IMPAX Comments On Schering Lawsuit Related to Generic Version of Claritin Reditabs.Health/Medical & Business Editors HAYWARD, Calif.--(BW HealthWire)--Feb. 1, 2001 IMPAX Laboratories Inc. (Nasdaq NM: IPXL) today announced that the Schering unit of the Schering-Plough Corporation (NYSE NYSE See: New York Stock Exchange : SGP SGP Singapore (ISO Country code) SGP Schering-Plough (stock symbol) SGP Stability and Growth Pact SGP Southern Great Plains SGP Staatkundig Gereformeerde Partij SGP Speedway Grand Prix ) has filed a lawsuit against the Company in federal district court in Newark, New Jersey 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 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 a generic version of Claritin(R) (loratadine) Reditabs. Schering markets Claritin Reditabs for the relief of symptoms of seasonal allergic rhinitis seasonal allergic rhinitis, n See hay fever. seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See Allergic rhinitis. (hayfever). U.S. sales of this product were approximately $240 million during the 12-month period ended September 30, 2000. On December 7, 2000, IMPAX announced that the Food and Drug Administration (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. ) had accepted the Company's filing of the ANDA for a generic version of Claritin Reditabs. IMPAX made that application under Paragraph IV of the Hatch-Waxman Amendments stating the Company's belief that its product does not infringe Schering's listed patents on Claritin Reditabs. "We are not surprised Schering filed this lawsuit. The filing of such lawsuits has become a routine means by which branded pharmaceutical manufacturers attempt to extend marketing exclusivity of a product. We believe the lawsuit is without merit and intend to defend our position vigorously. " said Barry R. Edwards, Co-Chief Executive Officer of IMPAX Laboratories. IMPAX Laboratories has previously announced that the FDA had accepted the Company's ANDAs for generic versions of Claritin(R) Reditabs (loratadine) Orally Disintegrating Tablets, Claritin-D(R) 12-Hour (loratadine/ pseudoephedrine sulfate pseudoephedrine sulfate Drixoral Nasal Decongestant, Drixoral Non-Drowsy Formula Pharmacologic class: Sympathomimetic Therapeutic class: Decongestant (systemic) Pregnancy risk category C ) Extended Release Tablets and Claritin-D 24-Hour (loratadine/ pseudoephedrine sulfate) Extended Release Tablets. Combined, these branded products posted U.S. sales of almost $1 billion during the 12-month period ended September 30, 2000.IMPAX currently has eight ANDA filings pending at the FDA that address more than $5.6 billion in U.S. branded product sales. Seven of these filings were made under Paragraph IV of the Hatch-Waxman Amendments. IMPAX Laboratories, Inc. is a technology focused specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and niche 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. 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 To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. |
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