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Nicox poised to develop international ophthalmic product portfolio
Recent acquisitions and agreements are expected to position the company to expand its product lines.
Nicox, which started building a commercial infrastructure in Europe in 2013, is moving ahead with plans to expand its ophthalmic product lines in the United States and Europe.
“The company has restructured,” Gavin Spencer, Nicox executive vice president for corporate development, said in an interview with Ocular Surgery News. “We will be establishing commercial operations across all five of the top European markets. That’s France, Germany, Italy, Spain and the U.K.”
Gavin Spencer
The company’s strategy involves diagnostic and therapeutic technologies, Jerry St. Peter, executive vice president and general manager of Nicox, said during the interview.
Jerry St. Peter
“The diagnostic platform is really one pillar of two key pillars that we are building in the U.S. to strengthen our business. One will be dedicated to diagnostics, and one will be dedicated to therapeutics,” St. Peter said.
In January, Nicox and Sequenom Laboratories reached an agreement in which Nicox obtained exclusive North American marketing and promotion rights for RetnaGene, a laboratory-developed test that evaluates the risk of age-related macular degeneration progression within 2, 5 and 10 years, Nicox announced in a news release.
RetnaGene will be promoted by the same U.S. sales team that launched Sjö, a diagnostic test for early detection of Sjögren’s syndrome in patients with dry eye symptoms. Nicox plans to begin promoting RetnaGene in the U.S. in the first half of this year, the release said.
Meanwhile, Nicox acquired Eupharmed, an Italian company, in December, and in March 2013, Nicox reached an agreement with an undisclosed European pharmaceutical company and plans to launch some of the company’s products early this year, Spencer said. Nicox also plans to launch AdenoPlus, a test for acute conjunctivitis licensed from Rapid Pathogen Screening, in Europe this year.
Nicox has made several appointments in the U.S. and Europe in sales, marketing, medical affairs and logistics. The company had 24 employees in the U.S. and 64 in the European commercial team at the end of January.
Launches in diagnostics
Nicox plans to launch two add-ons to AdenoPlus.
The first add-on, RPS-AP, will include immunoglobulin E (IgE) testing for allergies and an immunoassay test for adenovirus.
“You’ve essentially turned the product into a two-for-one where the doctor will be able to determine if someone is positive or negative for either adenovirus or IgE allergy,” St. Peter said.
The other add-on, RPS-OH, will enable testing for herpes simplex virus, St. Peter said.
Nicox launched Sjö in November 2013. The company has exclusive rights to promote Sjö in North America under an agreement with Immco Diagnostics.
Sjö uses three Sjögren’s-specific biomarkers and three existing biomarkers. The new biomarkers tend to show up in early-stage disease, while the existing biomarkers show up in late-stage disease, St. Peter said.
“Essentially, this diagnostic test will now allow practitioners to test the patient and, with very high sensitivity and specificity, be able to determine if somebody is positive or negative for these biomarkers for Sjögren’s syndrome,” he said.
Glaucoma drug in clinical trials
In January 2013, Bausch + Lomb launched two phase 3 clinical trials, APOLLO and LUNAR, for latanoprostene bunod, a nitric oxide-donating prostaglandin F2 alpha analog for IOP reduction in patients with glaucoma and ocular hypertension. In July 2013, the phase 3 JUPITER study and phase 1 KRONUS study were initiated in Japan.
“Latanoprostene bunod is the subject of our collaboration with Bausch + Lomb. We’ve been working with them since 2010 when the program had completed a phase 2,” Spencer said.
Previous phase 2b results were promising, he said.
“Phase 2 data that we presented have shown a statistically significant difference compared to latanoprost itself, Xalatan, which was the market leader before it went to generic,” he said.
The APOLLO and LUNAR phase 3 clinical trials include about 800 patients at centers in the U.S. and Europe, Spencer said. – by Matt Hasson