DANBURY, Conn., July 10, 2008 (PRIME NEWSWIRE) -- Penwest Pharmaceuticals Co. (Nasdaq:PPCO) today announced that it has begun dosing in a Phase I clinical trial of PW 4153, a drug candidate for the treatment of the symptoms of Parkinson's disease.
Jennifer Good, President and CEO of Penwest, said, "We are pleased to have initiated this Phase I trial of PW 4153, a product candidate that leverages Penwest's strengths in both reformulation and drug development. We expect to have data from this trial to share in the fourth quarter of this year."
PW 4153 is an extended release (ER) reformulation of a marketed drug that is dosed multiple times a day. The goal of this formulation is to extend the dosing interval of the drug while minimizing the peak-to-trough ratio, which Penwest believes may enhance the efficacy, tolerability and convenience of the drug for Parkinson's patients. The purpose of the Phase I trial of PW 4153 is to assess the bioavailability and pharmacokinetic blood levels of Penwest's formulation of the drug in healthy volunteers.
Penwest Pharmaceuticals
Penwest is a drug development 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 disorders of the nervous system. Penwest is currently applying its drug development and drug delivery expertise to a pipeline of potential products that are in various stages of development and that it intends to commercialize 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 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" 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, including our reliance on Endo for the commercial success of Opana ER and risks of generic competition; the need for capital; regulatory risks relating to drugs in development, including the timing and outcome of regulatory submissions and regulatory actions; uncertainty of success of collaborations; the timing of clinical trials; whether the results of clinical trials 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 and prevent others from infringing it; actual and potential competition; 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 12, 2008, 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.