Valeant Pharmaceuticals International and EyeGate Pharmaceuticals announced that they have entered into an exclusive, worldwide licensing agreement through which EyeGate has granted a subsidiary of Valeant commercial and manufacturing rights to the EyeGate II Delivery System and EGP-437 combination product candidate for the treatment of postoperative pain and inflammation in ocular surgery patients.
Under the agreement, Valeant will pay the EyeGate an upfront payment of $4 million, and EyeGate is eligible to receive milestone payments totaling up to approximately $99 million, upon and subject to the achievement of certain specified developmental and commercial milestones, according to an SEC filing. In addition, EyeGate is eligible to receive royalties based on a specified percent of net sales of the EyeGate II Delivery System, subject to adjustment in certain circumstances.
This partnership follows a 2015 agreement in which Valeant secured an exclusive worldwide license for its subsidiary to this product for uveitis. Valeant has maintained its right of last negotiation to license the product for other indications.
“We are pleased to extend our relationship with EyeGate, and to obtain the global commercial and manufacturing rights to the EyeGate II Delivery System for the indication of postoperative inflammation and pain in ocular surgery patients. We believe that the product has significant potential in the market as part of our Bausch + Lomb business and applaud EyeGate for a remarkable job in advancing the product’s development in both uveitis and cataract surgery,” Joseph C. Papa, Chairman and CEO of Valeant, said in a company news release. “We look forward to further supporting EyeGate as they continue their progress in bringing this product to market to meet the needs of our customers and their patients.”
“This second licensing agreement with Valeant provides an important validation of both the clinical and commercial potential of iontophoretic EGP-437. We believe that Bausch + Lomb’s sales, marketing, and commercial capabilities in ophthalmology are unrivalled, making them the optimal partner to bring this unique product to market,” Stephen From, President and Chief Executive Officer of EyeGate, said in the news release. “For the approximately 3 million cataract surgery patients in the U.S. each year, adherence to the postoperative therapeutic regimen is imperative. As many of these patients are older and may struggle with self-administration of corticosteroid eye drops, we believe that iontophoretic EGP-437 administered by the eye care practitioner will provide a promising new treatment in addressing the needs of this large patient population.”
EyeGate will be responsible for the continued development of the EyeGate II delivery system in the US for the treatment of postoperative pain and inflammation in ocular surgery patients, and all associated costs. Valeant has the right to further develop the product outside of the US, at its cost. In December 2016, EyeGate reported positive topline data from a phase 1b/2a trial assessing iontophoretic EGP-437 in the treatment of ocular inflammation and pain in postsurgical cataract patients.