SAN DIEGO, Jan. 9, 2014 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders and pain, and Mallinckrodt (NYSE:MNK) announced today that the co-promotion of SUMAVEL ® DosePro ® (sumatriptan injection) Needle-free Delivery System will end on January 31, 2014. SUMAVEL DosePro is Zogenix's first commercial product and was launched in January 2010 for the acute treatment of migraine and cluster headache. Beginning February 1, 2014, Zogenix will assume full responsibility for the continued commercialization of the brand, with a focus on headache specialists, pain specialists and neurologists who treat a significant number of migraine patients. The early termination of the co-promotion by five months, originally scheduled to end on June 30, 2014, is timed to precede the previously disclosed expansion of the Zogenix sales force planned in February 2014. The companies have agreed to a detailed customer transition plan with a goal of uninterrupted access and service to prescribers of SUMAVEL DosePro. Under the amended co-promotion agreement, neither company will incur any penalty payments related to the early termination of the agreement which was originally slated to expire June 30, 2014. Mallinckrodt will continue to earn a service fee based on product sales to its physician segment through January 31, 2014. Zogenix will no longer pay service fees to Mallinckrodt for sales of SUMAVEL DosePro beginning February 1, 2014. About SUMAVEL DosePro INDICATION and IMPORTANT LIMITATIONS Sumavel DosePro (sumatriptan injection) is a serotonin (5-HT 1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and the acute treatment of cluster headache in adults. Limitations of Use SUMAVEL DosePro is intended for use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine attack treated with SUMAVEL DosePro, reconsider the diagnosis of migraine before SUMAVEL DosePro is administered to treat any subsequent attacks. SUMAVEL DosePro is not indicated for the prevention of migraine attacks.
Dosage and AdministrationThe maximum single recommended dose of Sumavel DosePro for the acute treatment of migraine or cluster headache is 6 mg given subcutaneously. SUMAVEL DosePro is intended for subcutaneous use only. SUMAVEL DosePro is intended for use as an acute treatment of migraine or an acute treatment of cluster headache. For the treatment of cluster headache, the efficacy of a lower dose has not been established. The maximum cumulative dose of SUMAVEL DosePro in a 24-hour period is 12 mg, with doses separated by at least 1 hour. SUMAVEL DosePro is intended to be administered only to the abdomen or thigh. IMPORTANT SAFETY INFORMATION SUMAVEL DosePro is contraindicated in patients with ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina; Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders; history of stroke or transient ischemic attack (TIA); hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; uncontrolled hypertension; recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan) or of an ergotamine-containing medication; current or recent (past 2 weeks) use of monoamine oxidase-A inhibitor; and known hypersensitivity to sumatriptan. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of SUMAVEL DosePro. Some of these reactions occurred in patients with no known CAD. SUMAVEL DosePro may cause coronary artery vasospasm (Prinzmetal's angina), even in patients without a history of CAD. Cerebrovascular events, some fatal, have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief the symptoms experienced were a consequence of migraine when they were not. It is important to advise patients not to administer SUMAVEL DosePro if a headache being experienced is atypical.
Warnings and PrecautionsDiscontinue use of SUMAVEL DosePro if the following occur: arrhythmias; cerebral hemorrhage, subarachnoid hemorrhage, and stroke; gastrointestinal ischemia and infarction events, peripheral vasospastic reactions; serotonin syndrome; and/or anaphylactic/anaphylactoid reactions. Perform cardiac evaluation in patients with multiple cardiovascular risk factors, including myocardial ischemia/infarction and Prinzmetal's angina. While generally not associated with myocardial ischemia; evaluate for CAD in patients at high risk with the following symptoms: chest/throat/neck/jaw pain, tightness, pressure, or heaviness. In the event of a headache associated with medication overuse, detoxification may be necessary. In the event of an increase in blood pressure, monitor blood pressure. Use with caution in patients with epilepsy or a lowered seizure threshold. Adverse Reactions In controlled clinical trials with sumatriptan injection, the most common adverse reactions were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness. For full prescribing information, please click here: http://www.zogenix.com/downloads/SV0468.1113_SDP_PI.pdf For more information about SUMAVEL DosePro, please visit www.SUMAVELDosePro.com. About Zogenix 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 central nervous system disorders and pain-related conditions who need innovative treatment alternatives to help them return to normal daily functioning. Zogenix recently received FDA approval for Zohydro ER (hydrocodone bitartrate) extended-release capsules, the first extended-release oral formulation of hydrocodone without acetaminophen. Zogenix developed and commercialized the first needle-free subcutaneous injection, SUMAVEL ® DosePro ® (sumatriptan injection) for migraine and cluster headache. The development pipeline for Zogenix includes a once-monthly subcutaneous injection for schizophrenia. 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," "plans," "expects," "will," "potential" 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 planned expansion of the Zogenix sales force and Zogenix assuming full responsibility for the continued commercialization of SUMAVEL DosePro .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 release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: the market potential for migraine treatments, and Zogenix's ability to compete within that market; inadequate therapeutic efficacy or unexpected adverse side effects relating to SUMAVEL DosePro that could delay or prevent commercialization, or that could result in recalls or product liability claims; Zogenix's ability to successfully execute its sales and marketing strategy for the commercialization of SUMAVEL DosePro, including through the planned expansion of its sales force; and other risks described in the company's prior press releases and 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 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.SUMAVEL ®, DosePro ®, Relday TM and Zohydro TM are trademarks of Zogenix, Inc. FPR
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