Heron Therapeutics says timeline for Sustol resubmission delayed

US specialty pharma group Heron Therapeutics (Nasdaq: HRTX) saw its shares plunge after the company revealed an around  one-quarter delay to its timeline for the resubmission of the New Drug Application for Sustol, a long-acting formulation of granisetron, to the US Food and Drug Administration for chemotherapy-induced nausea and vomiting (CINV).

The company received notice last week from the supplier of the syringes used for Sustol injections that the production order of syringes manufactured for Heron, and scheduled to be used in the validation of the commercial manufacturing process for Sustol required for resubmission of the NDA, will be delayed due to equipment failure of an in-process quality control check. The equipment failure is not specific to Sustol or Heron, and remedial efforts are underway.

“The manufacturer of our syringe is a well-established global manufacturer of medical products and we are confident that the issue they have identified can and will be rectified within a quarter,” said Barry Quart, chief executive of Heron Therapeutics. “Although this delay is extremely frustrating for us, we are looking at every possible alternative to accelerate the timing of resubmission. We expect the delay in delivery of final syringes, which were planned for use in our commercial validation of Sustol and the impact on associated activities to result in an approximate one quarter delay in resubmission of the NDA for Sustol, which we had previously targeted for end of the first quarter of 2014,” he added.