Teva Canada Innovation Announces Approval of Three-Times-a-Week COPAXONE® 40mg/mL by Health Canada
Montreal, Quebec – August 23, 2016 – Teva Canada Innovation, a subsidiary of Teva Pharmaceutical Industries Ltd., announced today that Health Canada has approved three-times-a-week COPAXONE® (glatiramer acetate) 40 mg/mL injection. This new formulation of COPAXONE® will allow for a less frequent dosing regimen for patients with relapsing remitting multiple sclerosis (RRMS). In addition to the newly approved dose, daily COPAXONE® 20 mg/mL will continue to be available.
Three-times-a-week COPAXONE® 40 mg/mL is expected to become commercially available to patients, by prescription, later this fall. Patients throughout Canada will continue to benefit from Shared Solutions®, a unique and personalized support program from Teva Canada Innovation available to anyone touched by MS including family members, friends, caregivers and health professionals.
Health Canada approval is based primarily on data from the Phase III Glatiramer Acetate LowFrequency Administration (GALA) study, the largest COPAXONE® clinical trial to date 01 which included more than 1,400 patients.
Three-times-a-week COPAXONE® 40 mg/ml was approved by the U.S. Food and Drug Administration in January, 2014 and at the end of June 2016, approximately 61,500 patients were on COPAXONE 40mg. 02 In Europe, the MHRA and other EU member states issued a positive assessment report under the decentralized procedure in December 2014, and since launch, three-times-a-week COPAXONE® 40 mg/ml has been prescribed to more than 36,000 patients.
About COPAXONE® 40 mg/mL Injection
COPAXONE® 40 mg/mL (glatiramer acetate) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Doses of three-times-a-week COPAXONE® 40 mg/mL are injected subcutaneously at least 48 hours apart. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. COPAXONE® is now approved in more than 50 countries worldwide, including Canada, the United States, Russia, Mexico, Australia, Israel, and many European countries.
About Teva Canada Innovation
Teva Canada Innovation (TCI) is a branded, specialty medicines company, with operations in Canada since 1997. TCI’s mission is to introduce new, innovative health care solutions for Canadians in the central nervous system (CNS), respiratory and pain care therapeutic areas. The company also markets brands in women’s health and oncology, and has established partnerships with other Canadians pharmaceutical companies in these areas. Throughout 2017, TCI will introduce a portfolio of new respiratory medicines and technologies to Canada ranging from intuitive rescue and maintenance inhalers to a new targeted biologic option for patients with severe asthma. TCI is a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. For more information, visit www.tevacanadainnovation.ca.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forwardlooking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our specialty products, especially Copaxone® (which faces competition from orally-administered alternatives and a generic version); our ability to integrate Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”) and to realize the anticipated benefits of the acquisition (and
the timing of realizing such benefits); the fact that following the consummation of the Actavis Generics acquisition, we are dependent to a much larger extent than previously on our generic pharmaceutical business; potential restrictions on our ability to engage in additional transactions or incur additional indebtedness as a result of the substantial amount of debt incurred to finance the Actavis Generics acquisition; the fact that for a period of time following the Actavis Generics acquisition, we will have significantly less cash on hand than previously, which could adversely affect our ability to grow; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from investments in our pipeline of specialty and other products; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents,confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures;
governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; adverse effects of political or economic instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; the impact of continuing consolidation of our distributors and customers; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the U.S. Securities and Exchange Commission (the "SEC"). Forward-looking statements speak only as of the date on which they are made and we assume no obligation to update or revise any forward-looking statements or other information, whether as a result of new information, future events or otherwise.