For a drugmaker whose name makes it sound like it's going places, Momenta Pharmaceuticals (NASDAQ:MNTA) has been stuck in a bit of a rut lately. Yesterday, the drugmaker updated investors on the status of its pipeline at the Bear Stearns Healthcare Conference.
Momenta's goal is to bring generic drugs to the market, similar to the job done by more established generics manufacturers such as Teva (NYSE:TEVA) or Barr Pharmaceuticals (NYSE:BRL). Unlike these other generic drugmakers, however, Momenta is focused solely on developing generic versions of drugs that are hard to characterize and reproduce like complex sugars and proteins.
This focus on harder to reproduce compounds means that Momenta will face less competition if it can successfully get a drug through the FDA or European Union regulatory rigmaroles. This means that Momenta would be able to reap a significantly higher selling price (and gross margins) than if there were multiple generic copies of a drug on the market.
Momenta's lead drug is a generic version of Sanofi-Aventis' (NYSE:SNY) blockbuster compound Lovenox, an anticoagulant to prevent blood clots. Earlier in the year a judge threw out the key Lovenox patent protecting it from generic competition; Sanofi is appealing the ruling.
Unlike the legal path, the regulatory path forward for any of the generic Lovenox products has not been cleared. Momenta had previously guided for an 18- to 24-month FDA review of the marketing application for its generic Lovenox compound, which was submitted in August 2005. In July it withdrew that guidance and now says it has no idea when the FDA will finish reviewing its application.
In the first six months of 2007, sales of Sanofi's Lovenox were up 12% year over year to about $1.75 billion, so any drugmaker that brings a generic copy to the market will be facing a rather large market opportunity.
If it gets approved, Momenta's generic Lovenox would be marketed by partner Novartis (NYSE:NVS).
Momenta is also working on other complex generics and a proprietary drug candidate. Until the FDA makes up its mind on its lead drug, though, it's anyone's guess as to what the value of Momenta's pipeline is.
