Nicox SA provided an update on its activities and cash balance as of September 30, 2017.
Earlier this month, Nicox entered into two collaborations to explore the potential for sustained-release formulations of Nicox's next generation of stand-alone nitric oxide (NO)-donors for the reduction of IOP, with Re-Vana Therapeutics concerning their EyeLief long-acting photo-crosslinked biodegradable drug delivery platform, and with pSivida Corp concerning their bioerodible sustained-release drug delivery system.
In September, Nicox entered into an exclusive licensing agreement with Eyevance Pharmaceuticals for the commercialization of Zerviate (cetirizine ophthalmic solution) 0.24%, in the US and received a non-refundable upfront payment of $6 million. In September, Nicox and VISUfarma amended certain elements of their agreement relating to the August 2016 transfer of Nicox's European and International commercial operations to VISUfarma. This amendment results in a net income of €2.8 million. In August, Nicox completed a financing through a reserved capital increase of ordinary shares of the company with a specific category of investors. Gross proceeds from the financing were €26.3 million, and net proceeds were €24.5 million.
In August, Nicox's licensee Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.) announced that it submitted a response to the FDA complete response letter (CRL), also received in August, concerning the new drug application (NDA) for Vyzulta (latanoprostene bunod ophthalmic solution), 0.024% for intraocular pressure lowering in patients with open angle glaucoma or ocular hypertension. The CRL from the FDA referred to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida. The NDA had been resubmitted to the FDA by Bausch + Lomb in February 2016 following receipt of a previous CRL. Neither CRL issued to Bausch + Lomb mentioned any efficacy or safety issues with respect to the NDA for VYZULTA, nor any additional clinical trials for the approval of the NDA.
Following an update on the manufacturing timelines for the NCX 4251 formulation, the IND application to support a phase 2 clinical study is now expected to be submitted in H2 2018. NCX 4251 is a novel formulation of fluticasone propionate being developed for the first time as a topical treatment for acute exacerbation of blepharitis.
The IND application to support a phase 2 clinical study with NCX 470 is expected to be submitted in H1 2018. NCX 470 is a novel NO-donating bimatoprost analog in development for reduction of IOP in patients with open-angle glaucoma or ocular hypertension.
"We continued to execute on our strategy in the third quarter with a partnership for the U.S. commercialization of Zerviate, licensing the rights to Eyevance Pharmaceuticals. Eyevance is a newly created ophthalmic specialty pharmaceutical company backed by an investment group with a long track record of success in the creation and growth of U.S. specialty pharma companies. Eyevance is led by a seasoned, entrepreneurial leadership team with specific expertise in the commercialization of products in the U.S. ophthalmic market. We believe that the launch, planned for late 2018, will be a success for both Eyevance and Nicox." Michele Garufi, Chairman and Chief Executive Officer of Nicox, said in a company news release.
"Our two mid-stage products, NCX 470 for IOP lowering and NCX 4251 for blepharitis, are progressing toward their IND submissions in H1 and H2 2018 respectively to enter directly into phase 2. Moreover, we continue to pursue additional opportunities within our pipeline of early stage next generation stand-alone NO-donors through the recently announced research collaborations with pSivida and Re-Vana Therapeutics to evaluate the potential for sustained-release delivery of our promising new compounds. We continue to focus on our strategy of becoming a fully-integrated pharmaceutical company focused on the discovery, development and commercialization of novel ophthalmic therapeutics and believe we are in a position to rapidly advance our clinical programs and realize the value of Vyzulta and Zerviate through our partnerships with Bausch + Lomb and Eyevance respectively."