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Details:
Under the agreement, Amgen will develop, manufacture, and commercialize a subcutaneous formulation of Tepezza (teprotumumab) using Xeris’ XeriJect® technology in Thyroid Eye Disease (TED).
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: $75.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 10, 2024
Details:
The acquisition strenghens Amgen pipeline for rare, autoimmune and severe inflammatory diseases by gaining Horizon’s first-in-class medicines like Tepezza (teprotumumab-trbw), Krystexxa (pegloticase) And Uplizna (inebilizumab-cdon).
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: $2,780.0 million Upfront Cash: $2,780.0 million
Deal Type: Acquisition October 06, 2023
Details:
Tepezza (teprotumumab-trbw), an insulin-like growth factor-1 receptor inhibitor, is being developed for the treatment of active thyroid eye disease (TED) in Japan. TEPEZZA is approved by the U.S. FDA as the first and only medicine for TED.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 26, 2023
Details:
Tepezza (teprotumumab-trbw), an insulin-like growth factor-1 receptor inhibitor, is being developed for the treatment of active thyroid eye disease (TED) in Japan. TEPEZZA is approved by the U.S. FDA as the first and only medicine for TED.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2023
Details:
Tepezza (teprotumumab-trbw) binds to IGF-1R and blocks its activation and signaling. It is approved by FDA for the treatment of patients with thyroid eye disease.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2023
Details:
Tepezza (teprotumumab-trbw) binds to IGF-1R and blocks its activation and signaling. It is approved by FDA for the treatment of patients with thyroid eye disease.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2023
Details:
Tepezza (teprotumumab-trbw) binds to insulin-like growth factor-1 receptor (IGF-1R) and blocks its activation and signaling. It is being investigated in patients with thyroid eye disease.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 10, 2023
Details:
The acquisition will enable Amgen to strengthens the potential of new medicines in Horizon’s pipeline for rare, autoimmune and severe inflammatory diseases and Horizon’s first-in-class medicines like TEPEZZA, KRYSTEXXA and UPLIZNA.
Lead Product(s): Teprotumumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: $27,800.0 million Upfront Cash: $27,800.0 million
Deal Type: Acquisition December 12, 2022
Details:
Eprotumumab is the first and only medicine approved by the U.S. FDA for the treatment of Thyroid Eye Disease (TED) – a serious, progressive and potentially vision-threatening rare autoimmune disease. Teprotumumab-trbw is known as TEPEZZA® in the United States.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Horizon Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration November 23, 2022
Details:
TEPEZZA (teprotumumab-trbw), the first and only FDA-approved treatment specifically for TED, works at the source of the disease,has been shown to be effective in patients with a wide range of clinical manifestations.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2022
Details:
TEPEZZA (teprotumumab-trbw) is indicated for the treatment of Thyroid Eye Disease. TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2022
Details:
TEPEZZA® (teprotumumab-trbw), a monoclonal antibody against insulin-like growth factor-1 receptor (IGF-1R) used in patients with moderate-to-severe active TED.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2022
Details:
Results of the clinical development program demonstrated TEPEZZA (teprotumumab-trbw) markedly improves symptoms of TED, including proptosis and diplopia.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2022
Details:
TEPEZZA (teprotumumab-trbw) reduces eye bulging and double vision. It also improves the signs and symptoms of Thyroid Eye Disease (TED), including eye pain, redness, and swelling. TEPEZZA is a prescription medicine used to treat TED.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
The OPTIC-J trial will evaluate efficacy, tolerability, and safety of teprotumumab, a fully human mAb and a targeted inhibitor of the IGF-1R in the treatment of patients in Japan with moderate-to-severe active TED. Teprotumumab is marketed under brand name TEPEZZA in US.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2022
Details:
Tepezza, (teprotumumab-trbw) first medicine approved by FDA for treatment of TED, among thousands of patients included in this 19-month new post-marketing Safety analysis, approximately 10% of all cases reported to safety database have included a hearing-related event.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2022
Details:
The analysis found that over 90% (n=995) of people who were prescribed TEPEZZA for TED went on to complete all eight infusions, indicating a high level of adherence to TEPEZZA in clinical practice.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2021
Details:
Teprotumumab (TPT) is a type I insulin-like growth factor receptor inhibitor reduces eye bulging and double vision. It also improves the signs and symptoms of Thyroid Eye Disease (TED), including eye pain, redness, and swelling.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2021
Details:
This randomized, double-masked, placebo-controlled, parallel-group, multicenter trial will evaluate the efficacy, safety and tolerability of TEPEZZA compared to placebo in treating patients with chronic TED.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2021
Details:
The facility, which is located in an IDA Ireland business park, includes a filling line and lyophiliser, or freeze dryer, that can be used for both Horizon’s commercial medicines, including its rare disease biologics TEPEZZA, KRYSTEXXA and UPLIZNA and development compounds.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Horizon Therapeutics
Deal Size: $65.0 million Upfront Cash: $65.0 million
Deal Type: Acquisition June 17, 2021
Details:
For patients in the follow-up period with data available at 51 weeks after the last dose of TEPEZZA, 67 percent had a proptosis response, 69 percent had a diplopia response and 83 percent had an ophthalmic composite outcome response.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2021
Details:
Horizon intends to use ENHANZE® to develop a SC formulation of TEPEZZA (teprotumumab-trbw), indicated for the treatment of Thyroid Eye Disease.
Lead Product(s): Teprotumumab,rHuPH20
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Horizon Therapeutics
Deal Size: $190.0 million Upfront Cash: $30.0 million
Deal Type: Collaboration November 23, 2020
Details:
Horizon’s TEPEZZA® (teprotumumab-trbw) treatment will be produced from AGC Biologics’ new facility in Boulder. The facility is well equipped for the production of TEPEZZA. Following approval, it is expected that the facility will produce the majority of the TEPEZZA supply.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Horizon Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 29, 2020
Details:
OPTIC-X results demonstrate that 89 percent of patients who received placebo during OPTIC and then entered OPTIC-X and received TEPEZZA achieved the primary endpoint of 2 mm or more reduction in proptosis at Week 24.
Lead Product(s): Teprotumumab
Therapeutic Area: Immunology Product Name: Tepezza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2020
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