Long-term efficacy and safety data for AJOVY® (fremanezumab-vfrm) injection for the preventive treatment of migraine are the highlight of over 20 abstracts, including four platform presentations
Data for AUSTEDO® (deutetrabenazine) tablets further our understanding of treatment for tardive dyskinesia
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Company will present data at the 71st Annual Meeting of the American Academy of Neurology (AAN) in Philadelphia from May 4-10, 2019. The diverse selection of data to be presented includes research across central nervous system (CNS) disorders, including migraine, tardive dyskinesia (TD), dyskinesia in cerebral palsy (DCP) and multiple sclerosis (MS). The research spans pediatric to adult populations and contains long-term data across two therapeutic areas.
“Improving the lives of patients is Teva’s driving force, and the data being presented at this year’s AAN meeting are a testament to that commitment,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D at Teva. “With a wide range of exciting data on AJOVY® (fremanezumab-vfrm) injection, accompanied by ongoing research on AUSTEDO® (deutetrabenazine) tablets, we believe the quality and breadth of Teva’s findings reinforce the Company’s legacy in diseases of the central nervous system and focus on improving patient treatment.”
Among the data to be presented for AJOVY®, Teva will highlight new analyses on the long-term efficacy and safety data from the long-term extension of the Phase III HALO long-term study in chronic and episodic migraine. Long-term data presentations include analyses on efficacy and safety, quarterly dosing persistency, reversion from a chronic to an episodic migraine classification and quality of life results. Additional Teva data include a platform presentation on long-term data from an open-label study of AUSTEDO® treatment in TD and a poster presentation of the design of a Phase III study investigating deutetrabenazine for the treatment of DCP.
The full set of Teva-sponsored data to be presented includes:
- [S17.005] Fremanezumab Cardiovascular and Cerebrovascular Safety Profile: Pooled Data From Placebo-Controlled and Long-Term Studies (Session 17, May 6, 2019, 1:44 pm ET)
- [S17.006] Long-Term Data on Fremanezumab in Patients Who Reverted From a Chronic to an Episodic Migraine Classification (Session 17, May 6, 2019, 1:55 pm ET)
- [S38.001] Long-Term Data on Fremanezumab on Response Rates: Results of a 1-Year Study (Session 38, May 8, 2019, 1:00 pm ET)
- [S38.004] Long-Term Data on Fremanezumab in Migraine: Results of a 1-Year Study (Session 38, May 8, 2019, 1:33 pm ET)
- [P1.10-004] Data on Fremanezumab on Response Rates, Migraine Days, and Acute Medication Use in Patients with Chronic Migraine Who Have Failed at Least One Prior Migraine Preventive Medication (Poster Session 1, May 5, 2019,11:30 am – 6:30 pm ET)
- [P1.10-005] Long-Term Data on Response Rates, Acute Headache Medication Use, and Disability in Patients With Episodic Migraine: Results of a 1-Year Study (Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-006] Data on Migraine-Specific Health-Related Quality of Life in Chronic Migraine Patients Who Previously Used Topiramate (Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-008] Long-Term Data on Fremanezumab in Patients With Chronic Migraine With Concomitant Preventive Medication Use (Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-011] Data on Fremanezumab in Migraine Patients Who Have Failed at Least One Prior Migraine Preventive Medication (Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-012] Data on Migraine-Specific Health-Related Quality of Life in Chronic Migraine Patients With Concomitant Preventive Medication Use (Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-013] Data on Response Over Time With Fremanezumab in Patients Who Reverted From a Chronic to an Episodic Migraine Classification (Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-015] Long-Term Data on Fremanezumab: Results of a 1-Year Study (Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-022] Long-Term Data on Fremanezumab on Headache-Related Disability and Quality of Life in Patients Who Reverted From a Chronic to an Episodic Migraine Classification (Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-024] Long-Term Data on Fremanezumab in Patients With Chronic Migraine and Comorbid Moderate to Severe Depression (Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P1.10-026] Data on Medication Overuse in Patients With Chronic Migraine (Poster Session 1, May 5, 2019, 11:30 am – 6:30 pm ET)
- [P2.10-001] Data on Response Rates, Acute Medication Use, and Disability in Patients With Episodic Migraine Who Have Failed at Least One Prior Migraine Preventive Medication (Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm ET)
- [P2.10-002] Data on the Severity of Headache in Patients With Chronic and Episodic Migraine With Fremanezumab Treatment (Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm ET)
- [P2.10-008] Data on the Number of Headache Hours in Chronic and Episodic Migraine With Fremanezumab (Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm ET)
- [P2.10-013] Data on Quarterly Administration of Fremanezumab During Third Month After Injection (Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm ET)
- [P2.10-015] Long-Term Data on Response Rates, Acute Headache Medication Use, and Disability in Patients With Chronic Migraine: Results of a 1-Year Study (Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm ET)
