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Andrx Signs Agreement with Impax and Teva for Generic Formulations of Wellbutrin SR and Zyban
Business Wire, July 31, 2003
Business Editors/Health/Medical Writers
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--July 31, 2003
Andrx Corporation (Nasdaq:ADRX) ("Andrx" or the "Company") announced today that it has entered into an Exclusivity Transfer Agreement with Impax Corporation (Nasdaq:IPXL) and a subsidiary of Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) pertaining to pending Abbreviated New Drug Applications (ANDAs) for bioequivalent versions of Wellbutrin(R) SR and Zyban(R) (Bupropion Hydrochloride) 100 mg and 150 mg Extended Release Tablets filed by Andrx, as well as by Impax. Pursuant to Impax's existing strategic alliance agreement with Teva, Teva has U.S. marketing rights to Impax's versions of these products. Wellbutrin SR and Zyban (GlaxoSmithKline products) had U.S. sales of approximately $1.6 billion for the twelve-month period ending March 31, 2003 according to IMS.
The parties believe that the Andrx ANDAs for the products are entitled, under the Hatch-Waxman Act, to a 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 Impax and Teva certain payments for a 180-day period.
Andrx's Chief Executive Officer, Richard J. Lane, said: "Though Andrx is continuing to work towards resolving the FDA and USP issues that have to date delayed the approval of our ANDAs for generic versions of Wellbutrin SR and Zyban, this Exclusivity Transfer Agreement better ensures that generic versions of these products will become available, thereby benefiting both consumers and our shareholders."
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.
About Andrx Corporation
Andrx Corporation develops and commercializes: bioequivalent versions of controlled-release brand name pharmaceuticals using its proprietary drug delivery technologies; bioequivalent versions of specialty, niche and immediate-release pharmaceutical products, including oral contraceptives; and brand name or proprietary controlled-release formulations of existing immediate-release or controlled-release drugs where it believes the application of Andrx's drug delivery technologies may improve the efficacy or other characteristics of those products. Andrx's distribution operations purchase primarily generic pharmaceuticals manufactured by third parties and sells them primarily to independent pharmacies, pharmacy chains which do not maintain their own central warehousing facilities, pharmacy buying groups and, to a lesser extent, physicians' offices.
Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including but not limited to, the timing and outcome of litigation and future product launches; government regulation generally; competition; manufacturing capacities and output; litigation asserting the Company's infringement of third party proprietary rights; commercial obstacles to the successful introduction of brand products generally; exclusion of Andrx's brand products from formularies; the success of Andrx's joint ventures; product liability claims; rising costs and availability of insurance, including product liability insurance; and the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals; Andrx Corporation is also subject to other risks detailed herein or detailed from time to time in its filings with the U.S. Securities and Exchange Commission, including, but not limited to, the Company's Annual Report on Form 10-K for the year ended December 31, 2002 and Form 10-Q for the quarter ended March 31, 2003.
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