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Zohydro ER

Pernix Therapeutics Holdings, Inc.

Drug Names(s): hydrocodone bitartrate, ZX002, hydrocodone bitartrate extended-release capsules

Description: ZX002 is an oral version of hydrocodone designed to offer a controlled-release profile that combines immediate and extended release properties to enable twice daily dosing, using Elan Pharma's proprietary Spheroidal Oral Drug Absorption System (SODAS) technology. It is aimed at the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. If approved, ZX002 will be the first hydrocodone product approved in the US that does not contain acetaminophen. FDA has expressed concerns about the hepatotoxicity of acetominophen, and requested producers of acetominophen-containing combination products to limit the quantity of acetominophen per dose to less than 375 mg.

Deal Structure: Zogenix and Elan
In November 2007, Zogenix announced that they had entered into a License Agreement under which Zogenix had been granted exclusive US rights from an affiliate of Elan Corporation to develop and commercialize a late stage, controlled-release opioid for the treatment of pain.

Under the terms of the Agreement, Elan will receive from Zogenix an undisclosed upfront payment and future payments upon the achievement of clinical and regulatory milestones for the product. Additionally, Elan will receive royalty payments based on sales of the product upon commercialization. Zogenix will assume responsibility for the clinical development and commercialization of the product in the U.S., and Elan will manufacture the product for Zogenix.

Elan and Paladin
In May 2011, Paladin Labs announced that they have entered into a licensing anddistribution agreement under which Paladin has been granted exclusiveCanadian rights from Elan tomarket and sell, upon...See full deal structure in Biomedtracker

Partners: Alkermes plc Endo International plc Purdue Pharma LP Zogenix, Inc.

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