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To develop abuse-deterrent formulations of Zohydro ER
November 4, 2013
By: Tim Wright
Altus Formulation has entered into a development and option agreement with Zogenix, Inc. to develop abuse deterrent formulations of Zohydro ER using Altus’ Intellitab drug delivery platform. Zohydro ER (hydrocodone bitartrate), an opioid agonist, is an extended-release oral formulation of hydrocodone without acetaminophen, for the management of severe pain. Zogenix plans to launch Zohydro ER in the U.S. in approximately four months. Altus has granted Zogenix an option to enter an exclusive license to develop and commercialize abuse deterrent formulations of Zohydro ER in the U.S. Zogenix will pay Altus a technology access fee of $750,000 and will fund all development activities. Altus is eligible for an additional $3.5 million in development and regulatory milestones. Following exercise of the option, Altus will be eligible to receive additional regulatory and sales milestones as well as royalties on sales of the licensed product. “We are extremely pleased that Zogenix has chosen Altus and Intellitab technology to develop abuse deterrent formulations of Zohydro ER,” said Dr. Damon Smith, President and CEO of Altus. Smith continued, “We believe that Zohydro ER fulfills a critical need among people living with chronic pain and are delighted to now be playing a part in its development. We look forward to working closely with the Zogenix team to rapidly bring this important new product to the market.” Dr. Stephen Farr, president, Zogenix, added, “We conducted an extensive review of available abuse deterrent technologies and chose Intellitab because of its versatility, demonstrated abuse deterrent features, and Altus’ intellectual property portfolio. Of equal importance, Intellitab can be customized to match the current pharmacokinetic profile of Zohydro ER, which we believe, in turn, will allow us to bridge to the current product’s safety and efficacy established in the recently approved NDA and streamline overall development timelines.”
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