Altus Pharmaceuticals Inc. (ALTU)

[ghmm]

A date to keep in mind is June 20th. This is the PDUFA date for Eurand's Zentase. I think the markets are anticipating that they will get approved and they very well might. If however the FDA makes them wait a great deal of time or does it via an approvable especially if the deficiencies are manufacturing or characterization related then it is a big plus for Altus.

Its hard to get details on Axcan especially now that they have been acquired by a private company. From Altus last call and the lack of public statements otherwise it would appear ultrase has not yet gotten FDA approval and they submitted their NDA back on August 2nd (the CMC portion was submitted June 21, 2007). They received priority review when the NDA was accepted in December 2007 and (according to Eurand filing) they provided a date suggesting a 4 month review!

In August 2007 Solvay received an approvable letter for Creon with CMC issues.