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UPDATE: Zogenix Announces Closing of Sale of SUMAVEL DosePro Migraine Therapy to Endo Int'l, Zogenix Repaid $40M in Debt to Healthcare Royalty Partners


Endo International plc (NASDAQ: ENDP) (TSX: ENL) announced today that affiliates of the company have completed the acquisition of worldwide rights to Sumavel® DosePro® (sumatriptan injection), a needle-free delivery system for subcutaneous use, from Zogenix, Inc, for $85 million in cash and rights to additional cash payments based on the achievement of certain commercial milestones. In addition, Endo will assume an existing third party royalty obligation on net sales. The transaction will be financed with Endo's current cash on hand.

Sumavel DosePro is a prescription medicine, given with a needle-free delivery system for the acute treatment of migraine, with or without aura, or cluster headaches in adults. In clinical studies, relief started within 10 minutes for some patients following self-administration, with most achieving relief within 1 or 2 hours. A burst of air delivers sumatriptan just under the skin in less than a second. Sumavel DosePro is designed to be used in just 3 simple steps: SNAP, FLIP, PINCH & PRESS. In a study evaluating ease of use, 51 out of 52 people used Sumavel DosePro correctly the first time with little instruction during a migraine attack.


SUMAVEL DosePro is contraindicated in patients with:

Ischemic coronary artery disease (CAD) (e.g. 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, transient ischemic attack (TIA) because these patients are at a higher risk of stroke History of hemiplegic or basilar migraine Peripheral vascular disease Ischemic bowel disease Uncontrolled hypertension Recent use (i.e., within 24 hours) of another 5-HT1 agonist, an ergotamine containing or ergot-type medication such as dihydroergotamine (DHE) or methysergide Concurrent use of a MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor Hypersensitivity to Sumavel DosePro (angioedema and anaphylaxis seen) There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of SUMAVEL DosePro. SUMAVEL DosePro may cause coronary artery vasospasm (Prinzmetal's angina). These types of reactions have occurred in some patients without known CAD.

For triptan-naive patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administrating the first SUMAVEL DosePro dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following SUMAVEL DosePro administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of SUMAVEL DosePro.

Life-threatening arrythmias have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue SUMAVEL DosePro if these disturbances occur.

Sensations of tightness, pain, pressure, and heaviness have been reported in the chest, throat, neck, and jaw after treatment with SUMAVEL DosePro and are usually non-cardiac in origin.

Cerebrovascular events, some fatal; non-coronary vasospastic reactions such as peripheral or gastrointestinal vascular ischemia and Raynaud's syndrome; and increases in blood pressure have been reported in patients treated with 5-HT1 agonists. Monitor blood pressure in patients treated with SUMAVEL DosePro.

Overuse of acute migraine drugs may lead to exacerbation of headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary.

Serotonin syndrome may occur with SUMAVEL DosePro particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MOA) inhibitors. Discontinue SUMAVEL DosePro if serotonin syndrome is suspected.

In controlled clinical trials with sumatriptan injection, the most common adverse reactions (≥5% and > placebo) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.

Please see full Prescribing Information for Sumavel DosePro at

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