Key Developments: TEVA TA`ASIYOT FARMATSEVTIYOT BE`AM (TEVA.O)
57.10USD
4:00pm EST
$0.18 (+0.32%)
$56.92
$57.35
$57.59
$56.72
4,539,807
5,121,943
$59.62
$41.70
Latest Key Developments
Teva Pharmaceuticals Industries Limited Announces Settlement In Principle Regarding Certain Drug Pricing Lawsuits
Teva Pharmaceuticals Industries Limited announced that several of its subsidiaries in the United States reached a settlement in principle to resolve claims brought by Ven-A-Care of the Florida Keys, Inc. on behalf of the United States, Texas, Florida, and California under federal and state False Claims Acts. Together with many other pharmaceutical manufacturers, Teva is named in numerous civil lawsuits that relate to drug price reporting by manufacturers in about 15 states. The cases, which are pending in federal and state courts, generally allege that the prices reported by pharmaceutical companies caused governments to pay inflated reimbursements for drugs under Medicaid or other programs. Teva denies the allegations. Upon execution of definitive settlement documents and certain government and court approvals, the settlement will resolve a lawsuit relating to federal contributions to all state Medicaid programs and claims of Texas, Florida, and California relating to their Medicaid programs. The settlement will eliminate the majority of the alleged damages asserted against Teva in the various drug pricing litigations.
Teva Pharmaceutical Industries Ltd. Announces FDA Accepts BLA For XM02
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva`s Biologics License Application (BLA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer. Teva's BLA for XM02 was submitted to the FDA on Nov. 30, 2009. The proposed trade name for XM02 is NEUTROVAL.
Teva Pharmaceutical Industries Ltd.'s Teva UK Limited Launches Lercanidipine Hydrochloride Film-Coated Tablets
Teva Pharmaceutical Industries Ltd.'s Teva UK Limited announced the patent expiry launch of lercanidipine hydrochloride film-coated tablets, available in 10mg and 20mg strengths in packs of 28. Lercanidipine hydrochloride film-coated tablets are indicated for the treatment of mild to moderate, essential hypertension. It is a generic version of Zanidip from Recordati and is available immediately in the Teva 360 livery, which is designed to aid patient safety.
Teva Pharmaceutical Industries Ltd.'s Teva UK Limited Launches Dorzolamide 2% Eye Drops Solution
Teva Pharmaceutical Industries Ltd.'s Teva UK Limited announced the launch of dorzolamide 2% eye drops solution available in a 5ml bottle. Dorzolamide solution is indicated as adjunctive therapy to beta-blockers, as monotherapy in patients unresponsive to beta-blockers or in whom beta-blockers are contraindicated.
Gilead Sciences, Inc. May Commence Patent Infringement Lawsuit Against Teva Pharmaceutical Industries Ltd.
Gilead Sciences, Inc. (Gilead) announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceutical Industries Ltd. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Viread (tenofovir disoproxil fumarate). In the Notice Letter, the Company alleges that three patents associated with tenofovir disoproxil - U.S. Patent Numbers 5,922,695; 5,977,089; and 6,043,230; and one patent associated with tenofovir disoproxil fumarate - U.S. Patent Number 5,935,946 - owned by Gilead are invalid, unenforceable and/or will not be infringed by the Company's manufacture, use or sale of the product described in its ANDA submission. Gilead is reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against the Company. Such a lawsuit would restrict the FDA from approving the Company's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first.
Teva Pharmaceutical Industries Ltd. Receives Favorable Court Decision Regarding Generic Temodar
Teva Pharmaceutical Industries Ltd. announced that U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Schering-Plough`s brain tumor treatment Temodar (temozolomide). The Court found that U.S. Patent No. 5,260,291 is not enforceable due to prosecution laches and inequitable conduct. Teva`s tentatively approved ANDA to market temozolomide is currently pending final approval at the U.S. Food and Drug Administration (FDA). As the first company to file the ANDA that contained a paragraph IV certification for Temodar, Teva is eligible to receive 180-day Hatch-Waxman statutory exclusivity to market this product.
Abbott Laboratories Seeks To Block Teva Pharmaceuticals Industries Limited Plan For Generic Simcor Drug-DJ
Dow Jones reported that Abbott Laboratories sued Teva Pharmaceuticals Industries Limited, seeking to block the Israeli company from making a generic version of its Simcor cholesterol treatment, Reuters reported, citing Delaware District Court documents. In the lawsuit, Abbott claims Teva violated its patents when Teva sought the U.S. Food and Drug Administration's approval to market a generic version of Simcor. Teva declined comment.
Teva Pharmaceutical Industries Ltd. Announces Tentative Approval of Generic Femara Tablets
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' breast cancer treatment Femara (letrozole) Tablets, 2.5 mg. Final approval of the Company's Letrozole Tablets is expected upon expiry of patent protection for the brand product in June 2011.
Pfizer Sues Teva Pharmaceutical Industries Ltd. For Infringing Zyvox Patent-Reuters
Reuters reported that Pfizer asked a U.S. federal court to block Teva Pharmaceutical Industries Ltd from selling a generic form of its Zyvox antibiotic that it said would infringe a patent, according to court documents. Pfizer asked the court for an injunction to prevent Teva from making or selling a generic version of Zyvox, according to the complaint filed in U.S. District Court in Delaware. Teva filed an abbreviated new drug application with the U.S. Food and Drug Administration, seeking approval to sell a generic version of Zyvox. Pfizer said the move infringed its patent. Pfizer said in the complaint that its Zyvox patent would not expire until at least 2014. The case is Pfizer Inc. et al v. Teva Parenteral Medicines Inc. et al, U.S. District Court, District of Delaware, No. 10-00037.
Pfizer and Teva Pharmaceuticals Industries Limited Set To Tussle For Ratiopharm-Reuters
Reuters reported that according to German business daily Handelsblatt, the race for German generic-drug maker Ratiopharm has practically narrowed to Teva Pharmaceuticals Industries Limited and Pfizer Inc. EQT also remains a bidder but the company's chances are seen as slim because it stands to gain fewer synergies from the deal and has less financial fire power than its rivals from the healthcare industry. The three suitors are to file binding offers for Ratiopharm by early February. The winning bid could be in the EUR2.8-EUR3 billion range.
Astra gets Crestor boost
LONDON (Reuters) - AstraZeneca has pulled ahead of the pack with an expanded label in the United States for its heart drug Crestor, but the medicine's future remains uncertain ahead of a vital patent trial this month.
Earnings vs. 
Estimates
Thomson Reuters is the world's largest international multimedia news agency, providing investing news, world news, business news, technology news, headline news, small business news, news alerts, personal finance, stock market, and mutual funds information available on Reuters.com, video, mobile, and interactive television platforms. Thomson Reuters journalists are subject to an Editorial Handbook which requires fair presentation and disclosure of relevant interests.
NYSE and AMEX quotes delayed by at least 20 minutes. Nasdaq delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.
