|Healthcare Review: Insmed, Dendreon, Allergan, Edwards Lifesciences, Intercept Pharmaceuticals|
|By Staff and Wire Reports|
|Tuesday, 20 May 2014 12:58|
Shares of Insmed ($INSM +8.8%) are up in light volume in apparent response to its announcement of results from its Phase 2 clinical trial for Arikayce (liposomal amikacin for inhalation) for the treatment of treatment-resistant nontuberculous mycobacterial lung infections. Investors may not have read the entire press release, though. Although the title states "positive open label data" the product failed to achieve the primary endpoint of a statistically significant change in mycobacterial density on a seven-point scale from baseline to the end of the randomized portion of the trial. Only a positive trend was observed. It did achieve the secondary endpoint of culture conversion.
Shares of Dendreon ($DNDN +8.4%) are up in heavy volume in response to the company's presentation of data from two Provenge clinical studies at the American Urological Association meeting in Orlando. Interim data from the ProACT and IMPACT studies suggest that Provenge elicits an immune response associated with an overall survival benefit.
Allergan ($AGN) ramps up its propaganda efforts in its battle to stay out the clutches of Valeant (VRX), saying that it expects EPS to increase 20-25% in 2015 and at an annual compound rate of 20% over five years. The company also forecasts "double-digit revenue growth" next year and over the coming five years. Meanwhile, Allergan has received over 500 letters from physician customers, patient advocacy groups and medical associations expressing support for the company following its rejection of Valeant's bid.
Edwards Lifesciences ($EW) says the outcomes at 30 days in a trial of its Sapien 3 transcatheter aortic valve were "excellent." Immortality was a "very low" 2.1% and the stroke rate was 1%, while there were few access-site complications. Over 96% of patients had a mild paravalvular leak, although there were no severe such leaks.
Shares of Intercept Pharmaceuticals ($ICPT) are off 12% on mediocre volume in apparent response The Street's article stating the company's liver disease drug, obeticholic acid (OCA), may cause significant lipid abnormalities, an observation made from its Phase 3 clinical trial evaluating the drug in patients with nonalcoholic steatohepatitis (NASH). Intercept executives appear to have made the decision to downplay the potential negative ramifications of the lipid effects according to a series of January 2014 emails exchanged between the company and a division of NIH.