Healthcare Industry News: metformin
News Release - April 4, 2006
Andrx Announces Filing of NDA by Takeda for ACTOS and Extended-Release Metformin Combination ProductFORT LAUDERDALE, Fla.--(HSMN NewsFeed)--April 4, 2006--Andrx Corporation (Nasdaq:ADRX ) announced today that Takeda Global Research & Development Center Inc. filed a New Drug Application (NDA) for a combination product consisting of Takeda's ACTOS® (pioglitazone HCl) and Andrx's extended-release metformin to the U.S. Food and Drug Administration (FDA) for the treatment of type 2 diabetes.
Thomas P. Rice, Andrx Corporation Chief Executive Officer, said: "We are extremely satisfied to see several years of development work come to fruition with the filing of an NDA for a product jointly developed by Andrx and Takeda. This once-a-day combination product is designed to provide a more convenient treatment option for those affected by type 2 diabetes. Through our Andrx Therapeutics contract services segment, we hope to forge more relationships like the one we have with Takeda in which we can utilize our strengths in formulation and process development and extend the life cycle of brand products," Rice said.
In January 2004, Andrx and Takeda Pharmaceutical Company Limited announced they entered into an agreement to manufacture and develop a combination product consisting of Takeda's ACTOS and Andrx's extended-release metformin. Under the agreement, Andrx will manufacture this combination product, if and when it is approved, and Takeda will hold exclusive, worldwide marketing rights. This NDA filing triggers the payment to Andrx of the third $10 million development milestone. Andrx may receive an additional development milestone from Takeda upon the occurrence of a future specified event. Andrx may also receive a transfer price for tablets manufactured, together with royalties and certain additional milestones related to the level of sales of the combination product.
Andrx Corporation is a pharmaceutical company that:
- develops and commercializes generic versions of primarily controlled-release pharmaceutical products, as well as oral contraceptives and selective immediate-release products;
- distributes pharmaceutical products, primarily generics, which have been commercialized by others, as well as our own, primarily to independent and chain pharmacies and physicians' offices; and
- develops and manufactures pharmaceutical products for other pharmaceutical companies, including combination products and controlled-release formulations.
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, risks and uncertainties related specifically to our collaborative agreement with Takeda, including whether the NDA for the Andrx/Takeda combination product of ACTOS and extended-release metformin will be approved and, if approved, whether it will be successfully commercialized; our ability to meet the supply and manufacturing requirements relating to the Andrx/Teva combination product; as well as other risks and uncertainties, including which sanctions, if any, the Food and Drug Administration (FDA) may seek in connection with its decision to place us in Official Action Indicated (OAI) status or after any current or future inspections, including without limitation sanctions relating to any failure to comply with current Good Manufacturing Practices (cGMP) requirements and if and when the "hold" on our Abbreviated New Drug Application (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; the timing and scope of patents issued to our competitors; whether we will be awarded any marketing exclusivity period for any of our products and, if so, the precise dates thereof; whether additional charges related to pre-launch inventory will be required; government regulation generally; competition; manufacturing capacities; our ability to develop and successfully commercialize new products; active pharmaceutical ingredients (API) issues; the loss of revenues and profits from existing products; our inability to obtain, or the high cost of obtaining, licenses for third party technologies; the consolidation or loss of customers; our relationship with our suppliers; our inability to obtain sufficient finished goods for distribution, supplies and/or API from key suppliers; product liability claims; rising costs and limited availability of product liability and other insurance; management changes and the potential loss of key personnel; the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals; our ability to commercialize all of our pre-launch inventory; and the completion of our merger with Watson Pharmaceuticals, Inc. Actual results may differ materially from those projected in a forward-looking statement. We are also subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2005, or from time to time 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, 2005, and in our other SEC filings.
Readers are cautioned not to place reliance on these forward-looking statements, which are valid only as of the date they were made. We undertake no obligation to update or revise any forward-looking statements to reflect new information or the occurrence of unanticipated events or otherwise, except as expressly required by law.
This release and additional information about Andrx Corporation is also available on the Internet at: http://www.andrx.com.
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