NorCal's Aimmune Signs Lease for Huge Facility in Florida

NorCal’s Aimmune Therapeutics Leases Manufacturing Space in Florida
August 11, 2015
By Alex Keown, BioSpace.com Breaking News Staff

BRISBANE, Calif. – Fresh off a stock IPO that raised $160 million, Bay Area-based Aimmune Therapeutics, Inc. will expand its operations to Florida, the Tampa Bay Business Journal reported this morning.

Aimmune Therapeutics, which first launched as Allergen Research Corporation in 2011, is focused on developing treatments for peanut allergies. Aimmune changed its name from Allergen in May. The company leased a 40,000 square-foot facility in Clearwater, Fla. About half the space will be used for manufacturing, the Journal said. The company is likely gearing up for approval of its lead investigational product AR101, an oral immunotherapy of peanut-allergic children and adolescents ages four to 17. The company will soon begin Phase III clinical trials for the drug.

The Journal said Aimmune’s lease begins in mid-September and is signed through 2025. It is not known how many the new facility will employ, or if the company will be shifting existing personnel to the site. The Journal noted the lease indicates the site has 50 dedicated parking facilities. At the end of June the company employed 21, according to a company overview on NASDAQ.

Last week Aimmune Therapeutics raised $160 million by selling 10 million shares at $16 each. The company had been projected to sell shares between $14 and $16 per share. Since then the stock has ticked up and is at $22.97 per share. Aimmune is listed on the NASDAQ Global Market under the symbol AIMT.

Before going public, the company raised $80 million Series B Funding in March and prior to that $17 million in Series A Funding in 2013.

In June Aimmune won Breakthrough Therapy Designation status from the U.S. Food and Drug Administration (FDA) for AR101. The designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

Under the program, the FDA will work closely with Aimmune Therapeutics on the subsequent development of AR101, including providing guidance on generating evidence needed to support approval of the drug in an efficient manner. In its most recent trials AR101 had a 100 percent success rate for patients to tolerate exposure to at least 443 milligrams of peanut protein. Of those, 78 percent tolerated exposure to a cumulative amount of 1,043 milligrams of peanut protein, the company said.

It is estimated that more than 30 million people in the United States and Europe have a food allergy. Peanut allergies have grown at an annual rate of about 10 percent between 1997 and 2008, the company said.

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