Pozen Submits Safety Data

When Pozen (Nasdaq: POZN  ) and partner GlaxoSmithKline (NYSE: GSK  ) received their second approvable letter for Trexima, I predicted that the companies would likely have to run another clinical trial to ensure that the FDA would approve the drug. The companies didn't listen to me and announced Friday that they'll submit a response without any new trial data. You may be surprised to hear that I think they're making the right move.

The companies are under a time constraint: Trexima is a combination of the generic painkiller naproxen and Glaxo's migraine drug Imitrex, which loses patent protection in 2009. After both of those drugs have generic equivalents available, it may be hard for Pozen to get doctors to prescribe Trexima when prescribing two generics would serve the same purpose.

Essentially Pozen is taking a calculated risk, with the understanding that Trexima is worth a heck of a lot more if it gets an approval in six months or less, than if it runs a six-month clinical trial and gets an approval in well over a year. It's certainly possible that the FDA might be satisfied with the non-trial safety data that Pozen plans to submit in its response -- after all, it was pre-clinical data that triggered the second approvable letter.

Since I haven't sat in on the meetings at the FDA, it's difficult to know if this is what's really going on, or if the FDA has assured Pozen that the drug will be approved after the additional safety data is turned in. The latter is how the companies presented it in their press release, but Encysive Pharmaceuticals (Nasdaq: ENCY  ) and GPC Biotech (Nasdaq: GPCB  ) also thought they could get away with submitting less data than the FDA wanted, so I'm inclined to take Pozen's opinion with a grain of salt.

Now, I do I think it's a good idea for the companies to take the risk, but that doesn't mean Pozen is a good investment. I'm no more convinced that the drug will be approved without a clinical trial than I was before the companies announced their intention to submit their response. In addition, taking the gamble now will cost you about 8% more than it would have on Thursday.