The Medicines Co. ($MDCO) has had a tough time winning FDA approval for its blood-thinning injection Cangrelor, suffering a series of setbacks since it kicked off late-stage studies for the drug almost a decade ago. But now, the company is enjoying a bright point as the agency did an about-face and signed off on the drug for a smaller subset of patients, giving Medicines Co. a boost as it braces for generic competition for one of its bestsellers.
Regulators approved Cangrelor, also known as Kengreal, to prevent blood clots in patients undergoing percutaneous coronary intervention (PCI), or coronary angioplasty, a non-surgical procedure that props open a blocked or narrowed coronary artery to improve blood flow to the heart often with stents inserted. About 500,000 people in the U.S. undergo PCI each year, and cangrelor cuts down on risks associated with the procedure including heart attack and stent clotting, the FDA said in a statement. Medicines Co. expects the drug to hit the market in July, the company said in a statement.
"For patients undergoing percutaneous coronary intervention, blood clotting can cause serious problems," Norman Stockbridge, director of the agency's Division of Cardiovascular and Renal Drugs, Center for Drug Evaluation and Research, said in a statement. "The approval of kengreal provides another treatment option for patients."
The FDA based its approval on a revised study of Cangrelor which compared the drug against Bristol-Myers Squibb's ($BMY) and Sanofi's ($SNY) Plavix in about 11,000 patients. Regulators last year asked Medicines Co. to re-examine data from its Champion-Phoenix trial, saying that Cangrelor did not prevent clots any better than Plavix and actually increased bleeding rates in patients.
The drugmaker bounced back, narrowing the med's indication and showing that it improved outcomes for PCI patients. But Cangrelor was also associated with more serious bleeding than Plavix in the revised study, with one in every 170 patients taking the drug experiencing serious bleeding compared to one in every 275 patients taking Plavix, the FDA said in a statement.
Medicines Co. could still face a tough road ahead as it recovers from 9 years setbacks with the med. The company has funneled about $200 million into developing Cangrelor over the past decade, Reuters reports, including two unsuccessful trials and the Phase III study that drew the FDA's ire last year. Analysts once set peak annual sales of the drug at about $400 million. But RBC Capital Market analyst Adnan Butt expects that number to be much lower, with peak annual sales of about $80 to $100 million in the U.S., according to the Reuters story.
Still, approval for Cangrelor helps Medicines Co. at a critical moment as it prepares for generic competition to its best-selling anticoagulant, Angiomax. The company has fought tooth and nail to protect its patent for the drug, suing the U.S. Patent and Trademark Office a few years ago over a patent extension filing and mounting a legal battle against its law firms last year for busting a key patent filing deadline. A little help from Cangrelor could go a ways toward helping Medicines Co. recover sales when generics take their toll.
|Medicines Co. CEO Clive Meanwell|
"The approval of Kengreal provides a new option for PCI," Medicines Co. CEO Clive Meanwell said in a statement. "This novel drug will potentially decrease thrombotic risk in the acute care setting, deliver value to the healthcare system alongside Angiomax, and help us to increase our commercial offerings in the cath lab."
- read the FDA's statement
- here's Medicines Co.'s release
- get the Reuters story