PPCO..$3.72
Penwest Signs Multi-Drug Generics Agreement With Alvogen, Inc.
PATTERSON, N.Y., April 9, 2010
GLOBE NEWSWIRE
Penwest Pharmaceuticals Co. (Nasdaq:PPCO) today announced that it has signed a drug development and commercialization agreement with Alvogen, Inc. under which Penwest and Alvogen have agreed to identify and select up to five compounds for generic development. Penwest's TIMERx technology may be used for each compound selected. Penwest will formulate the agreed-upon compounds and receive milestone and royalty payments that are linked to the development of each compound.
Alvogen, the U.S.-based pharmaceutical manufacturer of complex generic products for U.S., E.U. and other international markets, will be responsible for manufacturing, clinical trials and regulatory filings for each of the formulations, as well as commercialization of the products worldwide.
Jennifer L. Good, Penwest's President and CEO, said, "We are very pleased to be partnering with Alvogen because of their record for successful product introductions within the generic pharmaceutical industry. This multi-drug, multi-national agreement allows Penwest to leverage its drug delivery technology for the formulation of generic drugs, an important segment of the market for extended release technology.
"TIMERx technology had its start in generics with the development of the first generic to Pfizer's Procardia XL product, which was formulated using the Alza Oros technology. We are pleased to be leveraging this valuable advantage of TIMERx in the development of difficult-to-formulate generic products with the expertise of the team from Alvogen."
The collaboration agreement with Alvogen represents a valuable addition to Penwest's growing drug delivery portfolio of development programs, which is being built upon broader strategic partnerships. Penwest currently has four individual research and development agreements with Otsuka Pharmaceutical Co., Ltd. working on branded products, and will now add this multi-drug agreement with Alvogen focused on generic drug development.
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.
About Alvogen, Inc.
Alvogen, Inc. is a multinational pharmaceuticals company focused on complex generic products. Alvogen is building the pharmaceutical company of tomorrow through the strategic selection of products, partners and markets, and the utilization of a consolidated global supply chain. The company product portfolio consists of a broad range of leading molecules for the treatment of conditions in the areas of Oncology, Cardiology, Respiratory, Neurology and Gastroenterology. With more than 100 years in operation, Alvogen possesses first-class regulatory, development and manufacturing capabilities in Asia, Europe and North America. Visit www.alvogen.com for additional information.
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.
CONTACT: Penwest Pharmaceuticals Co.
Investors:
Jennifer Good
845-878-8401
(877) 736-9378
Kekst and Company
Media:
John Patteson
(212) 521-4800
