In an interview with Liz Cermak, Executive Vice President and Chief Commercial Officer of POZN, we discuss the implications of a European licensing deal for their migrane drug MT 400.
Last week, Pozen Inc. (POZN) announced a licensing deal with Germany's CNS focused Desitin Arzneimittel GmbH for the development and commercialization of MT 400 for the European Union as well as Switzerland and Norway. MT 400 is Pozen's proprietary combination of sumatriptan and naproxen sodium, the first multiple mechanism triptan therapy for the treatment of migraine.
Q: What do investors need to know about this news? How does this deal change your financial forecast, if at all?
Liz Cermak, VP, Pozen Inc.:
"Our investors should know that we continue to leverage our products in the best partnership deals possible to create increased shareholder value. Desitin will make an initial upfront payment to Pozen, followed by milestone payments related to the development and launch of MT 400 in certain specified countries. The pre-commercialization payments will total $3.0 million, $0.5 million of which is due on signing. Desitin also will pay Pozen a double digit royalty on net sales of MT 400 that increases based on annual sales volume. The European regulatory approval of this product also will facilitate licenses and approvals with other partners in other territories."
Q: How does Pozen plan to utilize the revenue from this deal?
Cermak: "As with the milestone and royalty payments received under past agreements, the revenue from this deal will be used to continue to advance the Pozen pipeline, so that we can bring products to market that are affordable to patients and physicians alike."
Q:Why did you select Desitin as your partner for the development and commercialization of MT 400 in these countries?
"Desitin has a strong European presence and history of success in marketing CNS products. We believe Desitin will be an outstanding partner in bringing this novel migraine product to the millions of migraine patients living in Europe."
Q: How is your partnership with Cilag GmbH International, a division of Johnson & Johnson, for MT 400 in Brazil, Colombia, Ecuador and Peru going?
"It is going well. Cilag continues to move forward with their manufacturing set-up and regulatory advice and approval process."
Q: Are you looking for other partners for MT 400 in any additional countries and if so, where?
"Pozen is actively seeking other licensing partners for the additional available territories outside of the U.S. to develop and market sumatriptan and naproxen combinations at other doses. Also, as you know, we are also seeking strong commercial licensing partners for our PA portfolio."
Q: Are there any milestones or catalysts that investors should be paying attention to going forward for the rest of 2012?
"We continue to progress our PA32540 program and New Drug Administration (NDA) submission. At a recent pre-NDA meeting, the U.S. Food and Drug Administration suggested that we also seek approval of a lower dose formulation containing 81 mg of aspirin. We are currently evaluating the best way to do that. However, a major milestone for us this year would be securing a partner or partners for one or more of our PA assets, which we anticipate doing by year-end."
The company reminds investors that Migraine afflicts between 10-12 percent of people, of which roughly three out of four migraine sufferers are women. Migraine attacks can last from 4 hours to 72 hours and are typically characterized by sharp pulsating pain on one side of the head, nausea, and extreme sensitivity to light and sound. While the precise mechanism of migraine is unknown, researchers believe migraine attacks are caused by acute inflammation surrounding selected vessels in the head. The average migraine sufferer experiences the first attack during the early teen years, and the attacks generally continue throughout adulthood.
Shares of the company have been rebounding since slumping 19 percent in late April -- the most since 2008 -- after the Food and Drug Administration threw a cruveball; suggesting that POZN seek approval for a lower dose formulation for its PA32540 product.