- [P2.10-023] Long-Term Data on Fremanezumab on Headache-Related Disability, Quality of Life, and Patient Satisfaction in Episodic Migraine and Chronic Migraine (Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm ET)
- [P3.10-013] Data on Offering Monthly and Quarterly Dosing Options for a Class of Migraine Preventive Therapy on Likelihood of Acceptance and Adherence in Adults With Migraine (Poster Session 3, May 7, 2019, 11:30 am – 6:30 pm ET)
- [S4.009] Long-Term Treatment With Deutetrabenazine in Tardive Dyskinesia (TD): Data From an Open-Label Extension Study (Session 4, May 5, 2019, 2:28 pm ET)
- [P4.8-036] RECLAIM-DCP: A Randomized, Double-Blind, Placebo-Controlled Study of Deutetrabenazine for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents (Poster Session 4, May 8, 2019, 11:30 am – 6:30 pm ET)
- [P4.2-096] Pregnancy Outcomes In Patients With Multiple Sclerosis And Exposure To Branded Glatiramer Acetate (Poster Session 4, May 8, 2019, 11:30 am – 6:30 pm ET)
Other Teva data:
- [P2.1-014] Impact of Antipsychotic Treatment Switching in Patients With Schizophrenia, Bipolar Disorder, And Major Depressive Disorder (Poster Session 2, May 6, 2019, 11:30 am – 6:30 pm ET)
- [P3.8-027] Hospital Utilization Rates Following Antipsychotic Dose Reductions Among Patients With Bipolar And Major Depressive Disorders (Poster Session 3, May 7, 2019, 11:30am – 6:30 pm ET)
- [P3.2-099] Real-World Switching Patterns Among US Generic Glatiramer Acetate Multiple Sclerosis Patients (Poster Session 3, May 7, 2019, 11:30 am – 6:30 pm ET)
AJOVY is indicated for the preventive treatment of migraine in adults. AJOVY is available as a 225 mg/1.5mL single dose injection in a prefilled syringe with two dosing options – 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), administered as three subcutaneous injections. AJOVY can be administered in office by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.
Important Safety Information about AJOVY®
Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.
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.
Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.
Please click here for full Prescribing Information for AJOVY® (fremanezumab-vfrm) injection.
AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of tardive dyskinesia in adults and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established.
The use of deutetrabenazine for the treatment of dyskinesia in cerebral palsy is investigational and not currently approved by the U.S. Food and Drug Administration or any other country’s regulatory agency for this use.
Important Safety Information about AUSTEDO®
AUSTEDO® can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO® must balance the risks of depression and suicidality with the clinical need for treatment of chorea. AUSTEDO® is contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression.
AUSTEDO® is also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine (Xenazine®) or valbenazine (Ingrezza®).
AUSTEDO® may cause a worsening in mood, cognition, rigidity, and functional capacity in patients with Huntington’s disease. Tetrabenazine (a closely related VMAT2 inhibitor) causes an increase in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur in some patients treated with AUSTEDO® who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor or other drugs that are known to prolong QTc. Neuroleptic Malignant Syndrome has been observed in patients receiving tetrabenazine. AUSTEDO® may increase the risk of akathisia, agitation, and restlessness. AUSTEDO® may cause parkinsonism in patients with Huntington’s disease. Sedation is a common dose-limiting adverse reaction of AUSTEDO®.
The most common adverse reactions (4% of AUSTEDO®-treated patients and greater than placebo) in controlled clinical studies of patients with tardive dyskinesia were nasopharyngitis and insomnia. The most common adverse reactions (>8% of AUSTEDO®-treated patients and greater than placebo) in a controlled clinical study of patients with chorea associated with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue.
Please click here for U.S. Full Prescribing Information, including Boxed Warning.
COPAXONE® is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Important Safety Information about COPAXONE®
COPAXONE® is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of patients exposed to COPAXONE® 20 mg per mL compared to 4% of those on placebo, and approximately 2% of patients exposed to COPAXONE® 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® 20 mg per mL patients compared to 6% of placebo patients, and approximately 2% of COPAXONE® 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® can modify immune response, it may interfere with immune functions. For example, treatment with COPAXONE® 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® does this, but there has not been a systematic evaluation of this risk.
In controlled studies of COPAXONE® 20 mg per mL, the most common adverse reactions with COPAXONE® 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® 40 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were ISRs, such as erythema (22% vs 2%).
ISRs were one of the most common adverse reactions leading to discontinuation of COPAXONE®. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with COPAXONE® than placebo.
Please click here for Full Prescribing Information.
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, 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; 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® and 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, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.