Altus Formulation Inc. has announced that it has entered into a Development and Option Agreement (“D&O Agreement”) with Zogenix, Inc. to develop abuse deterrent formulations of Zohydro™ ER using Altus’s proprietary, clinically validated Intellitab drug delivery platform.
Altus and Zogenix have initiated development of Intellitab abuse deterrent formulations of Zohydro ER with the entry into the agreement.
Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, an opioid agonist, is the first approved extended-release oral formulation of hydrocodone without acetaminophen, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
In 2012, existing hydrocodone products generated $3.5 billion in sales on approximately 131 million prescriptions and are the most commonly prescribed pharmaceutical products in the United States (Source® PHAST Prescription January 2012 - December 2012). Zogenix expects to launch Zohydro ER in the United States in approximately four months.
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 an additional $3.5 million in development and regulatory milestones through to submission of a New Drug Application.
Following exercise of the option, Altus will be eligible to receive additional regulatory and sales milestone payments and royalties based on net 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 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.”