Ophthalmic companies Aerie Pharmaceuticals Inc. (NASDAQ: AERI) and Presbia PLC (NASDAQ: LENS) are pursuing Food and Drug Administration approval of their drugs and device, respectively.
Irvine-based Aerie has late-stage glaucoma drugs Rhopressa and Roclatan. It received FDA approval for Rhopressa in December, two months earlier than the company anticipated, and said it’s on track to submit Roclatan for approval in the second quarter. Rhopressa’s once-daily eye drops are designed to lower intraocular pressure in patients with glaucoma; Aerie views Roclatan as a first-line treatment for glaucoma with greater market potential.
Aerie has a $2 billion market cap, up 40% since it filed for Rhopressa approval in February.
The company’s been ramping up in preparation of approval, including hires in research and development, commercialization and business development. It also signed a lease for a 30,000-square-foot manufacturing facility in Ireland to supply the drugs by 2020. Chief Executive Vicente Anido said the company plans to hire 100 sales representatives in the first quarter and commercially launch midyear.
Medical device maker Presbia is also zeroing in on the FDA, but its plans include a restructuring. The company’s slashed marketing, manufacturing and engineering efforts here to stall its cash burn rate and focus solely on securing FDA approval for the presbyopia-correcting Flexivue Microlens. It will continue ongoing clinical and commercial efforts in Germany and South Korea, where its presbyopia-correcting lens is approved for sale.
Presbia, whose device received the European CE mark in 2016, has incurred significant operating losses since inception and continues to, according to a recent quarterly report filed with the Securities and Exchange Commission. The company’s conducting a 346-patient second-phase trial and said it plans to file for FDA approval at the end of the year.
Presbia maintains its headquarters in Dublin, Ireland, for tax purposes. Its Irvine site provides administrative and manufacturing services.
Executive Chairman Randy Thurman and Todd Cooper, board member, president and chief executive, resigned last month, and their roles were taken over by majority shareholder Mark Yung.
Yung is also affiliated with Orchard Capital Corp., where he previously served as a managing director. Orchard plans to invest up to $5 million in the company’s preferred shares to fund 2018 operations. Presbia will continue “to explore other financing options and plans to finalize the capital raise by mid-February,” according to the company.
Avid Update
Tustin-based Peregrine Pharmaceuticals Inc.’s rather public restructuring is complete, and the company begins the year with a new business focus, board of directors and leader. Roger Lias, who took over as president of biologics manufacturing business Avid Bioservices in September, led the company’s fiscal second-quarter earnings call for the period ended Oct. 31.
Lias said his leading off of the call in place of Peregrine Chief Executive Steve King—King previously also served as head of Avid—marked the company’s complete pivot into a contract development and manufacturing organization, or CDMO, with Avid “[representing] the future of the company.”
The Business Journal has followed Peregrine through the process, beginning in July, when a group of investors released a proxy calling for the company to stop research and development activities related to its cancer drug, as well as appointed new independent members to the board of directors.
Peregrine is well on that path. Lias said it plans a “complete divestiture of all of Peregrine’s legacy R&D assets.”
Its expanded board now has seven members, three of them new independent members from the investor group, three independent members from Peregrine, and one mutually designated independent member. Incumbent directors King, Carlton Johnson, Eric Swartz and David Pohl resigned in November and were replaced.
Avid reported $12.8 million in quarterly revenue. It set manufacturing revenue guidance for the full fiscal 2018 of $50 million to $55 million.
Lias said the company plans to grow revenue by expanding offered services and hiring additional CDMO professionals with sales and marketing experience.
Last month it added Tracy Kinjerski as vice president of business operations. Kinjerski was most recently senior director of business development at CMC Biologics in Bothell, Wash.
Peregrine shares shot up 60% in the fall on news of it becoming a full-fledged CDMO, trading at more than $5 per share in mid-December, but have settled at $4.25 per share and about a $190 million market cap.
Bits & Pieces
Irvine-based Cercacor Laboratories Inc. last month rolled out the Android version of Ember, its noninvasive hemoglobin tracker for endurance athletes. Founder and Chief Executive Joe Kiani said the version “offers the most commonly used features of the iOS version.” Kiani is also head of patient monitoring device maker Masimo Corp. in Irvine.
