BioCentury
ARTICLE | Strategy

Icos chronicles

October 23, 2006 7:00 AM UTC

Icos chroniclesIcos (ICOS) has successfully developed one product, Cialis tadalafil, which was discovered with former partner Glaxo Wellcome and repartnered with Eli Lilly (LLY) in October 1998, when it was in Phase II. But the biotech has had a hard time getting a second product out of its pipeline, which now is all preclinical.ICOS expects to submit an sNDA for once-daily dosing of Cialis by year end. Regulatory approvals in Canada and Europe also could result in launches by the end of 2007. Cialis also is in Phase III testing for pulmonary arterial hypertension (PAH) and in Phase II for hypertension and benign prostatic hyperplasia (BPH). Phase II data for hypertension are expected by year end.The weekly stock price of ICOS is tracked against selected product development milestones since 1998. The company, which went public in June 1991, had a market cap high of $3.7 billion in June 2001. Last week's takeout deal is for about $2.1 billion in cash. A. September 1998 - Pafase fails in a Phase II asthma trial B. June 1999 - LeukArrest (Hu23F2G) fails in a Phase II trial to treat trauma-induced hemorrhagic shockC. October 1999 - LeukArrest fails in a Phase II trial to treat exacerbations in multiple sclerosis (MS)D. October 1999 - Starts Phase III testing of Cialis for erectile dysfunction (ED)E. November 1999 - Drops Pafase to prevent acute pancreatitis after failing in a Phase II trialF. November 1999 - LeukArrest fails in a Phase II trial to treat myocardial infarctionG. April 2000 - Discontinues Phase III trial of LeukArrest to treat ischemic stroke after the compound failed to meet predefined criteria of successH. June 2001 - Submits NDA for Cialis to treat EDI. July 2001 - Submits marketing application in the EU for Cialis to treat ED J. October 2001 - Reports pooled data from a total of 972 ED patients in four Phase III trials in which Cialis significantly improved erections vs. placeboK. April 2002 - Receives FDA approvable letter for Cialis in which the agency requested additional trials and other dataL. November 2002 - EMEA approves Cialis for EDM. December 2002 - Drops Pafase for severe sepsis after the compound failed in a Phase III trial...