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Agreements

Date: 2014-08-21

Type of information: Product acquisition

Compound: Treximet® (sumatriptan / naproxen sodium)

Company: GSK (UK) Pozen (USA - NC) Pernix Therapeutics (USA - SC)

Therapeutic area: CNS diseases

Type agreement:

sale

Action mechanism:

Treximet® was approved by the 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 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.

Disease: migraine attacks

Details:

* On August 20, 2014, Pozen has announced that the acquisition of all of GGSK rights to Treximet® (sumatriptan / naproxen sodium) have been acquired by Pernix Therapeutics. The previously announced transaction was contingent upon Pernix securing financing, which is now complete. 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. 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 have been eliminated, and Pozen may seek approval for these combinations on the basis of the approved U.S. New Drug Application.

Pernix had 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 common stock underlying the warrant will be registered by Pernix with the Securities and Exchange Commission. The warrant will be exercisable from August 20, 2014, the closing date of the divestiture, until February 28, 2018.

Financial terms:

Financial details were not disclosed.

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