Here are the week’s headlines in North Carolina tech and biotech news:
—BioCryst (NASDAQ: [[ticker:BCRX]]) received Food and Drug Administration approval on an intravenous antiviral treatment for influenza, marking the first U.S. drug approval for the Durham, NC-based company.
Peramivir (Rapivab) was developed in partnership with the with the Biomedical Advanced Research and Development Authority, which had financed development of the BioCryst drug under a contract valued at $235 million. BARDA sought the drug as a treatment for pandemic influenza. The drug, which is expected to be available for use in hospitals only, had previously been approved in Japan and South Korea.
—Scioderm closed on $20 million to finance additional clinical studies of an experimental treatment for the rare skin disease epidermolysis bullosa, which results in fragile skin that is susceptible to wounds, blistering, and tearing. The Redmile Group, a new investor, led the Series B round.
EB has no cure, nor are there any FDA-approved medical treatments for the genetic disease. Durham, NC-based Scioderm has developed a topical cream containing the active ingredient allantoin (Zorblisa) that is intended to improve wound healing. Scioderm’s drug has completed Phase 2B clinical trials. The company plans to start the latest round of clinical studies in the first quarter and expects to have initial results from the trial in the second half of 2015.
—Pozen’s (NASDAQ: [[ticker:POZN]]) cardiovascular disease drug candidate failed to secure regulatory approval for the second time. The Chapel Hill, NC, drug developer says the FDA declined approval on the aspirin combination drug, again citing manufacturing issues with a third party manufacturer. The news comes nearly three weeks after the abrupt termination of a partnership with Sanofi (NYSE: [[ticker:SNY]]), the large pharma company that had signed on to market the drug in the United States for secondary prevention of cardiovascular disease.
During a conference call about the latest development, Pozen CEO John Plachetka noted that the wording of the FDA letter is exactly the same as the complete response letter the FDA sent in April, leading the company to believe that the agency has not had the opportunity to reinspect the plant following its initial findings. Plachetka says the manufacturing facility is overseas and is manufacturing over-the-counter aspirin products for other companies without any FDA problems. But he said one difference is that Pozen’s drug is the manufacturer’s first prescription aspirin product. Pozen plans to request a meeting with the FDA before it determines its next steps.
—Red Hat (NYSE: [[ticker:RHT]]) CFO Charlie Peters is retiring. The long-time executive has been at the Raleigh, NC, open source software company for more than 10 years, a tenure that has seen annual revenue grow from $150 million to a projected fiscal 2015 figure of nearly $1.8 billion.
During a conference call to discuss fiscal third quarter financial results, Peters said he is retiring to spend more time with his family, which now includes six grandchildren. He has not set a firm retirement date but says it will be within 12 months and he will use that time to work on a transition to his yet-to-be-determined successor.
—Chimerix (NASDAQ: [[ticker:CMRX]]) has a new partner to develop and commercialize an antiviral drug that could have applications in HIV. The Durham, NC, company licensed CMX157 to Edison, NJ-based ContraVir Pharmaceuticals (OTC: [[ticker:CTRV]]) for $1.2 million in ContraVir stock.
Chimerix stands to gain up to $20 million more if the antiviral hits development and commercialization milestones. That’s considerably less than the $150 million in milestones, plus royalties, that Chimerix stood to gain from former partner, Merck (NYSE: [[ticker:MRK]]). In 2012, the large pharmaceutical company paid Chimerix $17.5 million up front to license worldwide rights to the investigational drug. Merck returned the antiviral to Chimerix in May, saying that after assessing its drug portfolio, it decided it would no longer pursue the compound. The Chimerix antiviral has completed Phase 1 clinical trials.
