Hubei Gedian Humanwell Pharmaceutical Testosterone Hubei Gedian Humanwell Pharmaceutical Testosterone

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[{"orgOrder":0,"company":"Aytu BioPharma","sponsor":"Acerus Pharmaceuticals","pharmaFlowCategory":"D","amount":"$7.5 million","upfrontCash":"$7.5 million","newsHeadline":"Aytu BioPharma Divests U.S. Rights to Natesto(R) to Acerus Pharma","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Amneal Pharmaceuticals","sponsor":"Acerus Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Acerus Pharmaceuticals Announces Co-Promotion Agreement with Amneal Pharmaceuticals for NATESTO\u00ae","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"HavaH Therapeutics","sponsor":"Clarus Therapeutics","pharmaFlowCategory":"D","amount":"$11.2 million","upfrontCash":"$0.5 million","newsHeadline":"Clarus Therapeutics and HavaH Therapeutics Announce Licensing Agreement","therapeuticArea":"Immunology","highestDevelopmentStatus":"Undisclosed","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Aleor Dermaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aleor Dermaceuticals Receives USFDA Tentative Approval for Testosterone Gel, 1.62% (20.25 mg\/1.25 gm actuation).","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Alembic Pharmaceuticals Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Alembic Pharma's JV Aleor Dermaceuticals Gets American Regulator Nod for Testosterone Gel","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Freya Pharma","sponsor":"Emotional Brain BV","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Freya Pharma Solutions to Acquire All IP From Emotional Brain, Giving Opportunities to Further Examine Pharmaceutical Therapies for Female Sexual Interest\/Arousal Disorder in A Double Blind, Randomized Phase 3 Trial","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase II","country":"NETHERLANDS","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase II"},{"orgOrder":0,"company":"Verity Pharmaceuticals Inc","sponsor":"Acerus Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Acerus Pharmaceuticals Announces Commercial Agreement With Verity Pharmaceuticals for the Promotion of NATESTO\u00ae in Puerto Rico","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Alembic Pharmaceuticals Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aleor Dermaceuticals Receives USFDA Final Approval for Testosterone Topical Solution USP, 30 mg Per Pump Actuation","therapeuticArea":"Endocrinology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Endocrinology","graph2":"Approved"},{"orgOrder":0,"company":"Freya Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Freya Pharma Solutions Announces Response from the FDA on its US Clinical Development Program of LybridoTM for the treatment of Female Sexual Interest\/Arousal Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"NETHERLANDS","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"}]

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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 III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 19, 2023

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Acerus Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement January 10, 2022

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            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 II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Emotional Brain BV

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition December 17, 2021

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 16, 2021

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            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: Undisclosed Product 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

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Acerus Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement May 10, 2021

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Acerus Pharmaceuticals

            Deal Size: $7.5 million Upfront Cash: $7.5 million

            Deal Type: Divestment April 01, 2021

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 04, 2021

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            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: Approved Product 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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