POZEN recently announced it had struck a licensing deal with Cilag GmbH, a division of Johnson & Johnson to develop and commercialize its migraine treatment, MT-400 in Brazil, Colombia, Ecuador and Peru. The company also reported positive data in a Phase I study titled Co-Rx of its combination aspirin/ immediate-release omeprazole tablet, PA32540 in conjunction with Plavix for platelet inhibition.
I had the opportunity to speak with Elizabeth Cermak, the company’s Chief Commercial Officer. Liz is charged with designing and implementing POZEN’s unique sales model, which has a limited dependence on traditional sales reps and focuses more on digital interactions.
“There is certainly risk in any new model, but Big Pharma will need to move down that path, so I think it’s a pretty exciting time for the industry, I’m just glad POZEN has the opportunity to not have to figure out how to shed reps from the old model and gets to build the new model. Since we’re two and a half years away, maybe three, we will learn from all the things that are going on right now and create some of our own. It is because of that that I’m pretty excited,” she explains.
Jason: Please explain the difference between Treximet and MT-400.
Liz: MT-400 is actually the internal POZEN name for the development effort- MT being “Migraine Treatment”, 400 is the series. We licensed US only rights of MT400, which became Treximet, to GSK. Their dosage combination is 85mg sumatriptan/500mg naproxen. We’ve retained rest of world rights to dosage combinations using 60mg of sumatriptan or lower to market or license outside the U.S. as part of that deal. We still call it MT-400 because we haven’t given it another name yet and we’ve been working on licensing agreements, one of which closed this week. So Johnson & Johnson will give it a name, but it is specifically a combination of 50 sumatriptan/500 naproxen.
Jason: Is there any clinical advantage to a lower dose?
Liz: We believe you can get a better side-effect profile when you lower the dose. The dose response curve in terms of efficacy for sumatriptan is pretty flat between 25 and 300, so the advantage may be a better side effect profile.
Jason: What are the anticipated peak sales of Treximet in the US, MT-400 in ex-US, particularly countries licensed to Cilag/J&J?
Liz: We usually try to defer to our commercialization partners because they’re the ones making the forecasts. Treximet did about $87M in US sales last year. I can’t predict what the peak sales will be. It’s definitely a product that’s well accepted in the market place. In terms of ex-US, it’s hard to say what that will be- it’s more of a question for J&J.
Jason: How does POZEN plan on marketing MT-400 in ROW- by small geographical areas, or larger partnerships?
Liz: It’s always easier for a little company like us to have a global deal like we did with AstraZeneca for VIMOVO. However, it’s not always optimal since not everyone’s in the CNS or migraine business. We want partners who are strong in their region in the category, so that is our first priority. If we do form more partnerships, which we may not, it’ll likely be more regional, not unlike the J&J deal.
Jason: It seems Par Laboratories was able to file an ANDA for Treximet very quickly, doesn't the Hatch-Waxman Act offer an automatic 5 yr regulatory exclusivity?
Liz: Normally a product that is filed the way Treximet is filed, which is under the combination rule, gets 3 years of exclusivity from the time that it’s approved. Treximet’s regulatory exclusivity goes from April 15, 2008 until April 15, 2011. During that time, Par, being the first to file an Abbreviated New Drug Application or ANDA, filed a Paragraph IV certification to challenge the patents. We had a trial last October and we are awaiting the judge’s decision. We had hoped that we would have a decision by now given that the regulatory exclusivity ends on April 15, which is only a couple of weeks from now. As a result, we filed a preliminary injunction to keep Par from launching at risk on the market on April 15. The same judge that heard the case will be reviewing the injunction and we’ll just have to wait and see what he does.
Jason: How does the Treximet patent case effect MT-400 in other regions?
Liz: Not at all
Jason: When do you expect J&J to gain approval and begin marketing MT-400 in Brazil, and is that all that is need for marketing in the rest of that region?
Liz: The countries are independent from each other from a regulatory perspective but they will start in the largest, which is Brazil. They will need to do manufacturing and they will need to do some work around bioequivalence and work through the exact timing of that. If I were projecting, I would say 18 to 24 months from now. Then they will proceed with the other countries.
Jason: With the successful Phase I Co-Rx study of PA32540, what is the next step?
Liz: We are currently in Phase 3 with PA32540. We will be completing the long-term safety study sometime in the second quarter of this year and we will be completing enrollment for the two six-month pivotal trials by the end of this year. We will submit an NDA sometime next year and if we receive a first cycle approval sometime in 2013, we are targeting a late 13, early 14 launch date. We’re pretty excited about that, and we’re thrilled with the progress of our commercialization plans. We think this is going to be a really nice product meeting an unmet need. We’ve done a substantial amount of market research and it’s been quite positive. Physicians would like to solve the GI toxicity of daily aspirin use and because they want their patients to take daily aspirin for secondary protection of cardiovascular vascular disease. This should have high appeal particularly with pricing of about $1/day. It’s been a very exciting time for POZEN.
Jason: PA32540 combined with an anti-clotting agent is a crucial component of POZEN's strategy, are there concerns regarding interactions between Plavix and omeprazole?
Liz: In our phase 1 study that we’re talking about this week, we are studying the platelet inhibition of PA32540, which has immediate release omeprazole versus a standard of care regimen. The results in our CoRx study reported that our PA product, when combined with Plavix, resulted in a 20% improvement in the anticlotting effect compared to a standard of care, dual antiplatelet regimen. This was preceded by another Phase 1 Study (presented at AHA in November) that reported that PA32540 showed no ex-vivo interaction with clopidogrel when administered ten hours apart based on the study’s pre-specified primary analysis. We conducted the Phase I work to understand this better.
Jason: Does POZEN anticipate sales and licensing revenue will be sufficient for the development and launch of PA32540?
Liz: That’s hard to say. It clearly depends on our partners, how well VIMOVO and Treximet do so it’s difficult to project at this point. In addition, we just did the deal with Johnson and Johnson, we potentially could do others, we had $64 million at the end of the year and we think we’re in pretty good shape for right now.
Jason: Do you have any other comments?
Liz: We believe bringing products like PA32540 to market and making them affordable and accessible to customers, in this much more cost-effective and efficient way can allow Pozen to be successful and drive shareholder value. We look forward to delivering on that and that’s why it is a pretty exciting time here.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.