Zogenix Reviews Positive Sales Trends and 2012 Commercial Initiatives for SUMAVEL(R) DosePro(R)
Evaluating New Co-Promotion Opportunities to Supplement Zogenix U.S. Sales Team
Based on current sales trends and the economics of the co-promotion agreement,
During the third quarter 2011,
Zogenixgenerated 63% of SUMAVEL DosePro unit demand from specialists within its segment; combined with institutions within the Zogenixsegment plus unit demand from the jointly-called on Astellas segment of primary care practices, Zogenix'sresponsibility totals 71% of the unit demand1 Much of the remaining primary care prescription activity is concentrated with approximately 500 physicians prescribing 14% of unit demand in the third quarter. These physicians will become a key priority for the Zogenixsales force. Combined with currently called on physicians, the Zogenixsales force will be calling upon physicians who prescribe 85% of the total SUMAVEL DosePro unit demand1 By February 1, 2012, a detailed transition plan will be agreed to by Zogenixand Astellas to ensure uninterrupted access and service to physicians within the Astellas segment Growth in the third quarter was driven primarily by continued performance of the Zogenixsales force2 The Zogenixsales force expansion from 80 to 95 representatives was recently completed Zogenixwill leverage its existing strong relationships with neurologists and headache specialists to create more brand awareness among primary care physicians. Sales tools deployed by the Zogenixsales force have proved effective in driving prescriptions for SUMAVEL DosePro and will now be introduced to primary care physicians. This includes the new Migraine Toolbox, a comprehensive patient starter kit, and the published Phase 4 clinical data Meeting expectations for the brand, prescription refill rate for SUMAVEL DosePro remained consistent at 38% for the third quarter3 During the first ten weeks of the fourth quarter, total prescriptions were up 16% over the first ten weeks in the third quarter4 Payer coverage for SUMAVEL DosePro continues to expand and additional contracts have been signed in the third and fourth quarters The co-promotion agreement calls for tail payments which are estimated to be approximately $3.6 millionin July 2013and $2.1 millionin July 2014. These amounts are estimates and actuals will be based on the final sales results for the 12 months ending March 31, 2012
Hawley continues, "Our long-term goal with SUMAVEL DosePro is unchanged. The unmet patient need is significant. We have a clear objective to get more physicians to treat the varying intensity of the attacks with the right form of triptan therapy and focus on pain-free outcomes as the acute treatment goal."
Conference Call and Web Cast
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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.
Forward Looking Statements
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and
1Source ® Prescriber,
2Source ® PHAST Prescription and Institution,
32Source ® PHAST Prescription and Institution,
4Wolters Kluwer data on file w/e
SUMAVEL®, DosePro®, ReldayTM and ZohydroTM are trademarks of
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