CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that GlaxoSmithKline (GSK) will divest all of its rights to Treximet® (sumatriptan / naproxen sodium) to Pernix Therapeutics Holdings, Inc. (Pernix). As part of the Divestiture, GSK will assign the Product Development and Commercialization Agreement between POZEN and GSK to Pernix, and POZEN and Pernix will amend the agreement to address rights of the parties and future development.
“We are very pleased that Pernix will take over the sales and marketing of Treximet in the United States,” said Dennis L. McNamara, Sr. Vice President and Chief Business Officer. “We look forward to working with Pernix to assist them in growing and expanding the brand and appreciate their collaborative approach.”
Under the amended agreement, Pernix will continue certain of GSK’s ongoing development activities and undertake certain new activities, for which POZEN will provide reasonable assistance. 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 will be eliminated, and POZEN may seek approval for these combinations on the basis of the approved U.S. New Drug Application (NDA).
Pernix has also granted POZEN a warrant to purchase 500,000 shares of Pernix common stock at an exercise price equal to the closing market price on May 13, 2014. The warrants, which will be registered by Pernix with the Securities and Exchange Commission, will be exercisable from the closing date of the Divestiture until February 28, 2018.
The amended Agreement provides for a guaranteed quarterly minimum royalty amount of $4 million for the calendar quarters commencing on January 1, 2015 and ending on March 31, 2018. In November 2011, POZEN entered into a Purchase and Sale Agreement with CPPIB Credit Investments Inc. (CII), pursuant to which it sold its right to receive future royalty payments arising from U.S. sales of MT 400, including Treximet to CII. Under the Purchase and Sale Agreement, POZEN will receive a twenty percent (20%) interest in any royalties received by CII relating to the period commencing on April 1, 2018.
The transaction will become effective only upon approval of the transaction by the U.S. Federal Trade Commission under the Hart Scott Rodino notification program, and closing of financing by Pernix.
POZEN will host a webcast on Wednesday, May 14, 2014 at 11:00 a.m. (ET). The webcast can be accessed live and will be available for replay at www.pozen.com.
POZEN Inc. is a small pharmaceutical company that specializes in developing novel therapeutics for unmet medical needs and licensing those products to other pharmaceutical companies for commercialization. By utilizing a unique in-source model and focusing on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products. Funded by these milestones/royalty streams, POZEN has created a portfolio of cost-effective, evidence-based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.
POZEN is currently seeking strategic partners to help maximize the opportunities for its portfolio assets.
The Company's common stock is traded under the symbol “POZN” on The NASDAQ Global Market. For more detailed company information, including copies of this and other press releases, please visit www.pozen.com.
Treximet was approved by the U.S. Food and Drug Administration (FDA) in April 2008 for the acute treatment of migraine attacks, with or without aura, in adults. The product is formulated with POZEN’s patented technology of combining a triptan with a non-steroidal anti-inflammatory drug (NSAID) and GlaxoSmithKline’s (GSK) RT Technology™. This migraine medication contains sumatriptan, a 5-HT1 receptor agonist that mediates vasoconstriction of the human basilar artery and vasculature of human dura mater, which correlates with the relief of migraine headache. It also contains naproxen, an NSAID that inhibits the synthesis of inflammatory mediators. Therefore, sumatriptan and naproxen contribute to the relief of migraine through pharmacologically different mechanisms of action. As a result of this dual mechanism of action, Treximet has been shown to provide superior sustained pain relief compared to placebo and to both of the single mechanism of action components.
For Full Prescribing Information see www.treximet.com.
Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results, our ability to return value to our stockholders, including any cash distributions, and our future prospects could differ materially from those contained in the forward-looking statements, which are based on current market data and research (including third party and POZEN sponsored market studies and reports), management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our inability to further license our PA product candidates on terms and timing acceptable to us, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval of our product candidates, including as a result of the need to conduct additional studies or due to issues with third-party manufacturers, or the failure to obtain such approval of our product candidates for all expected indications, including as a result of changes in regulatory standards or the regulatory environment during the development period of any of our product candidates; uncertainties in clinical trial results or the timing of such trials, resulting in, among other things, an extension in the period over which we recognize deferred revenue or our failure to achieve milestones that would have provided us with revenue; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products, including our dependence on AstraZeneca and Horizon for the sales and marketing of VIMOVO®, our dependence on Sanofi US for the sales and marketing of PA8140/PA32540 in the United States, if approved, and our dependence on Patheon for the manufacture of PA8140/PA32540; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events, including those discussed herein and in our Quarterly Report on Form 10-Q for the period ended March 31, 2014. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.