Penwest Pharmaceutical Announces Results Of Phase IIa Trial For PW2132

DANBURY, Conn., Dec. 20 /PRNewswire-FirstCall/ -- Penwest Pharmaceuticals Co. today announced positive results from its Phase IIa trial of PW2132 -- torsemide extended release (ER), a product that the company is developing for chronic management of edema resulting from congestive heart failure (CHF).

Torsemide ER, a controlled-release formulation of torsemide that was developed using Penwest’s Geminex(R) dual drug delivery technology, is designed to be taken as a tablet once daily. It provides extended release of the drug during the waking hours when CHF patients need protection from absorbing salt in the diet. Torsemide is currently given as an immediate release oral tablet.

CHF is a major cardiovascular disease in the United States affecting 5 million to 7 million patients annually according to the American Heart Association’s 2004 statistics on heart disease. The class of products to which torsemide belongs -- loop diuretics -- remains a key part of the clinical management of CHF.

The 37-patient study was an open-label, single-center study using a dose escalation trial design studying the safety, pharmacokinetics and pharmacodynamics of single dose torsemide ER tablets in patients with Class II or Class III CHF. Patients were placed on a sodium-restricted diet for three days prior to dosing. The study also included a comparator arm of DEMADEX(R) 200 mg, which is the branded immediate release version of torsemide.

The goal of the study was to investigate the total 24-hour urinary sodium excretion, as well as the rate of sodium excretion over the 24-hour period. Administration of torsemide ER 100 mg resulted in a total 24-hour urinary sodium excretion comparable to DEMADEX(R) 200 mg. The total sodium excretion of torsemide ER was accomplished at a more sustained and slower rate over the course of the day using half the amount of drug than is in the DEMADEX(R) formulation.

Chronically treated CHF patients typically need to excrete between 150mEq and 200mEq of sodium per day to prevent water retention weight gain that can eventually lead to cardiac decompensation. The current formulations of loop diuretics have short periods of action in which most of the sodium excretion takes place. These short durations of action can both leave the patient unprotected for long periods of time during the day, when sodium retention is occurring with food intake, and create the potential for large urinary volume diuresis after drug ingestion, resulting in unpleasant side effects that can affect compliance.

Dr. Thomas Sciascia, Penwest’s Chief Medical Officer, said, “We are very pleased with the results of this trial. Although the study was conducted in the artificial environment of a regulated food intake of a sodium-restricted diet, we are encouraged that the data supports the conclusion that torsemide can be formulated and administered once daily in a manner that can result in a longer duration of action than that provided by currently marketed brands of the drug. This difference could be significant to congestive heart failure patients in the real world situation in which dietary sodium intake is large and sodium intake occurs throughout the waking hours.”

As previously reported, Penwest has completed Phase I studies on this compound to optimize the formulation, met with the U.S. Food and Drug Administration (FDA) to confirm the scope of the development program and filed initial patent applications. Penwest is filing additional patent applications based on the clinical data from this trial. Penwest is currently evaluating the next phase of the development program and its commercialization options for this product.

Penwest Pharmaceuticals

Penwest develops pharmaceutical products based on innovative oral drug delivery technologies. We are focusing our development efforts principally on products that address diseases of the central nervous system. The foundation of our technology platform is TIMERx(R), an extended release delivery system that is adaptable to soluble and insoluble drugs and that is flexible for a variety of controlled release profiles. We have also developed two additional oral drug delivery systems, Geminex(R) and SyncroDose(TM). Geminex is a dual release rate drug delivery system that is designed to provide independent release of different active ingredients contained in a drug, and SyncroDose is a drug delivery system that is designed to release the active ingredient of a drug at the desired site and time in the digestive tract.

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; dependence on collaborators such as Endo Pharmaceuticals to, among other things, sell products for which the Company receives royalties, file for regulatory approvals, and/or to advance clinical development and commercialization of products; regulatory risks relating to drugs in development such as oxymorphone ER and torsemide ER, including the timing and outcome of regulatory action; uncertainty of success of collaborations; the timing of clinical trials and whether the results of clinical trials such as the results described above will be indicative of results obtained in future trials, will warrant further clinical trials, 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 Certain Factors That May Affect Future Results in Penwest’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2005, which risk factors are incorporated herein by reference. Penwest disclaims any intention or obligation to update any forward-looking statements.

Contacts: Investors: Media: Diane D’Alessandro Caroline Gentile/Jim Fingeroth (203) 796-3706 Kekst and Company (877) 736-9378 (212) 521-4800

Penwest Pharmaceuticals

CONTACT: Investors - Diane D’Alessandro, +1-203-796-3706, or+1-877-736-9378; or Media - Caroline Gentile of Kekst and Company,+1-212-521-4800, or Jim Fingeroth of Kekst and Company, or +1-212-521-4800,all for Penwest Pharmaceuticals

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