-- Addition of product to Specialty Pharmaceuticals portfolio expected to be immediately accretive to adjusted diluted earnings per share
DUBLIN, April 24, 2014 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) (TSX: ENL) announced today that affiliates of the company have acquired worldwide rights to Sumavel® DosePro® (sumatriptan injection) for subcutaneous use, a needle-free delivery system for sumatriptan, from Zogenix, Inc.
Under the terms of the agreement, Endo is acquiring the product for an upfront payment of $85 million 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.
"We are pleased to acquire the worldwide rights to Sumavel DosePro to enhance our branded pharmaceutical portfolio," said Rajiv De Silva, President and CEO of Endo. "We are focused on completing a seamless transition of commercial support for this currently marketed product that will leverage our existing commercial expertise in pain and migraine management and the current infrastructure of our branded pharmaceuticals business overall."
Sumavel DosePro is a prescription medicine given with a needle-free delivery system to treat adults who have been diagnosed with acute migraine or cluster headaches. In clinical studies, relief started within 10 minutes for some patients, 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 the effectiveness of instructions for use, 51 out of 52 people used Sumavel DosePro correctly the first time with little instruction during a migraine attack.
IMPORTANT SAFETY INFORMATION
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 coronary artery disease (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.
Sumavel DosePro is contraindicated in patients with: Ischemic coronary artery disease (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-HT1 agonist (e.g., another triptan) or of an ergotamine-containing medication, Current or recent (past 2 weeks) use of monoamine oxidase-A inhibitor, Known hypersensitivity to sumatriptan.
Warnings and Precautions. Myocardial ischemia/infarction and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. Arrhythmias: Discontinue Sumavel DosePro if occurs. Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk. Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue Sumavel DosePro if occurs. Gastrointestinal ischemia and infarction events, peripheral vasospastic reactions: Discontinue Sumavel DosePro if occurs. Medication overuse headache: Detoxification may be necessary. Serotonin syndrome: Discontinue Sumavel DosePro if occurs. Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. Increase in blood pressure: Monitor blood pressure. Anaphylactic/anaphylactoid reactions: Discontinue Sumavel DosePro if occurs.
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.
Please see full Prescribing Information for Sumavel DosePro at www.sumaveldosepro.com
About Endo International plc
Endo International plc is a global specialty healthcare company focused on improving patients' lives while creating shareholder value. Endo develops, manufactures, markets, and distributes quality branded pharmaceutical, generic and device products through its operating companies. Endo has global headquarters in Dublin, Ireland, and US headquarters in Malvern, PA. Learn more at www.endo.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Risks and uncertainties include the degree to which, if any, the transaction will be accretive to Endo, whether any of the net sales milestones for Sumavel DosePro will be achieved, the satisfaction of closing conditions for the acquisition, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act and receipt of certain other regulatory approvals for the transaction, and the possibility that the transaction will not be completed. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
