Boston, MA 10/11/2013 (wallstreetpr) – Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) is a global oncology company focused on the development, discovery, and commercialization of medicines for cancer patients. Since the data showing the rising number of test patients who suffered from blood clots and increasing heart problems, the company has stopped enrolling any new patients in current trials of its drug, which has been issued warning sign (leukemia).
The FDA ordered a “partial clinical hold” until the company does the modification in its study pertaining to the doses and changed the rules for eligibility in FDA updates pertaining to the warning issued for the drug, called Iclusig. I believe that this is a significant risk for the fast growing oncology company, which, in over a year, has invested a handsome amount of capital in research and development activities; the benefits of this can be spoiled by a single FDA warning report.
Looking at current FDA warnings, the risk profile on ARIA went significantly higher and commercial visibilities on the forthcoming drug have gone down which has resulted in a significant impact on company fundamentals
Though drug sales are likely to continue, timelines for the same would be phased out over time because trials aimed at increasing the number of patients as per their eligibility will tell who can receive Iclusig drugs. In order to expand the market, ARIA has been moving forward with the new testing. However, the same will come at higher cost, thereby impacting the cash flow of the company.
I believe that it is likely to take a much longer time for the company to get final approval for the drug under question (Iclusig) as a treatment. However, the company is going ahead with changes in the trial protocol, by reducing number of doses of Iclusig dosing and changing the eligibility norms by restricting patients with heart problems.
I am of the view that, until the company gets all its trials in place on the lclusig product, there is a chance for a significant chances for improving clinical trial, thereby impacting company cash flow in coming years.
