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teva pharmaceutical-sp adr (TEVA) Key Developments

Teva Pharmaceutical Industries Ltd. and Active Biotech to Present New Follow-Up Data Evaluating the Clinical Safety of Laquinimod in Patients with Relapsing-Remitting Multiple Sclerosis

Teva Pharmaceutical Industries Ltd. and Active Biotech announced new follow-up data evaluating the clinical safety of laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS) who were treated with laquinimod in Phase II, Phase III and open-label extension studies for two or more years. The pooled safety analysis of the Phase II LAQ/5063 and the Phase III ALLEGRO and BRAVO extension studies supports findings observed in the core studies where currently identified risks were observed within the first months of laquinimod treatment. These data will be presented as part of a platform presentation, September 12, 2014, at the MS Boston 2014: Joint ACTRIMS-ECTRIMS Meeting being held in Boston, Massachusetts. In the pooled safety analysis, rates of adverse events (AEs) and serious AEs were lower in the open-label extensions than in the core studies and less than 3% of patients discontinued treatment due to AEs during these extensions. Additionally, shifts to potentially significant laboratory values were considerably lower in patients exposed to at least two years of laquinimod (1.18% reached >3xULN ALT vs. 4.72% for laquinimod and 2.6% for placebo during the core study). The safety analysis included patients exposed to laquinimod 0.6 mg for two or more years (n=1009), with a mean exposure of 3.7 (±1.0) years, in the double-blind phase and open-label extensions of the Phase II LAQ/5063 and the Phase III ALLEGRO and BRAVO trials.

Teva Pharmaceutical Industries Ltd. Announces New Data from the Open-Label Phase IIIb Glatiramer Acetate Low Frequency Safety and Patient ExpeRience (GLACIER) Study

Teva Pharmaceutical Industries Ltd. announced new data from the open-label Phase IIIb GLatiramer Acetate low frequenCy safety and patIent ExpeRience (GLACIER) study, comparing the safety and tolerability of three-times-a-week COPAXONE (glatiramer acetate injection) 40 mg to daily COPAXONE 20 mg in patients with relapsing-remitting multiple sclerosis (RRMS). During a platform presentation this week, the results from the GLACIER study were shared at the MS Boston 2014: Joint ACTRIMS-ECTRIMS Meeting being held in Boston, Massachusetts. The primary endpoint of the GLACIER study, the adjusted mean annualized rate of injection-related adverse events (IRAEs), was achieved with a 50% reduction with the three-times-a-week COPAXONE 40 mg dosing regimen versus the daily COPAXONE 20 mg regimen. In a post-hoc analysis, a similar reduction in moderate/severe IRAEs was observed with the less frequent, three-times-a-week COPAXONE 40 mg arm relative to the daily COPAXONE 20 mg arm. The company said that these results provide supportive data that fewer injections with three-times-a-week COPAXONE 40 mg resulted in half as many reported IRAEs compared to the number of IRAEs with the COPAXONE 20 mg once-daily dosing regimen, said Michael Hayden, Teva's President of Global R&D and Chief Scientific Officer. In the GLACIER study, 209 patients who had received daily COPAXONE 20 mg for an average of 6.7 years, from 30 U.S. sites were randomized to receive COPAXONE 40 mg (n=108) or COPAXONE 20 mg (n=101). Patients were then assessed in the open-label design at months 1, 2 and 4. IRAEs included all local injection-site reactions (ISRs) and symptoms related to immediate post-injection reactions (IPIR; flushing, palpitations, anxiety, dyspnea) and were determined through patient diaries. Patient reported ISRs were classified as mild, moderate or severe. One patient in the 40 mg COPAXONE arm withdrew due to injection site necrosis. The overall safety was consistent with prior experience, and the study results will be submitted to a peer-reviewed publication. The less frequent IRAEs resulting from the reduction of dosing frequency from daily to three-times-a-week is an additional consideration for patients when making treatment decisions. This is useful data for physicians counseling their patients interested in transitioning from a daily to three-times-a-week injection schedule.

Federal Trade Commission Sues Abbvie and Teva over Generic AndroGel

The Federal Trade Commission is suing AbbVie and Teva, saying they conspired to temporarily keep generic versions of AbbVie's low-testosterone drug AndroGel off the market. The FTC says AbbVie Inc. and its partner and Besins Healthcare filed baseless patent infringement lawsuits against Teva Pharmaceutical Industries Ltd. and Perrigo Co. to delay the approval and sale of less-expensive generic versions of the drug. AbbVie then struck a deal with Teva that will allow Teva to sell a generic at a later date. The FTC says that agreement included payments to Teva the government alleges were illegal. The agency is asking a court to throw out the agreement between the companies.

Teva Pharmaceutical Industries Ltd. Announces Results from Two Phase III Asthma Studies

Teva Pharmaceutical Industries Ltd. has announced that reslizumab, an investigational anti-IL-5 monoclonal antibody, demonstrated clear levels of efficacy in achieving the primary endpoint of reduction in the frequency of clinical asthma exacerbations, or CAE, compared to placebo in two pivotal Phase III studies in patients with inadequately controlled moderate to severe asthma with elevated levels of blood eosinophils. This initial set of results shows the adverse event profile of reslizumab was comparable to placebo in both trials. The incidence of common AEs (> 5%) was consistent with those seen in a moderate to severe asthma population, the most frequent being upper respiratory tract infections, asthma and headache. Further analyses of additional efficacy and safety data are ongoing. These new data are from two global Phase III 12-month, randomized, double-blind, placebo-controlled, parallel-group studies, evaluating the efficacy and safety of intravenously administered reslizumab (3.0 mg/kg) once every four weeks, compared to placebo in asthma patients (12-75 years of age with elevated blood eosinophils) that are inadequately controlled by standard of care therapy. The two pivotal Phase III studies involved 953 patients across 232 medical centers worldwide including the US, EU and the Far East. These studies are part of the Phase III BREATH program that evaluated the safety and efficacy of reslizumab treatment in four separate Phase III trials involving more than 1,700 adolescent and adult asthma patients with elevated eosinophils, whose symptoms were inadequately controlled with inhaled corticosteroids with or without another controller medication.

Teva Announces Launch of Generic Baraclude(R) Tablets, 0.5mg and 1mg, in the United States

Teva Pharmaceutical Industries Limited announced the launch of the generic equivalent to Baraclude(R) (Entecavir) Tablets, 0.5mg and 1mg, in the United States. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Baraclude(R) (Entecavir) Tablets, 0.5mg and 1mg, marketed by Bristol-Myers Squibb, had annual sales of approximately $328 million in the United States, according to IMS data as of June 2014.


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