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Andrx Announces Filing of NDA by Takeda for ACTOS and Extended-Release Metformin Combination Product.


FORT LAUDERDALE Fort Lauderdale (lô`dərdāl), residential, commercial, and resort city (1990 pop. 149,377), seat of Broward co., SE Fla., on the Atlantic coast; settled around a fort built (c.1837) in the Seminole War, inc. 1911. , Fla. -- Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) announced today that Takeda Global Research & Development Center Inc. filed a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for a combination product consisting of Takeda's ACTOS(R) (pioglitazone HCl) and Andrx's extended-release metformin metformin /met·for·min/ (met-for´min) an antihyperglycemic agent that potentiates the action of insulin, used in the treatment of type 2 diabetes mellitus.

met·for·min
n.
 to the U.S. 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.
) for the treatment of type 2 diabetes type 2 diabetes
n.
See diabetes mellitus.
.

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 Takeda Pharmaceutical Company Limited (武田薬品工業株式会社   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.

About Andrx

Andrx Corporation is a pharmaceutical company that:

--develops and commercializes generic versions of primarily controlled-release pharmaceutical products, as well as oral contraceptives Oral Contraceptives Definition

Oral contraceptives are medicines taken by mouth to help prevent pregnancy. They are also known as the Pill, OCs, or birth control pills.
 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

Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the 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.
 provisions of 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  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 relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 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 (Open Application Interface) A computer to telephone interface that lets a computer control and customize PBX and ACD operations. ) 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 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
) 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 When customers of the PSTN make telephone calls, they commonly make use of a telecommunications network called a switched-circuit network. In a switched-circuit network, devices known as switches are used to connect the caller to the callee.  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 Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.
Pharm Livy
Livy-Elcon Emereonye (Member): Extended Release Metformin 4/2/2009 5:35 PM
I would like to know the excipients used in the formulation extended release metformin. What are the challenges inherent in this formulation, and how best can they be resolved?

Thank you.

Livy-Elcon Emereonye.

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Publication:Business Wire
Geographic Code:1USA
Date:Apr 4, 2006
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