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news.Zogenix, a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, has entered into an agreement with Purdue Pharma L.P. under which the two companies have exchanged waivers of regulatory exclusivity applicable to their respective single-entity, extended-release hydrocodone products.
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These waivers are applicable to current or pending New Drug Applications (NDAs) as well as successor products, including those with abuse-deterrent properties and associated labeling claims.
In connection with the exchange of waivers, Purdue has agreed to pay Zogenix $10 million with the first payment of $5 million due within 15 days and the second-half payment due on July 1, 2015. Zogenix may also be eligible to receive royalties on future net sales of Purdue’s once-daily hydrocodone product, for a limited period of time, if certain sales conditions are met.
"This agreement allows prescribers and patients to have treatment options to help manage severe chronic pain. Zogenix remains committed to responsibly providing Zohydro(R) ER and to the continued development of our abuse deterrent formulations. Although advancing the science of abuse deterrent technology is an important component, we are pleased that the steps we are taking to identify and address early warning signs of potential abuse, misuse or diversion of our medicine are working as intended," said Roger Hawley, chief executive officer of Zogenix.
Hawley continued, "We will continue these efforts as well as the other programs we have implemented, including the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategy (REMS) for extended-release/long-acting opioid analgesics, that are designed to reduce abuse potential, while ensuring that those with chronic pain who need Zohydro ER will have access to it."
Hawley continued, "Execution of this agreement reduces risk and provides greater clarity on the regulatory pathway for the pending supplemental NDA (sNDA) for Zohydro ER with abuse-deterrent properties and the planned NDA submission of our next extended-release hydrocodone incorporating innovative abuse-deterrent technology developed by Altus Formulations. We anticipate potential approval of the sNDA for Zohydro ER in the first quarter of 2015 and remain on track with the Altus formulation.
"The non-dilutive capital from this agreement provides us with additional funds to invest in our recently expanded development pipeline," added Hawley.
Zohydro ER is an extended-release opioid agonist indicated 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.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.