Nicox and Fera Pharmaceuticals sign exclusive license agreement for naproxcinod in the U.S.

November 10, 2015

Nicox eligible to receive up to $35 million in commercial milestones, plus 7% royalties on future sales

Sophia Antipolis, France and Locust Valley, New York

Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, and Fera Pharmaceuticals, a privately-held specialty pharmaceutical company, announced today that they have entered into an exclusive license agreement for the development and commercialization of Nicox’s naproxcinod, a CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory candidate, in the United States.

Fera’s initial focus will be the signs and symptoms of osteoarthritis. Fera plans to seek advice from the United States Food and Drug Administration (FDA) regarding the additional clinical work required before submitting a New Drug Application (NDA) for naproxcinod. Nicox already completed a broad clinical program for naproxcinod in osteoarthritis, including three phase 3 studies with over 2,700 patients.

Under the terms of the agreement, Nicox will be eligible to receive up to $35 million in sales-based milestones, plus 7 percent royalties based on net sales of naproxcinod in the U.S. Fera will be responsible for, and will fully finance, all clinical development, manufacturing and commercialization activities. The agreement covers all indications excluding ophthalmology-related conditions and Duchenne Muscular Dystrophy (DMD), and Nicox will retain all rights for naproxcinod outside of the U.S. Fera is eligible to receive an undisclosed royalty should naproxcinod be approved and commercialized in any indication in any ex-U.S. territory using data generated by Fera. A joint steering committee will be put in place with representation from both companies to ensure that development of naproxcinod proceeds in accordance with the agreement.

Fera has a long track record in the development and commercialization of specialty pharmaceuticals and recognizes the value of naproxcinod’s unique product profile,” said Gavin Spencer, Executive Vice President, Corporate Development at Nicox. “Following our alliance with Bausch + Lomb for latanoprostene bunod, this transaction further underscores the value of Nicox’s nitric oxide-donating pipeline. If approved and commercialized, naproxcinod could become a meaningful treatment option for patients suffering from osteoarthritis and could bring royalties to Nicox that would provide important non-dilutive cash flow to support the development of our ophthalmology pipeline.

Frank DellaFera, Co-founder of Fera Pharmaceuticals, commented: “Nicox’s nitric oxide-donating research platform places them at the forefront of innovation and we believe naproxcinod, which is supported by robust, late-stage clinical data, is a highly promising compound for patients suffering with pain associated with osteoarthritis. We look forward to collaborating with Nicox and ensuring naproxcinod has the opportunity to display its full potential.

The U.S. intellectual property relating to this transaction is comprised of a patent for the naproxcinod S enantiomer which is protected until 2021 as well as a formulation patent.

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