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. On December 17, 2014, POZEN received a second CRL from the FDA. In this CRL, the FDA used identical wording to that of the first CRL. Satisfactory resolution of these deficiencies is required before this application may be approved. Subsequently, The active ingredient supplier informed POZEN that they received a warning letter relating to the Form 483 inspection deficiencies. They are evaluating what additional corrective actions may be required to address the matters raised in the warning letter. POZEN will continue to provide assistance to our active ingredient supplier in taking corrective actions to address the inspectional observations at its facility. See the Posters & Publications page for more information.
To maximize the global sales potential of the PA product portfolio, identifying the right partner for PA8140 and PA32540, who can bring this potentially life-saving product to patients, has been a key activity for POZEN. In September 2013, we signed an exclusive license agreement with Sanofi US for the commercialization of PA8140 and PA32540. Under the terms of the agreement, Sanofi would have had exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. In November, 2014, we executed a termination agreement with Sanofi US terminating the license agreement for PA. As of the termination date, all licenses granted to Sanofi US were terminated and all rights to the products licensed to Sanofi US under the agreement reverted to us. We are currently evaluating all strategic options available to us now that we have full ownership of the PA products. Ex-US partnership discussions continue to progress.
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.
In August 2014, POZEN announced that the acquisition of all of GlaxoSmithKline’s (GSK) rights to Treximet® had been acquired by Pernix Therapeutics Holdings, Inc. (Pernix). As part of the divestiture, GSK has assigned the Product Development and Commercialization Agreement between POZEN and GSK to Pernix, and POZEN and Pernix have amended the agreement to address rights of the parties and future development. In addition, any restrictions on POZEN’s right to develop and commercialize additional certain dosage forms of sumatriptan / naproxen combinations outside of the United States have been eliminated, and POZEN may seek approval for these combinations on the basis of the approved U.S. New Drug Application. 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.
POZEN is actively seeking licensing partners for the 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.