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Fort Lauderdale, Fla. US | Jan 23, 2006 | Andrx Corporation (Nasdaq:ADRX) ("Andrx" or the "Company") announced today that it has entered into an agreement with InvaGen Pharmaceuticals Inc. ("InvaGen") to commercialize 11 abbreviated new drug
applications (ANDA), which, according to IMS data, had total brand sales exceeding $13 billion for the trailing 12 months ended September 2005. ANDAs for two of the products have been filed with the U.S. Food and Drug Administration ("FDA") and it is anticipated the ANDAs for the remaining products will be submitted during 2006 and through early 2007.
Pursuant to the agreement, InvaGen will be responsible for all formulation work, regulatory submissions and manufacture of each of the products. Andrx will be responsible for sales and marketing efforts and coordination of legal activities, if any. In addition, the agreement also provides that Andrx, at its option, may site transfer manufacturing of certain products to InvaGen's facility.
InvaGen is a U.S. generic pharmaceutical company based in Long Island, New York. To date, InvaGen has filed 10 ANDAs with the FDA, two of which have been approved and are being marketed by other parties.
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 pharmaceutical products, 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 Andrx 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," "should," "would," "estimate," or "continue" or the negative or 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, the timing and outcome of patent, class action and other litigation; the submission of Citizen Petitions, if any; the timing and outcome of future product launches by us or by InvaGen pursuant to this agreement; the timing and scope of patents issued to our competitors; the FDA's pending inspection; what sanctions, if any, FDA may seek following its decision to place us in OAI status, including without limitation sanctions relating to any failure to comply with cGMP requirements and if and when the "hold" on our ANDA approvals will be lifted; business interruption due to hurricanes or other events outside of our control; our dependence on a relatively small number of products; licensing revenues; government regulation generally; competition; manufacturing capacities, safety issues, output and quality processes; our ability to develop and successfully commercialize new products; the loss of revenues from existing products; the success of our joint ventures; the impact of sales allowances; product liability claims; recent management changes and the potential loss of senior management and other key personnel; the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals; and our ability to commercialize all of our pre-launch inventory. Actual results may differ materially from those projected in a forward-looking statement. We are also subject to other risks detailed herein or detailed from time to time in our 2004 10-K 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 2004 10-K 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.
SOURCE: Andrx Corporation |
