Business Wire - Andrx Announces ANDA Filing for Cardizem LA
FORT LAUDERDALE, Fla. — Andrx Corporation (Nasdaq:ADRX) (”Andrx” or “Company”) today announced that it has a pending abbreviated new drug application (”ANDA”) with the United States Food and Drug Administration (”FDA”) for generic versions of Cardizem(R) LA (diltiazem HCl extended-release tablets), 120mg, 180mg, 240mg, 300mg, 360mg and 420mg strengths. Andrx initially filed its ANDA for the 420mg strength on April 25, 2005, with a Paragraph IV certification and notification to the patent holder. On August 10, 2005, Biovail Laboratories Int’l SRL. (”Biovail”), which is the holder of the New Drug Application for Cardizem LA, initiated a patent infringement lawsuit against the Company for the 420mg strength in the U.S. District Court for the District of Delaware. On August 30, 2005, Andrx amended its initial ANDA submission to include the 120mg, 180mg, 240mg, 300mg and 360mg strengths, along with a related Paragraph IV certification and notice letter. On October 14, 2005, Biovail initiated a patent infringement lawsuit on the remaining strengths. Andrx believes that it may have been the first ANDA applicant with a Paragraph IV certification for each of the six strengths, and accordingly may be entitled to 180 days of market exclusivity under the Hatch Waxman Amendments.
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According to IMS data, U.S. sales of Cardizem LA, which is now marketed by Kos Pharmaceuticals, Inc., for the trailing 12 months ended June 2005, were approximately $85 million.
About Andrx Corporation
We are a pharmaceutical company that:
–develops, manufactures and commercializes generic versions of controlled-release, niche and immediate-release pharmaceutical products, including oral contraceptives;
–distributes pharmaceuticals, primarily generics, which have been commercialized by others, as well as our own, primarily to independent pharmacies, pharmacy chains and physicians’ offices; and
–develops and manufactures pharmaceutical products for other pharmaceutical companies, including combination products and controlled-release formulations utilizing our patented technologies and formulation capabilities.
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: what sanctions, if any, FDA may seek, following its decision to place Andrx in OAI (Official Action Indicated) status, and when the “hold” on the Company’s ANDA approvals will be lifted, the timing and ability to obtain FDA approval of the Company’s Cardizem LA ANDA, whether such ANDA is entitled to the 180-day exclusivity period, and the timing and outcome of litigation related thereto, the Company’s dependence on a relatively small number of products, licensing revenues, the timing and outcome of litigation and future product launches, government regulation, competition, manufacturing capacities, safety issues, output and quality processes, recent management appointments and changes and the potential loss of senior management and other key personnel. We are also subject to other risks detailed herein or detailed from time to time in our Annual Report on Form 10-K for the year ended December 31, 2004, or in our other SEC filings. Subsequent written and oral forward-looking statements attributable to us or to persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth in our Annual Report on Form 10-K for the year ended December 31, 2004, and in our other SEC filings.
This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com.
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