02
May
2008
Off to Phase IV for Letairis® and the Market for Volibris®
Posted in CO Pub Rel: Gilead, CO Pub Rel: GSK, CO Public: Myogen
Among the core assets that Gilead (Nasdaq: GILD) acquired from Myogen in 2006 for $2.5B was Letairis® (ambrisentan), for the treatment of pulmonary arterial hypertension (PAH), which was then approved by the FDA in mid 2007. After about a quarter in the market Gilead has initiated a Phase IV, randomized, double-blind, placebo-controlled study evaluating Letairis® [...]
29
Feb
2008
Michael Bristow, M.D., Ph.D. Wins 2008 PhRMA Award
Posted in CO Pub Rel: Gilead, CO Pub Rel: GSK, CO Public: Myogen, People
Congratulations to Michael Bristow, M.D., Ph.D., the S. Gilbert Blount Professor of Medicine at University of Colorado, Head of Cardiology, Co-director of the University of Colorado Cardiovascular Institute, co-founder of Myogen (acquired by Gilead (NASDAQ: GILD), founder of ARCA Discovery and now add to that list winner of the Pharmaceutical Research and Manufacturers of America [...]
20
Oct
2007
Gilead (NASDAQ: GILD) announced total revenues for 3Q07 of $1.06B, up 41% percent compared to total revenues of $748.7MM for 3Q06, along with record product sales of $962MM, up 44% over 3Q06! An amazing 90-day run, but what I am most interested in is how is Letaris® (ambrisentan) faring? Now don’t quote me here because [...]
19
Jun
2007
You can hear the champagne corks popping from Westminster, CO to Foster City, CA as the FDA late Friday approved Gilead‘s (Myogen) Letairis® (ambrisentan) for the treatment of pulmonary arterial hypertension (PAH). There are up to an estimated 90,000 people in the US suffering from PAH, a disease where blood pressure is raised due to [...]
16
Feb
2007
Happily tracking the progress of Gilead Sciences, Inc. (NASDAQ: GILD) Ambrisentan asset; for the treatment of pulmonary arterial hypertension. Gilead’s recent announcement that the FDA has accepted for filing and granted a priority review for the NDA is exciting news for the Colorado bio-scape. This approval may result in an accelerated review with an expectation [...]
05
Jun
2006
Myogen, Inc. (NASDAQ: MYOG) now has two candidates in Phase III trials, Ambrisentan and now Darusentan. The Darusentan trial will evaluate patients with resistant hypertension (RHTN). RHTN is the “the failure to achieve goal blood pressure in patients who are adhering to full doses of an appropriate three-drug regimen that includes a diuretic.” The primary [...]
10
Apr
2006
Mayhem at Myogen?
Posted in CO Public: Myogen
So what the heck is going on at Myogen today? The company announced that ambrisentan met its primary goal of helping people increase the amount of exercise they could do, and doing so without hurting their livers. Two great data points. Good news right? Share price zooms right? Well good news but not good enough [...]
09
Mar
2006
More Good News for Myogen
Posted in CO Public: Myogen
The FDA has granted Fast Track status for Myogen’s ambrisentan, currently in Phase III clinical trials. This designation is aimed to expedite the review process. The FDA designated ambrisentan as a Fast Track product for the following reasons: 1. Ambrisentan is intended to treat PAH, a life-threatening, progressive, and incurable disease of the pulmonary vasculature.2. [...]
07
Mar
2006
Myogen signed off on a two-tiered relationship with GlaxoSmithKline (GSK) whereby first, commercialization rights to ambrisentan have been licensed to GSK for all territories ex-US and secondly, Myogen will now be responsible for marketing and distributing GSK’s Flolan (for the treatment of primary pulmonary hypertension) in the US. Myogen President and CEO J. William Freytag [...]
03
Feb
2006
Myogen, Inc. (Nasdaq: MYOG) has sold its wholly-owned European subsidiary Myogen GmbH for $6.1 million to Wulfing Holding GmbH. The deal centers around a sublicense for rights to Perfan® I.V. (intravenous enoximone) in markets outside North America, from which the former parent will continue to receive a royalty on future net sales. Shedding this particular [...]
12
Dec
2005
Myogen announced today that Ambrisentan®, for pulmonary arterial hypertension, met the primary efficacy endpoint and several strategic secondary endpoints in this first Phase III trial. Results are expected shortly, in 1Q06, on an additional Phase III study. To date Ambrisentan® has demonstrated: • Improvement in exercise capacity• Improvement in time to clinical worsening• An apparent [...]
28
Jun
2005
Myogen is Hunkering Down
Posted in CO Public: Myogen
Three cheers for Myogen (MYOG). The company reported yesterday that the enoximone program, for the treatment of advanced stage chronic heart failure, has been terminated as a result of their two phase III trials failing to demonstrate a statistically significant benefit for any of the three co-primary endpoints. Despite the news something needs to be [...]
Life Science Deal Flow PARTNERS
-
