Adamis Plummets More Than 30% After FDA Rejects Its Allergy Shot Application

March 30, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Shares of Adamis Pharmaceuticals Corp. have cratered more than 30 percent since Friday, when the company announced the U.S. Food and Drug Administration (FDA) had rejected its application for approval of its epinephrine injection device used to treat severe allergic reactions.

That news caused Adamis’ stock price to plummet more than 37 percent in after-market trading Friday, a trend that has continued Monday, where shares sit at $3.96 from a high of $7.07 a month ago.

Adamis announced Friday is got the news via a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for its lead product candidate, Epinephrine Pre-filled Syringe (PFS), for the emergency treatment of acute anaphylaxis (severe allergic reaction).

Adamis said in a statement that the FDA appeared to be mainly concerned with the amount of the dosage delivered by the two pre-filled syringes, and had not raised any concerns about safety, efficacy or cost. The company said the regulator would now meet with Adamis to discuss where the product might go from here, including possible modifications that could qualify it for approval.

"We are reviewing the CRL and plan to request a meeting with the FDA to discuss the letter, including clarifying the product delivery volume specifications,” said President and CEO Dr. Dennis J. Carlo in a statement.

“Although we expect to have more clarity with respect to timing, we believe we can satisfy all of the requests in the CRL and will work closely with the FDA to address the items raised in the CRL and finalize its review of our NDA. Adamis remains committed to bringing the epinephrine PFS to market."

Adamis is a specialty biopharmaceutical company focused on developing and commercializing respiratory disease, allergy, oncology and immunology products. The Epinephrine Injection PFS syringe product was it primary candidate, and was designed to be used in the emergency treatment of anaphylaxis.

Other candidates include APC-1000 and APC-5000 for the treatment of asthma and chronic obstructive pulmonary disease; and APC-3000, an HFA inhaled nasal steroid product for the treatment of allergic rhinitis. It has also has vaccine and cancer prospects TeloB-VAX, a cell-based therapeutic cancer vaccine, and three drugs, APC-100, APC-200, and APC-300, for the treatment of prostate cancer.