Full Press Release Details
Completes Licensing Deal with Merck Animal Health for Its Nanomicellar
Formulation of Voclosporin for the Treatment of Canine Dry Eye Syndrome
retains rights to all human uses
topical formulation expands indication potential for voclosporin
VICTORIA, British Columbia--(BUSINESS WIRE)--April 17, 2017--Aurinia
Pharmaceuticals Inc. (NASDAQ:AUPH/TSX:AUP) ("Aurinia" or the "Company")
today announced that it has signed a Definitive Agreement ("the
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
"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 CEO 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 multi-billion 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
enrollment 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," says 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, out-licensing or
divestiture while remaining focused on the Phase III lupus nephritis
About Dry Eye in Dogs
Keratoconjunctivitis sicca (KCS or dry
eye) is a common eye disease of dogs. This disease is characterized by
inflammation of the lacrimal glands, resulting in reduced or absent tear
formation and secondary bacterial conjunctivitis. If left untreated,
damage to the tear glands is irreversible, leading to painful dry eye,
and often leads to permanent blindness.
About Dry Eye in Humans
Dry Eye Syndrome (DES), also known as
keratoconjunctivitis sicca (KCS), is a multifactorial, heterogeneous
condition wherein the eyes have insufficient amount of tears, which are
necessary for normal eye function. Prevalence estimates range from 14%
to 33% of the general population, with between 30 and 40 million people
believed to be affected in the U.S. It is one of the most common reasons
for visits to ophthalmologists. DES prevalence is likely to continue to
grow as a result of the ageing population, (risk of DES increases 35%
each decade after age 40), higher physician and patient awareness,
increasing visual tasking and worsening environmental conditions.
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 (LN). The company is headquartered in Victoria, BC and focuses
its development efforts globally. www.auriniapharma.com
About Merck Animal Health
For over a century, Merck has been a
global health care leader working to help the world be well. Merck
Animal Health, known as MSD Animal Health outside the United States and
Canada, is the global animal health business unit of Merck. Through its
commitment to the Science of Healthier Animals , Merck Animal Health
offers veterinarians, farmers, pet owners and governments one of the
widest range of veterinary pharmaceuticals, vaccines and health
management solutions and services. Merck Animal Health is dedicated to
preserving and improving the health, well-being and performance of
animals. It invests extensively in dynamic and comprehensive R&D
resources and a modern, global supply chain. Merck Animal Health is
present in more than 50 countries, while its products are available in
some 150 markets. For more information, visit www.merck-animal-health.com or
connect with us on LinkedIn, Facebook and Twitter at @MerckAH.
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