SAN DIEGO and COLUMBUS, Ohio (GLOBE NEWSWIRE)
— Zogenix, Inc., 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.”
About Zogenix
Zogenix, Inc., 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.
About Battelle
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.
1 Hibbard, 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.
Posted by Sean Fenske, Editor-in-Chief, MDT