Tags : Esperion

Otsuka Signs a Development and Commercialization Agreement with Esperion for

Shots: Esperion to receive $60M up front, $450M as development & commercial milestone and is eligible to receive 15-30% royalties in the sale of products in Japan. Otsuka will get exclusive rights to Nexletol and Nexlizet and will fund Japan-specific development costs associated with the products The collaboration leverages Esperion’s expertise in lipid management and […]Read More

Insights+: Novel Approvals of February 2020

The US FDA has approved multiple NDAs and BLAs in Feb 2020, leading to treatments for patients and advances in health care. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 13 novel products so far in 2020, including 10 in Feb and 3 in Jan […]Read More

PharmaShots Weekly Snapshot (February 24-28, 2020)

1. Companion Medical’s InPen Diabetes Management System Receives the US FDA’s Approval for Fixed Dosing and Meal Estimation Published: Feb 28, 2020 | Tags: Companion Medical, InPen Diabetes Management System, Receives, US, FDA, Approval, Fixed Dosing, Meal Estimation 2.  Takeda’s Vedolizumab SC Receives CHMP’s Positive Opinion as a Maintenance Therapy for Moderately to Severely Active […]Read More

Daiichi Signs an Exclusive License Agreement with Esperion, for $1.2B

Shots: Esperion to receive $150M upfront, $150M sales milestones and up to $900M regulatory milestones including royalties. Daiichi to get exclusive commercialization rights for Esperion’s bempedoic acid and bempedoic acid /ezetimibe drug in EU and Switzerland Esperion plans for the file NDA and MAA for bempedoic acid / ezetimibe to the US FDA and EMA […]Read More

Esperion Reports Completion of Bempedoic Acid in Global P-III LDL-C

Shots: The P-III development programs involves five studies assessing Bempedoic Acid (180 mg) (1,2,3,4 study) and bempedoic acid / ezetimibe combination pill vs PBO (053 study) in 4000 patients with ASCVD or HeFH Global P-III results: LDL-C lowering (18% to 31%); Reduction in hsCRP (19% to 33%); Reduction in HbA1c (0.19% to 0.31%); MACE 3/4 […]Read More

Esperion Reports Results of Bempedoic Acid in P-III Study 2

Shots: The P-III (1002-047) study involve assessing of Bempedoic Acid (180 mg qd) vs PBO in 779 patients in ratio 2:1 with ASCVD OR HeFH for 52 wks. P-III Study 2 or 1002-047 results: LDL-C lowering 18%; reduction in High-Sensitivity C-reactive protein (hsCRP) 19%; Reduction in Hemoglobin A1c (HbA1c) 0.21%; MACE events 3/4/5 component (2.7%, […]Read More