Zogenix Highlights DosePro(R) Needle-Free Delivery System at 2011 AAPS National Biotechnology Conference
SAN DIEGO, May 18, 2011 (GlobeNewswire via COMTEX) -- Zogenix, Inc. (Nasdaq:ZGNX) today announced that it presented three posters highlighting its proprietary DosePro(R) Needle-free Delivery System (DosePro) at the 2011 American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference in San Francisco, CA.
DosePro is designed to deliver a single dose of a liquid drug subcutaneously, without a needle, and it is validated by the Company's first commercial product, SUMAVEL(R) DosePro(R) (sumatriptan injection), which is approved in the United States and certain territories in Europe for the acute treatment of migraine and cluster headache.
"The data we presented further validate and broaden DosePro's clinical utility and enhance its overall attractiveness as a differentiated drug delivery platform," stated Stephen J. Farr, Ph.D., president and chief operating officer of Zogenix. "Over ten years of DosePro development has put Zogenix in a very strong position as we continue to advance our development programs and have discussions with potential out-licensing partners."
The poster presentations provide quantitative results demonstrating various attributes of the DosePro Delivery System. Key conclusions are summarized below:
DosePro is strongly preferred over needle-based subcutaneous injection
-- 188 patients received a total of 752 evaluable doses of saline using DosePro -- DosePro is well tolerated and free of any clinically meaningful safety concerns -- 81.2% of patients preferred DosePro vs. conventional needle-injection; an additional 11% of patients had no preference -- Administration site sensation was minimal immediately following dosing (2.3 + 1.6 on an 11-point scale); 98.5% and 99.3% of patients had no negative site sensation (Grade 0) at 1 hour and 24 hours post administration
DosePro enables consistent delivery of highly viscous formulations that cannot be delivered by needle-based injection systems
-- DosePro was evaluated using a viscosity model that mimics the behavior of recombinant protein formulations -- Critical performance characteristics such as delivery volume and injection time were equivalent to that of saline up to a viscosity of ~2000cP -- DosePro performed as designed at 100 times the viscosity of formulations that can be delivered practically by a needle for subcutaneous injection
DosePro demonstrates better than 99.99% reliability
-- A case study was presented demonstrating the effective use of Quality by Design principles to refine manufacturing processes and optimize DosePro performance reliability -- The case study demonstrates how DosePro is designed to work reliably, and showed that DosePro actuates perfectly more than 99.99% of the time
About DosePro Needle-free Delivery System
Zogenix' proprietary DosePro technology is a first-in-class, easy-to-use drug delivery system designed for self-administration of a pre-filled, single dose of liquid drug, subcutaneously, without a needle. DosePro offers several potential benefits compared to other subcutaneous delivery methods, and has the potential to become a preferred delivery option for patients and physicians for many injected medicines. DosePro is protected by more than 80 patents, issued and applied for, worldwide. Zogenix plans to leverage its technology to develop internal product candidates by pairing DosePro with proven drugs to enhance their commercial attractiveness, as well as form strategic partnerships with other pharmaceutical and biotech companies seeking to enhance, differentiate or extend the life-cycle of their own injectable products.
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.
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
For more information about SUMAVEL DosePro, please visit www.SUMAVELDosePro.com.
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 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.
SUMAVEL(R) and DosePro(R) are registered trademarks 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 patent protection of DosePro, the potential for DosePro to become a preferred delivery option and the potential for Zogenix to develop additional internal product candidates or establish strategic partnerships. 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 scope, validity and duration of patent protection and other intellectual property rights for DosePro; difficulties in identifying, negotiating and carrying out strategic transactions relating to DosePro and obtaining regulatory approval for other DosePro products; 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 dependence on its collaboration with Astellas Pharma US, Inc. to promote SUMAVEL DosePro; 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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