POZEN Product Pipeline Status
PA Product Portfolio
POZEN’s active PA product portfolio is focused on designing cost-effective, integrated aspirin therapies that enable the full power of aspirin by reducing its potential gastrointestinal damage. The PA product portfolio has the potential to benefit the millions of Americans who use daily aspirin to treat cardiovascular disease, osteoarthritis and potentially other diseases.
The first candidates within the PA product portfolio are PA8140 and PA32540. They are coordinated-delivery tablets combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around pH-sensitive enteric-coated aspirin (81 mg or 325 mg) core. The pivotal Phase III trials of PA32540 are complete. Top-line results were announced in March 2012 and presented at both ACG and AHA in October and November 2012, respectively; the New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in March 2013. On August 25, 2014, POZEN received a complete response letter (CRL) from the FDA. In the CRL, the FDA noted that, during an inspection of the manufacturing facility of an active ingredient supplier, inspection deficiencies were found. On June 30, 2014, following the suppliers response to the FDA, POZEN resubmitted the NDA for PA8140/PA32540. On July 16, the FDA accepted the resubmission for review. The FDA indicated the NDA would be treated as a Class 2 resubmission, with a new user fee goal date of December 30, 2014. See the Posters & Publications page for more information.
To maximize the global sales potential of the PA product portfolio, POZEN is actively seeking one or more strategic partners, beginning with PA8140 and PA32540. Through a partnership with POZEN, the strategic licensing partner would be granted rights to the intellectual property behind PA8140 and PA32540 in the licensed territory and would benefit from POZEN’s manufacturing expertise and supply. Additionally, POZEN completed the initial commercial strategy development for PA8140 and PA32540, including all foundational market research, branding, positioning and innovative commercial marketing plan creation.
For additional information about the PA product portfolio, visit the Development Products – PA Pipeline page.
Treximet® (sumatriptan / naproxen sodium) is FDA-approved for the acute treatment of migraine attacks, with or without aura, in adults. In June 2003, POZEN licensed US only rights of Treximet® to GlaxoSmithKline. GlaxoSmithKline (GSK) is responsible for all commercialization activities for Treximet® in the United States. In November 2011, POZEN sold most of the future royalty and milestone payments covering Treximet® sales in the United States to a financial investor for $75 million. However, POZEN has retained ex-U.S. rights to develop and market a lower dose sumatriptan and naproxen combination (MT400).
MT 400 is POZEN’s proprietary combination of sumatriptan and naproxen sodium, the first multiple mechanism triptan therapy for the treatment of migraine headaches. MT 400 has proven to be superior to triptan monotherapy on multiple efficacy endpoints.
In March 2011, POZEN announced a license agreement with Cilag GmbH International, a division of Johnson & Johnson, for the development and commercialization of MT 400 in Brazil, Colombia, Ecuador and Peru.
POZEN is actively seeking other licensing partners for the additional available territories.
For additional information about MT 400, visit the Licensed Products – MT 400 page.
VIMOVO® (naproxen / esomeprazole magnesium) delayed-release tablets, co-developed by POZEN and AstraZeneca, is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID), and immediate release esomeprazole, a proton pump inhibitor (PPI). VIMOVO is FDA-approved for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. In August 2006, POZEN licensed worldwide rights for VIMOVO, except for Japan, to AstraZeneca.
In November 2013, AstraZeneca AB and Horizon Pharma USA, Inc. entered into an agreement for Horizon to acquire the U.S. rights for VIMOVO. Under the terms of the agreement, POZEN will continue to receive a 10% royalty on Net Sales of products sold in the United States, with guaranteed annual minimum royalty payments of $5 million in 2014, and $7.5 million each year thereafter, provided that the patents owned by POZEN which cover VIMOVO are in effect and no generic forms of VIMOVO are on the market. AstraZeneca will continue to have rights to commercialize VIMOVO outside of the United States.