Jerusalem, Israel, December 15, 2004 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Gabapentin Tablets, 600 mg and 800 mg. Shipment of this product has commenced.
Gabapentin Tablets are the AB-rated generic equivalent of Pfizer's anticonvulsant, Neurontin® Tablets, which had annual sales of approximately $1.05 billion for the twelve months ended September 2004.
Teva's launch follows Alpharma's recent introduction of Gabapentin Tablets. The companies will share Alpharma's 180-day period of market exclusivity following Alpharma's request that the FDA allow Teva to sell its product during the exclusivity period. This is pursuant to an agreement signed by the parties in April 2004. Under the terms of that agreement, Teva would make payments under certain conditions, based on its own sales of Gabapentin Capsules and Tablets, to Alpharma relating to the period of exclusivity. The companies commenced shipment of Gabapentin Capsules, 100 mg, 300 mg and 400 mg on October 8th.
Summary judgment motions in this litigation were presented by Teva and other defendants to the U.S. District Court for the District of New Jersey in November. The motions are fully briefed and argued. Teva and Alpharma have entered into risk sharing arrangements relating to this litigation.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% 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 Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell or license their own generic products (so called "authorized generics") or successfully extend the exclusivity period of their branded products, the effects of competition on Copaxone® sales, including potential competition from the expected launch of Antegren®, Teva's ability to rapidly integrate the operations of acquired businesses, including its acquisition of Sicor Inc., regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to completion of appellate litigation, including that relating to Neurontin, 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 Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations outside the United States that may be adversely affected by terrorism or major hostilities, 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.