*APD371
-Favorable results were reported in April from a Phase 1b multiple-ascending dose clinical trial of APD371, a highly selective and full agonist of the cannabinoid 2 (CB2) receptor.
-APD371 will next be evaluated in a Phase 2 clinical trial for the treatment of pain associated with Crohn's disease. The Company anticipates initiating the trial in early 2017.
*Favorable results were reported in April from a Phase 1b multiple-ascending dose clinical trial of APD371, a highly selective and full agonist of the cannabinoid 2 (CB2) receptor.
*APD371 will next be evaluated in a Phase 2 clinical trial for the treatment of pain associated with Crohn's disease. The Company anticipates initiating the trial in early 2017.
*Ralinepag (APD811)
-Ralinepag is currently being evaluated in a Phase 2 clinical trial for pulmonary arterial hypertension (PAH).
-The Company expects Phase 2 data mid-year 2017.
*Ralinepag is currently being evaluated in a Phase 2 clinical trial for pulmonary arterial hypertension (PAH).
*The Company expects Phase 2 data mid-year 2017.
Collaborations Update
*Eisai, Ltd. and Eisai Inc.
-In connection with two regulatory approvals subsequent to the second quarter, Arena will receive $11.0 million in milestone payments from Eisai:
-On July 14, we announced the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) approved lorcaserin HCl in Mexico. The product will be sold under the brand name VENESPRI®.
-On July 19, we announced the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for BELVIQ XR® (lorcaserin HCl) CIV extended-release 20 mg tablets.
Corporate Update
*Kevin R. Lind appointed as Executive Vice President and Chief Financial Officer, effective June 15, 2016.
*U.S. workforce reduction announced, primarily in the areas of discovery research, manufacturing and administrative functions to focus the
organization on its proprietary clinical pipeline.
The Company estimates a reduced annualized cash
expenditure of approximately $23-$25 million. In July, the
Company also reduced the workforce in Arena GmbH,
primarily in the areas of manufacturing and G&A. The
Company estimates this will result in an additional reduced
annual cash expenditure of approximately $2.1 million.
62