SAN DIEGO, June 7, 2012 (GLOBE NEWSWIRE) -- Zogenix Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, and Mallinckrodt LLC, the pharmaceuticals business of Covidien (NYSE:COV), today announced an exclusive co-promotion agreement for SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System in the United States.
Under terms of the agreement, Mallinckrodt's sales team will begin selling SUMAVEL DosePro to its customer base of prescribers. The initial term of the agreement will be through June 30, 2014, and can be extended by mutual agreement of the parties in additional six month increments. Zogenix will continue to record all product revenues and Mallinckrodt will be compensated in the form of a quarterly service fee that is calculated as a percentage of net sales over a baseline amount to their prescriber audience.
SUMAVEL DosePro is the first and only needle-free delivery system for subcutaneous sumatriptan for the treatment of acute migraine and cluster headache. Clinical data has shown that SUMAVEL DosePro can provide migraine pain relief within 10 minutes for some patients (16% of patients versus 4% for placebo). The product was launched in January 2010 and sales have grown sequentially every quarter since launch, reaching over 129,000 total prescriptions at the end of the first quarter 2012.
"We are pleased to have Mallinckrodt join our efforts to bring SUMAVEL DosePro to a broader audience of prescribers who are committed to helping patients manage the debilitating impact of migraine," said Roger Hawley, chief executive officer of Zogenix. "Adding Mallinckrodt's large sales force to the efforts of our 95 sales representatives will double our reach to prescribers of migraine products and significantly expand our sales coverage for SUMAVEL DosePro within the primary care market. The Mallinckrodt team has extensive experience in the pain market, and is committed to educating their customers on the unique benefits of adding SUMAVEL DosePro as an exciting migraine treatment option. Our team will remain engaged with neurologists, headache specialists, and other key migraine prescribers while working closely with our new partner at the field level to effectively drive sales and implement our new sales campaign which we've recently introduced."
Mark Trudeau, president of Mallinckrodt, added, "We are leaders in pain management, and the inclusion of SUMAVEL DosePro to our sales efforts allows us to grow in that space, as we prepare to spin off from Covidien next year. We look forward to working with Zogenix and to launching SUMAVEL DosePro to our customers."
According to the National Headache Foundation, acute migraines affect nearly 30 million Americans, primarily women between the ages of 25 and 40, who are treated by primary care physicians, neurologists and headache specialists. Tablets are a treatment option for some of these migraine sufferers, but not all patients are satisfied with tablet therapy. Fast-acting, non-oral options are needed, particularly for those who experience migraine attacks associated with sudden onset, waking, nausea or vomiting. The U.S. Headache Consortium has recently endorsed updated migraine treatment guidelines which support a "toolbox" approach to providing treatment options.
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.
Do not use SUMAVEL DosePro and any ergotamine-containing or ergot-type medication within 24 hours of each other; do not use SUMAVEL DosePro and another 5-HT1 agonist (e.g. triptan) within 24 hours of each other (with the exception of a single dose of another sumatriptan product, provided the doses are separated by at least 1 hour). SUMAVEL DosePro 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, please click here: http://www.zogenix.com/downloads/SV0468.0611_SDP_PI.pdf
For more information about SUMAVEL DosePro, please visit www.SUMAVELDosePro.com.
About Zogenix
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, Zohydro™ (hydrocodone bitartrate) is a novel, oral, single-entity (without acetaminophen) extended-release formulation of various strengths of hydrocodone intended for administration every 12 hours for around the clock management of moderate to severe chronic pain. Zogenix's second DosePro investigational product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia. In May 2012, Zogenix submitted to the FDA a New Drug Application for Zohydro and an Investigational New Drug Application for Relday.
For additional information, please visit www.zogenix.com.
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," "plans," "expects," "will," "potential" 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 its usefulness as a therapeutic option in relieving migraine pain and symptoms and the potential for the co-promotion arrangement to increase sales of SUMAVEL DosePro. 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: unexpected adverse side effects relating to SUMAVEL DosePro that could result in recalls or product liability claims; the ability of our co-promotion partner to successfully market SUMAVEL DosePro to its customers; the potential early termination of the co-promote arrangement; 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 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®, ReldayTM and ZohydroTM are trademarks of Zogenix, Inc.
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