Key Developments: Teva Pharmaceutical Industries Ltd (TEVA.N)
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Latest Key Developments (Source: Significant Developments)
Teva Pharmaceutical Industries Ltd Declares First Quarter Dividend
Teva Pharmaceutical Industries Ltd announced that it has declared a cash dividend for the first quarter of 2013 of NIS 1.15 (approximately 32 cents according to the rate of exchange on April 30, 2013) per share. The record date will be May 20, 2013, and the payment date will be June 3, 2013. Full Article
Teva Pharmaceutical Industries Ltd and Xenon Announce FDA Orphan Drug Designation for Pain Drug XEN402
Teva Pharmaceutical Industries Ltd and Xenon Pharmaceuticals Inc. (Xenon) announced that the US Food and Drug Administration (FDA) has granted orphan-drug designation to the investigational drug XEN402 being developed for the treatment of pain associated with erythromelalgia (EM). EM is a rare autosomal dominant condition characterized by debilitating spontaneous or easily evoked attacks of symmetrical burning pain in the feet and hands, typically associated with elevated skin temperature and erythema (redness of the skin). Symptoms are generally induced by exercise, prolonged standing, exposure to heat, and/or changes in humidity. The pain can be so severe that it can lead to suicide, and adequate treatment remains very challenging. Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products to drugs intended to treat rare disease or condition affecting fewer than 200,000 people in the U.S. This designation confers special incentives to the drug developer, including tax credits towards the cost of clinical trials, prescription drug user fee waivers and may entitle a period of seven years U.S. market exclusivity upon FDA approval.XEN402 is a chemical entity that has been exclusively licensed worldwide to theComapny. XEN402 inhibits the SCN9A sodium channel. Data from a published phase II study, suggest that XEN402 may relieve the pain associated with erythromelalgia (Pain 2012 Jan; 153(1):80-5). Full Article
NeuroSearch A/S Ends Transfer of Huntexil to Teva and Confirms FY 2013 Earnings Guidance
NeuroSearch A/S announced that on April 23, 2013 it received notification from Teva Pharmaceutical Industries Ltd that the escrow of DKK 28.7 million relating to Huntexil® will be released on 25 April 2013. The release of the escrow marks the end of the transfer of Huntexil® to Teva who from now on will be responsible for the continued clinical development of the project. For 2013, NeuroSearch still expects an operating loss of approximately DKK 15 million. Full Article
FDA Approves New Drug Application For Teva Pharmaceutical Industries Ltd's Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets For Prevention Of Pregnancy
Teva Pharmaceutical Industries Ltd announced that the U.S. Food and Drug Administration (FDA) has approved Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy. Quartette represents the next generation of extended regimen oral contraceptives to be approved by the FDA, and was designed to minimize bleeding (BTB) between scheduled periods. The approval was based on a development program that included results from Phase I, Phase II and Phase III clinical trials designed to evaluate the safety and efficacy of Quartette. The Phase III clinical trial, which involved more than 3,000 women, found that Quartette was 97% effective at preventing pregnancy. Data further demonstrated that the common adverse reactions (≥2%) in the Phase III clinical trial were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, mood changes, anxiety/panic attack, breast pain and migraines. The primary clinical trial that evaluated the efficacy of Quartette also assessed BTB. BTB and unscheduled spotting decreased over successive 91 day cycles. Full Article
Active Biotech AB and Teva Pharmaceutical Industries Ltd Announce Results of Study on Laquinimod
