Zogenix Receives 2010 Most Innovative Product Award for SUMAVEL(R) DosePro(TM)
SAN DIEGO, Dec 13, 2010 (GlobeNewswire via COMTEX) -- Zogenix, Inc. ("Zogenix") (Nasdaq:ZGNX) today announced that CONNECT, a regional San Diego nonprofit organization, selected SUMAVEL(R) DosePro(TM) (sumatriptan injection) Needle-free Delivery System as a 2010 Most Innovative Product (MIP) winner at the MIP Awards Luncheon on December 10, 2010.
The 2010 CONNECT MIP Awards recognize the emerging technologies and cutting-edge products that drive San Diego's innovation economy. SUMAVEL DosePro received top honors as the most innovative product for 2010 in the Life Sciences -- Medical Products category.
SUMAVEL DosePro offers fast-acting, easy-to-use, needle-free subcutaneous administration of sumatriptan for patients suffering from migraine attacks, and has demonstrated consistent monthly growth in total prescriptions since its U.S. commercial launch in January 2010. It is the first drug product approved by the U.S. Food and Drug Administration (FDA) which allows for the needle-free, subcutaneous delivery of medication.
Roger L. Hawley, Chief Executive Officer and Director of Zogenix, said, "We are honored that CONNECT has recognized SUMAVEL DosePro, and by extension our proprietary DosePro delivery system, as a significant innovation. San Diego is a rich source of new and exciting technologies, and we are proud to be distinguished in the region as the most innovative medical product within the life sciences category."
SUMAVEL DosePro is currently approved in the United States and Denmark for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache. SUMAVEL DosePro may offer a fast-acting and efficacious treatment alternative to oral and nasal triptans with 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.
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. Desitin plans to launch SUMAVEL DosePro in Denmark in early 2011.
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 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.
SUMAVEL and DosePro are trademarks of Zogenix.
CONNECT is a nonprofit organization dedicated to creating and sustaining the growth of innovative technology and life science businesses in San Diego. Since 1985, CONNECT has assisted in the formation and development of over 2,000 companies and is widely regarded as the world's most successful regional program linking inventors and entrepreneurs with the resources they need for success. CONNECT focuses on research institution support, business creation and development, entrepreneurial learning, access to capital, public policy advocacy, awards, recognition and networking. There are more than 40 organizations in 18 countries that have adopted the CONNECT model, including New York City, the UK, Sweden, Norway, Denmark, Australia and India.
For more information about CONNECT's MIP Awards, please visit: http://www.connect.org/programs/most-innovative-products-award/
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 timing of Desitin's planned launch in Denmark. 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 the 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; 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 European Union; 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 and Desitin's ability to operate its business without infringing the intellectual property rights of others; 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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