Healthcare Industry News: Biovail
News Release - December 18, 2006
IMPAX Announces FDA Approval of Generic Wellbutrin XL 300 mgProduct Launched Under Exclusivity Transfer Agreement with Anchen and Teva
HAYWARD, Calif.--(HSMN NewsFeed)--IMPAX Laboratories, Inc. (OTC: IPXL ; "IMPAX" or "the Company") announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Wellbutrin XL, 300 mg. The product has been launched, pursuant to an Exclusivity Transfer Agreement with Anchen Pharmaceuticals, Inc. and a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA ).
Anchen obtained approval of its generic Wellbutrin XL product, and in accordance with this agreement, selectively waived its 180-day period of marketing exclusivity in favor of IMPAX Laboratories. Pursuant to the Company's existing strategic alliance agreement with Teva, Teva has U.S. marketing rights to IMPAX's version of this product. Wellbutrin XL 300 mg, marketed by GlaxoSmithKline, had U.S. sales in excess of $1.0 billion for the 12 months ended October 31, 2006, according to Wolters Kluwer Health.
Under the Exclusivity Transfer Agreement, Teva will make certain payments to Anchen in return for a waiver of its exclusivity to IMPAX. In addition, Teva is indemnifying IMPAX against certain losses that might arise from certain legal risks.
"We are very pleased to have received our ninth FDA approval this year, and look forward to offering patients this widely sold anti-depressant as a generic drug beginning immediately," commented Larry Hsu, Ph.D., President and Chief Executive Officer of IMPAX Laboratories.
"In addition, generic Wellbutrin XL is the first of our Tier 3 products to be marketed under the 12-product Strategic Alliance Agreement signed with Teva in July 2001. Under that agreement, upon the first launch date of any Tier 2 or Tier 3 product in the U.S., IMPAX plans to repurchase for $1.00, 16.67% of the IMPAX common stock, or approximately 244,000 shares, sold to Teva during the development phase of the agreement," Dr. Hsu added.
Both the IMPAX and Anchen ANDAs for generic Wellbutrin 300 mg were filed with Paragraph IV certifications with respect to certain patents held by Biovail Laboratories International SRL and listed in the Orange Book. Biovail initiated patent infringement lawsuits against both companies. The IMPAX litigation is ongoing, and IMPAX has filed a motion for summary judgment of noninfringement. Anchen has been granted summary judgment of noninfringement with regard to the Anchen product.
About IMPAX Laboratories, Inc.
IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and markets its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause IMPAX's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, possible adverse effects resulting from the delisting of IMPAX's stock, IMPAX's delay in filing its 2004 Form 10-K, its Form 10-Q for each of the first three quarters of 2005, its Form 10-K for 2005, and its Form 10-Q for each of the first three quarters of 2006, IMPAX's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, IMPAX's ability to successfully develop and commercialize pharmaceutical products, IMPAX's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in IMPAX's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and IMPAX undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
Source: IMPAX Laboratories
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