DANBURY, Conn., July 23, 2007 (PRIME NEWSWIRE) -- Penwest Pharmaceuticals Co. (Nasdaq:PPCO) today reported that the U.S. Patent and Trademark Office (PTO) has indicated on its website that a Penwest patent application claiming the sustained-release formulation of oxymorphone related to OPANA(r) ER (oxymorphone HCl) extended-release tablets CII has been allowed.
Penwest previously announced that it received a final rejection from the PTO for this application on March 15, 2007. In response to the rejection, the Company amended the claims and the PTO examiner found these amended claims allowable.
OPANA ER uses Penwest's TIMERx(r) technology and is indicated for the treatment of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. OPANA ER is not intended to be used on an as-needed basis. It is marketed by Endo Pharmaceuticals Inc.
"We are very pleased that this patent application related to OPANA ER has been allowed by the U.S. Patent and Trademark Office," said Jennifer L. Good, President and Chief Executive Officer of Penwest. "We believe that this patent is an important component in the intellectual property estate protecting OPANA ER."
Upon payment of the issue fee, the PTO will prepare the allowed patent application for printing and publication. The patent, once issued, will be scheduled to expire in 2022. Penwest expects that Endo will list this patent at the earliest opportunity in the Orange Book published by the U.S. Food and Drug Administration (FDA).
Penwest Pharmaceuticals
Penwest is a specialty pharmaceutical company dedicated to bringing to the marketplace innovative products that help improve the lives of patients. The Company's goal is to identify, develop and commercialize prescription products that address unmet medical needs, primarily for diseases of the nervous system. The launch by Endo Pharmaceuticals in mid-2006 of OPANA(r) ER (oxymorphone hydrochloride extended-release tablets) formulated with the Company's TIMERx(r) extended release delivery technology demonstrates the execution of this strategy and the value of the Company's TIMERx(r) technology. The Company is currently applying its expertise to a pipeline of potential products that are in various stages of development. The Company intends to commercialize these products independently or through third party alliances.
Penwest Forward-Looking Statement
The matters discussed herein contain forward-looking statements that involve risks and uncertainties, which may cause Penwest's 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," and similar expressions are intended to identify forward-looking statements. Important factors that could cause results to differ materially include: risks relating to the commercial success of OPANA ER and our reliance on Endo for the commercial success of OPANA ER; regulatory risks relating to drugs in development, including the timing and outcome of regulatory action; uncertainty of success of collaborations including the collaboration with Edison Pharmaceuticals; the timing of clinical trials, including the impact of enrollment rates; whether the results of clinical trials will warrant further clinical trials or warrant submission of an application for regulatory approval of, or the regulatory approval of, the product that is the subject of the trial; actual and potential competition; the need for capital; and other risks as set forth under the caption Risk Factors in Penwest's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2007, 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 statement made. Penwest disclaims any intention or obligation to update any forward-looking statements. TIMERx is a registered trademark of Penwest. All other trademarks referenced herein are the property of their respective owners.