Cornerstone Therapeutics (NASDAQ:CRTX) expects its latest respiratory drug will get U.S. Food and Drug Administration approval in time for the coming cold and flu season.
The Cary, North Carolina-based respiratory therapeutics company has received a response from the FDA and Cornerstone is preparing to answer the regulator’s questions. Cornerstone CEO Craig Collard assured analysts that the FDA’s questions were “minor” and the company believes approval on the cold and cough medicine is forthcoming. And soon.
“It’s weeks, not months,” Collard said Thursday morning during the company’s quarterly conference call.
The drug in question is CRTX067, Cornerstone’s generic version of cold treatment Tussionex, a consistent performer for UCB (EBR:UCB) that generates about $226 million in annual U.S. sales. If approved, CRTX067 would join generics produced by Par Pharmaceuticals (NYSE:PRX) and also UCB. Despite the presence of other Tussionex generics, Collard said there is still money to be made from selling the drug.
Cornerstone reported second-quarter net income of $200,000 on revenue of $28 million. A year ago, Cornerstone reported a net loss of $200,000 on revenue of $28.5 million. Cornerstone’s top-selling product in the quarter remained Curosurf, which treats respiratory distress in premature infants. Curosurf generated second-quarter sales of $8.5 million, which was down about 1 percent from a year ago.
Cornerstone does anticipate completing an acquisition soon. In June, Collard said Cornerstone was closing in on a strategic transaction that could be either a product or a company. Collard said Cornerstone was “close to a couple of things,” but he declined to offer specifics when pressed by analysts.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“Unfortunately, sometimes these things take a little longer than we’d hoped,” he said.
But Cornerstone does appear to be in a better cash position to execute a deal. In June, the company said it had more than $86 million in cash available through the first quarter and no debt. As of June 30, that cash pot has grown to $92.8 million.
