07:00 , Aug 31, 2009 |  BC Week In Review  |  Company News

Endo, ProStrakan sales and marketing update

Endo received exclusive, U.S. rights to commercialize ProStrakan's Fortigel testosterone. In May, ProStakan submitted a complete response to FDA for Fortigel to treat male hypogonadism. ProStrakan will receive $10 million up front and is eligible...
07:00 , May 11, 2009 |  BC Week In Review  |  Clinical News

Fortigel testosterone regulatory update

FDA accepted a complete response from ProStrakan to a 2003 not approvable letter for Fortigel testosterone to treat male hypogonadism. The PDUFA date is undisclosed. The transdermal 2% testosterone gel is already marketed in the...
08:00 , Dec 8, 2008 |  BC Week In Review  |  Company News

ProStrakan, Bayer deal

Bayer's Bayer Schering Pharma AG subsidiary received an exclusive license to develop and commercialize ProStrakan's Tostran testosterone gel to treat male hypogonadism in Canada, Latin America, the Middle East, Africa, Asia and the Pacific. The...
07:00 , Jul 7, 2008 |  BioCentury  |  Finance

2H milestones

2H milestones Company Product Indication Event Milestone Accentia (NASDAQ:ABPI) Biovaxid Indolent follicular B cell non-Hodgkin's lymphoma (NHL) Ph III data; submit BLA and MAA September; YE08 Acura (NASDAQ:ACUR) Acurox Moderate to severe pain Ph III...
07:00 , Jun 23, 2008 |  BC Week In Review  |  Clinical News

Tostran testosterone: Phase IIIb/IV data

In the Phase IIIb/IV TIMES 2 trial, Tostran met the primary endpoint of a significant improvement in insulin sensitivity vs. placebo after 6 and 12 months (p=0.05 and p=0.01, respectively). The compound also significantly improved...
07:00 , May 12, 2008 |  BC Week In Review  |  Clinical News

Fortigel testosterone: Phase III data

In the open-label, U.S. Phase III Fortify trial in 149 patients, Fortigel met the primary endpoint of >=75% of patients achieving a plasma testosterone reference range of 300-1,140 ng/dL at day 90. The trial also...
07:00 , May 12, 2008 |  BioCentury  |  Finance

Ebb & Flow

Rumors that GPC Biotech (Xetra:GPC; NASDAQ:GPCB) may merge with Wilex (FSE:WL6) triggered a major rally for GPC last week. Fueled by newspaper reports on Wednesday, GPC gained E1.53 (83%) to E3.38 on Xetra and $1.66...
01:13 , May 9, 2008 |  BC Extra  |  Clinical News

Fortigel meets hypogonadism endpoint

ProStrakan (LSE:PSK) said Fortigel testosterone met the primary endpoint of at least 75% of patients achieving a plasma testosterone reference range of 300-1140 ng/dL at day 90 in the Phase III Fortify trial to treat...
07:00 , Apr 7, 2008 |  BioCentury  |  Finance

2Q milestones

2Q milestones Company Product Indication Event Milestone Accentia (NASDAQ:ABPI) Biovaxid Follicular non-Hodgkin's lymphoma (NHL) Interim Ph III data April Acusphere (NASDAQ:ACUS)/ Nycomed Imagify (AI-700) Detect coronary heart disease (CHD) Submit NDA April Adolor (NASDAQ:ADLR)/ GlaxoSmithKline...
07:00 , Mar 17, 2008 |  BC Week In Review  |  Clinical News

Fortigel testosterone: Completed Phase III enrollment

ProStrakan completed enrollment of 140 patients in the open-label, U.S. Phase III Fortify trial. The company licensed worldwide rights to Fortigel from Cellegy (see BioCentury, Dec. 4, 2006). Cellegy Pharmaceuticals Inc. (OTCBB:CLGY), Huntingdon Valley, Pa....