Acacia gets 2nd FDA rejection as manufacturing fault drags on

Acacia Pharma has suffered its second FDA rejection in seven months. The British drug developer moved quickly to bounce back from the complete response letter (CRL) it received in October, only to be hit with a second rejection after its contract manufacturer failed to resolve the problems.

After disclosing the first CRL for post-operative nausea and vomiting drug Barhemsys last year, Acacia continued to prepare to introduce the drug in the first half of 2019 in the belief the problems behind the rejection would be quick to resolve. Acacia told investors the issue was limited to one regulatory compliance deficiency at the third party that produces the active ingredient in Barhemsys, and that the FDA had no qualms with the quality of the drug or the R&D data included in the submission.

Within one month of the CRL, the contract manufacturer submitted a plan to fix the problem and Acacia refiled for FDA approval of Barhemsys. Shares in Acacia rose sharply in March and April in anticipation of the May 5 PDUFA decision.

Now, Acacia has received another CRL, sending its stock down 47% in early trading. FDA issued the second CRL after finding “continuing deficiencies at the contract manufacturer,” according to Acacia.

The failure of the contract manufacturer to resolve the problem has caused Acacia to lose patience. Acacia is now working to qualify an alternative supplier and will “engage with FDA as soon as possible to determine the most rapid route to obtaining approval,” CEO Julian Gilbert said in a statement.

Acacia’s active ingredient, amisulpride, has been used in the treatment of schizophrenia for years, over which time multiple companies have submitted Drug Master Files (DMF) covering the ingredient to the FDA. 

Only one company, Icrom, has an active DMF for amisulpride. Icrom submitted the second of its two amisulpride DMFs in July 2017. The FDA accepted the first Barhemsys New Drug Application in January 2018.

Acacia ended 2018 with £29.4 million ($38.2 million) in the bank.