teva pharmaceutical-sp adr (TEVA) Key Developments
Teva Pharmaceutical Industries Limited and Active Biotech Announce the Completion of Patient Enrollment in Laquinimod Phase III CONCERTO Trial
Jun 25 15
Teva Pharmaceutical Industries Ltd. and Active Biotech announced that the patient enrollment for the pivotal Phase III CONCERTO trial has been finalized, as well as a planned sample size re-assessment analysis of the study. CONCERTO, the third Phase III trial of laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS), is designed to evaluate the safety and efficacy of laquinimod (0.6mg or 1.2mg/day) with a primary endpoint of time to Confirmed Disability Progression (CDP), as measured by the Expanded Disability Status Scale (EDSS). The sample size reassessment was included as part of the protocol to confirm that the original assumptions are in line with the study and that the sample size is adequate. Based on recent agreement with FDA, under a Special Protocol Assessment (SPA) agreement, study completion will occur when either 260 events are reached or all patients complete 24 months of study treatment (whichever occurs first). CONCERTO study results are expected to be available toward mid-2017.
Alexza Amends ADASUVE® Commercial Partnership Agreements with Grupo Ferrer Internacional, S.A. and Teva Pharmaceutical Industries Ltd
Jun 18 15
Alexza Pharmaceuticals Inc. announced that it has updated and amended its ADASUVE® (Staccato® loxapine) commercial partnerships with Grupo Ferrer Internacional, S.A. and Teva Pharmaceutical Industries Ltd. Ferrer is Alexza's commercial partner for ADASUVE in the European Union, Latin America, the Commonwealth of Independent States and other countries in Europe. Teva is Alexza's commercial partner for ADASUVE in the United States. Ferrer and Alexza Agreement Amendment: Alexza's Manufacturing Obligations: Alexza and Ferrer have agreed to identify more suitable long-term solutions for future ADASUVE manufacturing. Alexza's current ADASUVE manufacturing obligations are to be suspended for a period of time. During the manufacturing suspension period, Alexza and Ferrer will evaluate internal and possible external (third party) manufacturing capabilities. Ferrer's Right to Manufacture: Ferrer and Alexza have agreed that Ferrer will have the option to manufacture ADASUVE at its facilities. If Ferrer chooses to exercise its option, it will be granted ADASUVE manufacturing rights for the Ferrer territories, including an option to manufacture certain additional Staccato products for the Ferrer territories. MAA Transfer to Ferrer: Alexza will transfer the EU Marketing authorization for ADASUVE (MAA), to Ferrer. The MAA transfer includes the responsibilities for the ongoing post-approval clinical studies (the PASS and DUS studies), a future Phase 3 study in adolescents, as well as ongoing pharmacovigilance responsibilities. Milestone Payment Elimination: In consideration for taking on additional responsibilities, the specific milestone payments for first commercial sales in Russia, Brazil and Turkey have been eliminated. Territory and Technology Expansion: Ferrer will gain ADASUVE registration and commercialization rights for Middle East and North Africa (MENA), Korea, Philippines, and Thailand territories. In addition, Ferrer will have the option to develop and commercialize additional Staccato products for the Ferrer territories, with certain rights outside of the current Ferrer territory, in consideration for royalties to Alexza. Teva and Alexza Agreement Amendment: Alexza's Manufacturing Obligations: Alexza and Teva have agreed to identify more suitable long-term solutionsfor future ADASUVE manufacturing. Alexza's current ADASUVE manufacturing obligations are to be suspended for a period of time. During the manufacturing suspension period, Alexza and Teva will evaluate internal and possible external (third party) manufacturing capabilities. Modification of Teva's Commercial Obligations: Alexza and Teva have agreed to adjust certain of Teva's commercial diligence obligations related to ADASUVE for a period of time. Teva will continue to use commercially reasonable efforts to commercialize ADASUVE in the U.S., be responsible for all related regulatory and clinical activities, and will continue to be responsible for royalties and milestone payments on the U.S. sales of ADASUVE. Modification to Teva note: The maturity note will be extended for a time equal to the duration of manufacturing suspension period. No interest will accrue on the Teva note during the manufacturing suspension period. During the manufacturing suspension period Alexza plans to work with its commercial partners to find the most efficient path for future ADASUVE manufacturing and assure ADASUVE supplies for current and new markets.
Teva Pharmaceutical Industries Ltd. Announces New Data from Additional Analyses of Phase 2B Studies in Migraine Prevention
Jun 18 15
Teva Pharmaceutical Industries Ltd. announced new data from additional analyses of its phase 2b studies in migraine prevention on efficacy and speed of onset of two distinct doses of TEV-48125, a novel monoclonal anti-CGRP antibody administered subcutaneously once monthly for the preventive treatment of high frequency episodic migraine (characterized by 8-14 days of headache per month) and chronic migraine (headaches on at least 15 days per month). The data is to be presented at the 57th Annual Scientific Meeting of the American Headache Society (AHS), June 18-21, 2015, Washington DC. The episodic migraine efficacy and onset data will be the subject of an oral platform presentation on June 20, 2015. A total of 297 individuals, with a an average of 11.4 monthly migraine days and an average of 12.5 headache days were randomized to receive placebo or TEV-48125 (225 mg or 675 mg) given monthly. Patients were permitted to continue using other preventive migraine medications if in stable doses. Both doses of TEV-48125 were superior to placebo and met the primary endpoint defined as decrease in monthly migraine days at month 3 relative to baseline as well as the secondary endpoint, defined as decrease monthly headache days relative to baseline. Results demonstrated that a single administration of both tested doses of TEV-48125 resulted in a statistically significant separation from placebo. Furthermore, a decrease of at least 50% of migraine days for the duration of the study (weeks1-12) were seen in 28% of those receiving placebo relative to 53% (p<0.001) and in 59% (p<0.001) of the individuals given 225mg and 675mg correspondingly. These findings were even further pronounced in the sub group of patients that had not used other preventive medications in parallel 'a decrease of at least 50% in episodic migraine days was observed in 22% of those receiving placebo, relative to 66% (p<0.001) and in 67% (p<0.01) of the individuals given 225mg and 675mg correspondingly.
