Ernie Els won the British Open on Sunday, rising to the top following a four-man playoff. When the winning putt went down, Els threw his cap into the air and raised his arms.
Pozen Inc. CEO John Plachetka thought of golf Monday when discussing positive preliminary data from a Phase III trial of MT 300 for migraine, a trial that hit its primary and secondary endpoints.
"Ask Ernie Els how he feels today," he said, adding: "You are always gratified when your products work. We have a lot of happy people [at Pozen]."
The study, MT 300-301, involved 619 patients with acute migraine and was conducted at 36 centers in the U.S. It compared MT 300 to placebo and had a primary endpoint of sustained pain response. Secondary endpoints were nausea and sensitivity to light and sound. Sustained response was defined as patients achieving pain relief within two hours of administration and not using rescue medicine or experiencing a relapse during the following 22 hours.
Preliminary analysis of the data shows the sustained response for MT 300 was statistically significant compared to the rate for placebo - 37 percent vs. 19 percent (p<0.001). MT 300 provided relief to patients quicker, too, compared to placebo, as it provided pain relief in more patients at two and four hours. And it provided statistically significant relief vs. placebo in the secondary endpoint measurements.
Pozen's stock (NASDAQ:POZN) jumped 90 cents Monday, or 26.5 percent, to close at $4.30.
"The data showed the product clearly works to relieve migraine symptoms," Plachetka told BioWorld Today. "This is one of the pivotal Phase III trials we need to complete, completed."
The second Phase III trial is "similarly sized," Plachetka said, and is "just finishing up now." Chapel Hill, N.C.-based Pozen expects to submit its NDA for the product in December.
MT 300 is a semi-synthetic variant of an ergot alkaloid, Plachetka said. Although "no one has pinpointed its exact mechanism of action yet," he said, it hits a variety of receptors for the serotonin family and patients tell Pozen "they just know they get pain relief."
If and when approved, Pozen intends to sell the product in a pre-filled syringe and take on GlaxoSmithKline plc's Imitrex, the reigning pre-filled syringe treatment for migraine that brings in $200 million in annual sales. There was a 35 percent incidence of injection-site reaction in the Phase III trial. However, Imitrex has a 60 percent injection-site reaction rate, Plachetka said.
"We think MT 300 will offer an alternative product that is convenient," he said.
Pozen is nearing the end of its clinical path for another product, MT 100, as well. The product is an oral tablet designed to be a first-line treatment for migraine. The company is finishing "the last of the clinical trials for registration," Plachetka said, and the company should file an NDA in the first half of 2003. In January 2001, the FDA requested Pozen conduct carcinogenicity studies of MT 100 before filing for approval. (See BioWorld Today, Jan. 29, 2001.)
Pozen said the search for marketing partners for both MT 100 and MT 300 is ongoing.
MT 400, also an oral tablet designed to treat migraine, got "great results" in its proof-of-concept study, he said. "We've had conversations with the FDA, and you'll hear more relatively shortly. We are really, really pleased with the interaction we've had."
With the stock markets sliding and the biotechnology sector experiencing untimely drug failures, there has been a shortage of positive drivers in the industry recently. Pozen is pleased to step into the void.
"Good news is scarce," Plachetka said. "We're happy to deliver some."