NicOx have reported financial results for the first three months of 2010 and provided an overview of its activities, in particular those related to its lead compound naproxcinod which is currently under review by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Michele Garufi, Chief Executive Officer of NicOx commented: “The first quarter of 2010 was marked by the signature of the Worldwide Licensing Agreement with the leading eye health company Bausch + Lomb for our glaucoma candidate NCX 116.”
“Moreover, with naproxcinod under review by the relevant Authorities both in the United States and in Europe, the entire Company has been fully committed and engaged by continuous interactions with the FDA and the EMA and, in particular, in the preparation of the upcoming FDA Advisory Committee meeting of May 12th.”
Key highlights for the first quarter of 2010
- In March 2010, NicOx and Bausch + Lomb signed a Worldwide Licensing Agreement granting Bausch + Lomb exclusive rights to develop and commercialize NCX 116, a nitric oxide-donating prostaglandin F2-alpha analog for the treatment of glaucoma and ocular hypertension. Under the terms of this agreement, NicOx received an initial license payment of $10 million and stands to receive potential milestones totaling $169.5 million, as well as tiered double-digit royalties on the sales of NCX 116.
- The US Food and Drug Administration (FDA) announced in the beginning of March that the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee would meet on May 12, 2010, to discuss the New Drug Application (NDA) for naproxcinod.
- The European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for naproxcinod in January 2010.
- NicOx and TOPIGEN Pharmaceuticals Inc. have mutually terminated their collaboration for TPI 1020, as a result of the acquisition of TOPIGEN by Pharmaxis announced on January 11.
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