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Zogenix and Purdue Pharma Exchange Waivers of Regulatory Exclusivity for Extended-Release Hydrocodone Products

SAN DIEGO, Oct. 31, 2014 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today announced it has entered into an agreement with Purdue Pharma L.P. (Purdue) under which the two companies have exchanged waivers of regulatory exclusivity applicable to their respective single-entity, extended-release hydrocodone products. 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® 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.

About Zohydro® ER

INDICATION

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.

LIMITATIONS OF USE

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.

Zohydro ER is not indicated as an as‑needed (prn) analgesic.

Please click here to see the Zohydro ER professional product labeling for the complete boxed warning and safety information.

WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; and CYTOCHROME P450 3A4 INTERACTION

See full prescribing information for complete boxed warning.

  • Zohydro ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor regularly for development of these behaviors or conditions.

  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow Zohydro ER whole to avoid exposure to a potentially fatal dose of hydrocodone.

  • Accidental ingestion of Zohydro ER, especially in children, can result in a fatal overdose of hydrocodone.

  • Prolonged use of Zohydro ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

  • Instruct patients not to consume alcohol or any products containing alcohol while taking Zohydro ER because co-ingestion can result in fatal plasma hydrocodone levels.

  • Initiation of CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone from Zohydro ER.

IMPORTANT SAFETY INFORMATION

Zohydro ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma; known or suspected paralytic ileus; and hypersensitivity to hydrocodone bitartrate.

Zohydro ER warnings for: interactions with CNS depressants; elderly, cachectic, debilitated patients, and those with chronic pulmonary disease; hypotensive effects; patients with head injury or increased intracranial pressure; and concomitant use of CYP3A4 may increase opioid effects. Please see full prescribing information for the complete warning information.

Potential serious adverse events caused by opioids include addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; interactions with other CNS depressants; hypotensive effects; gastrointestinal conditions, and seizures. The most common adverse reactions associated with Zohydro ER (≥2%) include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, peripheral edema, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain, and tremor.

About Zogenix

Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with pain-related conditions and CNS disorders who need innovative treatment alternatives to help them return to normal daily functioning.

Forward-Looking Statements

Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "indicates," "will," "intends," "suggests," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: the development of, and planned NDA submission for, Zogenix's next extended-release hydrocodone incorporating innovative abuse deterrent technology with Altus Formulations; and potential for and timing of approval of the sNDA for Zohydro ER. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: risks and uncertainties associated with regulatory review and approval of the sNDA, including the risk that additional information or data requests from the FDA could significantly delay the FDA's review period; unexpected adverse side effects or inadequate therapeutic efficacy of the modified formulation that could limit approval and/or commercialization, or that could result in recalls or product liability claims; public concern regarding the safety of drug products such as Zohydro ER and the impact of negative publicity and political influences relating to the regulation of the pain management market in general and opioids and Zohydro ER in particular; competition from other pharmaceutical or biotechnology companies; other difficulties or delays relating to the development, testing, manufacturing and marketing of and obtaining regulatory approval for an abuse deterrent formulation of Zohydro ER; and other risks detailed in Zogenix's prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Zohydro® ER is a registered mark of Zogenix, Inc.

FPR

CONTACT: Investors Zack Kubow |The Ruth Group 646.536.7020 | zkubow@theruthgroup.com Media David Polk | Chandler Chicco Companies 310.309.1029 | DPolk@chandlerchiccocompanies.comSource:Zogenix