I listened to the PGNX conference call last week. Here are some of the highlights.
1) Scripts for Relistor were up 18% over in Q4 over Q3 2011.
2) Approval of Relistor in chronic pain will generate a $40 million milestone payment from Salix to PGNX
3) Sales force being geared up for Relistor in chronic pain, so launch is expected by August if approval is given.
4) The sNDA for the oral formulation of Relistor expected to be filed in Q3 of this year.
5) European partnership for Relistor is still being negotiated so no firm estimate of when the deal will be made can be given.
6) Salix is moving ahead with the Relistor multi-dosage pen and expects to submit for approve by year end.
7) anti-PMSA dosage may be nearing the MTD. Baker didn't give definitive reasons but rather used a comparison to other anti-PMSA antibodies. My view is that I am not sure how accurate that comparison is as the PGNX anti-PMSA antibody recognizes the dimeric (activated) form of PMSA, and the anybody is drug conjugated.
8) Expectations are for the anti-PMSA antibodies to enter a phase II trial later this year. The trial will likely NOT be a comparative trial but rather a single arm trial.