ADMP= MC $33 M / Cash $17 M / FDA Decision on OCT.
Post# of 85
ZIMHI (naloxone) Injection
On March 14, 2019, Adamis announced that the FDA had accepted the company’s New Drug Application (NDA) for review and provided a target agency action date (PDUFA) of October 31, 2019. The company believes that if approved, ZIMHI could be an important part of the solution to this growing health crisis of opioid overdose. The company is in discussions with several potential partners for ZIMHI with the goal of finalizing a commercial distribution agreement for the U.S. prior to a potential approval.
SYMJEPI (epinephrine) injection
Indication-Anaphylaxis
Addressable Market -$1.5 billion
Launched–January 2019
First products using patented, FDA-approved injection device
Both doses (0.3mg and 0.15mg) are FDA approved
Sandoz a division of Novartis –commercial partner in U.S.
Commercial deal terms –50% of net profits, upfront fee and potential performance-based milestone payments