Preliminary evaluation found that cangrelor would not meet requirements for approval.
The Medicines Company is stopping Phase III trials with cangrelor in patients undergoing percutaneous coronary intervention (PCI). An interim analysis found that the program would not show significant clinical effectiveness required for regulatory approval.
The company dropped almost 44% to open trading at $6.25. Joseph P. Schwartz and Eric Varma, M.D., biotech analysts at Leerink Swann says that this creates a compelling buying opportunity. They believe that the market is not accurately valuing Angiomax, the firms approved anticoagulant, which has patent protection until the middle of 2010 and is not likely to come under too much generic competition thereafter.
They add that Oritivancin, an antibacterial, could bridge the revenu gap after 2011. Schwartz and Dr. Varma expect Phase III trials to start in the second half, launch in 2011, and peak sales of $150 million.
Cangrelor is an investigational intravenous antiplatelet agent exclusively licensed in December 2003 from AstraZeneca. The company noted that the discontinuation of the Champion program will result in cost savings of approximately $5 million in 2009.
The Champion-Platform trial compared cangrelor in combination with usual care to standard of care alone in patients who require PCI. The independent interim analysis review committee (IARC) predicted that results would not form the basis of an NDA. The Champion-PCI study, comparing cangrelor to clopidogrel, also showed no significant differences in measures of clinical effectiveness.
Safety findings for the program were consistent with those expected from short-term P2Y12 platelet inhibition and included an increase in minor bleeding among patients given cangrelor in comparison to placebo but not in comparison to clopidogrel.
Based on the totality of these data, the IARC has recommended that enrollment in both trials be discontinued and that all remaining data should be collected and analyzed. The IARC also recommended that the company should consider focusing on short-term use of cangrelor in settings where oral drugs cannot be used or when a short half-life is highly desirable.
The Medicines Company had begun studying cangrelor in such a setting. This research, known as the Bridge study, aims to establish the dosage of cangrelor that achieves greater than or equal to 60% inhibition of platelet aggregation for five days. The firm plans to enroll approximately 200 patients who have discontinued clopidogrel in preparation for cardiac surgery. The aim is to show safe bridging of patients during the pre- and post-surgical period of risk.
“In this setting of high unmet medical need, long-term clopidogrel is often discontinued at considerable risk to patients,” according to Clive Meanwell, M.D., Ph.D., CEO. “The rapid onset, offset, and titratable antiplatelet pharmacology of cangrelor seems ideally suited for this potential use.”
Past News from The Medicines Company
The Medicines Company Makes a $42M Move for Targanta (Jan. 13, 2009)
The Medicines Company Picks Up Curacyte’s Subsidiary Curacyte Discovery for $22.34M (Aug. 6, 2008)