Aerie Pharma Seeks FDA Nod to Sell Ireland-based Product in US
If the FDA grants Aerie Pharma approval, it will be able to manufacture Rocklatan in Ireland for sale in the US in early 2020.
Aerie Pharmaceuticals (NASDAQ:AERI) is seeking approval to produce its drug, Rocklatan, a treatment for open-angle glaucoma, in Ireland.
In a press release on Thursday (September 19), the company said it has submitted a prior approval supplement (PAS) to the US Food and Drug Administration (FDA). If approved, it will allow the company to produce the drug in its Athlone, Ireland, facility and sell it in the US.
The company previously received FDA approval for Rocklatan in March, and it launched in the US in May.
Aerie Pharmaceuticals estimates the review will take roughly 60 days, with the finalized PAS review done within four months. Should the approval go through, the company will be able to produce Rocklatan in its Athlone facility with sales in the US projected for the first half of next year.
Prior to submitting the PAS application, the company received good manufacturing practices inspection and authorization for its Athlone-based plant from Ireland’s Health Products Regulatory Authority.
CEO Vicente Anido, Jr., said that Aerie Pharmaceuticals has also performed process validation studies for the drug and has created stability data for registration of the facility with the FDA.
“Our PAS submission is another milestone for Aerie as we continue to move towards having our state-of-the-art plant facilitate the global supply of Aerie products,” Anido said in a release.
In addition to its proposal to develop Rocklatan in Ireland, the company expects to file a PAS application with the FDA to develop its other drug, Rhopressa, in its Athlone facility. Aerie Pharmaceuticals anticipates it will file this application in the first half of next year.
Rhopressa received FDA approval in December 2017 to also treat open-angle glaucoma or ocular hypertension. Open-angle glaucoma is an eye disease that slowly results in loss of vision and damage to the optic nerve. Open-angle glaucoma is the most common form of glaucoma, with others including closed angle and normal tension glaucoma.
According to a research report from Technavio, the open-angle glaucoma market will grow by US$1.23 billion between 2019 and 2023, growing at a compound annual growth rate of 4 percent.
Along with Aerie Pharmaceuticals, companies such as Allergan (NYSE:AGN), Bausch Health Companies (TSX:BHC), Novartis AG (NYSE:NVS) and Pfizer (NYSE:PFE) will also be at the forefront of innovation in this arena.
Shares of Aerie Pharmaceuticals rose 5.87 percent following Thursday’s announcement to close the trading session at US$22.91. Year-to-date, however, the company’s share price is down 40.42 percent.
Based off five analyst ratings on TipRanks, Aerie Pharmaceuticals currently has a “strong buy” rating with an average price target of US$55, a high of US$63 and a low of US$45.
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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.