Aerie Pharmaceuticals plans to build a new €25 million ($26.5 million) manufacturing plant that will initially employ 50 people at the recently built IDA Advanced Technology Building in Athlone, Ireland, the country’s economic development agency IDA Ireland said today.
Aerie has entered into lease talks with IDA Ireland to establish the company’s first manufacturing plant, which is expected to produce commercial supplies for its two lead product candidates—Rhopressa™ (netarsudil ophthalmic solution) 0.02% and Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a fixed-dose combination of Rhopressa and the widely prescribed prostaglandin analog (PGA) latanoprost.
Both candidates are once-daily intraocular pressure (IOP)-lowering therapies with novel mechanisms of action designed to treat patients with glaucoma or ocular hypertension. Should Rhopressa and Roclatan win approval, the candidates are expected to offer the first new mechanisms of action for treatment of patients with glaucoma in some 20 years.
Aerie originally submitted an NDA for Rhopressa in the third quarter of 2016, but will resubmit that application near the end of the first quarter of 2017. On October 27, Aerie said the original filing was withdrawn because a third-party manufacturing facility in Tampa, FL, was not ready for preapproval inspection by the FDA. The NDA will be resubmitted upon notification from the contract manufacturer of its readiness for preapproval inspection by the FDA, Aerie states on its website.
In IDA Ireland’s announcement, Aerie said commercial product supply for Rhopressa is expected to be available by 2020.
Roclatan currently has two Phase III registration trials underway, named Mercury 1 and Mercury 2. If these trials are successful, a Roclatan NDA filing is expected to take place near year end 2017.
In addition to Rhopressa and Roclatan, Aerie is developing additional product candidates and technologies in ophthalmology.
Aerie has begun design planning for the manufacturing facility and expects to begin internal construction in early 2017. Up to 50 new jobs would be created in sterile manufacturing, quality, engineering, and other support capabilities, IDA Ireland said.
The manufacturing plant would occupy space within the 2650 square-meter (28,524-square-foot) building and cost approximately €25 million ($26.5 million) in project-wide construction and equipment costs, excluding ongoing labor-related and lease expenses.
“As we prepare for commercialization, it is increasingly important that we ensure greater independence regarding our finished product sourcing while also meaningfully reducing our future product costs,” Aerie CEO and chairman Vicente Anido, Jr., Ph.D., said in a statement.