Zogenix and Desitin Announce Marketing Approval for SUMAVEL(R) DosePro(TM) in Germany and the United Kingdom
SAN DIEGO and HAMBURG, Germany, Jan 6, 2011 (GlobeNewswire via COMTEX) -- Zogenix, Inc. ("Zogenix") (Nasdaq:ZGNX) and Desitin Pharmaceuticals GmbH ("Desitin") today announced that the Federal Institute for Drugs and Medical Devices of Germany (BrArM), and the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) have approved the Marketing Authorization Application (MAA) for SUMAVEL(R) DosePro(TM) (sumatriptan injection) Needle-free Delivery System for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache.
SUMAVEL DosePro offers fast-acting, easy-to-use, needle-free subcutaneous administration of sumatriptan as a potential treatment alternative to oral and nasal triptans, and simple, convenient administration when compared to traditional, needle-based sumatriptan injection. These unique attributes may be ideally suited for challenging migraine attacks, such as morning migraines, fast onset migraine and migraines with vomiting.
Dr. Martin Zentgraf, Desitin's General Manager, said, "With MAA approvals in Denmark, and now Germany and the United Kingdom, preparations are underway for the European Union product launch in early 2011 through our CNS-focused sales representatives and partner companies. We are currently awaiting additional E.U. marketing authorizations under our strategy to commercialize SUMAVEL DosePro throughout the territory."
Roger L. Hawley, Chief Executive Officer and Director of Zogenix said, "SUMAVEL DosePro has been granted marketing authorization in Germany and the United Kingdom, two of the largest pharmaceutical markets in Europe, five weeks after receiving its initial European Union approval in Denmark. We look forward to the upcoming commercial launches of SUMAVEL DosePro by our partner, Desitin."
Germany is the reference member state for the SUMAVEL DosePro MAA through the E.U. Decentralized Procedure, and is now one of three E.U. countries to grant marketing authorization for SUMAVEL DosePro. As previously announced on December 2, 2010, Denmark was the first E.U. member state to approve SUMAVEL DosePro.
Desitin plans to launch SUMAVEL DosePro in Denmark and Germany in early 2011, and then follow with its U.K. launch. Desitin is responsible for pursuing additional MAA approvals and broader commercialization on a country-by-country basis under the E.U. decentralized procedure in territories in the E.U. for which Desitin elects to undertake such activities.
In March 2008, Zogenix and Desitin entered into a license agreement granting exclusive rights in the European Union to Desitin to develop and commercialize SUMAVEL DosePro. Zogenix and its co-promotion partner, Astellas Pharma U.S., Inc., currently market SUMAVEL DosePro in the United States, where it has demonstrated consistent monthly growth in total prescriptions since its launch in January 2010.
About SUMAVEL DosePro
SUMAVEL DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.
SUMAVEL DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. SUMAVEL DosePro is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine and should not be administered intravenously. For a given attack, if a patient does not respond to the first dose of SUMAVEL DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose. For more information about SUMAVEL DosePro, please visit www.SUMAVELDosePro.com.
IMPORTANT SAFETY INFORMATION
SUMAVEL DosePro is contraindicated in patients with uncontrolled hypertension, in patients with history, symptoms or signs of ischemic heart disease, coronary artery vasospasm, cerebrovascular or peripheral vascular disease including ischemic bowel disease and in patients with other significant underlying cardiovascular diseases or known hypersensitivity to sumatriptan. SUMAVEL DosePro should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation.
Serious cardiovascular events, including death, have been reported when taking sumatriptan, including patients with no findings of cardiovascular disease. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low. 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 should not be used within 24 hours of other ergotamine-containing or ergot-type medications or other 5-HT1 agonists and is not generally recommended for use with MAO-A inhibitors. The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with SUMAVEL DosePro, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). SUMAVEL DosePro should be used during pregnancy only if the potential benefit justifies the potential risk.
In controlled clinical trials with sumatriptan injection, the most common adverse reactions were injection site reactions, tingling, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, feeling of tightness, numbness, feeling strange, tight feeling in head, flushing, tightness in chest, discomfort in nasal cavity/sinuses, jaw discomfort, dizziness/vertigo, drowsiness/sedation and headache.
For full prescribing information, go to http://www.zogenix.com/docs/SV0018.0709A_SDP_PI.pdf
About DosePro Technology
The DosePro technology is an easy-to-use, pre-filled drug delivery system designed to enable self-administration of single doses of liquid drug formulations, subcutaneously, without a needle. The DosePro technology has undergone more than 10 years of design, process engineering, clinical evaluation and development work. DosePro is protected by more than 80 patents, issued and applied for, worldwide. Approximately 9,000 injections have been delivered in clinical trials in healthy volunteers using the DosePro needle-free drug delivery system.
Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead product candidate, ZX002, is a novel, oral, single-entity controlled-release formulation of hydrocodone currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy.
For additional information, please visit www.zogenix.com.
Desitin Pharmaceuticals GmbH, based in Hamburg, Germany is an independent, private, fully integrated, German pharmaceutical company focused on the development, manufacturing and distribution of products for the treatment of central nervous system disorders. Desitin, with turnover in 2009/2010 of over $115 million, is one of the leading European companies in the field of epilepsy with additional expertise in Parkinson's disease and psychiatric disorders. With their pharmaceutical and clinical development capabilities, the company develops innovative products such as controlled-release and high-dose antiepileptics. Desitin's sales infrastructure offers comprehensive coverage in Germany, Switzerland, Northern and Eastern Europe. The company also has strategic partnerships with other companies covering nearly all of the remaining countries in Europe. For additional information, visit www.desitinpharma.com.
Zogenix(TM) and DosePro(TM) are trademarks of Zogenix, Inc.
SUMAVEL (R) is a registered trademark of Zogenix, Inc.
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 attributes of SUMAVEL DosePro, the commercial potential of the product, the timing of Desitin's planned launch in Denmark, Germany and the United Kingdom, and the prospects for the MAA submissions in other E.U. markets. 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 ability of Zogenix and Desitin to ensure adequate and continued supply of SUMAVEL DosePro to successfully launch commercial sales or meet anticipated market demand in the E.U.; the scope, validity and duration of patent protection and other intellectual property rights for SUMAVEL DosePro; whether the approved label for SUMAVEL DosePro is sufficiently consistent with such patent protection to provide exclusivity for SUMAVEL DosePro; Zogenix's and Desitin's ability to operate their businesses without infringing the intellectual property rights of others; the market potential for migraine treatments, and the companies' 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 reliance on Desitin for the commercial sales success and regulatory approval and compliance of SUMAVEL DosePro in the E.U.; 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 news 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.
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