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Specialised Therapeutics
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Level 2, 17 Cotham Road Kew, Victoria 3101
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Specialised Therapeutics will commercialise Ascendis' weekly injectable paediatric human growth hormone treatment SKYTROFA (lonapegsomatropin), hypoparathyroidism treatment YORVIPATH (palopegteriparatide) and investigational achondroplasia therapy TransCon CNP (navepegritide).


Lead Product(s): Lonapegsomatropin

Therapeutic Area: Endocrinology Product Name: Skytrofa

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Ascendis Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement January 07, 2024

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Under the terms of the arrangement, ST will be responsible for all commercial, medical, regulatory and distribution activities for oregovomab in its key territories of Australia, New Zealand, Singapore, Thailand, Vietnam, Brunei and Malaysia.


Lead Product(s): Oregovomab,Carboplatin,Paclitaxel

Therapeutic Area: Oncology Product Name: MAb-B43.13

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: CanariaBio

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement October 12, 2023

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Under the licensing agreement, ST will be responsible for all marketing, regulatory and distribution activities of TW001, a unique oral formulation of edaravone which works by reducing the oxidative damage associated with neuron death in ALS, in Australia and New Zealand.


Lead Product(s): Edaravone

Therapeutic Area: Neurology Product Name: TW001

Highest Development Status: Phase IIIProduct Type: Small molecule

Recipient: Treeway

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement August 28, 2023

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Monjuvi® and Minjuvi® (tafasitamab) is a humanized Fc-modified CD19 targeting immunotherapy used in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.


Lead Product(s): Tafasitamab,Lenalidomide

Therapeutic Area: Oncology Product Name: Minjuvi

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 28, 2023

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Yondelis (trabectedin) binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix triggering a cascade of events like DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death.


Lead Product(s): Trabectedin

Therapeutic Area: Oncology Product Name: Yondelis

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 17, 2023

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Qinlock (ripretinib) is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases, involved in GIST, by using a dual mechanism of action that regulates the kinase switch pocket and activation loop.


Lead Product(s): Ripretinib

Therapeutic Area: Oncology Product Name: Qinlock

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 20, 2023

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PEMAZYRE (pemigatinib) a FGFR inhibitor, is used for the treatment of adult patients with metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy.


Lead Product(s): Pemigatinib

Therapeutic Area: Oncology Product Name: Pemazyre

Highest Development Status: ApprovedProduct Type: Small molecule

Recipient: Incyte Corporation

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 15, 2022

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Under the terms of the agreement, Incyte will be responsible for the development, manufacture and supply of both products tafasitamab (sold as Monjuvi) and pemigatinib (Pemazyre) and ST will be responsible for regulatory, distribution and local marketing related activities.


Lead Product(s): Tafasitamab,Lenalidomide

Therapeutic Area: Oncology Product Name: Minjuvi

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Incyte Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement October 22, 2021

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ZEPZELCA® (lurbinectedin) is an alkylating drug that binds guanine residues within DNA. This triggers cascade of events that can affect activity of DNA binding proteins, including some transcription factors to treat 2L metastatic small cell lung cancer.


Lead Product(s): Lurbinectedin

Therapeutic Area: Oncology Product Name: Zepzelca

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: PharmaMar

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 22, 2021

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ZEPZELCA® (lurbinectedin) is the first new therapy approved to treat second-line metastatic SCLC in Australia in more than 20 years. ZEPZELCA approval granted under a provisional regulatory pathway.


Lead Product(s): Lurbinectedin

Therapeutic Area: Oncology Product Name: Zepzelca

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: PharmaMar

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 14, 2021

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