Rheumatology and Immunology, Section 13: 1147-1151

3 Borchers A.T., et al. Giant cell arteritis: A review of classification, pathophysiology, geoepidemiology and treatment. Autoimmunity Reviews. 11 (2012): A544-5554

4 Ponte C, et al. Giant cell arteritis: Current treatment and management. World J Clin Cases 2015;3(6):484-94.

5 Lawrence C, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis & Rheum 1998;41:778-99