Mr. Richard Glickman reports
AURINIA COMPLETES LICENSING DEAL WITH MERCK ANIMAL HEALTH FOR ITS NANOMICELLAR FORMULATION OF VOCLOSPORIN FOR THE TREATMENT OF CANINE DRY EYE SYNDROME
Aurinia Pharmaceuticals Inc. has signed a definitive agreement granting Merck Animal Health, known as MSD Animal
Health outside of the United States and Canada, worldwide rights to
develop and commercialize Aurinia's patented nanomicellar voclosporin
ophthalmic solution (VOS) for the treatment of dry eye syndrome in dogs.
Under the terms of this agreement, Aurinia will receive an upfront
payment and is eligible to receive further payments based on certain
development and sales milestones. Furthermore, Aurinia will receive
royalties based on global product sales. Merck Animal Health will be
responsible for the remaining clinical development and commercialization
of VOS for use in the animal health field, while Aurinia retains all
human health rights. The companies will share in the final work product
and any technical knowledge that may be generated during the
collaboration.
"This partnership with Merck Animal Health underscores our long-standing
belief that voclosporin has the potential to be effectively used across
a range of therapeutic areas, in addition to its primary potential
indication for the treatment of lupus nephritis," said Richard Glickman,
Aurinia's chief executive officer and chairman of the board. "In addition to enhancing dry
eye treatment options in the animal health field, VOS has a
differentiated product profile with long patent life that has the
potential to compete in the multibillion-dollar human prescription dry
eye market. While this ophthalmology project will continue to be
advanced by Merck Animal Health, the Aurinia clinical team will remain
focused on our lupus nephritis program, which is on track to begin
enrolment for the Aurora phase III trial this quarter."
Throughout the past year, Merck Animal Health has conducted proof-of-concept research in dogs suffering from dry eye syndrome, which affects
one out of every 22 dogs. The early symptoms can be easily missed by pet
owners, leading to irreversible damage to a dog's vision and eventually
resulting in blindness.
"VOS has the potential to address significant unmet medical needs in
ophthalmology, and the preliminary results of our canine dry eye trial
are very promising," said Holger Lehmann, DVM, PhD, associate vice-president, drug discovery, Merck Animal Health. "We look forward to
continuing our collaboration with Aurinia and believe this partnership
is a prime example of the synergies that exist between human and animal
health drug development for the benefit of all of our patients."
"Completed preclinical and human phase Ib studies using Aurinia's
nanomicellar VOS formulation have shown encouraging results in terms of
delivery of active drug to the target tissues of the eye," said Neil
Solomons, MD, chief medical officer of Aurinia. "The nanomicellar
formulation enables high concentrations of voclosporin to be
incorporated into a preservative-free solution for local delivery to the
ocular surface. This has been shown to potentially improve efficacy,
dosing frequency and tolerability versus the current treatments for dry
eye syndrome. We are excited about the potential for topical ocular
administration of voclosporin utilizing this unique and proprietary
nanomicellar drug delivery technology."
Aurinia is exploring all options to create value with its proprietary
nanomicellar ocular formulation of voclosporin in the human health field, including, but not limited to, further development, outlicensing or
divestiture while remaining focused on the phase III lupus nephritis
program.
About Aurinia
Pharmaceuticals Inc.
Aurinia is a clinical-stage biopharmaceutical
company focused on developing and commercializing therapies to treat
targeted patient populations that are suffering from serious diseases
with a high unmet medical need. The company is currently developing
voclosporin, an investigational drug, for the treatment of lupus
nephritis. The company is headquartered in Victoria, B.C., and focuses
its development efforts globally.
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