Aerie Pharmaceuticals Inc. (NASDAQ: AERI) continues to ramp up in anticipation of upcoming Food and Drug Administration approval of glaucoma drug Rhopressa. The company announced last week that it plans to build its first manufacturing plant in Athlone, a town in central Ireland. The facility will commercially supply global markets with Aerie’s current late-stage drug candidates, Rhopressa and Roclatan, in 2020.
Roclatan is its other late-stage clinical drug. The Irvine-based company said it plans to file for FDA approval next year.
The facility will include end-to-end operations ranging from compounding to sterile filling to packaging. The company said it will hire “self-starters who will enjoy the challenge of working within a small, high performing team and being able to apply their experience and passion to sterile manufacturing startup.”
Aerie didn’t return calls or emails regarding whether it plans to change its headquarters designation or tax residence to Ireland, but it won’t be alone if it chooses to do so. Botox maker Allergan PLC had claimed Ireland as its tax residence, Parsippany, N.J., as its corporate headquarters, and significant operations at its longtime home in Irvine.
Aerie also announced last week that it appointed Nhi Ong as director of analytics reporting to Gerry McKenzie, vice president of commercial operations. Ong previously held related positions at Valeant Pharmaceuticals International Inc. and ThromboGenics. Ong will receive awards totaling 16,000 stock options, which will vest over four years, 25% on his first anniversary.
Ong’s appointment followed a series of research and development appointments in October, including the addition of 11 employees to the research and development team in Durham, N.C.
Aerie develops therapies for patients with glaucoma and other eye diseases. Shares of the company currently trade at $59 per share for a $2.1 billion market cap.
IPO Plans
Bioprosthetic device maker Hancock Jaffe Laboratories Inc. filed for an initial public offering. It plans to raise $13 million, offering 1.88 million shares at a price range of $6 to $8. At the midpoint of the proposed range, the company would command a market value of $62 million. It plans to list on the NASDAQ under the symbol HJLI.
Hancock was founded in 1999 and reported $1 million in revenue for the 12 months ended June 30.
The company didn’t respond to calls or emails.
The Irvine-based medical device maker has three products in its research and development pipeline. The BHV is designed to improve aortic and mitral valve performance, CoreGraft is for coronary artery bypass surgeries, and VenoValve for lower limb chronic venous insufficiency.
Hancock is still a long way from attaining regulatory approval—all three products are in the preclinical stage—but the company had an earlier success securing FDA approval for its ProCol Vascular Bioprosthesis in 2013. It sold the product in March 2016 to LeMaitre Vascular Inc. in Burlington, Mass., for $665,000 and a three-year royalty deal of up to $5 million.
The ProCol device is designed to create a bridge graft for vascular access to allow blood to flow back and forth in hemodialysis, a treatment for patients with kidney failure.
WallachBeth Capital and Network 1 Financial Securities are the joint book runners on the deal. IPO timing wasn’t disclosed.
FDA Nod
Irvine-based patient monitoring device maker Masimo Corp. (NASDAQ: MASI) received FDA clearance and U.S. release of the full family of NomoLine capnography sampling lines, which are available in more than 40 configurations. They’re used to monitor the concentration of carbon dioxide in the breath.
Masimo’s technology eliminates the need for water traps and for extended monitoring time in high-humidity applications.
Chief Executive Joe Kiani said the “innovative moisture-wicking technology” is applied in “an entire line of cannulas, including neonatal airway adapter sets.”
Bits & Pieces
San Clemente-based LightMed Corp. was awarded a competitive tender for ophthalmic laser equipment from Mexico’s Ministry of Health, the government department in charge of social health services. The global medical device company makes ophthalmic lasers.
