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New Data Supporting the Safety and Efficacy Profile of AJOVY® (fremanezumab) Shared at 7th European Academy of Neurology Congress

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A new analysis presented by Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) on AJOVY® (fremanezumab) injection for the preventive treatment of migraine, indicates to the European neurology community that the medicine has a positive safety profile in relation to risk of cardiovascular events.

The data, drawn from an analysis of three published Phase 3 studies of fremanezumab and presented at the 7th Congress of the European Academy of Neurology (EAN), showed minimal changes in the heart rate and blood pressure of those patients studied over a 12 week period. 1

“As a CGRP inhibitor, fremanezumab has been shown to provide protection against migraine in suitable patients, and we remain focused on continued assessment of the safety profile of this therapy, particularly in relation to heart-related issues as it is believed CGRP itself acts as a ‘safeguard’ during cardiovascular ischemia and other events,” said Dr Joshua M. Cohen, Senior Director and Global Therapeutic Area Lead, Migraine and Headache, Teva.

“These new data offer the neurology prescribing community added confidence and further reassurance that any CV risks associated with fremanezumab use are minimal, particularly in relation to concerning issues such as hypertension.”

The data were arrived at following a pooled analysis of the HALO episodic migraine [EM], HALO chronic migraine [CM], and FOCUS Phase 3 clinical trials, which were designed to assess (fremanezumab) in the preventive treatment of migraine in adults.They are the first data to suggest that changes in heart rate and blood pressure remain unaffected by the action of any calcitonin gene-related peptide (CGRP) inhibitor when used at its recommended dose.

Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa), selectively targets the CGRP ligand.1 Potential effects of CGRP inhibition are important for patients as this peptide has been described to have a cardioprotective role, particularly during ischemic events, and migraine patients are well known to carry a potentially higher risk of stroke and myocardial infarction.2

Across the phase 3 studies, 1,897 patients received fremanezumab (quarterly, n=943; monthly, n=954) and 945 received placebo. At the end of 12 weeks of double-blind treatment, mean increases from baseline in heart rate (measured in beats per minute) were minimal, as were decreases in systolic (SBP) and diastolic (DBP) blood pressure (measured in mmHg) for the population studies. None of these changes were deemed clinically significant.1

“EAN is among the premier annual meetings for professionals invested in the ongoing improvement of clinical practice in neurology,” said Dr Cohen.

“Teva is excited to continue its close working partnership with the Academy and is grateful to have this important platform to deliver fresh insights on the cardiovascular profile of fremanezumab and give neurologists more evidence and confidence in its use as an important migraine therapy.”

Additional data presented confirms most adverse events occur within the first month of treatment and are more common in the limb than abdominal region

Further data taken from the pooled analysis of HALO EM, HALO CM, and FOCUS may improve the guidance prescribers can give to patients around managing potential issues at injection sites.

Injection site adverse events were shown to be most common in the first month following the start of treatment, and when taken quarterly or monthly, were seen to be more common in a limb rather than the abdomen.

“Most injectable therapies carry a risk of adverse events at the injection site, and our data are providing some useful guidance that could indicate abdominal injections may be a preferable choice for patients, where fewer events were detected as opposed to injection via a limb. This may feel like a relatively small consideration in the grander scheme of assessing overall efficacy and safety, but it is an important consideration for individuals who have been prescribed the medicine,” said Dr Cohen.

This pooled analysis included 2,842 patients. In the quarterly fremanezumab (n=943), monthly fremanezumab (n=954), and placebo (n=945) groups, respectively, injection-site AEs were reported for 37%, 37%, and 31% of patients, most commonly pain (22%, 20%, and 20%), induration (15%, 18%, and 13%), and erythema (16%, 15%, and 12%). These AEs were most common within the 1 month of initiating study treatment. With quarterly fremanezumab, monthly fremanezumab and placebo, injection-site AEs were more common in the limb than in the abdomen.3

Accessing EAN 2021 Presentations

The ePresentations shared by Teva at EAN 2021 can be accessed by healthcare professionals via the EAN conference website, and available on-demand for EAN members.

Additional resources on migraine, including articles, publication summaries, podcasts and webinars can be accessed at Neurologybytes. Neurologybytes is a platform published by Teva to support neurologists in accessing timely, bite-sized content on the latest research developments and clinical care perspectives in the world of migraine and multiple sclerosis (MS).

Information for Europe about AJOVY® from the European Medicines Agency (EMA) can be found here.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. 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, 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:

  • our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to develop and commercialize biopharmaceutical products; competition for our specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; 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: uncertainty regarding the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic;
  • the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; 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: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; 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 (including as a result of potential tax reform in the United States); 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 this press release, in our Quarterly Report on Form 10-Q for the first quarter of 2021 and in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” 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.

References

  1. Naegel S. EAN 2021 Pooled HALO-FOCUS HR, SBP, DBP. TGT-70183 EAN21 Pooled HALO-FOCUS HR, SBP, DBP.doc; 1/12/2021.
  2. Rubio-Beltrán E, van den Brink AM. Understanding CGRP and Cardiovascular Risk. Handb Exp Pharmacol. 2019;255:131-140. doi: 10.1007/164_2019_204. PMID: 30879200.
  3. Jurgens T. EAN 2021 Pooled HALO CM, HALO EM, FOCUS injection-site AEs. TGT-70182 EAN 2021 Pooled HALO-FOCUS injection-site AEs.doc; 1/12/2021

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Contact information

PR Contacts
Fiona Cohen, Teva Europe
Fiona.Cohen@TevaEU.com
+31 6 20 08 25 45

Con Franklin, Ketchum
con.franklin@ketchum.com
+44 (0) 7974 434 151

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