Teva’s COPAXONE® 40mg – Favorable Response from European Patent Office
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that a three-member panel of the European Patent Office’s (EPO) Opposition Division upheld patent EP 2 949 335 covering Teva’s COPAXONE® 40mg product in Europe. The Opposition Division will issue its written underlying rationale on the decision within a few months.
COPAXONE® is a highly complex molecule for which consistent proprietary manufacturing methods are required. These determine the composition, purity and batch-to-batch consistency of COPAXONE®. The patent protects the three-times-weekly subcutaneous injection of 40 mg/mL (“40mgTIW”) of glatiramer acetate for the treatment of certain forms of multiple sclerosis.
Richard Daniell, Executive Vice President Teva Europe noted: “We are pleased that the EPO agreed with Teva’s stance on the patent for COPAXONE® 40mg. Teva will continue to robustly defend the validity of the intellectual property portfolio protecting COPAXONE® 40mg.” Teva has already obtained preliminary injunction orders on the basis of European patent EP 2 949 335 to prevent the commercialization of follow on glatiramer acetate in Belgium, Denmark and Slovakia.
“We believe in the value of COPAXONE®, a treatment that has been studied extensively for more than 20 years and has 2.5 million years of patient experience. We remain strongly committed in the field of neurosciences and are privileged to improve people’s lives in the field of multiple sclerosis”.
COPAXONE® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. 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. See additional important information at: www.CopaxonePrescribingInformation.com. For hardcopy releases, please see enclosed full prescribing information. The COPAXONE® brand is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.
According to the European Multiple Sclerosis Platform (EMSP) more than 700,000 people in Europe are affected by MS. The prevalence of MS in women is more than twice as high as in men.1 MS is more common among women of childbearing age.2 The average age of diagnosis is approximately 30 years3
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 43,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the European Patent Office’s Opposition decision to uphold patent EP 2 949 335 covering Teva’s COPAXONE® 40mg product in Europe, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
- the uncertainty of our continued ability to successfully defend our IP rights relating to COPAXONE® 40mg;
- our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; the uncertainty of commercial success of AJOVY® and AUSTEDO®; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; and the effectiveness of our patents and other measures to protect our intellectual property rights;
- our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
- our business and operations in general, including: failure to effectively execute our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel; variations in intellectual property laws that may adversely affect our ability to manufacture our products; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets ;
- compliance, regulatory and litigation matters, including: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into selling and marketing practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
- other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and 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;
and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2018, including the sections thereof captioned "Risk Factors." 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 contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
1 Bevan S et al. Multiple Sclerosis & Employment in Europe – Literature Summary. The Work Foundation Part of Lancaster University. 2015.
2 National Multiple Sclerosis Society. Pregnancy and Reproductive Issues. Available at: http://www.nationalmssociety.org/Living-Well-With-MS/Family-and-Relationships/Pregnancy. Last accessed May 2017.
3 University of Maryland Medical Center. Multiple Sclerosis. Available at: http://www.umm.edu/health/medical/reports/articles/multiple-sclerosis. Last accessed May 2017...
Kevin C. Mannix
972 (3) 926-7516
+1 (913) 777-3343
972 (54) 888 5898