Zogenix Reviews Positive Sales Trends and 2012 Commercial Initiatives for SUMAVEL(R) DosePro(R)

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| Source: Zogenix

Evaluating New Co-Promotion Opportunities to Supplement Zogenix U.S. Sales Team

Zogenix to Host Conference Call Today at 9:00 am ET

SAN DIEGO, Dec. 21, 2011 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced earlier today with Astellas Pharma US, Inc. (Astellas), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo:4503) that the co-promotion of SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System currently in place will end on March 31, 2012.  SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System, was launched with Astellas in January 2010 for the acute treatment of migraine and cluster headache.  Beginning in the second quarter of 2012, Zogenix will assume full responsibility for the continued commercialization of the brand, with a focus on headache specialists, neurologists and primary care physicians who treat a significant number of migraine patients.  Zogenix is also evaluating potential co-promotion partners who could complement the Zogenix sales force efforts.

Based on current sales trends and the economics of the co-promotion agreement, Zogenix expects minimal impact on brand cash flow in 2012 as highlighted by the following:

  • During the third quarter 2011, Zogenix generated 63% of SUMAVEL DosePro unit demand from specialists within its segment; combined with institutions within the Zogenix segment plus unit demand from the jointly-called on Astellas segment of primary care practices, Zogenix's responsibility 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 Zogenix sales force.  Combined with currently called on physicians, the Zogenix sales 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 Zogenix and 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 Zogenix sales force2
  • The Zogenix sales force expansion from 80 to 95 representatives was recently completed
  • Zogenix will leverage its existing strong relationships with neurologists and headache specialists to create more brand awareness among primary care physicians.  Sales tools deployed by the Zogenix sales 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 million in July 2013 and $2.1 million in July 2014.  These amounts are estimates and actuals will be based on the final sales results for the 12 months ending March 31, 2012

Roger Hawley, chief executive officer of Zogenix, said, "The conclusion of our co-promotion agreement with Astellas starting in the second quarter will lower expenses as a result of the elimination of the service fee.  We are evaluating a number of potential pharmaceutical company partners who have expressed interest in promoting SUMAVEL DosePro within their prescriber audiences.  Alternatively, we will explore a modest expansion of our sales force.  We expect to provide an update on these activities by the end of the first quarter."  

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

Zogenix will host a conference call today to discuss the amended agreement at 9:00 am ET.  To participate, please dial 866-783-2142 (U.S.) or 857-350-1601 (International); participant passcode: 53560933.  To access the live webcast please visit the Zogenix Investor Relations website at http://ir.zogenix.com.

The conference call will be hosted by Chief Executive Officer Roger L. Hawley, President and Chief Operating Officer Stephen J. Farr, Ph.D., and Executive Vice President and Chief Financial Officer Ann Rhoads.

A replay of the conference call will be available beginning December 21, 2011 at 12:00 p.m. ET (9:00 a.m. PT) until December 28, 2011, by dialing 888-286-8010 (U.S.) or 617-801-6888 (International); passcode: 88138799.  A replay of the webcast will also be available on the Zogenix Investor Relations website for one month, through January 21, 2012.

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 product candidate, Zohydro™ (hydrocodone bitartrate), is a novel, oral, single-entity (without acetaminophen) extended-release capsule formulation currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy.  Zogenix's second DosePro product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.

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 its usefulness as a therapeutic option in relieving migraine pain and symptoms; accelerated adoption of SUMAVEL DosePro in the primary care segment; the potential for a co-promotion arrangement for SUMAVEL DosePro; and the ability of Zogenix to leverage its relationships with neurologists and headache specialists or to enter into another co-promotion arrangement.  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 secure another co-promotion partner to promote SUMAVEL DosePro on acceptable terms, or at all; 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.

1Source ® Prescriber, July 2011 - September 2011 and Source ® PHAST Institution, July 2011 - September 2011

2Source ® PHAST Prescription and Institution, January 2011 - September 2011

32Source ® PHAST Prescription and Institution, July 2011 - September 2011

4Wolters Kluwer data on file w/e 7/8/11-9/9/11 and w/e 10/7/11-12/9/11

SUMAVEL®, DosePro®, ReldayTM and ZohydroTM are trademarks of Zogenix, Inc.

ZOGENIX INVESTORS:
Zack Kubow | The Ruth Group
646.536.7020 | 

ZOGENIX MEDIA:
Victoria Aguiar | The Ruth Group
646.536.7013 |