Peter,
Noting a little recent weakness in POZN, I decided to scratch the surface in my usual fashion. Here's the last batch of results, which predates your post. What hasn't been mentioned here, according to my fallible perceptions, is that POZN's approach is to have several different combos with different profiles, so that they can cover various patient subsets of the migraine sufferer population. Seems to be a crude attempt at pharmacogenomics. Anyone have comments on this aspect?
>>CHAPEL HILL, N.C., May 21 /PRNewswire/ -- POZEN Inc. (Nasdaq: POZN - news), a pharmaceutical development company with a portfolio of product candidates for the treatment of migraine, today announced the positive results from a 972- patient, Phase II double-blind, placebo-controlled clinical trial with MT 400, its third product candidate being developed for the acute treatment of migraine.
In the clinical trial, MT 400 was significantly better than placebo with respect to the primary endpoint, sustained pain relief, and the secondary endpoints, including relief of pain, nausea, sensitivity to light, and sensitivity to sound, two hours after dosing. All results were statistically significant beyond the p<0.001 level versus placebo. Significant pain relief (p<0.001) with MT 400 was seen between 30 and 45 minutes after dosing and was maintained throughout the remaining 24-hour post-dose period.
MT 400 was also superior to the oral triptan comparator included in the study as a positive control. At the present time, triptans such as Imitrex®, Zomig®, and Maxalt® are considered ``the gold standard'' of oral treatments for acute migraine attacks. With respect to the primary endpoint, sustained pain relief, the therapeutic gain with MT 400 was more than twice the therapeutic gain seen with the triptan (p<0.001). Therapeutic gain is equal to the percent of patients with response on active agent minus the percent of patients with response on placebo control agent.
MT 400 also provided superior efficacy versus the triptan with respect to the total number of patients with pain relief at two hours (72 percent more therapeutic gain, p<0.001) and the number of patients made pain free at two hours (more than twice as much therapeutic gain, p<0.001). Significant differences favoring MT 400 were also seen in other secondary migraine symptoms such as relief of sensitivity to light and sound. MT 400 was well tolerated throughout the trial.
``MT 400 has met all our expectations. Although this is only a single double-blind, well-controlled clinical trial, the database is large, robust and compelling,'' said John R. Plachetka, Pharm.D., POZEN's chairman, president and chief executive officer. ``However, Phase II results do not necessarily predict the eventual outcomes of Phase III trials and we have substantial work to complete before this product is ready for a New Drug Application to the Federal Drug Administration.
``Based on our clinical trial data, we believe that MT 400, and our other acute treatment product candidates, MT 100 oral tablets and MT 300 injection, will be excellent complementary products for migraine patients. Each has a unique profile, which will allow physicians and patients the opportunity to customize their treatment strategy once these product candidates reach the market,'' Dr. Plachetka said.
``POZEN is the only company with a portfolio of well-differentiated product candidates that allows this patient-friendly approach. Our marketing research indicates that both physicians and patients really like the profiles of these product candidates and, because of that, we think that they have the potential to generate substantial revenue in the marketplace.''<<
sniparoo
Steady flow of 144s since lockup expiration lows. Always fun to look at the chart in conjunction with this stuff:
siliconinvestor.com
ipolockup.com
insidertrader.com
Note that the flow continues even after the release of nice data. Mostly VC, it would appear, but occasional selling by officers. Recent big sales by the Cleveland Clinic. Some digging in the 10-K may be required to see if there are clues to the other big holders, and what their intentions might be. 10-K worth reading for other reasons, too, of course:
10kwizard.com
They still have a fair slug of cash, but I know zip about their burn rate.
biz.yahoo.com
Cheers, Tuck |
