Healthcare Industry News: OPANA
News Release - April 13, 2010
Penwest and Endo Enter Into Agreement With Barr to Settle Patent Litigation Over Opana(R) ERPATTERSON, N.Y., April 13, 2010 -- (Healthcare Sales & Marketing Network) -- Penwest Pharmaceuticals (Nasdaq:PPCO ) and Endo Pharmaceuticals (Nasdaq:ENDP ) announced today that the companies have settled litigation with Barr Laboratories, Inc. regarding the production and sale of generic formulations of OPANA(R) ER (oxymorphone hydrochloride) Extended Release Tablets CII.
Under the terms of the settlement, Penwest and Endo have agreed to grant Barr a license to sell a generic of OPANA(R) ER on or after Sept. 15, 2012, or earlier under certain circumstances.
About Penwest Pharmaceuticals
Penwest is a drug development company focused on identifying and developing products that address unmet medical needs, primarily for rare disorders of the nervous system. Penwest is currently developing A0001, or a-tocopherolquinone, a coenzyme Q10 analog demonstrated to improve mitochondrial function in-vitro. Penwest is also applying its drug delivery technologies and drug formulation expertise to the formulation of our collaborators' product candidates under licensing collaborations.
Penwest Forward-Looking Statements
The matters discussed herein contain forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, which may cause the actual results in future periods to be materially different from any future performance suggested herein. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "intends," "potential," "appears," "estimates," "projects," "targets," "may," "could," and similar expressions are intended to identify forward-looking statements. Important factors that could cause results to differ materially include the following: the dependence on third parties for the advancement of compounds utilizing the Company's drug delivery technology, the timing of clinical trials, such as the Phase IIa clinical trials, and risks related to patient enrollment; risks relating to the commercial success of OPANA ER, including our reliance on Endo Pharmaceuticals Inc. for the commercial success of OPANA ER, risks of generic competition and risks that OPANA ER will not generate the revenues anticipated; the need for capital; regulatory risks relating to drugs in development, including the timing and outcome of regulatory submissions and regulatory actions with respect to A0001; whether the results of clinical trials will be indicative of the results of future clinical trials and will warrant further clinical trials, warrant submission of an application for regulatory approval of, or warrant the regulatory approval of, the product that is the subject of the trial; whether the patents and patent applications owned by us will protect the Company's products and technology; actual and potential competition; and other risks as set forth under the caption Risk Factors in Penwest's Quarterly Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2010, which risk factors are incorporated herein by reference.
The forward-looking statements contained in this press release speak only as of the date of the statements made. Penwest disclaims any intention or obligation to update any forward-looking statements, and these statements should not be relied upon as representing the Company's estimates or views as of any date subsequent to the date of this release.
TIMERx is a registered trademark of Penwest. All other trademarks referenced herein are the property of their respective owners.
Source: Penwest Pharmaceuticals
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