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Zohydro ER (reformulation)

Pernix Therapeutics Holdings, Inc.

Drug Names(s): hydrocodone bitartrate, ZX002, hydrocodone bitartrate extended-release capsules, ZX007

Description: Zogenix and Altus are developing an abuse-deterrent formulation of Zohydro ER using Altus' proprietary Intellitab drug delivery platform.

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 Altus
In November 2013, Zogenix entered into a Development and Option Agreement with Altus Formulation to develop abuse deterrent formulations of Zohydro ER (hydrocodone bitartrate) extended-release capsules, using Altus's proprietary Intellitab drug delivery platform. Concurrent with entry into this agreement, Altus and Zogenix have initiated development of alternative abuse deterrent formulations of Zohydro ER.

Zogenix and Pernix
In March 2015, Zogenix announced that it has entered into a definitive agreement to sell its Zohydro ER business to Pernix Therapeutics for $100 million plus regulatory and sales milestones up to $283.5 million. Both companies plan to transition the Zogenix sales team and other select employees to Pernix.

Under terms of the agreement, at closing, Pernix will pay Zogenix $30 million in cash, $20 million in common stock and provide a $50 million short-term promissory note. Ten percent of the cash consideration...See full deal structure in Biomedtracker

Partners: Altus Formulation Inc. Zogenix, Inc.

Zohydro ER (reformulation) News

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