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WINLEVI (clascoterone) cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Lead Product(s): Clascoterone
Therapeutic Area: Dermatology Product Name: Winlevi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hyphens Pharma
Deal Size: $5.0 million Upfront Cash: $1.0 million
Deal Type: Licensing Agreement December 21, 2022
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:
New agreement further expands manufacturing capacity for orally-administered opaganib following positive top-line data from its Phase 2 COVID-19 study, progress with the ongoing global Phase 2/3 study, and amid the urgent need to address emerging viral strains.
Lead Product(s): Opaganib
Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: RedHill Biopharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 28, 2021
Details:
The trial investigated the efficacy and safety of two doses of Rifamycin SV-MMX 600mg against placebo after a 2-week course of treatment followed by a 3 months follow-up.
Lead Product(s): Rifamycin
Therapeutic Area: Gastroenterology Product Name: Aemcolo
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: RedHill Biopharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2021
Details:
Under the Investment Agreement, Cosmo would have become eligible to receive a €5 million payment from the Company payable in new ordinary shares in the Company conditional upon the first commercial sale of the BYFAVO™ product in the United States.
Lead Product(s): Remimazolam Besylate
Therapeutic Area: Neurology Product Name: Byfavo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Acacia Pharma
Deal Size: $45.0 million Upfront Cash: Undisclosed
Deal Type: Agreement December 15, 2020
Details:
The Company plans to deploy this capital to support its ongoing US launches of BARHEMSYS® (amisulpride injection) for postoperative nausea & vomiting and BYFAVO™ (remimazolam for injection) for procedural sedation.
Lead Product(s): Amisulpride
Therapeutic Area: Gastroenterology Product Name: Barhemsys
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Acacia Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing October 09, 2020
Details:
Winlevi (clascoterone cream 1%) is approved for the treatment of acne vulgaris in people aged 12 and older. In pivotal clinical trials, WINLEVI demonstrated treatment success and reductions in acne lesions and was well tolerated when used twice a day.
Lead Product(s): Clascoterone
Therapeutic Area: Dermatology Product Name: Winlevi
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: Cassiopea
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2020
Details:
Pursuant to the agreement, the companies will co-develop a novel next-generation therapy for the eradication of H. pylori infection. Cosmo is to receive the exclusive European rights to the new drug.
Lead Product(s): Omeprazole Magnesium,Amoxicillin Trihydrate,Rifabutin
Therapeutic Area: Infections and Infectious Diseases Product Name: Talicia
Highest Development Status: ApprovedProduct Type: Small molecule
Recipient: RedHill Biopharma
Deal Size: $21.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 13, 2020
Details:
Acacia Pharma has been assigned the US license to BYFAVO™ (remimazolam) for injection by Cosmo Pharmaceuticals NV. BYFAVO for injection is a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures lasting 30 minutes or less.
Lead Product(s): Remimazolam Besylate
Therapeutic Area: Neurology Product Name: Byfavo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Acacia Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 15, 2020
Details:
The US Food and Drug Administration (FDA) has approved BYFAVO™ (remimazolam injection) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
Lead Product(s): Remimazolam Besylate
Therapeutic Area: Neurology Product Name: Byfavo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 02, 2020
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