Teva Pharmaceutical Industries Limited Announces Novartis Corporation's Sandoz Pharma A.G. Unit Seeks To Delay First FDA Approval Of Generic Zocor(R)
The decision in April granted Teva's motion for summary judgment on the issue of whether its Abbreviated New Drug Application (ANDA) to market a generic version of Merck's Zocor® (Simvastatin) Tablets, 5, 10, 20, and 40 mgs is entitled to 180-day Hatch-Waxman statutory exclusivity. The Court found unlawful the FDA's October 24, 2005 decision denying a citizen's petition on the exclusivity issue and, accordingly, remanded the matter back to the FDA, which has since appealed to the United States Court of Appeals.
Teva is eligible to receive final approval for the 5 mg, 10 mg, 20 mg, and 40 mg strengths with exclusivity on June 23, 2006, when the product patent expires.
Sandoz has asked the Court to order the FDA not to approve Teva's generic Zocor® products pending a determination of its motion for a preliminary injunction ordering the FDA to approve Sandoz's ANDA. A hearing has been scheduled for this morning at 10:00 am EDT.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80% of Teva's sales are in North America and Europe.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the expected reintroduction of Tysabri® into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Contact: Teva Pharmaceutical Industries Ltd. Dan Suesskind, (011) 972-2-589-2840 or Teva North America George Barrett, 215-591-3030 or Investor Relations: Liraz Kalif, (011) 972-3-926-7281 Kevin Mannix, 215-591-8912 www.tevapharm.com
Source: Teva Pharmaceutical Industries Ltd.