- With a laser focus on becoming a leader in the ophthalmology space, Shire is adding a new eye treatment to its pipeline through a deal with a privately-held drugmaker.
- Announced Monday, the global licensing agreement with Parion Sciences gives Shire exclusive commercial and developmental rights to P-321, an epithelial sodium channel (ENaC) inhibitor in mid-stage testing as a treatment for dry eye in adults.
- The Irish pharma is dropping up to $535 million in the agreement. That includes $20 million upfront plus a $20 million near-term milestone. Additional milestones are on the table for Parion, though Shire didn't elaborate further in a May 1 statement.
Shire investors barely batted their eyes at the idea of the company potentially spending half a billion dollars on a mid-stage candidate — an interesting reaction given the large drugmaker reported just $529 million in cash and cash equivalents as of Dec. 31. Shares fell about 50 cents apiece, a less than 1% decline, by close of market Monday.
That mild stock change may be due to investor confidence in the global ophthalmology drug market, which some industry followers anticipate hitting $26 billion by 2022.
Other drugmakers have certainly spent big bucks building and preserving their eye care businesses. Novartis, for example, has actively pursued ophthalmology deals while considering strategic options for its Alcon unit. Last month, it in-licensed an investigational medication for dry eye from the small biotech Lubris in a deal worth up to $1 billion, according to one report.
"Ophthalmics is a continued focus for Shire, and the program for P-321 will benefit from our development and commercial infrastructure and expertise,” Flemming Ornskov, the company's chief, said in the statement. "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."
Shire is relatively new to the ophthalmology space and has been a bit of a pet project for Ornskov since he took the top slot at Shire in 2012. The company gained its first approval in the space last July with the okay of Xiidra (lifitegrast). Shire reported in first quarter earnings on Tuesday that Xiidra now has a 22% marketshare in the dry eye space as of March.
Parion kicked off a placebo-controlled Phase 2 study of P-321 ophthalmic solution back in July. The study is evaluating the drug in 60 patients with mild to moderate dry eye, with the primary endpoint being significant change from baseline in disease symptoms, which include stinging, redness and stints of low or no tear production.
As an ENaC inhibitor, P-321 aims to regulate salt movement across membranes, a process that in turn controls the transportation of fluids. A Phase 1/2 safety and tolerability study found patients taking the drug demonstrated "positive trends" with regard to improvement of their dry eye symptoms, as well as adverse events similar to a placebo arm, according to Parion.
Dry eye treatments have been few and far between over the years, spearheaded mostly by Allergan's Restasis (cyclosporine), Regeneron's Eylea (aflibercept) and Roche's Lucentis (ranibizumab). But things are heating up. As of late 2016, 63 drugs made up the the global pipeline for the disease, according to GBI research.