BioDelivery Sciences International is apparently on the verge of winning approval for its first drug, the culmination of a regulatory process that began more than 18 months ago.
The Triangle is home to many drug-development companies, but it takes years to shepherd an experimental drug through clinical trials and regulatory requirements. Many companies falter along the way. Success would put BioDelivery in a select class that includes local companies such as Trimeris and Pozen.
"We expect an action very soon, and we are anticipating a positive outcome," BioDelivery CEO Mark Sirgo said during a conference call.
Although the Food and Drug Administration missed its target date for acting on the medicine's application, BioDelivery announced last week that it is confident the agency will pass final judgment in a matter of weeks.
The drug, Onsolis, is a treatment for cancer patients' acute pain. It could generate annual sales of $133 million, mostly in the U.S., in 2012, said Ladenburg Thalmann analyst Matthew Kaplan.
"It would have potential for further growth beyond that," Kaplan said.
The approval process for Onsolis has been drawn out.
BioDelivery, which has 13 employees in Raleigh and 21 overall, submitted its new drug application in October 2007. In August, the FDA notified the company that the application met the agency's requirements, except for the lack of a risk management program for dealing with the drug's adverse side effects, something that wasn't required when BioDelivery filed its application.
"Had it not been for that, we would be on the market by now," Sirgo said.
BioDelivery submitted a risk evaluation and mitigation strategy in December and recently was informed by agency officials that the plan was favorably received by the team that reviewed it.
Kaplan said he thinks approval is imminent. "But," he added, "you can never tell what the FDA is going to do."
Investors have been betting that the FDA will give Onsolis the go-ahead. Shares of BioDelivery are near a high after more than doubling this year. Shares have more than tripled since August.
BioDelivery shares closed Wednesday at $6.39, up 10 cents.
In the beginning
BioDelivery was founded in 1997 in New Jersey. In 2004, it moved its headquarters to the Triangle shortly after it acquired Arius Pharmaceuticals, a Research Triangle Park startup.
Arius, founded by Sirgo and Andrew Finn, who is executive vice president of product development at BioDelivery, previously acquired the technology that formed the foundation for Onsolis.
Onsolis delivers fentanyl, a type of narcotic, via a dissolvable film that adheres to the inside of the cheek. Although two competing fentanyls already are on the market, Kaplan projects that Onsolis will be easier to use and will deliver more consistent doses.
Meda Pharmaceuticals of Sweden, which acquired the marketing rights to Onsolis from BioDelivery, expects to begin selling the drug in the fourth quarter, Sirgo said.
BioDelivery also has a second drug in development, a treatment for post-surgical pain. That experimental drug is years away from gaining approval, even if everything goes smoothly.
BioDelivery has been strapped for cash at times, so much so that in the company's 2008 annual report, its auditors questioned its ability to continue as a going concern.
The company, which has had minimal revenue, posted a loss of $17.2 million last year.
The company has taken several steps to raise cash.
Most recently, BioDelivery reported last week that investors had exercised enough warrants for stock to "allow us to comfortably manage the company into the fourth quarter of this year."
Moreover, a major infusion of cash is on the horizon.
Meda Pharmaceuticals is obliged to pay BioDelivery $12 million upon FDA approval, plus an additional $15 million when Onsolis is launched. Meda also has committed to double-digit royalty payments on Onsolis sales.
"I couldn't be more pleased for our employees, who have weathered a lot of adversity to this point," Sirgo said.
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