SAN DIEGO, April 24, 2014 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, announced today that it has entered a definitive agreement to sell its SUMAVEL® DosePro® Needle-free Delivery System (sumatriptan injection) migraine therapy business to Endo International plc (Nasdaq:ENDP) for $85 million in cash and milestone payments of up to $20 million.
Roger Hawley, Chief Executive Officer of Zogenix, said, "This agreement allows the Company to have a greater level of focus on the launch of Zohydro™ ER and provides capital to continue the development of two abuse deterrent formulations of Zohydro ER and advance its novel pipeline in CNS disorders, including product opportunities which leverage our DosePro technology. We will now focus the full efforts and energy of the entire commercial and business development teams on building the pain business."
Mr. Hawley added, "We believe this agreement represents a positive opportunity for both companies. Endo is well positioned to immediately serve SUMAVEL DosePro prescribers and patients. The agreement allows SUMAVEL DosePro to receive the resources it deserves to reach more prescribers and help more migraine patients. We believe the selection of Endo, with their strong experience and reputation in this market, is in the best interest of the migraine community."
SUMAVEL DosePro was launched in January 2010, reaching over 270,000 total prescriptions with more than 2 million units distributed by the end of 2013.1 SUMAVEL DosePro net sales for 2013 were $31.7 million.
Under terms of the agreement, Endo will pay Zogenix $85 million in cash to acquire the SUMAVEL DosePro business upon closing of the deal, a portion of which will be deposited into escrow to fund potential indemnification claims for a period of 12 months. In addition to the upfront cash payment, Zogenix is eligible to receive additional cash payments of up to $20 million based on the achievement of pre-determined sales and manufacturing milestones. Zogenix will continue to manufacture SUMAVEL DosePro under a supply agreement. Upon closing, Endo will purchase the finished goods inventory and support the manufacturing operations with a working capital loan. The transaction is expected to close during the second quarter of 2014, after customary closing conditions have been met.
The SUMAVEL DosePro New Drug Application will be transferred to Endo, who will obtain worldwide rights to the product. Zogenix will maintain ownership of the DosePro Needle-Free Delivery System technology and all manufacturing assets upon which SUMAVEL DosePro is based as well as retain responsibility for the entire DosePro manufacturing supply chain. For Zogenix, these assets are essential because of its plans to leverage the technology for other product opportunities. Endo will assume responsibility for Zogenix's royalty obligation to Aradigm on sales of SUMAVEL DosePro.
Ann Rhoads, Chief Financial Officer of Zogenix, commented, "Approximately $40 million of the proceeds will be used to eliminate our debt obligation with HealthCare Royalty Partners. More importantly, the remainder will add a significant amount of capital to support our commercial activities and expand our pipeline."
Conference Call
Zogenix will host a conference call to discuss the definitive agreement to sell SUMAVEL DosePro at 8:30 am ET on Thursday, April 24, 2014. The Company will also discuss clarifying facts regarding Zohydro ER.
To access the live webcast please visit the Company's Investor Relations website at ir.zogenix.com, and to participate, please dial 800-688-0836 (U.S.) or 617-614-4072 (International); participant passcode: 91642156.
A replay of the conference call will be available beginning April 24 at 12:30 pm ET (9:30 a.m. PT) until May 1, by dialing 888-286-8010 (U.S.) or 617-801-6888 (International); passcode: 97163902. A replay of the webcast will also be accessible on the Investor Relations website for one month, through May 1, 2014.
About SUMAVEL DosePro
INDICATION and IMPORTANT LIMITATIONS
Sumavel DosePro (sumatriptan injection) is a serotonin (5-HT1B/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 Administration
The 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-HT1 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 Precautions
Discontinue 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) is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with pain-related conditions and CNS disorders who need innovative treatment alternatives to help them return to normal daily functioning.
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," "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 timing and likelihood of closing the SUMAVEL DosePro transaction; increased focus by Zogenix on Zohydro ER; and the potential to develop two abuse deterrent formulations of Zohydro ER and advance Zogenix's novel pipeline in CNS disorders. 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: the uncertainty of approval under the Hart Scott Rodino Antitrust Improvements Act for the proposed sale of SUMAVEL DosePro; the parties' ability to satisfy the conditions to closing the proposed transaction on the anticipated timeline or at all; Zogenix's dependence on third-party suppliers to ensure continued adequate supply of SUMAVEL DosePro to affiliates of Endo; Zogenix's dependence on the successful commercialization of Zohydro ER; the effect of public concern regarding the safety of drug products such as Zohydro ER and the impact of negative publicity and political influences relating to the regulation of the pain management market in general and opioids and Zohydro ER in particular; the likelihood that continued commercialization of Zohydro ER may involve expensive and protracted litigation and may distract management from traditional product launch activities; Zogenix's ability to successfully enforce its marketing exclusivities and intellectual property rights, and to defend the patents covering Zohydro ER, including the potential for Paragraph IV litigation relating to the product; Zogenix may require additional capital and may not be able raise sufficient capital when needed, on acceptable terms or at all; 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.
SUMAVEL® DosePro® are registered trademarks and ZohydroTM ER is a trademark of Zogenix, Inc.
1 Source Healthcare Analytics, Source® PHAST Prescription Monthly, January 2010 – December 2013