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Zogenix Announces Initiatives To Reach Key Business Milestones

Stocks in this article: ZGNX

SAN DIEGO, June 5, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced today initiatives to extend its cash runway to reach key business milestones that may occur over the remainder of the year. These milestones include the Company's efforts to gain U.S. Food and Drug Administration (FDA) approval for its New Drug Application (NDA) for Zohydro ER TM (hydrocodone bitartrate extended release capsules) for chronic pain, to secure a development partner for Relday TM, a once-monthly injectable formulation of risperidone for schizophrenia, and to out-license the Company's proprietary DosePro needle-free delivery technology. The initiatives underway are expected to extend the Company's cash runway beyond the potential achievement of one or more of these milestones during the second half of 2013.

The Company's initiatives include:

  • A reduction in the Company's workforce of 148 by a total of 55 full-time equivalent employees (approximately 37%) across all functional areas of the Company.
  • Maintaining the Company's core commercial capabilities and ability to support the potential launch of Zohydro ER three to four months after potential approval by retaining 93 full-time equivalent employees, including 57 in sales and marketing. The expected timeline for FDA action on the Zohydro ER NDA is unchanged and remains sometime this summer.
  • Cost control initiatives to further reduce operating expenses and capital expenditures.
  • Increase focus on reaching SUMAVEL DosePro brand-level profitability, and to leverage the Zogenix sale force presence in neurology. The Company is making encouraging progress towards securing a second product to co-promote with a goal of beginning sometime this summer.

Roger L. Hawley, chief executive officer of Zogenix, stated, "We have not received any new updates from the FDA on the timing of their decision regarding the Zohydro ER NDA and remain confident in the Zohydro ER program. In addition, Zogenix has other upcoming value creating milestones that could occur in the second half of the year. We are implementing these initiatives to ensure we are in a position to benefit from these potential milestones while also continuing to support our existing commercial business and partners. Our approach includes a balance of expense reduction, a reduction in workforce, cost controls, and progress in business development efforts.

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