Active Biotech AB announced that Teva Pharmaceutical Industries Ltd and Active Biotech announced on March 21, 2013 top-line results from the open-label extension of the Phase III ALLEGRO study that assessed progression of disability and safety of oral laquinimod in early versus delayed-start relapsing-remitting multiple sclerosis (RRMS) patients. The study compared effectiveness of laquinimod in patients who received 36 months (early-start) versus those who received 24 months of laquinimod treatment (delayed-start). Laquinimod is an oral, once daily, investigational drug in Phase III studies for RRMS. Of 864 RRMS patients who participated in the original double-blind ALLEGRO trial, 97% participated in the open-label extension and 87% completed one year of the open-label phase. During the entire study (double blind and open label phase), early start patients were less likely to experience disease progression than those with a delayed start of Laquinimod (11.8% risk of confirmed disability progression vs. 16.7%, HR = 0.62, p < 0.0038). The study also supports a favorable safety and tolerability profile of laquinimod in RRMS patients. No new safety concerns arose during the open-label phase. Additionally, a preclinical study in animal models demonstrated the ability of laquinimod to increase the myelinated axons and mature oligodendrocytes in the brain. This data suggests laquinimod has potential restorative and anti-inflammatory properties. Full Article
Teva Pharmaceutical Industries Ltd And H. Lundbeck A/S Announces Results Of Azilect
Teva Pharmaceutical Industries Ltd and H. Lundbeck A/S announced that a double-blind, placebo controlled, randomized, multicenter study of Azilect (rasagiline tablets) met primary endpoint. The study, known as ANDANTE (Add oN to Dopamine AgoNists in the TrEatment of Parkinson's disease), assessed the efficacy and tolerability of Azilect as add-on treatment to dopamine agonists compared to placebo. While the efficacy of Azilect as adjunct to levodopa has been established in previous studies (leading to indication as adjunct therapy to levodopa), efficacy in combination with dopamine agonist monotherapy has not previously been studied. Results from the study demonstrated that the addition of Azilect 1mg/day provided a statistically improvement (Primary endpoint: treatment effect ± SE -2.4 ± 0.95 [95% CI -4.3,-0.5, p=0.012]) in total Unified Parkinson's Disease Rating Scale (UPDRS) score (Parts I, II and III, version three) from baseline to week 18 in patients sub-optimally controlled with dopamine agonist monotherapy compared to placebo. Azilect was well-tolerated with no difference in adverse events compared to placebo. Full Article
Active Biotech AB and Teva Pharmaceutical Industries Ltd Announce Enrollment of First Patient in Third Phase II Study of Oral Laquinimod for Relapsing-Remitting Multiple Sclerosis
Active Biotech AB announced with Teva Pharmaceutical Industries Ltd the enrollment of the first patient in the CONCERTO study - the third Phase III placebo-controlled study designed to evaluate the efficacy, safety and tolerability of once-daily oral laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS). The primary outcome measure of CONCERTO will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS). The multinational, randomized, double blind placebo-controlled study will aim to enroll approximately 1,800 patients at over 300 sites. Along with the primary endpoint of time to confirmed disability progression, the study will also examine the impact of laquinimod on endpoints such as percentage change in brain volume and other clinical and MRI markers of disease activity. Full Article
Teva Pharmaceutical Industries Ltd Reaffirms FY 2013 Guidance; Comments On H1, H2 Revenue Guidance-Conference Call
Teva Pharmaceutical Industries Ltd announced that it remains confident with fiscal 2013 guidance, which it gave on November 30. The quarterly development during the year will have more sales in the second half of 2013 than in the first half of 2013. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $20.2 billion and EPS of $5.09 for fiscal 2013. Full Article
Teva Pharmaceutical Industries Ltd Declares Cash Dividend
Teva Pharmaceutical Industries Ltd announced that the Board of Directors, at its meeting on February 5, 2013, declared a cash dividend for the fourth quarter of 2012 of NIS 1.15 (approximately 31 cents according to the rate of exchange on February 6, 2013) per share. The record date will be February 21, 2013, and the payment date will be March 7, 2013. Tax will be withheld at a rate of 15%. Full Article
Teva Pharmaceutical Industries Ltd Announces Termination Of Agreements With CureTech Ltd
Teva Pharmaceutical Industries Ltd announced the termination of collaboration with CureTech Ltd. Teva entered into agreements with CureTech in 2006. Teva intends to book a noncash net charge of $109 million as a result of the impairment of investment in CureTech. Full Article
UPDATE 1-Sanofi fined in Plavix generics dispute
* Sanofi may appeal decision, shares down 0.6 percent (Adds details, Sanofi comments, shares)
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