DURHAM, N.C., June 12, 2014 /PRNewswire/ -- Parion
Sciences, Inc. (Parion) announced today that Parion and Santen
Pharmaceutical Co., Ltd. (Santen) have entered into the "OPTION,
LICENSE AND DEVELOPMENT AGREEMENT", an exclusive option agreement
for the development and commercialization of P-321 for dry eye
disease in certain Asian territories. On May 1, 2014 Parion announced FDA Acceptance of
the Investigational New Drug Application for clinical testing of
P-321 Ophthalmic Solution for the Treatment of Dry Eye
Disease. Parion plans to initiate a Phase 1/2a clinical trial
in patients suffering from dry eye disease in July, 2014 in
the United States.
Under the terms of agreement, Santen will make an undisclosed
option payment to secure certain rights to P-321 and to support the
upcoming Phase 1/2a clinical trial. Should Santen elect to
exercise their option, Santen will have responsibility for all
clinical, regulatory, and commercial activity for the ophthalmic
use of P-321 in the agreed Asian territories. Parion
retains all rights to develop and commercialize P-321 in the rest
of the world, including North
America and Europe.
"Parion is excited to be partnering with Santen, a global leader
in Ophthalmology, who has a proven track record in commercializing
multiple dry eye products in Asia," said Paul
Boucher, President of Parion Sciences. "P-321's unique
mechanism of action aims to restore the eye's tear film volume,
which is expected to bring relief for those patients with dry
eye. The combined expertise of the Parion and Santen teams
will greatly benefit the P-321 program and our collaborative Phase
1/2a study."
About ENaC and P-321
The epithelial sodium channel (ENaC) plays a key role in the
regulation of tear film volume and is, therefore, an attractive
target for the treatment of dry eye. Studies with preclinical
models of dry eye disease have demonstrated that by blocking ENaC,
the tear film volume is restored, maintaining its protective and
lubricating actions on the ocular surface.
P-321 is the product of a comprehensive research effort to
develop a potent ENaC inhibitor with unique pharmacokinetic and
pharmacodynamic characteristics designed for topical ocular
administration, metabolic stability and limited systemic exposure.
Parion Sciences has completed all the preclinical safety and
mechanistic studies required to initiate clinical studies in humans
in the US. Parion's dry eye program was supported by the NIH
through the National Eye Institute and the National Center for
Advancing Translational Sciences (NCATS) BrIDGs program.
About Santen
Founded in 1890, Santen is a global
company headquartered in Osaka,
Japan. Santen researches, develops and markets ophthalmic
products for physicians worldwide. Among prescription ophthalmic
pharmaceuticals, Santen holds the top share within the Japanese
market and is one of the leading ophthalmic companies worldwide.
Tokyo Stock Exchange code 4536. For more information, visit
www.santen.com.
About Parion Sciences
Parion Sciences is a
development-stage company dedicated to research, development, and
commercialization of treatments to restore patient's innate mucosal
surface defenses. Parion's science driven technologies target
ocular and respiratory diseases in which the patient's ability to
protect their mucosal surfaces is compromised.
Parion Sciences was founded based on proprietary ENaC inhibitor
technology from The University of North
Carolina, Chapel Hill and has received grant funding from
the National Institutes of Health and the Cystic Fibrosis
Foundation Therapeutics, Inc. Today, while Parion remains at the
forefront of ENaC research, the company is leveraging its research
and development expertise in epithelial biology to expand into new
indications and platforms that further treat additional mucosal
defects. Parion is currently advancing several programs
through clinical development including the tPAD platform, P-1037
for pulmonary diseases and P-321 for the treatment of dry eye
disease.
SOURCE Parion Sciences, Inc.