Aerie Reports Regulatory, Financial Progress
Durham-based Aerie Pharmaceuticals, an ophthalmic pharmaceutical company, has reported positive developments on its regulatory and financial fronts.
Roclatan, the company’s drug candidate for reducing intraocular pressure in patients with glaucoma or ocular hypertension, has achieved some regulatory milestones with the U.S. Food and Drug Administration.
Meanwhile, a major investor in Aerie, Deerfield Management Co. of New York, has converted $125 million in senior secured convertible notes into shares of Aerie stock and has arranged a $100 million credit facility for Aerie.
For Roclatan, its once-daily eye drop, Aerie said that it had received “Day 74” notification from the FDA earlier than expected, that the FDA had completed its initial 60-day review of the company’s new drug application (NDA) and that the agency had determined the application is sufficiently complete to allow a substantive review.
“We are delighted with this positive news on our Roclatan NDA, and, if approved, we expect to be fully prepared to launch Roclatan using our existing sales force,” said Vicente Anido Jr., Ph.D., chairman and chief executive officer at Aerie.
According to the Prescription Drug User Fee Act, the goal date for completion of the FDA’s review of the Roclatan NDA is March 14, 2019. The “Day 74” notification indicated that the FDA had not identified any potential review issues and did not mention the need for an advisory committee, the company said.
Roclatan is a fixed-dose combination of Aerie’s lead product, Rhopressa, and the widely prescribed prostaglandin analog latanoprost.
Rhopressa, a once-daily eye drop for lowering eye pressure in patients with open-angle glaucoma and ocular hypertension, was approved for sale by the FDA in December 2017 and was launched commercially this April. Rhopressa increases the outflow of aqueous humor, the fluid inside the eye, through the trabecular meshwork, the main fluid drain of the eye.
Roclatan achieved its primary efficacy endpoint in two Phase 3 registration trials and also achieved 12-month safety and efficacy results in one of the trials. A third Phase 3 trial for Roclatan is under way in Europe but is not required for U.S. approval.
Aerie said that if approved, Roclatan would be the first glaucoma product to lower intraocular pressure through all known mechanisms: increasing fluid outflow through the trabecular meshwork; increasing fluid outflow through the uveoscleral pathway, the eye’s secondary drain; reducing fluid production in the eye; and reducing episcleral venous pressure.
Stock conversion, credit facility
Aerie reported that $125 million of senior secured convertible notes held by Deerfield Management since September 2014 have been fully converted into 5,040,323 shares of Aerie common stock.
In addition, Aerie has entered into a $100 million senior secured delayed-draw term loan facility with Deerfield. Aerie may borrow up to $100 million at any time before July 23, 2020, for working capital and general corporate purposes.
No amounts were drawn under the credit facility at closing. Aerie said it had adequate cash, cash equivalents and investments to support ongoing business operations and currently had no intention to draw on the credit facility.
“Now that we are an operating company, the $100 million credit facility provides us with additional financial flexibility as we continue to grow, as we believe is a customary step for companies at our stage,” Anido said.
350 employees and growing.
Aerie, a spinout of Duke University, has about 350 employees at its sites in Durham, Irvine, Calif., Bedminster, N.J., and in Ireland, where it has an office in Dublin and a manufacturing plant in Athlone that is scheduled to come online in 2020.
“This gives us roots in or near several specific and critical ‘ecosystems’ -- biomedical research in RTP, ophthalmic innovation and commercialization in Irvine, the financial community through Bedminster, and world-class manufacturing expertise in Ireland, not to mention proximity to continental Europe,” said Tad Heitmann, head of communications.
About a third of Aerie’s workforce consists of a U.S. sales force that includes 100 territory managers and 15 district managers, in addition to a field-based medical affairs team, Heitmann said.
The Durham headquarters has about 60 employees and is advertising for six open positions, mostly R&D jobs.
“We continue to grow in all of our offices,” Heitmann said.
A year ago the company leased an additional 13,385 square feet of lab and office space at the Imperial Center at 4301 Emperor Boulevard in Durham, just outside Research Triangle Park. The added space gave the company a total of 32,586 square feet at the site.
Aerie is continuing to build out the lab space and is working on a cGMP (current good manufacturing practices) production facility that should be online later this year, Heitmann said.
The manufacturing facility will use PRINT technology acquired last year from Durham-based Envisia Therapeutics to produce clinical supplies of the company’s drug candidates for retinal conditions such as wet age-related macular degeneration and diabetic macular edema. PRINT, an acronym for particle replication in non-wetting templates, is a proprietary system for creating precisely engineered, sustained-release products based on fully scalable manufacturing processes developed by Liquidia Technologies, of Morrisville.
Aerie’s stock shares are traded on the NASDAQ Global Market stock exchange under the symbol AERI. Liquidia announced a month ago that it has applied to list its common stock on the Nasdaq Capital Market under the ticker symbol “LQDA.”