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[{"company":"Daiichi Sankyo","sponsor":"American Regent","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"American Regent, Inc. to Acquire a Daiichi Sankyo Affiliate API Manufacturing Facility","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Daiichi Sankyo"},{"company":"Chugai Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chugai's Osteoporosis Agent Edirol Obtains Regulatory Approval in China","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Chugai Pharmaceutical"},{"company":"Taisho Pharmaceutical","sponsor":"Chugai Pharmaceutical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Chugai Pharma, Taisho Pharma Terminate Co-Marketing Agreement for Edirol to Treat Osteoporosis","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Taisho Pharmaceutical"},{"company":"Fuji Yakuhin","sponsor":"Fortress Biotech","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Fortress Biotech Announces Exclusive License Agreement With Fuji Yakuhin to Develop Dotinurad in North America and Europe","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Fuji Yakuhin"},{"company":"Chugai Pharmaceutical","sponsor":"Towa Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Chugai Obtains Regulatory Approval for Osteoporosis Treatment Edirol Tablet","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Chugai Pharmaceutical"},{"company":"Kyowa Kirin","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kyowa Kirin Receives European Commission Approval for Use of CRYSVITA\u00ae (burosumab) for the Treatment of Tumour-Induced Osteomalacia (TIO)","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Kyowa Kirin"}]

Kyowa Kirin

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Kyowa Kirin Receives European Commission Approval for Use of CRYSVITA® (burosumab) for the Treatment of Tumour-Induced Osteomalacia (TIO)

Details:

CRYSVITA (burosumab) is a recombinant fully human monoclonal antibody that binds to and inhibits the activity of FGF23.2 CRYSVITA blocks the action of FGF23, which is produced in excess in TIO, restoring phosphate homeostasis.

Lead Product(s): Burosumab

Therapeutic Area: Musculoskeletal Product Name: Crysvita

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 19, 2022

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Chugai Pharmaceutical

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Chugai Obtains Regulatory Approval for Osteoporosis Treatment Edirol Tablet

Details:

Edirol (eldecalcitol), is an active vitamin D3 derivative created based on Chugai’s long-standing vitamin D research. Chugai takes responsibilities as a holder of the approval, Towa will be responsible for marketing and providing information on use of Edirol.

Lead Product(s): Eldecalcitol

Therapeutic Area: Musculoskeletal Product Name: Edirol

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Towa Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 15, 2022

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Fuji Yakuhin

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Fortress Biotech Announces Exclusive License Agreement With Fuji Yakuhin to Develop Dotinurad in North America and Europe

Details:

Dotinurad is a potential best-in-class urate transporter (URAT1) inhibitor that was approved for the treatment of gout and hyperuricemia in Japan in 2020.

Lead Product(s): Dotinurad

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Fortress Biotech

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement May 10, 2021

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Taisho Pharmaceutical

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Chugai Pharma, Taisho Pharma Terminate Co-Marketing Agreement for Edirol to Treat Osteoporosis

Details:

Chugai Pharmaceutical and Taisho Pharmaceutical announced termination of the agreement between both companies regarding co-marketing of Edirol® Capsules 0.5 µg and 0.75 µg, a treatment for osteoporosis for which Chugai has a marketing authorization.

Lead Product(s): Eldecalcitol

Therapeutic Area: Musculoskeletal Product Name: Edirol

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Chugai Pharmaceutical

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Termination January 22, 2021

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Chugai Pharmaceutical

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Chugai's Osteoporosis Agent Edirol Obtains Regulatory Approval in China

Details:

Chugai has obtained regulatory approval for eldecalcitol (product name: Edirol®), an active vitamin D3 derivative created by Chugai from the China National Medical Products Administration (NMPA).

Lead Product(s): Eldecalcitol

Therapeutic Area: Musculoskeletal Product Name: Edirol

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 December 18, 2020

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Daiichi Sankyo

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American Regent, Inc. to Acquire a Daiichi Sankyo Affiliate API Manufacturing Facility

Details:

The facility, previously owned by Daiichi Sankyo Europe, an affiliate of American Regent, produces the API for Adequan®i.m. and Adequan® Canine.

Lead Product(s): Polysulfated glycosaminoglycan

Therapeutic Area: Musculoskeletal Product Name: Undisclosed

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: American Regent

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition April 01, 2020

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