JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting a marketing authorization for AJOVY® (fremanezumab) 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. If approved by the European Commission (EC), AJOVY, a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, will be the first and only anti-CGRP treatment in the European Union (EU) with both quarterly and monthly dosing options.
Migraine is a disabling neurological disease often accompanied by nausea, vomiting, photophobia, phonophobia and changes in vision.1 Globally, there are approximately one billion people affected by migraine2, with more than 50 million people suffering from the disease across Europe.3 It is estimated that the total annual cost of migraine in Europe is €111 billion.4
“We are very pleased to report a positive opinion by the CHMP,” said Richard Daniell, Executive Vice President, European Commercial at Teva. “This is another important milestone for us and the migraine community as a whole. We hope to expand the availability of AJOVY to the EU so that eligible patients can potentially benefit from the flexibility AJOVY offers through quarterly and monthly dosing options.”
The positive CHMP opinion is based on the review of a Marketing Authorization Application (MAA) that included efficacy and safety data from the HALO clinical development program. The program evaluated fremanezumab in two pivotal Phase III clinical trials that enrolled patients with disabling migraine and studied fremanezumab as a prophylaxis of migraine in adults. In these trials, patients treated with fremanezumab had a significantly greater reduction in migraine days compared to placebo. Adverse drug reactions (ADRs) observed with AJOVY were mostly mild to moderate, short-lasting skin reactions around the injection area: pain, hardening, redness, itching and rash at the injection site.
“Migraine is the most prevalent disabling neurological disease in Europe,” said Professor Peter J. Goadsby, MD, PhD, Professor of Neurology at King's College, London. “It is the second most common cause of years lost to disability in the world, interrupting patients during their most active and productive years. Migraine disrupts their work and family lives at a time when others rely on them the most. Many patients have to live in fear of their next attack; the most disabled have chronic migraine, experiencing 15 or more days of illness per month. Fremanezumab is an anti-CGRP monoclonal antibody (mAb) specifically developed for migraine, and if approved for use in the EU, it will offer an additional treatment option for patients and more flexibility in managing their condition.”
The positive CHMP opinion is a formal recommendation to grant the marketing authorization for AJOVY in the EU. The recommendation will now be reviewed by the EC, which has authority to approve medicines for use in the 28 countries of the EU. A final decision is expected in the first half of 2019.
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 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.
Teva 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 Fremanezumab (commercialized in the United States as AJOVY), 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 obtaining regulatory approval for AJOVY in the EU;
- the uncertainty of commercial success of AJOVY;
- 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; 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 substantially increased indebtedness and significantly decreased cash on hand, 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 sales 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, 2017, including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. 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 IHS classification – Migraine classification criteria.
2 Migraine Facts, Migraine Research Foundation. Available at https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed January 2019.
3 Headache. EAN. Available at: https://www.ean.org/index.php?id=2796. Accessed January 2019.
4 Linde M1 Gustavsson A, Stovner LJ et al. 2011. The cost of headache disorders in Europe: the Eurolight project. [Online] Available from: https://www.ncbi.nlm.nih.gov/pubmed/22136117. Accessed January 2019.