Zogenix Receives 2011 Drug Delivery Partnerships Innovation Award for SUMAVEL(R) DosePro(TM)
SAN DIEGO, Feb 9, 2011 (GlobeNewswire via COMTEX) -- Zogenix, Inc. ("Zogenix") (Nasdaq:ZGNX) today announced that it has received the 2011 Drug Delivery Partnerships(TM) ("DDP") Innovation Award in the Industry Achievement category for SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System. Winners of this year's DDP Awards, which recognize success within the drug delivery industry, were selected by attendees at the 15th annual DDP conference, held in Miami, Florida.
SUMAVEL DosePro is the first drug product approved by the U.S. Food and Drug Administration (FDA) using the Zogenix DosePro needle-free drug delivery technology, which allows for the subcutaneous delivery of medication. SUMAVEL DosePro is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes. During the first year of production over 1,000,000 commercial units have been produced establishing the viability of a single-use, disposable, pre-filled needle-free technology for use in other important therapeutic applications.
Roger L. Hawley, Chief Executive Officer and Director of Zogenix said, "The DDP Industry Achievement Award is a significant honor at one of the pharmaceutical industry's largest drug delivery conferences. We believe it reinforces SUMAVEL DosePro as an innovative treatment for the migraine market and further validates our DosePro technology platform."
Stephen J. Farr, Ph.D., President and Chief Operating Officer said, "We believe this award recognizes the importance of our DosePro technology for the biopharmaceutical industry. The commercial experience of 2010 showed that physicians and patients alike are willing to use treatment administered subcutaneously instead of orally if it is available in an easy-to-use needle-free system like DosePro. The competitive advantage offered by the DosePro technology is now available for licensing to other biopharmaceutical firms. Clinical studies suggest that DosePro will have significant versatility in delivering various types of therapeutic compounds, including biologic products."
Zogenix and its co-promotion partner, Astellas Pharma US, Inc., launched SUMAVEL DosePro in the United States in January 2010. Zogenix has a partnership with Desitin Arzneimittel GmbH to develop and commercialize SUMAVEL DosePro in the European Union (EU). Desitin plans to launch SUMAVEL DosePro in Germany and Denmark in early 2011. Desitin is responsible for pursuing MAA approvals and broader commercialization on a country-by-country basis under the EU decentralized procedure in territories in the EU for which Desitin elects to undertake such activities.
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(R) DosePro(TM) (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational 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.
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 and the commercial potential of the product, the potential to broaden the application of the DosePro technology, the timing of Desitin's planned launch in Germany, and the potential for MAA submissions and commercialization of SUMAVEL DosePro 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 market potential for migraine treatments, and Zogenix's 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 ability to identify and acquire or in-license additional drug compounds that can be delivered via the current version of the DosePro technology, to out-license the technology to third parties and/or its ability to successfully develop and receive requisite approvals for higher dose versions of the technology; 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; 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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