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Details:
Under the terms of the agreement, Zydus will assume full responsibility for the clinical development and commercialization for leuprolide injectable in the US market, and Daewoong will be responsible for the pre-clinical studies, production and supply of the product.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Lupron Depot-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Zydus Lifesciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 12, 2023
Details:
Xtandi® (enzalutamide) is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. It decreased proliferation, tumor volume and induced cell death of prostate cancer cells.
Lead Product(s): Enzalutamide,Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Xtandi
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 September 12, 2023
Details:
Xtandi® (enzalutamide) is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. It decreased proliferation, tumor volume and induced cell death of prostate cancer cells.
Lead Product(s): Enzalutamide,Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Xtandi
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 August 23, 2023
Details:
Xtandi® (enzalutamide) is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. In combination with leuprolide it decreased proliferation, tumor volume and induced cell death of prostate cancer cells.
Lead Product(s): Enzalutamide,Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Xtandi
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 April 29, 2023
Details:
Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection. . It is supplied as lyophilized microspheres in a single dose vial as a kit with a prefilled syringe.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Leuprolide Acetate-Generic
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2022
Details:
Leuprolide acetate injection is a synthetic gonadotropin-releasing hormone that is indicated in the palliative treatment of advanced prostatic cancer.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Leuprolide Acetate
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2022
Details:
Ovarest® (leuprolide) is a gonadotropin-releasing hormone analogue that is used to treat endometriosis and uterine fibroids in women, prostate cancer in men, and central precocious puberty in boys and girls.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Ovarest
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
Oral administration of Ovarest (leuprolide) offers the potential to better address diseases in which gonadotropin-releasing hormone (GnRH) agonists are known to provide benefit and for which an oral format can improve patient compliance.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Ovarest
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: SWK Holdings
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2022
Details:
CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Camcevi
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Eversana
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 29, 2022
Details:
Through this partnership with Foresee on the launch of CAMCEVI, Accord BioPharma with razor sharp focus on specialty pharmaceuticals, which will go beyond biology to bring more access to high-quality medicines to patients across the U.S.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Camcevi
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Foresee Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership April 04, 2022
Details:
Throughout the transition, Sanofi Canada and Tolmar are collaborating fully to help ensure smooth transfer of the product and services for patients and healthcare providers, including the ELIGARD® Home Injection Program in place in Canada.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Eligard
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Sanofi
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 08, 2021
Details:
The Company's lead product, ELIGARD®, is a luteinizing hormone releasing hormone (LHRH) agonist indicated for the treatment of advanced prostate cancer.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Endocrinology Product Name: Eligard
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2021
Details:
The Scottish Medicines Consortium has accepted Takeda’s PROSTAP 3 DCS (leuprorelin acetate) treatment for use in patients with early and advanced breast cancer, which is the most common cancer in women globally.
Lead Product(s): Leuprolide Acetate,Tamoxifen Citrate
Therapeutic Area: Oncology Product Name: PROSTAP 3 DCS
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2021
Details:
Astellas Europe will return the in-licensing rights to “Eligard (leuprolide acetate for injectable suspension)” a treatment for advanced prostate cancer sold by Astellas Europe in Europe, the Middle East, the Commonwealth of Independent States (CIS)1 , and Asia, to Tolmar.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Eligard
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Astellas Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 01, 2021
Details:
Eligard® is a marketed medicinal product for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Eligard
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Tolmar
Deal Size: $168.6 million Upfront Cash: $42.1 million
Deal Type: Licensing Agreement January 29, 2021
Details:
The study evaluated 45-mg subcutaneous leuprolide acetate administered at a 6-month interval in 64 GnRHa-naïve children with CPP. Fensolvi effectively suppressed reproductive hormones and stopped or caused regression of pubertal progression.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Endocrinology Product Name: Fensolvi
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
Details:
Both companies collaborate to discover a long-acting injection pipeline, research dosage form, conduct pre-clinical and clinical studies, and build overseas partnerships.
Lead Product(s): Leuprolide Acetate
Therapeutic Area: Oncology Product Name: Luphere
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Daewoong Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 25, 2020
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