Pernix Therapeutics Holdings Inc. plans to acquire the U.S rights to Treximet, a treatment for migraine headaches, from GlaxoSmithKline.

Pernix Therapeutics Holdings, Treximet, GlaxoSmithKline, U.S. rights, treatment for migraine, sumatriptan and naproxen sodium, Doug Drysdale, Pozen, acute treatment of migraine attacks

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Pernix to buy Treximet migraine drug from GSK

May 14th, 2014

MORRISTOWN, N.J. – Pernix Therapeutics Holdings Inc. plans to acquire the U.S rights to Treximet, a treatment for migraine headaches, from GlaxoSmithKline.

Pernix said Wednesday that under the deal it will make an upfront payment of $250 million to GSK for the U.S rights to Treximet (sumatriptan and naproxen sodium). GSK will assign to Pernix the product development and commercialization agreement (PDC) between GSK and Pozen Inc., and Pernix and Pozen will amend the PDC agreement to facilitate further development of Treximet.

In addition, Pernix will purchase existing inventory from GSK, and GSK will continue to manufacture Treximet in the near future under a long-term supply agreement with Pernix. The company will continue to make royalty payments on net sales of the product.

The transaction is expected to close by Aug. 1, pending Hart Scott Rodino approval and the closing of financing by Pernix.

Pernix said the addition of Treximet, which has annual sales of nearly $79 million, leverages its current sales presence and experience across psychiatry and neurology customers and is expected to nearly double Pernix's revenue.

"The acquisition of Treximet further accelerates the transformation of Pernix into a specialty pharmaceutical company and expands our portfolio of CNS [central nervous system] brands, Silenor and Khedezla," Doug Drysdale, chairman and chief executive officer of Pernix, said in a statement. "With the strong presence Pernix is establishing in the adjacent psychiatric market, this acquisition provides Pernix an opportunity to expand the company's reach and penetration into the very important neurology space."

Pernix noted that Treximet faces minimal branded competition in a promotionally sensitive market and that it plans a staged relaunch of the medication with increased promotion, including a revised campaign for health professionals and consumers, as well as specific tactics addressing managed care and pharmacy programs.

The company, too, said it  plans to seek an extension of the exclusivity of Treximet with the first-ever pediatric indication (ages 12 to 17) for any sumatriptan treatment, expected to file by the end of 2014.

Approved by the Food and Drug Administration in 2008, Treximet is indicated 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 nonsteroidal anti-inflammatory drug (NSAID) and GSK's RT Technology. Pernix said Treximet has been shown to provide superior sustained pain relief compared to placebo and to both of the single mechanism of action components.

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