IMPAX Prevails in Tricor Capsules Patent Infringement Suit.Business Editors/Health/Medical Writers HAYWARD, Calif.--(BUSINESS WIRE)--March 28, 2003 IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that U.S. District Judge Joan B. Gottschall in Chicago ruled that its Fenofibrate Capsules, a generic form of Tricor(R) Capsules, Micronized, does not infringe Abbott Laboratories' (NYSE NYSE See: New York Stock Exchange :ABT ABT About ABT Abteilung (German: Department) ABT Abbott Laboratories (stock symbol) ABT American Ballet Theatre ABT Associação Brasileira de Telemarketing ABT Abort ABT Availability Based Tariff ) patent on this product. Tricor is marketed for the treatment of hypercholesterolemia Hypercholesterolemia Definition Hypercholesterolemia refers to levels of cholesterol in the blood that are higher than normal. Description Cholesterol circulates in the blood stream. It is an essential molecule for the human body. and hydertriglyceridemia. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. IMS Health IMS Health (NYSE: RX) is an international consulting and data services company that supplies the pharmaceutical industry with sales data and consulting services. IMS Health was founded in 1954 by Bill Frohlich and David Dubow. , U.S. sales of the capsule for the lipid-regulating agent were approximately $2.3 million for the year ending December 31, 2002, as Abbott converted usage to the tablet form prior to the availability of generic capsules. In February 2002, the U.S. Food and Drug Administration granted IMPAX Laboratories tentative approval of the Company's Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) for 67mg, 134mg and 200mg Fenofibrate Capsules (Micronized). Final approval is contingent upon Adj. 1. contingent upon - determined by conditions or circumstances that follow; "arms sales contingent on the approval of congress" contingent on, dependant on, dependant upon, dependent on, dependent upon, depending on, contingent the earlier of (1) the settlement of pending patent-infringement litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. brought by Abbott against IMPAX, or (2) the expiration of the 30-month stay process under the Hatch-Waxman Amendments; and the expiration of any generic marketing exclusivity. Final approval is also dependent upon FDA's evaluation of any new information subsequent to this tentative approval. The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. accepted for review IMPAX's application to market a generic version of Abbott's Tricor (Fenofibrate) Tablets in December 2002. IMPAX's submission included a Paragraph IV certification stating that, to the Company's knowledge, the product does not infringe upon Abbott's listed Tricor tablet patents. Abbott Laboratories (NYSE:ABT) has filed lawsuits against the Company in the federal district court in Delaware alleging patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. related to IMPAX's filing of an ANDA for a generic version of Abbott's Tricor(R) Tablets. These lawsuits are continuing. According to IMS Health, U.S. sales of Tricor Tablets were approximately $445 million in the 12 months ended December 31, 2002. Barry R. Edwards, Co-Chief Executive Officer of IMPAX Laboratories, commented, "We are very pleased to have prevailed in court. Our Global Pharmaceuticals division will begin marketing our generic Tricor capsules after receipt of final FDA approval for this product." IMPAX has 19 applications pending at the FDA, including three tentatively approved, that address more than $5.8 billion in U.S. branded product sales for the 12 months ended December 31, 2002. Thirteen of these filings were made under Paragraph IV of the Hatch-Waxman Amendments. 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 intends to market 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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, 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. |
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