Teva Announces Launch of 1% Sodium Hyaluronate in the United States
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the launch of 1% Sodium Hyaluronate. The product received approval from the Center for Devices and Radiological Health of the U.S. Food and Drug Administration. 1% Sodium Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).
The safety and effectiveness of 1% Sodium Hyaluronate was evaluated in a double-blind, prospective, multi-site, randomized, three-arm, parallel group, pivotal trial in adults. The primary objective of the trial was to evaluate the effectiveness of three weekly intra-articular injections of 2 mL of 1% Sodium Hyaluronate into the knee as compared to placebo for the treatment of pain in subjects with OA. The safety and effectiveness of 1% Sodium Hyaluronate was also compared with Euflexxa®1 (1% sodium hyaluronate).
Individuals receiving 1% Sodium Hyaluronate reported a statistically significant decrease in pain scores from baseline to week 26 compared to individuals in the placebo group. Overall, treatment-emergent adverse events were similar across all three study arms with the most common being pain in the knee or at the injection site. Effectiveness scores were similar between 1% Sodium Hyaluronate and Euflexxa®.
“The launch of 1% Sodium Hyaluronate is a great example of using the expertise within Teva to bring together skills from both our generic and specialty business,” said Brendan O’Grady, EVP and Head of North America Commercial. “We are proud to bring an additional offering to the physicians and patients seeking treatment options for OA knee pain.”
1% Sodium Hyaluronate is supplied in a 3 mL disposable prefilled syringe containing 2 mL of 1% sodium hyaluronate, and packaged as three syringes to a carton. For details on ordering call Teva Customer Service at 1-888-838-2872.
About 1% Sodium Hyaluronate
1% sodium hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).
IMPORTANT SAFETY INFORMATION
Do not use 1% sodium hyaluronate to treat patients who have a known hypersensitivity to hyaluronan preparations. Do not use to treat patients with knee joint infections or to treat patients with infections or skin disease in the area of the injection site.
Do not concomitantly use disinfectants containing quaternary ammonium salts or chlorhexidine for skin preparations because hyaluronan can precipitate in their presence. Do not inject intravascularly because intravascular injections of 1% sodium hyaluronate may cause systemic adverse events.
The safety and effectiveness of 1% sodium hyaluronate has not been established in pregnant women. It is not known if 1% sodium hyaluronate is excreted in human milk. The safety and effectiveness of 1% sodium hyaluronate has not been established in lactating women or in children (21 years of age or younger).
The most common target-knee related treatment-emergent adverse event (TEAE) was arthralgia. The most common device-related and injection-related TEAE was injection site joint pain.
For more information, please see accompanying Full Prescribing Information. A copy may be requested from Teva US Medical Information at 888-TEVA-USA (888-838-2872), email@example.com, or Teva’s Public Relations or Investor Relations contacts.
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 35,000 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 regarding the launch and potential benefits of 1% sodium hyaluronate 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 the commercial success of 1% sodium hyaluronate;
- 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® or 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.
1 Euflexxa is a registered trademark of Ferring BV
Kevin C. Mannix (215) 591-8912
Ran Meir 972 (3) 926-7516
Kelley Dougherty (973) 658-0237
Yonatan Beker 972 (54) 888 5898