|Healthcare Review: Ironwood Pharmaceuticals, OvaScience, Flamel Technologies, Ventrus, Pluristem Therapeutics|
|By Staff and Wire Reports|
|Wednesday, 11 September 2013 13:34|
Ironwood Pharmaceuticals (IRWD -4.1%) slides in morning trading. Mizuho cuts its price target on the shares to $16 from $23.Linzess FY13 revenue estimates slashed to $117M from $147M.The company presented yesterday at the Morgan Stanley Global Healthcare Conference.
Shares of Flamel Technologies (FLML +3.1%) pop after the FDA accepts the company's second NDA.A PDUFA date is set for April 28, 2014.Further analysis here is impeded by the following: "For competitive reasons, the company has decided not to identify the product at this time."
OvaScience (OVAS) shares plummet 38% after the FDA said the company has to file an Investigational New Drug application for its lead product, Augment, which is designed to increase IVF success rates. The FDA has doubts about the status of Augment as a human cellular tissue-based product (HCT/P), which isn't subject to the same scrutiny as a new chemical entity and so can avoid years of trials to gain FDA authorization. OvaScience has halted a U.S. study of Augment and will focus on trials outside the country, which are slated to start in 2014.The company plans to hold talks with the FDA but its hopes of launching the treatment in the U.S. by the end of next year are looking rather forlorn.
Ventrus Biosciences (VTUS) says two clinical dermal safety studies of VEN 307 demonstrate the treatment is safe and well tolerated. No serious AE's were reported. All pharmacokinetic parameters were met in a separate study, consistent with an earlier investigator sponsored trial. The data "mark another important step in [the] effort to develop and commercialize [the drug]," CEO Russell Ellison says.
Pluristem Therapeutics (PSTI +6.6%) has received a patent for the treatment of peripheral artery disease with "placental-derived adherent stromal cells. "The expiry of the IP is 2028.The patent is the 26th that the developer of cell-therapy products has received.