Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced safety and tolerability results representing 25 years of data from the open-label extension study of the original U.S. pivotal trial of COPAXONE(R) (glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (RMS). The extension study initially examined the safety of COPAXONE(R) 20 mg/mL daily and then also the 40 mg/mL three times weekly formulation when it became available approximately 20 years later. Patients who participated in the original 36-month, randomized placebo-controlled U.S. trial were eligible to proceed to the open-label extension, in which patients receiving COPAXONE(R) continued their treatment, while those who received placebo were switched to COPAXONE(R). Results show that for study patients who continued to take COPAXONE(R), long-term treatment has an acceptable safety and tolerability profile with low rates of serious adverse events (SAEs) and immediate post-injection reactions (IPIRs).
“COPAXONE(R) is unique in being the only treatment for RMS that has been studied in patients who were closely and prospectively monitored for more than two decades,” said Danny McBryan, M.D., Senior Vice President of Global Medical Affairs and Pharmacovigilance at Teva. “The safety profile demonstrated by COPAXONE(R) is reassuring, as it remains our priority to deliver a safe and effective treatment option for patients with RMS.”
In addition to these 25-year data, the clinical effectiveness and safety of this study were also reported at 2 and 3 years, and at 6, 8, 10, 15 and 20 years. These findings should be considered within the context of the disease course of these patients, who are now approaching 35 years with their illnesses, and also in conjunction with the existing evidence regarding the safety and tolerability of COPAXONE(R) as described in previous studies. Data on the long-term neurological disease course and effectiveness of COPAXONE(R) will be presented at a future meeting.
“Teva’s unwavering dedication to serve the MS community is deeply rooted in the commitment to carry out this study,” said lead author and board-certified neurologist Dr. Corey Ford, University of New Mexico Health Sciences Center. “We are grateful for the contributions of the study participants and their families that have allowed us to secure the clinical evidence to reinforce COPAXONE(R) as a safe and tolerable treatment option for those living with RMS.”
The poster, “Twenty-five years of continuous treatment of multiple sclerosis with branded glatiramer acetate: long-term clinical results of the US open-label extension study,” will be on display during Poster Session 1 on Wednesday, October 10 from 5:00 p.m. to 7:00 p.m. CET.
COPAXONE(R)is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Please click here for U.S. Full Prescribing Information:www.CopaxonePrescribingInformation.com.
Important Safety Information
COPAXONE(R) is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of patients exposed to COPAXONE(R) 20 mg per mL compared to 4% of those on placebo, and approximately 2% of patients exposed to COPAXONE(R) 40 mg per mL compared to none on placebo experienced a constellation of symptoms that may occur immediately (within seconds to minutes, with the majority of symptoms observed within 1 hour) after injection and included at least 2 of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and urticaria. In general, these symptoms have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.
Transient chest pain was noted in 13% of COPAXONE(R) 20 mg per mL patients compared to 6% of placebo patients, and approximately 2% of COPAXONE(R) 40 mg per mL patients compared to 1% on placebo. While some episodes of chest pain occurred in the context of the Immediate Post-Injection Reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was usually transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment.
At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy.
Because COPAXONE(R) can modify immune response, it may interfere with immune functions. For example, treatment with COPAXONE(R) may interfere with recognition of foreign antigens in a way that would undermine the body’s tumor surveillance and its defenses against infection. There is no evidence that COPAXONE(R) does this, but there has not been a systematic evaluation of this risk.
In controlled studies of COPAXONE(R) 20 mg per mL, the most common adverse reactions with COPAXONE(R) vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%).
In a controlled study of COPAXONE(R) 40 mg per mL, the most common adverse reactions with COPAXONE(R) vs placebo were ISRs, such as erythema (22% vs 2%).
ISRs were one of the most common adverse reactions leading to discontinuation of COPAXONE(R). ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with COPAXONE(R) than placebo.
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 inIsrael, 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.
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 COPAXONE(R), 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 specialty medicines business, including: competition for our specialty products, especially Copaxone(R), our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; our ability to achieve expected results from investments in our product pipeline; competition from companies with greater resources and capabilities; the commercial success of our products; and the effectiveness of our patents and other measures to protect our intellectual property rights;
— our business and operations in general, including: failure to effectively execute the recently announced restructuring plan; uncertainties relating to the potential benefits and success of our new organizational structure and recent senior management changes; our ability to develop and commercialize additional pharmaceutical products; 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 restructuring of our manufacturing network, including potential related labor unrest; the impact of continuing consolidation of our distributors and customers; and variations in patent laws that may adversely affect our ability to manufacture our products;
— 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; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; governmental investigations into sales and marketing practices; potential liability for sales of generic products prior to a final resolution of outstanding patent litigation; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complexMedicareandMedicaid reporting and payment obligations; and environmental risks;
and other factors discussed in our Annual Report on Form 20-F for the year endedDecember 31, 2016(“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with theU.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.
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SOURCE: Teva Pharmaceutical Industries Ltd.
IR ContactsKevin C. Mannix, (215) 591-8912orRan Meir, 972 (3) 926-7516orPR ContactsUnited StatesDoris Saltkill, (913) 777-3343orIsraelYonatan Beker, 972 (54) 888 5898