Aerie Pharmaceuticals Inc. in Irvine anticipates a one- to two-year schedule for both of its eye care drugs to move through the Food and Drug Administration process toward approval.
The drugs are Rhopressa and Roclatan, both eye drop products intended to lower intraocular pressure in patients with glaucoma or ocular hypertension. Roclatan is a year behind Rhophressa in the plan.
Aerie filed a new-drug application with the FDA for Rhopressa in September and plans to file one for Roclatan late next year.
“It takes 12 months for FDA to review it,” said Aerie Chief Executive Vince Anido.
That means that the applications, if successful, would be approved within about two years.
A Rhopressa study in April 2015 missed its endpoint, causing shares in Aerie to drop 68% to about $12 a share. It since rebounded and was recently trading at $36 per share.
Anido said the company discussed results with the FDA and followed its guidance on the drug application this year.
A Roclatan study last month showed positive results that some analysts questioned. One analyst suggested Aerie had set study parameters such that trial subjects were likely to show positive results.
Anido said the company didn’t try to get one kind of patient or another through its study enrollment criteria and that regardless of those criteria, the FDA approval process is the same.
“There are drugs approved for lower (intraocular) pressure and drugs approved for higher pressure,” he said. “It’s the same approval for both.”
Anido and other Aerie senior executives are based in Irvine, as are several other departments. Research and some manufacturing management are in the Raleigh-Durham area of North Carolina. Remaining departments are in Bedminster, N.J. Each location employs about 30 people.
Aerie plans to build a manufacturing plant in Ireland that will employ another 40. It needs a sales force, research and development on future products, and to work on approvals in Europe and Japan for Rhopressa and Roclatan, Anido said.
He said Aerie is prepared for the work of the next two years with “$250 million in the bank—more than enough to do everything we need to do.”
Irvine Firms Sell
Irvine Pharmaceutical Services Inc. and Avrio Biopharmaceuticals LLC, both in Irvine, will sell their assets to Nitto Denko Avecia Inc. in Milford, Mass., a press release from the buyer said.
All three companies are contract manufacturers of biopharmaceuticals.
A price wasn’t given for the transaction, which is set to close at month’s end.
Irvine Pharmaceutical’s services include preformulation and formulation; development; manufacturing; stability storage; and chemistry, manufacturing and controls testing for the drug and device industries. Avrio handles products from Phase I through marketing of finished products.
Nitto Denko Avecia offers manufacturing and development services at facilities in Massachusetts and Ohio.
The two local companies were founded by Assad Kazeminy.
Kazeminy and Detleft Rethage, president of Nitto Denko Avecia, said the companies operate in different segments, so the deal brings clients “breadth of capabilities and depth of expertise” and “seamless outsourcing solutions.”
In a Name
Smoofi Inc. in San Clemente said it would buy GandTex LLC in Dallas on undisclosed terms, then change its name.
Smoofi has said it plans to develop an online marketplace and community for cannabis companies and their clients.
GandTex is in the preclinical stage on a process it said could reduce the need for tissue matching prior to organ donation.
Leadership Switch
American Pathology Foundation in Laguna Beach named a new president and board of directors to serve through 2018.
The new president is Dr. Gregory Henderson, who holds medical and bachelor’s degrees in biochemistry and a doctorate in immunology, and completed a fellowship in breast and oncologic pathology. He’s president of BioReference Laboratories, a commercial lab in Elmwood Park, N.J.
Board members for the 2016-18 term are:
• Dr. Robert C. Babkowski, president and CEO of Stamford Pathology Group PC in Connecticut.
• Judy Frost, a registered nurse who’s business manager for Midwest Pathology Associates and Mid America Pathology Laboratory in Kansas.
• Stanette Kennebrew, who holds a law degree and MBA, is a group administrator for Affiliated Pathologists Medical Group in Rancho Dominguez, and is COO for the group practice and lab.
The 57-year-old nonprofit organization provides education and practice management resources for pathologists in private practice, hospitals, academia, at labs and in residency, as well as nonphysician practice managers.
Bits & Pieces
Allegro Opthalmics LLC in San Juan Capistgrano said Phase 2b clinical trials for Luminate had positive results in 136 patients with diabetic macular edema. Allegro develops therapies to treat vitro-retinal diseases. … Anaheim Convention Center hosts the annual meeting of the American Academy of Optometry Nov. 9 to 12. The Orlando-based group said 7,000 optometrists, vision scientists, optometry students or residents will be in town for the four-day meeting. Author Malcolm Gladwell is plenary session speaker. … Saddleback Memorial Medical Center in Laguna Hills said it received top ratings for orthopedic surgery; joint replacement; and cardiac, pulmonary and gastrointestinal care from a study of 45 million patient outcomes at 4,500 hospitals by Healthgrades Operating Co. in Denver.
