Pharmaceutical giant Allergan Plc is backing out of its deal with San Diego-based Adamis Pharmceuticals Corp. to commercialize the firm’s epinephrine pre-filled syringe for the treatment of life-threatening allergic reactions (anaphylaxis).
The deal was with Allergan’s business unit Watson Laboratories, which terminated its license agreement with Adamis on Thursday. The timing of Watson’s notice enables the company to avoid paying a non-refundable upfront fee and milestone payment.
Adamis has struggled to attain approval from the U.S. Food and Drug Administration for the syringe. Last month, the company received its second Complete Response Letter from the FDA due to insufficient human factors and reliability data. Adamis is working on the issues and expects to refile its New Drug Application later this year.
“I believe that today our pre-filled syringe represents a greater opportunity for the company than it did when we entered into the agreement with Watson,” said Adamis’ president and CEO Dennis Carlo in a statement. “Although Watson has chosen to terminate the license agreement, I view this as a good opportunity to further explore the wide range of strategic options that we believe currently exist in this ever improving market.”