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Details:
Lybrido is a novel combination tablet, consisting of a testosterone coating for sublingual administration and an inner-core component containing the PDE-5 inhibitor, sildenafil that used for the treatment of Female Sexual Interest/Arousal Disorder (FSIAD).
Lead Product(s): Sildenafil Citrate,Testosterone
Therapeutic Area: Psychiatry/Psychology Product Name: Lybrido
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 19, 2023
Details:
Under the terms of the agreement, Verity Pharma will promote NATESTO across the island of Puerto Rico, leveraging its existing commercial footprint and health care network. Acerus will maintain control of distribution, market access, and regulatory activities on the island of Puerto Rico.
Lead Product(s): Testosterone
Therapeutic Area: Endocrinology Product Name: Natesto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Acerus Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 10, 2022
Details:
Freya Pharma has been established to further advance two compounds for the FSIAD-disorder, Lybrydo and Lybrydos, that have shown clinical and statistical relevance in an earlier phase 2b clinical trial, clearly meeting the primary endpoints.
Lead Product(s): Sildenafil Citrate,Testosterone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Lybrido
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Emotional Brain BV
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 17, 2021
Details:
Testosterone topical solution USP, 30 mg per pump actuation is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism and hypogonadotropic hypogonadism.
Lead Product(s): Testosterone
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2021
Details:
CLAR-121 is a proprietary combination of testosterone (T) (natural ligand for the androgen receptor; AR) and anastrozole (inhibitor of T conversion to estradiol) delivered by a subcutaneous implant for treatment of AR-mediated breast disease that predominantly affects women.
Lead Product(s): Testosterone,Anastrozole
Therapeutic Area: Immunology Product Name: CLAR-121
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Clarus Therapeutics
Deal Size: $11.2 million Upfront Cash: $0.5 million
Deal Type: Licensing Agreement May 25, 2021
Details:
Under the terms of the agreement, Amneal will sell NATESTO, Testosterone Nasal gel to the company’s existing Endocrinology targets through June 30, 2024.
Lead Product(s): Testosterone
Therapeutic Area: Endocrinology Product Name: Natesto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Acerus Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 10, 2021
Details:
Acerus will acquire all remaining rights to Natesto in the United States from Aytu. Acerus will assume all product responsibilities associated with Natesto.
Lead Product(s): Testosterone
Therapeutic Area: Endocrinology Product Name: Natesto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Acerus Pharmaceuticals
Deal Size: $7.5 million Upfront Cash: $7.5 million
Deal Type: Divestment April 01, 2021
Details:
Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its ANDA for its abbreviated new drug application (ANDA) for Testosterone Gel, 1.62%, Alembic Pharmaceuticals said in a regulatory filing.
Lead Product(s): Testosterone
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2021
Details:
Testosterone gel, 1.62% (20.25 mg/1.25 gm actuation) is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism and Hypogonadotropic hypogonadism.
Lead Product(s): Testosterone
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 25, 2020
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