​Durham-based Parion Sciences has granted exclusive worldwide development and commercialization rights to its potential therapy for dry eye disease to Shire, a global pharmaceutical company.

Under the agreement, Shire will lead the development of P-321, an investigational compound for the potential treatment of dry eye disease in adults, with the opportunity for Parion to co-fund, the two companies said in a news release.

While the companies declined to disclose specific terms of the deal, Shire will make an initial $20 million upfront license payment with an additional $20 million payment based on the achievement of a near-term development milestone. Parion will be entitled to receive additional potential milestone payments, with a total potential deal value of up to $535 million.

“Advancing P-321 with Shire, an emerging global leader in ophthalmics, offers the expertise and resources to move this promising potential therapy for dry eye sufferers forward,” said Paul Boucher, president and CEO of Parion. “This collaborative license agreement enables us the opportunity to contribute and participate in P-321’s success, while continuing our drive to progress Parion’s pipeline of novel therapies.”

P-321 is a Phase 2 compound being developed to address tear volume deficiency and promote ocular surface healing. While further clinical trials are needed to fully evaluate its safety profile and efficacy, P-321 is a novel molecule that is believed to address dry eye disease by inhibiting the epithelial sodium channel, which is thought to block the absorption of tears, and help keep the ocular surface hydrated. Current prescription treatments target the effects of ocular inflammation.

“Ophthalmics is a continued focus for Shire, and the program for P-321 will benefit from our development and commercial infrastructure and expertise,” said Flemming Ornskov, M.D., M.P.H., CEO of Shire, a Dublin-based company with U.S. headquarters in Lexington, Mass.

“This is an opportunity to apply our knowledge and experience from ophthalmics and dry eye disease for further innovation in this space. If approved, P-321 would expand our eye care portfolio.”

Parion has the option to co-fund through additional stages of development in exchange for enhanced tiered double-digit royalties. In addition, Parion has the option to co-fund commercialization activities and participate in the financial outcome from those activities.

Parion, a 1999 spinout from the University of North Carolina at Chapel Hill, is a development-stage company focused on novel treatments for pulmonary diseases including cystic fribrosis, and ocular diseases such as dry eye disease. Its research focuses on restoring patients’ innate mucosal surface defenses in epithelial tissues.

The North Carolina Biotechnology Center provided early funding to help support some of the company’s initial research. NCBiotech provided a $206,000 Institutional Development Grant to UNC in 1995 and a $100,000 Collaborative Funding Grant in 2009. That was followed by a 2012 Industrial Fellowship Grant to enable a post-doctoral scientist to serve a two-year fellowship working in Parion’s labs.

The company has also received grant funding from the National Institutes of Health and Cystic Fibrosis Foundation Therapeutics.

(C) N.C. Biotechnology Center