19 December 2017
Nicox joins the select group of European R&D companies with U.S. FDA approved products, with two products approved in 2017
Valeant Pharmaceuticals International, Inc.’s wholly owned subsidiary, Bausch + Lomb, a leading global eye health company, announced yesterday that it has begun distributing VYZULTA™ (latanoprostene bunod ophthalmic solution), 0.024% to wholesale pharmaceutical distributors across the United States
VYZULTA® is the first approved product based on Nicox’s NO-donating research platform
Resources in 2018 will be focused on advancing Nicox’s pipeline candidates NCX 470 and NCX 4251 towards mid-stage clinical development and on progressing its next generation of discovery-stage NO-donating compounds targeting glaucoma into preclinical development
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), international ophthalmic company, today provided a review of the Company’s 2017 achievements, along with an outline of 2018 activities. The Company also highlighted that its partner, Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International Inc.) has informed Nicox that as of December 18, 2017 VYZULTA® is currently being shipped to U.S. wholesalers.
“2017 was an exceptional year for Nicox. With the first approval, received by our licensee Bausch + Lomb, of a product based on our NO-donating research platform, we have now joined the select few European R&D companies who succeeded in having products based on their own research approved by the U.S. FDA.” stated Michele Garufi, Chairman and Chief Executive Officer of Nicox. “VYZULTA™, which has just been launched by Bausch + Lomb, and ZERVIATE™ (cetirizine ophthalmic solution) 0.24%, expected to be launched in late 2018, should provide a sound financial foundation for our clinical programs and in-house proprietary research. With the anticipated revenues from VYZULTA and ZERVIATE, and an estimated cash balance of over €41 million at the end of November 2017, we are well positioned to advance our strategy of becoming a fully-integrated ophthalmic pharmaceutical company spanning discovery through commercialization.”
Key 2017 Highlights and Planned 2018 Activities
In 2017, both of Nicox’s lead assets were approved by the U.S. Food and Drug Administration (FDA). Commercial rights to both VYZULTA® and ZERVIATETM have been out-licensed to Bausch + Lomb and Eyevance Pharmaceuticals respectively and the Company expects to begin receiving royalty revenue in 2018, along with potential sales and development milestones payments.
- VYZULTA® launched in the U.S. by Bausch + Lomb and shipping commenced: Indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension, VYZULTA, the first prostaglandin analog with one of its metabolites being nitric oxide (NO), is the first approved product to utilize Nicox’s proprietary nitric oxide (NO)-donating research platform. Bausch + Lomb holds exclusively licensed worldwide rights to VYZULTA. The current lead products in this market, Travatan Z1 and Lumigan2, had sales of $570 million and $687 million respectively in 20163. Nicox estimates that the U.S. patents covering VYZULTA could be extended from 2025 to 2030.
- ZERVIATETM approved and partnered to Eyevance Pharmaceuticals: Indicated for the treatment of ocular itching associated with allergic conjunctivitis, ZERVIATE is the first and only topical ocular formulation of cetirizine. Eyevance Pharmaceuticals, an ophthalmic specialty pharmaceutical company backed by a specialized investment group and led by a team experienced in the U.S. ophthalmic market, holds licensed rights to commercialize ZERVIATE in the $700 million U.S.4 market of topical ocular allergy products. Eyevance plans to launch ZERVIATE in the U.S. in late 2018, coinciding with the fall allergy season. The product is protected by patents to 2030 and 2032. Nicox is currently exploring partnerships for ZERVIATE outside of the U.S.
Nicox continues to progress its two pipeline products towards mid-stage clinical development and is also advancing several innovative, discovery-stage assets at its research center of Bresso, Milan.
- NCX 470 targeting IND submission for Phase 2 in 2018: A novel NO-donating bimatoprost analog in development for the reduction of IOP in patients with open angle glaucoma or ocular hypertension. NCX 470 has the potential for an IOP lowering efficacy greater than VYZULTATM. Nicox is conducting IND-enabling nonclinical studies and, subject to their successful completion, currently plans to submit an Investigational New Drug (IND) application for NCX 470 to the U.S. FDA in the summer of 2018 to support a Phase 2 clinical study.
- NCX 4251 targeting IND submission for Phase 2 in 2018: A novel formulation of fluticasone propionate being developed for the first time as a targeted topical treatment administered directly to the eye lid for the treatment of acute exacerbation of blepharitis, a common eye condition characterized by eyelid inflammation and swelling. Annual revenues of anti-inflammatories, antibiotics and their combinations prescribed for blepharitis total more than $500 million5 in the U.S. alone. Nicox is conducting formulation and IND-enabling non-clinical studies and, subject to their successful completion, currently plans to submit an IND application to the U.S. FDA in the winter of 2018 to support a Phase 2 clinical study.
- Next Generation of Stand-alone NO-donors and Novel NO-Donating Compounds: Nicox has active research programs targeting NO-donation in the eye and has discovered multiple novel compounds that release NO from pharmacologically active and non-active scaffolds. These novel chemical entities are thought to lower IOP by stimulating the primary fluid outflow mechanism from the anterior segment of the eye. The Company’s next generation of stand-alone NO-donors is designed to optimize NO dosing when administered alone or with current standard-of-care treatments to lower IOP in patients with open-angle glaucoma or ocular hypertension. Multiple candidates currently in the lead optimization stage of development have demonstrated IOP-lowering in animal models of ocular hypertension. Some of these candidates are currently being investigated for extended release intraocular drug delivery as part of two exploratory strategic collaborations with pSivida and Re-Vana Therapeutics. The collaborations will evaluate whether these extended release technologies are suitable for use with Nicox’s new NO-donating compounds.
1. IMS Health Analytics 2016 reported sales and TRx (Total Prescriptions)
2. IMS Health Analytics 2016 reported sales and TRx (Total Prescriptions)
3. MS Health Analytics 2016 reported sales and TRx (Total Prescriptions)
4. IMS Health Analytics and TRx (Total Prescriptions), not including OTC products for ocular allergy
5. Internal estimate based on IMS Health Analytics data.