2010 was a great year for achievements at POZEN.
The highlight of our year was POZEN receiving approval by the U.S. Food and Drug Administration (FDA) for VIMOVO™ (naproxen and esomeprazole magnesium) delayed release tablets. This marked the 2nd new product approval for POZEN in two years, an accomplishment almost no other company of our size has achieved. Then, in November, positive agreement for approval of VIMOVO in 23 countries in the European Union, and marketing and pricing approval in the United Kingdom was received. These events triggered a total of $45 million in milestone payments to POZEN and that, coupled with increased royalty revenues from sales of Treximet® (sumatriptan and naproxen sodium), allowed us to report record revenues and net income for the fiscal year, and to begin 2011 with over $60 million in the bank. So, our financial position is good as we start 2011.
Vimovo will be the last product we intend to develop with the objective of out-licensing to others for commercialization in the United States, rather, we are currently seeking a strategic partner for our product candidate PA32540, currently in late stage Phase 3 development. In other words, we intend to be in greater control our own destiny with respect to the full development and sales and marketing of our integrated aspirin therapies, and all future products. We have added substantial value to this asset by executing the critical NDA development and pre-commercialization phases, and now it is our intention to secure a relationship with one or more strategic partners in order to maximize the sales potential of PA32540, both in the United States and globally. We believe that changing our business strategy will allow us to capture much more value for our shareholders compared to the out-license model used for Treximet and VIMOVO. We also believe that the time to make that change is now.
Regarding our commercialization strategy, it is our intent to make all of the products in our portfolio of evidence-based integrated aspirin therapies affordable. While others talk about value pricing, POZEN is leading the way with this new, but also historic, concept. Liz Cermak and her team are building our commercial infrastructure in such a way that we expect to be able to make a profit commensurate with typical pharma levels, even as we eschew the high prices typical of new products. Not surprisingly, we intend to use many of the successful ‘in-source’ strategies on the commercial side of POZEN that have helped us control costs while delivering results on the development side of the company. By embracing the use of digital communication, we will be leading the way with novel sales and marketing techniques that some classify as ‘high tech’, but we understand the need to balance those efforts with an appropriate ‘high touch’ and personal effort. I believe that building solid relationships with our customers will always be an important element in the success of our company, and so we will continue our efforts to build and nurture those relationships as we move forward.
On the product development front, our lead product candidate, PA32540, is currently in Phase 3 trials in the U.S., with a New Drug Application (NDA) submission scheduled for 2012. It is being investigated for the secondary prevention of cardiovascular and cerebrovascular disease in patients at risk for aspirin-induced gastric ulcers. We are also exploring other PA indications, including chronic pain relief and cancer prevention. You will find additional information in this Annual Report about PA32540 and other product candidates in the portfolio.
Our main objectives for 2011 are to continue to execute our transformational plan to become a fully integrated specialty pharmaceutical company and to maintain our PA32540 development program on track for a 2012 NDA submission. This is an exciting time for POZEN, and I hope you will like what you see in our 2010 annual report. Thanks for your continued interest.
Sincerely,
