Nicox SA has taken several steps in the past few months to increase shareholder value. It has two product candidates headed toward Phase II trials, with one of them recently licensed for development and commercialization in China. And while the company pulled back last fall from listing on NASDAQ, it hasn’t scrapped that plan and is waiting for a more appropriate time to make the move.
Nicox also just released a business update for Q4 2018, reporting net revenue of €4 million (about $4.54 million) for the year, and giving a number of recent highlights and key upcoming milestones.
Recently, Nicox announced that the 50% enrollment threshold was reached ahead of schedule in its US Phase II study of NCX 470, the compound being developed for use in patients with glaucoma or ocular hypertension.
Michele Garufi, PharmD, co-founder, chairman, and CEO of Nicox, says that while the quick enrollment is nice, there is no need to hurry. The company is well financed and will have revenue coming from Zerviate and Vyzulta. Its year-end report shows total Vyzulta prescriptions for Q4 2018 are up 47% compared with Q3. “For us the main goal is to deliver good results on NCX 470,” he says. The data so far have shown NCX 470 is clinically active, and Dr. Garufi and his team are looking to the clinical trial to confirm that.
Its market position was helpful when Nicox chose to postpone a proposed NASDAQ listing in October 2018, saying it would not be in the interest of its existing shareholders to enter at a time of extreme market volatility. Says Dr. Garufi, “When you do a listing, you try to do it in the best possible way, for the shareholders, for the company, and for the markets.”
He says it’s important for the company to be listed on NASDAQ at the appropriate time, to expand shareholder access and get coverage by US analysts. Dr. Garufi believes that the specialty investors NASDAQ tends to attract will recognize the company’s value. Nicox has no date targeted to obtain the listing.
Moving NCX 470 into China
Late last year Nicox entered into an exclusive license agreement with Ocumension Therapeutics for the development and commercialization of NCX 470 in China. Ocumension is funded by 6 Dimensions Capital, a global healthcare investment fund formed by the merger of WuXi Healthcare Ventures and Frontline BioVentures.
Following the announcement, the price of Nicox shares rose 14% on the Euronext stock market. While The Pharma Letter reported the announcement facilitated the increase, Dr. Garufi says he feels it’s also due to investors becoming more aware of the company’s value, especially as NCX 470 continues to show its potential.
For now, Nicox won’t be pursuing commercialization in any additional countries, nor will the company collaborate with a strategic partner for distribution in the US or Europe. Other potential partners have shown interest, particularly in Japan, and the company has received inquiries into licensing opportunities, but Nicox has turned them down. Dr. Garufi says the company wants to focus on continuing to build value rather than accept such offers.
Upcoming for Nicox, Dr. Garufi is looking for Bausch Health to get approval for Vyzulta in other countries, which will result in increased royalties for Nicox, and the company plans to license Zerviate outside the US. Within the US, he notes, Zerviate is licensed to Eyevance Pharmaceuticals for commercialization, and should launch this summer.
Nicox has another compound, NCX 4251, in development as a treatment for blepharitis. The company is aiming for an Investigational New Drug (IND) submission to the Food and Drug Administration for this compound by the end of Q1, and will begin a Phase II trial once the submission is approved. Dr. Garufi hopes both this Phase II trial and that for NCX 470 will be completed by year-end.
For questions about this article, please contact Steve Lenier at Steve@healthegy.com.
STAY UP TO DATE WITH OIS
Get the Latest News, Podcasts and Videos.