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 Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, using Altus's proprietary Intellitab™ 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towards development of an abuse deterrent formulation of Zohydro ER consistent with the Food & Drug Administration's draft guidance for industry on the evaluation and labeling of abuse deterrent opioids.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."
Dr. Damon Smith, CEO of Altus Formulation, said, "We are delighted that Zogenix has chosen to work with Altus and Intellitab technology on the development of an abuse deterrent formulation of Zohydro ER."
About Zohydro ER
Zohydro™ ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate 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 for use as an as-needed (prn) analgesic.
Please see the Zohydro ER full prescribing information for the complete boxed warning and safety information.
WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL
SYNDROME and INTERACTION WITH ALCOHOL
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 consumption of Zohydro ER, especially in children, can result in fatal overdose of hydrocodone.
For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome. Prolonged use during pregnancy can result in life-threatening neonatal opioid withdrawal syndrome.
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.
IMPORTANT SAFETY INFORMATION
Zohydro ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma or hypercarbia; known or suspected paralytic ileus; and hypersensitivity to hydrocodone bitartrate or any other ingredients in Zohydro ER.
Zohydro ER contains hydrocodone, a Schedule II controlled substance. As an opioid, Zohydro ER exposes users to the risks of addiction, abuse, and misuse. As modified-release products, such as Zohydro ER, deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.
Potential serious adverse events caused by opioids include respiratory depression, potential for misuse and abuse, CNS depressant effects, prolonged gastric obstruction, and severe hypotension. 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.
Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with CNS and pain-related conditions who need innovative treatment alternatives to help them return to normal daily functioning. Zogenix developed and commercialized the first needle-free subcutaneous injection, SUMAVEL® DosePro® (sumatriptan injection) for migraine and cluster headache. Zogenix recently received FDA approval for Zohydro ER (hydrocodone bitartrate) extended-release capsules, the first extended-release oral formulation of hydrocodone without acetaminophen. The development pipeline for Zogenix includes a once-monthly subcutaneous injection for schizophrenia.
About Altus Formulation
Altus Formulation is a Montreal-based drug formulation and development company using its proprietary and patent protected drug delivery technologies to generate novel, differentiated and cost effective new products for its clients. With a focus on an improved patient experience Altus technologies include Intellitab tamper and abuse resistant technologies, Contramid®, for high dosage product delivery, MicroSpheres Plus for taste-masked controlled release liquids and the PNDS micellar technology platform that enables delivery of insoluble small and large molecules via both oral and parenteral routes to achieve increased bioavailability and low volume intravenous administration. More information regarding Altus Formulation may be found at www.altusformulation.com.
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," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "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 potential to develop abuse deterrent formulations of Zohydro ER with Altus and the potential exercise of the licensing option by Zogenix under the D&O Agreement . The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: risks and uncertainties associated with the development and regulatory approval of an abuse deterrent formulation and Zogenix's reliance on Altus and its drug delivery platform in such development efforts; Zogenix will need to obtain the consent of Alkermes plc or otherwise amend Zogenix's license agreement with Alkermes for Zohydro ER in order to exercise the licensing option with Altus and ultimately commercialize any Altus abuse deterrent formulation of hydrocodone, and any inability to obtain such consent could have a negative impact on the long term opportunity for Zohydro ER, and even if Zogenix is successful, it may need to compensate Alkermes for its consent, which may include increased compensation in the form of royalties or other payments and other concessions compared to its existing license terms with Alkermes; the scope and validity of patent protection for Zohydro ER and Zogenix's ability to commercialize Zohydro ER without infringing the patent rights of others; unexpected adverse side effects or inadequate therapeutic efficacy of Zohydro ER that could limit commercialization, or that could result in recalls or product liability claims; 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 trademark and SUMAVEL® and DosePro® are registered trademarks of Zogenix, Inc.
SODAS® is a trademark of Alkermes Pharma Ireland Limited
Contramid® is a licensed trademark of Altus Formulation Inc.
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