Nicox Shares Climb On US FDA Approval For VYZULTA

(RTTNews) - Shares of Nicox S.A. (NICXF.PK) were gaining around 26 percent in the morning trading in Paris after the French ophthalmic company, Friday announced that its partnered product VYZULTA has been approved by the U.S. FDA, giving Nicox two approved products.

The company also provided an overview of its corporate and financial developments and upcoming pipeline initiatives.

On November 2, 2017, Nicox and its licensee Bausch + Lomb, a unit of Valeant Pharmaceuticals International, Inc., announced that the U.S. FDA approved the New Drug Application (NDA) for VYZULTA, a prostaglandin analog indicated for the reduction of IOP in patients with open angle glaucoma or ocular hypertension.

Nicox's partnership with Bausch + Lomb for VYZULTA could lead to potential future milestone payments of up to $145 million including a $20 million milestone payable upon Bausch + Lomb reaching $100 million sales.

Bausch + Lomb will also make tiered royalty payments on net sales of 10% to 15% on Bausch + Lomb global sales.

Bausch + Lomb expects to launch VYZULTA by the end of 2017.

Michele Garufi, Chairman and Chief Executive Officer, said, "We are delighted that VYZULTA has been approved by the U.S. FDA, giving Nicox two approved products. The launch of VYZULTA in the United States by our partner Bausch + Lomb, anticipated by year end, will mark a key milestone in our strategy for Nicox to become a fully-integrated pharmaceutical company, from discovery through commercialization."

The company added that the revenue stream from this first commercialized product using its NO-donating technology, along with that of ZERVIATE(cetirizine ophthalmic solution) 0.24%, expected to launch in late 2018, will help to support its pipeline programs. This includes advancing into Phase 2 clinical studies with two mid-stage products. They are NCX 470, its second NO-donating product candidate, currently in development for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension, and NCX 4251, a novel formulation of fluticasone propionate for blepharitis.

In Paris, Nicox shares were trading at 10.87 euros, up 26.29 percent.