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Endo Completes Acquisition Of Rights To SumavelA® DoseProA®

DUBLIN, May 19, 2014 /PRNewswire/ -- 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.

IMPORTANT SAFETY INFORMATION

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.

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