This month three Canaccord Adams analysts--Adam Cutler, George Farmer and Ritu Baral (bios and photos)--weigh in on five developers that are facing pivotal events. A timely regulatory approval would mean a lot for one of these companies, another is pushing a new cancer therapy into crucial late-stage trials and a third is fishing for a potential partnership that could make a big difference as it advances three programs in the clinic. A well-timed NDA filing could set the stage for another pact while our fifth company faces a near-term decision from the FDA and some big decisions on a possible partner. Featured in this issue of On the Radar are Cadence Pharmaceuticals, Micromet, Momenta Pharmaceuticals, Pharmasset, and Protalix BioTherapeutics.
Cadence Pharmaceuticals (CADX) Rated buy
Cadence Pharmaceuticals is awaiting FDA approval for its IV acetaminophen product for the treatment of acute pain and fever. While the PDUFA date--Feb. 12th--is three months later than the original date because of FDA's classification of additional information as a major amendment, we expect a timely approval. Acetaminophen is a very widely used oral analgesic (it is the active ingredient in Tylenol as well as many prescription drugs) but Cadence's product would be the first IV formulation approved in the US. IV acetaminophen has been shown to safely improve pain relief and reduce the need for opioid pain drugs (e.g. morphine). Cadence licensed North American rights to the product from BMS, who sells the product in Europe where it is the leading IV analgesic. Given the success of the product in Europe and the enthusiastic feedback we have received from clinicians in the US, we expect Cadence to be successful in driving strong sales of the product (we assume a Q2/10 launch). In addition, after the product is approved, investors will be able to focus on the sales and earnings potential of Cadence, which we expect will attract a much broader investor audience. - Adam Cutler