Includes Option for Joint Development of Expanded DosePro(R) Drug Delivery Platform
SAN DIEGO and COLUMBUS, Ohio, Jan. 25, 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 Battelle, the world's largest independent research and development organization, today announced a unique collaboration with the objective of advancing the development and commercialization of Zogenix's DosePro drug delivery technology outside Zogenix's core therapeutic focus areas.
The companies have signed a Letter of Intent to enter into an exclusive co-marketing and technology development option agreement to utilize Zogenix's DosePro® needle-free drug delivery technology for new commercial out-licensing opportunities. DosePro technology enables needle-free medication delivery under the skin. Instead of a needle injection, DosePro technology uses a small amount of compressed gas to deliver a liquid formulation through the skin as a thin jet of medication. DosePro is the world's only commercially available, single-use, disposable, needle-free, subcutaneous delivery technology.
In the joint marketing arrangement, Zogenix and Battelle intend to offer Zogenix's novel DosePro technology to pharmaceutical and biotechnology firms to develop and commercialize innovative drug delivery products for development pipelines and for life cycle management of marketed prescription drugs and biologics, subject to Zogenix and Battelle executing a definitive agreement on the terms contemplated by the non-binding Letter of Intent. In addition, the Letter of Intent contemplates that upon successful out-licensing of DosePro, Battelle will have the option to participate directly in further development of the DosePro technology. This work, for which Zogenix has completed prototype design, is intended to broaden the capability of the technology to deliver larger dose volumes required for high-dose biological products. The arrangement is intended to fulfill the needs of biopharmaceutical companies that want to offer more customizable platform technologies resulting in differentiated products that can potentially increase efficacy, patient compliance and market share.
Zogenix's DosePro has received regulatory approvals in the United States and Europe, and is covered by more than 46 international issued patents extending through 2026. Zogenix has shipped in excess of 1.5 million DosePro units of the Company's approved migraine therapy, SUMAVEL® DosePro®, and patient experience has demonstrated that they will switch from oral to injectable formulations when provided the option of using DosePro.1
John Turanin, Vice President and General Manager, DosePro Technology, of Zogenix, said, "We recognize that DosePro can provide sustainable competitive advantages for many injectable drugs, especially biologics. With Battelle's expertise in product development and strong relationships with biopharmaceutical companies, we can now match DosePro technology to drug candidates in a more efficient manner by providing customizable drug delivery solutions that can effectively deliver biologics, vaccines and other critical drugs. We believe this arrangement will accelerate entry into licensing agreements with major pharmaceutical companies."
Barbara Kunz, President of Battelle Health and Life Sciences Global Business, said the collaboration is a strategic way for Battelle to advance its leading-edge health care science and technology offering to new and existing customers.
"We believe DosePro features market-leading technology for the safe and effective delivery of biologics, especially high viscosity formulations, which is critically important to our customers," Kunz said. "This collaboration will enhance our ability to extend our leadership in drug delivery technology development to create innovative solutions for the pharmaceutical industry."
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 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 investigational product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.
As the world's largest independent research and development organization, Battelle provides innovative solutions to the world's most pressing needs through its four global businesses: Laboratory Management; National Security; Health and Life Sciences; and Energy, Environment and Material Sciences. It advances scientific discovery and application by conducting $6.5 billion in global R&D annually through contract research, laboratory management and technology commercialization. Headquartered in Columbus, Ohio, Battelle oversees 22,000 employees in more than 130 locations worldwide, including seven national laboratories which Battelle manages or co-manages for the U.S. Department of Energy and the U.S. Department of Homeland Security and a nuclear energy lab in the United Kingdom.
Battelle also is one of the nation's leading charitable trusts focusing on societal and economic impact and actively supporting and promoting science, technology, engineering and mathematics (STEM) education.
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 negotiation and execution of the definitive agreements establishing the co-marketing arrangement, the ability to successfully out-license the DosePro technology, and the expected duration of patent protection for the DosePro technology. 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 scope, validity and duration of patent protection and other intellectual property rights for DosePro; difficulties in identifying, negotiating and carrying out strategic transactions relating to DosePro and obtaining regulatory approval for other DosePro products; risks associated with the development of a larger volume, second generation version of the DosePro technology to accommodate drug formulation volumes greater than 0.5 mL; 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.
1Hibbard, J and Turanin, J. (2011), Will Patients Accept and Adopt a Subcutaneous Self-injection Dosage Form When Alternative Oral or Nasal Dosage Forms Are Available? A Case Study in Needle-free Subcutaneous Delivery of Triptans for Migraine Headache; Poster Presentation, PDA Universe of Prefilled Syringes and Injection Devices, Basel, Switzerland. J. Hibbard and J. Turanin are employees of Zogenix, which sponsored the article.
SUMAVEL®, DosePro®, ReldayTM and ZohydroTM are trademarks of Zogenix, Inc.
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