Biotech awaits FDA decision for sinus drug
Oscient could quintuple stock price with FDA blessing: analyst
NEW YORK (CNNMoney.com) -- A small biotech could get a big boost from the FDA next week, if a panel of expert smiles on the company's bronchitis drug.
Factive has been on the market since 2004 as a treatment for mild or moderate forms of pneumonia contracted outside health care facilities, and for bacterial complications related to bronchitis. The drug accounts for most of the Massachusetts-based biotech's sales, which totaled $24 million in 2005.
An FDA panel of expects will vote on Wednesday as to whether the agency should approve the drug for this extra treatment for sinusitis. The panel vote is not a final decision, but is taken as a suggestion by FDA regulators when they decide whether to approve the drug, which could happen later this year. The panel vote is important, because the FDA usually follows the advice of its experts.
If Factive is approved to treat sinusitis, the potential boost to sales is significant because the drug's patient pool could more than triple in size. Nearly 40 million Americans get sinusitis every year, according to the National Institutes of Health, and the U.S. market for treatments is nearly $6 billion. According to Oscient, three to four million Americans get pneumonia every year outside hospitals and nursing homes, and 13 million people in the U.S. get chronic bronchitis, which means that Factive is currently serving a population of less than 20 million patients.
Anthony Payne, senior managing director for When2Trade, said that if the FDA approves Factive for the additional use, it could push Oscient's stock price up to $5 a share, which is nearly five times the current price. If the company does not get FDA approval, Payne believes that the stock price could still go up, but would be capped at $2 a share because investors will "remain cautious."
"If the FDA does not approve the product [for the extra use,] the stock will come under pressure," wrote Payne, in an analyst note published Aug. 8. "However, we still think that Factive is an exciting product against drug resistant pathogens and could be a good revenue driver for the company even with refusal by the FDA to approve this product for [acute bacterial sinusitis.]"
There are many small biotechs like Oscient, including Genta (down $0.01 to $0.52, Charts), which received a negative vote from FDA advisors for its blood cancer drug, and Geron (down $0.04 to $6.71, Charts), which experiments with stem cells. These companies are tiny compared to market leaders Amgen (down $0.38 to $67.95, Charts), the biggest biotech in the world, and Genentech (up $0.15 to $82.23, Charts).