Benzinga

España
Italia
대한민국
日本
Français
Benzinga Edge
Benzinga Research
Benzinga Pro

  • Get Benzinga Pro
  • Data & APIs
  • Events
  • Premarket
  • Advertise
Contribute
España
Italia
대한민국
日本
Français

Benzinga

  • Premium Services
  • Financial News
    Latest
    Earnings
    Guidance
    Dividends
    M&A
    Buybacks
    Interviews
    Management
    Offerings
    IPOs
    Insider Trades
    Biotech/FDA
    Politics
    Healthcare
    Small-Cap
  • Markets
    Pre-Market
    After Hours
    Movers
    ETFs
    Options
    Cryptocurrency
    Commodities
    Bonds
    Futures
    Mining
    Real Estate
    Volatility
  • Ratings
    Analyst Color
    Downgrades
    Upgrades
    Initiations
    Price Target
  • Investing Ideas
    Trade Ideas
    Long Ideas
    Short Ideas
    Technicals
    Analyst Ratings
    Analyst Color
    Latest Rumors
    Whisper Index
    Stock of the Day
    Best Stocks & ETFs
    Best Penny Stocks
    Best S&P 500 ETFs
    Best Swing Trade Stocks
    Best Blue Chip Stocks
    Best High-Volume Penny Stocks
    Best Small Cap ETFs
    Best Stocks to Day Trade
    Best REITs
  • Money
    Investing
    Cryptocurrency
    Mortgage
    Insurance
    Yield
    Personal Finance
    Forex
    Startup Investing
    Real Estate Investing
    Prop Trading
    Credit Cards
    Stock Brokers
Research
My Stocks
Tools
Free Benzinga Pro Trial
Calendars
Analyst Ratings Calendar
Conference Call Calendar
Dividend Calendar
Earnings Calendar
Economic Calendar
FDA Calendar
Guidance Calendar
IPO Calendar
M&A Calendar
Unusual Options Activity Calendar
SPAC Calendar
Stock Split Calendar
Trade Ideas
Stock Reports
Insider Trades
Trade Idea Feed
Analyst Ratings
Unusual Options Activity
Heatmaps
Free Newsletter
Government Trades
Perfect Stock Portfolio
Easy Income Portfolio
Short Interest
Most Shorted
Largest Increase
Largest Decrease
Calculators
Margin Calculator
Forex Profit Calculator
100x Options Profit Calculator
Screeners
Stock Screener
Top Momentum Stocks
Top Quality Stocks
Top Value Stocks
Top Growth Stocks
Compare Best Stocks
Best Momentum Stocks
Best Quality Stocks
Best Value Stocks
Best Growth Stocks
Connect With Us
facebookinstagramlinkedintwitteryoutubeblueskymastodon
About Benzinga
  • About Us
  • Careers
  • Advertise
  • Contact Us
Market Resources
  • Advanced Stock Screener Tools
  • Options Trading Chain Analysis
  • Comprehensive Earnings Calendar
  • Dividend Investor Calendar and Alerts
  • Economic Calendar and Market Events
  • IPO Calendar and New Listings
  • Market Outlook and Analysis
  • Wall Street Analyst Ratings and Targets
Trading Tools & Education
  • Benzinga Pro Trading Platform
  • Options Trading Strategies and News
  • Stock Market Trading Ideas and Analysis
  • Technical Analysis Charts and Indicators
  • Fundamental Analysis and Valuation
  • Day Trading Guides and Strategies
  • Live Investor Events
  • Pre-market Stock Analysis and News
  • Cryptocurrency Market Analysis and News
Ring the Bell

A newsletter built for market enthusiasts by market enthusiasts. Top stories, top movers, and trade ideas delivered to your inbox every weekday before and after the market closes.

  • Terms & Conditions
  • Do Not Sell My Personal Data/Privacy Policy
  • Disclaimer
  • Service Status
  • Sitemap
© 2026 Benzinga | All Rights Reserved
February 3, 2020 3:30 AM 7 min read

Teva Announces Positive Top-Line Results from AJOVY® (fremanezumab) Clinical Trials in Japan

by Business Wire
Follow
FlipboardIcon version of the Flipboard logo

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced positive results from two Phase 2/3 trials evaluating AJOVY® (fremanezumab) in patients in Japan. AJOVY is under development in Japan by Otsuka Pharmaceutical Co., Ltd. (Otsuka) as part of a May 2017 exclusive license agreement for development and sales of AJOVY in Japan.

"This study adds to the wealth of positive AJOVY data we have in patients globally," said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache at Teva. "The annual prevalence of migraine in Japan is 8.4% of adults,1 so we are pleased to be one step closer to bringing AJOVY to patients in Japan who could benefit from a preventive treatment."

Preliminary trial results indicated that primary endpoints were achieved with both clinical and statistical significance versus placebo for subjects with chronic migraine and episodic migraine, respectively. Statistically significant improvements versus placebo were also demonstrated for all secondary endpoints. AJOVY was well tolerated with a similar adverse events profile compared to placebo. Following additional analysis, more detailed results will be presented at upcoming medical congresses and publications. These are pivotal studies that will enable filing for Pharmaceuticals and Medical Devices Agency (PMDA) approval for marketing authorization.

AJOVY is the first and only anti-CGRP drug approved in the US and EU that is designed for the preventive treatment of migraine that offers both quarterly and monthly dosing options.

U.S. Important Safety Information about AJOVY® (fremanezumab-vfrm) injection

Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.

Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.

Adverse events should be reported.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events.

Reporting forms and information can be found at https://www.hpra.ie. Adverse events should also be reported to Teva – please refer to local numbers.

About Teva

Cautionary Note Regarding Forward-Looking Statements

 

References

  1. Sakai F, Igarashi H. Prevalence of migraine in Japan: a nationwide survey. Cephalalgia 1997; 17(1): 15-22.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20200203005271/en/

Market News and Data brought to you by Benzinga APIs

© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

To add Benzinga News as your preferred source on Google, click here.


Posted In:
Press Releases
TEVA Logo
TEVATeva Pharmaceutical Industries Ltd
$30.96-0.29%
Overview

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Please click here for full U.S. Prescribing Information for AJOVY® (fremanezumab-vfrm) injection.

Information for Europe about AJOVY® can be found here.

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.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding FDA approval of AJOVY® (fremanezumab) injection Autoinjector, 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 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; the uncertainty of commercial success of 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 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; implementation of a new enterprise resource planning system that, if deficient, could materially and adversely affect our operations and/or the effectiveness of our internal controls; 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; increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S.; 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 Quarterly Reports on Form 10-Q for the first, second and third quarter of 2019 and in our Annual Report on Form 10-K for the year ended December 31, 2018, 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.

TEVA Logo
TEVATeva Pharmaceutical Industries Ltd
$30.96-0.29%
Overview
Comments
Loading...