Teva Signs Agreement With Andrx and Impax for Generic Formulations of Wellbutrin® Sr and Zyban®
2003-07-31 · Teva Branded Pharmaceutical Products R&D, Inc. · original tevapharm.com ↗
Jerusalem, Israel, July 31, 2003 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that one of its subsidiaries has entered into an exclusivity transfer agreement with Andrx Corporation (NASDAQ:ADRX) and IMPAX Laboratories, Inc. (NASDAQ NM:IPXL) pertaining to pending Abbreviated New Drug Applications (ANDAs) for bioequivalent versions of Wellbutrin® SR and Zyban® (Bupropion Hydrochloride) 100 mg and 150 mg Extended Release Tablets filed by Andrx, as well as by IMPAX. Pursuant to Teva's existing strategic alliance agreement with IMPAX, Teva has U.S. marketing rights to IMPAX's versions of these products. Wellbutrin® SR and Zyban®(GlaxoSmithKline products) had U.S. sales of over $1.6 billion for the twelve-month period ended March 31, 2003 according to IMS. The parties believe that the Andrx ANDAs for the products are entitled, under the Hatch-Waxman Act, to an 180-day period of marketing exclusivity. Under the exclusivity transfer agreement, Andrx will continue to seek approval of its ANDAs. The agreement provides, among other things, that if Andrx is unable to launch its own products within a defined period of time, and IMPAX is able to market its products, Andrx will enable IMPAX to launch its own products. IMPAX would then launch its products through Teva, with the parties sharing certain payments with Andrx relating to the sale of the products for a 180-day period. Should Andrx launch its own products prior to IMPAX launching its products, Andrx will share with Teva and IMPAX certain payments for a 180-day period. Mr. Israel Makov, President and CEO of Teva, said: "We are pleased to enter into this agreement with Andrx and IMPAX. We believe that this agreement will facilitate the introduction of these important treatments at lower prices at the earliest possible time." Andrx and IMPAX have both obtained favorable summary judgment decisions that their formulations of the products do not infringe GlaxoSmithKline's patents. GlaxoSmithKline, however, has appealed both decisions. The transactions contemplated by the exclusivity transfer agreement are subject to obtaining all necessary government approvals. Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 30 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Close to 90% of Teva's sales are in North America and Europe. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. 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 successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra® Neurontin®, Lotrel® and Famvir®, the effects of competition on our innovative products, especially Copaxone® sales, 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, our ability to achieve expected results though our innovative R&D efforts, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, 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 or revise any forward-looking statement, whether as a result of new information, future events or otherwise. In this press release, we present certain as adjusted numbers, which are non-GAAP financial measures. These numbers exclude items such as the effects of step-up of inventory upon acquisition, acquisition of R&D in process, product rights impairment, restructuring expenses, settlements and related tax effect. A reconciliation between the as adjusted numbers and the comparable GAAP measures is included later in this release. We provide such non-GAAP data because we believe that such supplemental data provide useful information to investors to better understand underlying trends in our business. However, adjusted financial measures are not, and should not be, viewed as a substitute for GAAP results. 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