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Zogenix Pursues Development Of Abuse Deterrent Formulations Of Zohydro(TM) ER With Altus Formulation

SAN DIEGO, Nov. 1, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders and pain, today announced that it has entered into a Development and Option Agreement ("D&O Agreement") with Altus Formulation Inc. ("Altus"), a private Montreal-based drug formulation and development company, to develop abuse deterrent formulations of Zohydroâ„¢ ER (hydrocodone bitartrate) extended-release capsules, using Altus's proprietary Intellitabâ„¢ drug delivery platform. Concurrent with entry into this agreement, Altus and Zogenix have initiated development of alternative abuse deterrent formulations of Zohydro ER.

Under the D&O Agreement, Altus has granted Zogenix an option (subject to the terms and conditions of the D&O Agreement) to enter into an exclusive license on mutually agreed terms to develop and commercialize abuse deterrent formulations of Zohydro ER in the United States. In connection with the transaction, Zogenix will pay Altus a technology access fee in the amount of $750,000. Zogenix will fund all development activities, and Altus may earn up to an additional $3.5 million in development and regulatory milestones through submission of a New Drug Application (NDA) under the D&O Agreement. Following exercise of the option, Altus will be eligible to receive additional undisclosed regulatory and sales milestone payments and a royalty based on net sales of the licensed product.

Dr. Stephen Farr, president, Zogenix, said, "We are excited to be working with our colleagues at Altus towards development of an abuse deterrent formulation of Zohydro ER consistent with the Food & Drug Administration's draft guidance for industry on the evaluation and labeling of abuse deterrent opioids. The technology developed by Altus can be customized to match the current pharmacokinetic profile of Zohydro ER, which we believe, in turn, will allow us to bridge to the safety and efficacy established in the recently approved New Drug Application." 

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