08 September 2017
ZERVIATETM (cetirizine ophthalmic solution), 0.24% New Drug Application (NDA) approved
Investigational New Drug (IND) submissions for NCX 470 for IOP lowering and NCX 4251 for blepharitis planned for H1 2018
Bausch + Lomb responded to VYZULTATM (latanoprostene bunod ophthalmic solution), 0.024% Complete Response Letter (CRL) received from U.S. Food and Drug Administration (FDA)
Gross proceeds from financing of €26.25 million
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced its financial results for the six months ended June 30, 2017, and provided an update on its activities.
“The first half of 2017 was marked by significant developments across our core programs” commented Michele Garufi, Chairman and Chief Executive Officer of Nicox. “The recent FDA approval of the ZERVIATE™ NDA brings us one step closer to our objective of securing a commercialisation partner for this innovative ophthalmic product for the U.S. market. For VYZULTA™, our partner Bausch + Lomb has resolved the FDA’s concerns surrounding their Tampa manufacturing plant and rapidly submitted a response to the CRL received in August.”
Michele Garufi concluded, “Subsequent to the close of the second quarter, we strengthened our balance sheet through a reserved capital increase of ordinary shares, the gross proceeds of which were €26.25 million. These funds allow us to advance our novel, patented pipeline candidates NCX 470 and NCX 4251 and to submit INDs for Phase 2 clinical studies during the first semester 2018.”
Second Quarter 2017 and Recent Developments
- In August 2017, 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 €26.25 million.
- On August 7, 2017, Nicox’s licensee Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.) announced that it had received a CRL from the FDA concerning the NDA for VYZULTATM (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. Bausch + Lomb has informed Nicox that it submitted its response to the FDA on August 17, 2017. 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 VYZULTATM nor any additional clinical trials for the approval of the NDA.
- On May 31, 2017, Nicox announced that the FDA had approved the NDA for ZERVIATE™ (cetirizine ophthalmic solution 0.24%; formerly AC-170), the first topical ocular formulation of this well-known antihistamine, for the treatment of ocular itching associated with allergic conjunctivitis. Nicox is currently seeking a licensing partner for commercialization in the United States.
Nicox and VISUfarma have amended certain elements of our agreement relating to the August 2016 transfer of Nicox’s European and International commercial operations to VISUfarma. Under the terms of the amended agreement, VISUfarma and Nicox have agreed to amend the terms and conditions related to the €5 million potential milestone payments, which would have been made in a combination of ordinary shares and interest-bearing loan notes. As a result, Nicox will receive an additional €1.65 million in deal consideration in a combination of ordinary shares and interest-bearing loan notes, making the total consideration for the assets equal to an aggregate of €22.65 million, increased from the €21 million initially. Nicox is now eligible to receive a milestone payment of up to €3.35 million in a combination of ordinary shares and interest-bearing loan notes if certain business objectives are achieved by VISUfarma. Nicox and VISUfarma also agreed that Nicox will no longer be responsible for completing development and regulatory approval for NCX 4240 in Europe. No payments are due by either party, now or subsequently, as a result of this change. Nicox retains rights to develop NCX 4240 in the United States and Japan. And finally, Nicox will make a one-time cash payment of €479,000 to VISUfarma.
H1 2017 Financial Summary
- Following reclassification in 2016 of the European commercial business as Discontinued Operations, the operating profit and loss account items described below include only the Continuing Operations.
- The operating expenses for the six month period ended June 30, 2017 were €10.2 million compared to €12.0 million for same period ended June 30, 2016. The decrease in operating expenses in 2017 is mainly due to the significant R&D expenses recorded during the first six months in 2016 due to the filing of an NDA for ZERVIATETM with the FDA as well as expenses for additional studies undertaken to address potential questions of the FDA as part of their review of this application.
- The Group recorded a net loss from continuing operations of €12.2 million as of June 30, 2017, compared to a net loss of €12.9 million for the same period in 2016.
The Group had cash, cash equivalents of €20.4 million as of June 30, 2017, compared to €28.9 million on December 31, 2016. Following the closing of the €26.25 million financing announced on August 15, 2017, the Group’s cash, cash equivalents as of August 31, 2017 are estimated to be €44,07 million (non-audited figures).