Details:
Budesonide is a prescription corticosteroid medicine used to help get active, mild to moderate ulcerative colitis that extends from the rectum to the sigmoid colon under control (induce remission).
Lead Product(s): Budesonide
Therapeutic Area: Gastroenterology Product Name: Uceris-Generic
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2023
Details:
MOVANTIK is the leading Peripherally-Acting Mu-Receptor Opioid antagonist (PAMORA) indicated for the treatment of opioid induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer.
Lead Product(s): Naloxegol Oxalate
Therapeutic Area: Gastroenterology Product Name: Movantik
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: HCR
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 14, 2022
Details:
Analysis of Movantik effects on rapid and sustained improvement of both spontaneous and complete spontaneous bowel movements in the Movantik group vs. placebo were evaluated across high and low opioid dosages.
Lead Product(s): Naloxegol Oxalate
Therapeutic Area: Gastroenterology Product Name: Movantik
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2021
Details:
Under the terms of the settlement agreement, Apotex may not sell a generic version of Movantik in the U.S. until October 1, 2030 (subject to U.S. FDA approval) or earlier under certain circumstances.
Lead Product(s): Naloxegol Oxalate
Therapeutic Area: Gastroenterology Product Name: Movantik
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Apotex Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 22, 2021
Details:
Both analyses included pooled data from two large, robust, identically designed Phase 3 studies of Movantik (Kodiak 4 and Kodiak 5), involving 891 treated patients across two doses (12.5 mg and 25 mg), compared to a total of 546 patients in the placebo arms.
Lead Product(s): Naloxegol Oxalate
Therapeutic Area: Gastroenterology Product Name: Movantik
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2021