Zogenix, Inc. (“Zogenix”), a private, specialty pharmaceutical company, today announced they have entered into a License Agreement under which Zogenix has been granted exclusive US rights from an affiliate of Elan Corporation, plc (NYSE:ELN) (“Elan”) to develop and commercialize a late stage, controlled-release opioid for the treatment of pain. The product, which incorporates Elan’s proprietary SODAS® Technology, has previously demonstrated in a Phase 2 clinical trial a clinically acceptable safety profile and a reduction in pain intensity for chronic moderate to severe osteoarthritis pain patients across multiple dosage strengths.
Under the terms of the Agreement, Elan will receive from Zogenix an undisclosed upfront payment and future payments upon the achievement of clinical and regulatory milestones for the product. Additionally, Elan will receive royalty payments based on sales of the product upon commercialization. Zogenix will assume responsibility for the clinical development and commercialization of the product in the United States, and Elan will manufacture the product for Zogenix.
In recent years, US sales of prescription opioids for the treatment of moderate to severe pain have grown dramatically and now exceed $9.1 billion annually. “Opioid analgesics will continue to play a very important role in the effective management of moderate to severe pain for the foreseeable future,” commented Dr. Stephen Farr, President and Chief Operating Officer of Zogenix. “There remains a significant unmet medical need for novel, controlled release opioids that can deliver on the promise of providing consistent, round-the-clock pain relief.”
“This addition means Zogenix now has two drug candidates in late stage development, consistent with our strategy to build a portfolio of products in central nervous system (CNS) indications and pain,” said Roger Hawley, Chief Executive Officer of Zogenix. “We will also have access to Elan’s manufacturing capabilities for this product, which have a proven track record of successfully formulating and manufacturing scheduled drug products that incorporate their proprietary drug delivery technologies. We look forward to advancing this product into Phase 3 development in 2008, and ultimately selling the product via our commercial team. The market potential, therapeutic fit, development timelines, and ability to leverage our commercial capabilities make this a compelling opportunity for Zogenix.”
“This agreement reflects the robustness and flexibility of our drug technology platforms and our commitment to developing improved products that address unmet medical needs,” commented Shane Cooke, Elan’s Chief Financial Officer and head of its Drug Technologies business. “We are delighted to be working with Zogenix and look forward to assisting them in their efforts to bring this important product to the market for the benefit of patients.”
About Zogenix
Zogenix, Inc., with offices in Emeryville and San Diego, CA, is a private, specialty pharmaceutical company focused on the development and commercialization of medicines to treat neuroscience disorders and pain. The company's initial focus is the completion of the late-stage development and commercialization of sumatriptan Intraject®– a needle-free, single-use, disposable, and easy-to-use subcutaneous delivery system for sumatriptan that will compete in the $2.7 billion triptan segment of the migraine market. The company also plans to license the patented Intraject drug delivery system to other companies. For additional information, visit www.zogenix.com.
About SODAS® Technology
SODAS (Spheroidal Oral Drug Absorption System) is Elan’s multiparticulate drug delivery system. SODAS Technology continues to be an accepted and approved system by regulatory authorities with approvals for the SODAS based system occurring in the US for Avinza®, Ritalin LA® and Focalin® XR. A number of other compounds are in late stage development utilizing Elan’s SODAS technology. The SODAS Technology is part of a suite of capabilities available through Elan Drug Technologies.
SODAS is a registered trademark of Elan Corporation, plc
AVINZA is a registered trademark of King Pharmaceuticals Research and Development, Inc.
FOCALIN and RITALIN LA are registered trademarks of Novartis AG
INTRAJECT is a registered trademark of Zogenix, Inc.
Contacts:
J.D. Haldeman, 858-436-8595
VP, Commercial
Strategy & Corporate Communications
jdhaldeman@zogenix.com
or
Kureczka/Martin
Associates
Joan Kureczka, 415-821-2413
jkureczka@comcast.net
