Back to Archived News
Oscient Pharmaceuticals and Ethypharm SA File Lawsuit Against Lupin for Infringement of ANTARA® Patent
Thursday, January 15, 2009
Waltham, MA & Saint-Cloud, France -- Oscient Pharmaceuticals Corporation (the "Company") (Nasdaq: OSCI) today announced that it, its wholly owned subsidiary Guardian II Acquisition Corporation, and its licensor, Ethypharm SA, have filed a lawsuit against Lupin Limited and its subsidiary Lupin Pharmaceuticals, Inc. ("Lupin") in the United States District Court for the District of Maryland for infringement of U.S. Patent No. 7,101,574 (the "‘574 Patent"), which covers ANTARA® (fenofibrate) capsules.
The Company filed this lawsuit under the Hatch-Waxman Act in response to the Paragraph IV certification notice received by the Company from Lupin in accordance with 21 U.S.C. 355(j)(2)(B)(iv) advising the Company of the filing of an Abbreviated New Drug Application ("ANDA") by Lupin with the U.S. Food and Drug Administration ("FDA") to market a generic version of ANTARA prior to the expiry of the ‘574 Patent in August 2020.
The Company is committed to protecting its intellectual property rights relating to ANTARA through patent expiration. In accordance with the Hatch-Waxman Act, final FDA approval of the generic drug product will be stayed until the earlier of 30 months from the date of receipt of the Paragraph IV certification notice or a court decision finding that the ‘574 Patent is either invalid, unenforceable or not infringed by Lupin’s proposed generic product. Should Lupin receive tentative approval of its generic version of ANTARA from the FDA, it cannot lawfully launch its generic version of ANTARA in the U.S. until it receives final approval.
On December 3, 2008, the Company announced that it and Ethypharm had received notice of a Paragraph IV certification on behalf of Lupin Limited, advising of the submission of an ANDA with the FDA for ANTARA.
About Oscient Pharmaceuticals
Oscient Pharmaceuticals Corporation is a commercial-stage pharmaceutical company marketing two FDA-approved products in the United States: ANTARA® (fenofibrate) capsules, a cardiovascular product and FACTIVE® (gemifloxacin mesylate) tablets, a fluoroquinolone antibiotic. ANTARA is indicated for the adjunct treatment of hypercholesterolemia (high blood cholesterol) and hypertriglyceridemia (high triglycerides) in combination with diet. FACTIVE is approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. Oscient promotes ANTARA and FACTIVE through a national sales force calling on primary care physicians, cardiologists, endocrinologists and pulmonologists.
For important information regarding the safety and use of ANTARA and FACTIVE, please see the full prescribing information available at www.antararx.com and www.factive.com.
Forward-Looking Statement for Oscient
This news release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements with regard to (i) the Company’s commitment to protect its intellectual property rights relating to ANTARA, and (ii) the availability of an FDA stay of approval of Lupin’s ANDA and the timing of FDA approval of the generic drug product which is the subject of Lupin’s ANDA. Forward-looking statements typically are identified by use of terms such as "may," "will," "should," "plan," "expect," "intend," "anticipate," "estimate," and similar words, although some forward-looking statements are expressed differently. We do not plan to update these forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements due to a number of risks affecting our business. These risks include, but are not limited to (a) our ability to maintain the listing of our common stock on The NASDAQ Global Market; (b) our ability to successfully commercialize and market ANTARA or FACTIVE due to: the limitations on our resources and experience in the commercialization of products; lack of acceptance by physicians, patients and third party payors; unanticipated safety, product liability, efficacy, or other regulatory issues; delays in recruiting and training sales personnel; problems relating to manufacturing or supply; delays in the supply of products by the third party manufacturers and suppliers on which we rely; inadequate distribution of the products by wholesalers, pharmacies, hospitals and other customers; and competition from other products; (c) the delay in or inability to obtain additional regulatory approvals of our products and product candidates due to negative, inconclusive or insufficient results in ongoing or future clinical trials, the FDA or EMEA requiring additional information or data, delays in the progress of ongoing clinical trials, safety concerns arising with respect to our products or product candidates and disputes with the third parties from whom we license our products or product candidates; (d) our ability to raise additional funds and/or refinance our maturing and existing debt or debt that may be accelerated due to our inability to maintain our common stock listing on a U.S. national securities exchange or approved for listing on a U.S. system of automated dissemination of quotations and to fund our operations including sales and marketing activities and potential product acquisitions and (e) claims against us by third parties, including claims relating to our intellectual property position. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statement are described under the heading "Risk Factors" in the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2008 and in other filings that we may make with the Securities and Exchange Commission from time to time.
Back to Archived News