Teva Pharmaceutical Industries Ltd., and Microchips Biotech, Inc. Announce Partnership
Jun 18 15
Teva Pharmaceutical Industries Ltd., and Microchips Biotech, Inc. announced that they have entered into a partnership under which the companies will explore innovative ways to apply Microchips Biotech’s implantable drug delivery device to Teva’s portfolio of products with the goal of enhancing clinical outcomes for patients on chronic drug therapies. Microchips Biotech’s electronic device is made up of microchip arrays that can store hundreds of therapeutic doses of drug for periods ranging from months to years and releases each dose at precise times. The device can be programmed to release drug on a pre-determined schedule and will have wireless control features. Under the terms of the agreement Teva will make a $35 million upfront payment to Microchips Biotech in the form of an equity investment and technology access fee. The partnership has an initial focus on one selected disease area, but will provide Teva with the option to later expand the program into several additional therapeutic areas and sensing applications that are proprietary to Teva. As programs advance, Microchips Biotech will receive development and commercial milestone payments and royalties on future product sales. Microchips Biotech will also receive funding to develop products for any future additional indications Teva may develop, and Teva will be responsible for Phase II and Phase III clinical development and regulatory filings.
Teva Pharmaceutical Industries Limited Announces Positive Results from the Pivotal Clinical Study of Investigational Treatment for Patients with Tardive Dyskinesia
Jun 16 15
Teva Pharmaceutical Industries Limited announced positive top-line results from the pivotal clinical study Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD) designed to evaluate the efficacy of SD-809 (deutetrabenazine) in the treatment of moderate to severe tardive dyskinesia. Top-line data showed that the study met its primary endpoint and demonstrated a positive trend in all secondary endpoints. Importantly, the study also showed a favorable safety and tolerability profile, including low rates of depression, somnolence, insomnia and akathisia. The primary endpoint of ARM-TD was the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to end of therapy, assessed by blinded centralized video rating. The study results show patients taking SD-809 achieved an improvement of 3.0 points on the AIMS score from baseline to end of therapy compared to 1.6 points in placebo (p = 0.0188) for a clinically meaningful effect. Study results also demonstrated a favorable safety and tolerability profile of SD-809. Fewer patients taking SD-809 than placebo experienced serious adverse events (SAEs) Three patients discontinued from the study for adverse events (1 in SD-809 group vs. 2 in placebo group). For all other side effects reported in the study, rates in the SD-809 group were similar or lower than the placebo group. Further analysis of the additional data from the study is ongoing and details will be shared at future medical meetings and through peer-reviewed publication. Tardive dyskinesia, a condition for which there are no approved therapies in the United States, is a hyperkinetic movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The often debilitating disorder affects about 500,000 people in the United States and is a result of treatment with widely used medications for psychiatric conditions such as schizophrenia and bipolar disease, and certain drugs used for treating various gastrointestinal disorders. SD-809 became part of Teva’s central nervous system (CNS) product portfolio with the acquisition of Auspex Pharmaceuticals in May 2015. Teva has numerous development programs in CNS focused on neurodegeneration and movement disorders which include Huntington’s disease, Tourette syndrome, Parkinson’s disease, multiple sclerosis, and tardive dyskinesia. In addition to SD-809, Teva is developing pridopidine, laquinimod and other undisclosed assets in the neurodegenerative category. The ARM-TD study was a 1:1 randomized, double-blind, placebo-controlled, parallel-group study of 117 patients globally (104 patients completed the study) with moderate to severe tardive dyskinesia. Enrolled patients received either SD-809 or placebo, which was titrated to optimal dosage over the course of six weeks, and then administered at that dose for another six weeks for a total treatment of 12 weeks. The objectives of the study were to evaluate the efficacy of SD-809 in reducing the severity of abnormal involuntary movements associated with tardive dyskinesia and to evaluate the safety and tolerability of titration and maintenance therapy with SD-809 in subjects with drug-induced tardive dyskinesia. SD-809 (deutetrabenazine) is an investigational, oral, small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is designed to regulate the levels of a specific neurotransmitter, dopamine, in the brain. SD-809 is being developed for the treatment of chorea associated with Huntington’s disease, a neurodegenerative movement disorder that impacts cognition, behavior, and movements. Teva is investigating the broad potential of SD-809 for treating additional movements disorders such as tardive dyskinesia and tics associated with Tourette syndrome.