Penwest confirms action on Oxymorphone patent application

Mar 15 2007

Penwest Pharmaceuticals has confirmed that the U.S. Patent and Trademark Office (PTO) has posted on its website an indication that a final rejection of Penwest's patent application claiming the sustained release formulations of Oxymorphone will be mailed.

This is one of several patent applications that Penwest is currently prosecuting related to Opana(R) ER (oxymorphone HCl) extended-release tablets CII, a product the Company developed with Endo Pharmceuticals. Opana ER 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. It is currently marketed by Endo.

A "final rejection" notice from the PTO is a part of the examining process by the PTO when the patent examiner does not allow all the pending claims. It does not end the Company's ability to pursue these claims. The Company has several options to respond to the final rejection, including appealing the final rejection by the examiner to the Board of Patent Appeals at the U.S. Patent and Trademark Office.

Jennifer L. Good, President and Chief Executive Officer of Penwest, said "We are disappointed with this action by the U.S. Patent and Trademark Office. Once we receive the Office Action from the Patent Office, we will respond as quickly as possible and continue to work with the Patent Office to move this application forward. In the meantime, Penwest and Endo continue to prosecute eight other patent applications related to Opana ER, some of which we believe could receive an Office Action later this year."

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