Key Developments For Penwest Pharmaceuticals Co
Penwest Pharmaceuticals Co (PPCO.O) (Consolidated Issue listed on NASDAQ Global Market)
Penwest Pharmaceuticals Co. Comments On FY 2010 Profit Outlook
Penwest Pharmaceuticals Co. announced that it expects to continue financial growth and to be profitable for fiscal 2010. According to Reuters Estimates, analysts on an average are expecting the Company to report net profit of $28 million for the same period.
Penwest Formulation Demonstrates Proof-of-Principal In Phase I Trial In Development Program With Otsuka Pharmaceutical
Penwest Pharmaceuticals Co. announced that its formulation of a product of Otsuka Pharmaceutical Co., Ltd. that Penwest had developed utilizing its TIMERx 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 payment from Otsuka. 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.
Penwest Pharmaceuticals Co. Sees FY 2009 Earnings Outlook At High End Of Prior Range
Penwest Pharmaceuticals Co. expects net loss for fiscal 2009 to be at the high end of its range of $1-$3 million.
Penwest Pharmaceuticals Co. Announces Results Of Phase Ib Trial of A0001
Penwest Pharmaceuticals Co. announced the results of its Phase Ib clinical trial of A0001, a compound the Company is developing for the treatment of mitochondrial diseases. In the Phase Ib trial, the drug was well tolerated by subjects, and no serious adverse events were reported. There was a dose-dependent increase in exposure approaching steady state within 2-4 days following repeat-dosing, and a maximum tolerated dose was established.Based on these results, Penwest plans to advance A0001 into Phase IIa studies in patients with mitochondrial diseases. The Company intends to commence two Phase IIa trials - one focused on patients with Friedreich's Ataxia and the second focused on patients with the A3243G mitochondrial DNA point mutation associated with the "MELAS" syndrome - in the fourth quarter of 2009. The Phase IIa trials will be conducted with twice daily oral dosing. The Company expects data from both of these trials in the first half of 2010.
Penwest Pharmaceuticals Co. Enters Into Third Research and Development Agreement With Otsuka Pharmaceutical
Penwest Pharmaceuticals Co. announced that it has signed its third research and development agreement with Otsuka Pharmaceutical Co., Ltd. of Japan to develop a formulation of an undisclosed Otsuka compound utilizing Penwest's TIMERx drug delivery technology. Under the terms of the agreement, Penwest will receive undisclosed fees and payments.
