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Annual Reports
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: ApprovedProduct 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: ApprovedProduct 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: ApprovedProduct 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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2021
Details:
The agreements secure high-quality manufacturing capacity of Movantik® for opioid-induced constipation and RHB-204, currently in a Phase 3 study for pulmonary NTM disease.
Lead Product(s): Naloxegol Oxalate
Therapeutic Area: Gastroenterology Product Name: Movantik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: RedHill Biopharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership February 18, 2021
Details:
RedHill Biopharma has gained the rights to Movantik (naloxegol)1 in Israel from AstraZeneca. RedHill now holds the worldwide rights to Movantik, excluding Europe and Canada. RedHill to evaluate partnering opportunities for commercialization of Movantik in Israel.
Lead Product(s): Naloxegol Oxalate
Therapeutic Area: Gastroenterology Product Name: Moventig
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: RedHill Biopharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 08, 2020
Details:
RedHill and Daiichi Sankyo replaced their co-commercialization agreement for Movantik® with a new royalty-bearing agreement, under which RedHill will maintain sole and exclusive responsibility for the commercialization of Movantik® in the U.S.
Lead Product(s): Naloxegol Oxalate
Therapeutic Area: Gastroenterology Product Name: Movantik
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: RedHill Biopharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 03, 2020
Details:
In 2015, AstraZeneca entered into a co-commercialisation agreement with Daiichi Sankyo, Inc. for Movantik in the US, which has now been transferred to RedHill.
Lead Product(s): Naloxegol Oxalate
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: RedHill Biopharma
Deal Size: $67.5 million Upfront Cash: $52.5 million
Deal Type: Divestment April 02, 2020