Penwest Formulation Demonstrates Proof-of-Principal in Phase I Trial in Development Program With Otsuka Pharmaceutical

Penwest to Receive Milestone Payment


DANBURY, Conn., Oct. 28, 2009 (GLOBE NEWSWIRE) -- Penwest Pharmaceuticals Co. (Nasdaq:PPCO) today announced that its formulation of a product of Otsuka Pharmaceutical Co., Ltd. that Penwest had developed utilizing its TIMERx(R) drug delivery technology under a collaboration with Otsuka had demonstrated proof-of-principal in a Phase I pharmacokinetic study. Under the terms of its agreement with Otsuka, Penwest will receive an undisclosed milestone payment from Otsuka.

Jennifer L. Good, Penwest's President and CEO, said, "Our research and development collaboration with Otsuka has been very productive. Achieving the targeted blood levels and demonstrating proof-of-principal for our formulation is a very important step in the overall development of a new formulation of Otsuka's product. We look forward to continuing our work with Otsuka to support the development of this formulation."

Under its agreement with Otsuka, Penwest has agreed to continue to support Otsuka in its scale-up work of this formulation and is eligible for additional development milestone payments and royalties. Penwest currently has three development programs with Otsuka involving its drug delivery formulation expertise and technology.

About Otsuka Pharmaceutical Co., Ltd.

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group comprises 153 companies and employs approximately 36,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned JPY955.9 billion (approx. US $9.7 billion*) in annual revenues in fiscal 2008.

* Exchange rate as of March 31, 2009.

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, a coenzyme Q analog drug candidate for inherited mitochondrial respiratory chain diseases. Penwest is also applying its drug delivery technologies and drug formulation expertise to the formulation of product candidates under licensing collaborations with partners.

Penwest Forward-Looking Statements

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," "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: risks relating to the commercial success of Opana ER, including our reliance on third party collaborators such as Otsuka and the uncertainty of success of collaborations; our reliance on Endo Pharmaceuticals Inc. 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; the timing of clinical trials; whether the results of clinical trials such as the results described above will be indicative of the results of future clinical trials or 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-Q filed with the Securities and Exchange Commission on August 10, 2009, 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.



            

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