americanpharmaceuticalreviewJanuary 13, 2021
Tag: Radius Health , Paladin Labs , Abaloparatide , TYMLOS
Radius Health has entered into definitive agreements with Endo Ventures Limited, a subsidiary of Endo International, to register, commercialize, and distribute abaloparatide on an exclusive basis in Canada. Paladin Labs, an operating company of Endo, will be responsible for all commercial activities related to abaloparatide. Under the terms of the agreements, Paladin will pay Radius upfront and milestone payments up to approximately $8.0 million and tiered royalties up to the mid-twenties on net sales in Canada.
In accordance with the terms of the agreements, Paladin will license Radius’ abaloparatide subcutaneous injection, TYMLOS®, and abaloparatide novel transdermal device (abaloparatide-TD) for the Canadian market. Paladin will be responsible for the registration distribution, sales, marketing, medical affairs, pricing and reimbursement activities in connection with abaloparatide. Radius will be responsible for supplying the drug to Paladin.
“Reaching an agreement with Paladin in Canada demonstrates both the interest in and opportunity to expand the global footprint of abaloparatide in select ex-U.S. markets. This is one of several key priorities for us and our goal is to make additional progress throughout 2021,” said Cole Ikkala, Head of Business Development at Radius.
Paladin is targeting to file a New Drug Submission (NDS) to Health Canada for TYMLOS® by the first quarter of 2022. The Company will provide additional business updates as and when appropriate.
TYMLOS® (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
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