Zogenix, Inc. ("Zogenix"), a private, specialty pharmaceutical
company, today announced that it has entered into a license agreement
to grant exclusive rights in the European Union to Desitin
Pharmaceuticals, GmbH ("Desitin") to develop and commercialize
Zogenix´s late stage, single use, needle-free product candidate for
migraine headache, sumatriptan DosePro. The product candidate, that
incorporates the Zogenix DosePro needle-free drug delivery technology,
has previously demonstrated bioequivalence to the Imitrex STATdose
System(R) (sumatriptan injection, GlaxoSmithKline) in a U.S. pivotal
clinical trial and compelling ease-of-use in a usability trial with
migraine sufferers.
Under the terms of the agreement, Desitin will oversee, and be
responsible for the expenses related to, all clinical development,
regulatory approvals and commercialization efforts required to market
and sell sumatriptan DosePro across Europe. Zogenix will be
responsible for the manufacture and supply of commercial product, and
will receive a transfer price payment on manufactured product and
royalty payments based on sales of the product upon commercialization.
Zogenix retains full commercial rights to sumatriptan DosePro in the
U.S., Canada, Asia and certain other countries.
Sales of triptans, the class of drugs in which sumatriptan DosePro
is expected to compete, total approximately $550 million annually in
the five major countries of Europe: Germany, France, Italy, Spain, and
the UK, according to IMS Health MIDAS. "Triptans remain the standard
of care in migraine treatment," commented Dr. Stephen Farr, President
and Chief Operating Officer of Zogenix. "However, there remains a
significant unmet medical need for more effective, easy-to-use
triptans that can deliver on the promise of providing faster onset and
more complete pain relief without the use of a needle. Sumatriptan
DosePro is designed to meet these needs."
"This license agreement expands the potential reach for
sumatriptan DosePro beyond the U.S., where, subject to regulatory
approval, Zogenix is preparing to commercialize sumatriptan DosePro
ourselves," said Roger Hawley, Chief Executive Officer of Zogenix. "In
Desitin, we have chosen a European partner that has a proven track
record of successfully developing, registering and commercializing
central nervous system (CNS) products. We look forward to seeing
sumatriptan DosePro advance through these steps and launch in the
European marketplace."
"This agreement reflects the unique and well respected position
Desitin holds in the European CNS market. We have the ability to both
move this product candidate through the European regulatory process
and to launch it with our CNS-focused sales representatives in more
than nine countries," commented Dr. Martin Zentgraf, Desitin´s General
Manager. "This product candidate fits with our ongoing commitment to
develop improved products that address unmet medical needs in the CNS
market. We are delighted to be working with Zogenix and, subject to
regulatory approval, look forward to bringing this important product
candidate 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 with two proprietary product
candidates in late-stage development for the treatment of central
nervous system disorders and pain. The company´s lead product
candidate, sumatriptan DosePro (previously Intraject(R)), enables
needle-free subcutaneous delivery of sumatriptan for the treatment of
acute migraine. In December 2007, Zogenix submitted a New Drug
Application with the U.S. Food and Drug Administration for sumatriptan
DosePro. Zogenix´s second product candidate, ZX002, is a novel
controlled release formulation of hydrocodone for the treatment of
chronic pain. This product candidate has completed Phase 2 clinical
trials, and the company anticipates initiating the Phase 3 clinical
program in the second half of 2008. The company also plans to license
the patented DosePro drug delivery system to other companies. For
additional information, visit www.zogenix.com.
About Desitin
Desitin Arzneimittel GmbH, based in Hamburg, Germany is an
independent, private, fully integrated, German pharmaceutical company
focused on the development, manufacturing and distribution of products
for the treatment of central nervous system disorders. Desitin, with
turnover in 2005/2006 of over $100 million, is one of the leading
European companies in the field of epilepsy with additional expertise
in Parkinson´s disease and psychiatric disorders. With their
pharmaceutical and clinical development capabilities, the company
develops innovative products such as controlled-release and high-dose
antiepileptics. Desitin´s sales infrastructure offers comprehensive
coverage in Germany, Northern and Eastern Europe. The company also has
strategic partnerships with other companies covering nearly all of the
remaining countries in Europe. For additional information, visit
www.desitinpharma.com
Bourne Partners, Charlotte N.C., acted as financial advisors to
Desitin on this transaction.
Zogenix(TM), DosePro(TM) and INTRAJECT(R) are trademarks of
Zogenix, Inc.
Imitrex STATdose System(R) is a registered trademark of
GlaxoSmithKline.
