Endo Announces Licensing Agreement for Paladin Labs Inc. to Commercialize Abaloparatide in Canada

IndustryPRwire - Endo International announced that its subsidiary Endo Ventures Limited has entered into definitive agreements with Radius Health, Inc. (NASDAQ: RDUS) to register, commercialize and distribute abaloparatide on an exclusive basis in Canada. Paladin Labs Inc., an operating company of Endo, will be responsible for all commercial activities related to abaloparatide. Under the agreement, Endo obtained the rights to abaloparatide-subcutaneous injection (abaloparatide-SC) and abaloparatide-transdermal patch (abaloparatide-TD), a novel formulation and route of administration currently undergoing clinical development. 

Abaloparatide is a parathyroid hormone-related protein (PTHrP) analog under investigation for osteoporosis; it is not approved in Canada.  Abaloparatide is an anabolic (bone-forming) agent self-administered once daily. Paladin plans to file a New Drug Submission (NDS) with Health Canada for abaloparatide-SC by the first quarter of 2022.

In accordance with the terms of the agreements, if abaloparatide is approved in Canada, Paladin will be responsible for the registration, distribution, sales, marketing, medical affairs, pricing and reimbursement activities in connection with commercialization while Radius will be responsible for supplying the drug to Paladin.

"We are very pleased to work with Radius to possibly bring a new treatment option to the market for Canadian osteoporosis patients," said Livio Di Francesco, Vice President and General Manager of Paladin. "This transaction marks our entry into the endocrine and metabolic therapeutic space.  Abaloparatide has shown promising clinical evidence to address an unmet need and it has the potential to become a very important addition to our existing Canadian portfolio."

About Abaloparatide:

Abaloparatide is a PTH-1 selective parathyroid hormone-related protein (PTHrP) analog used to treat osteoporosis. In May 2017, the U.S. Food and Drug Administration approved abaloparatide-SC, marketed under the trade name TYMLOS®, 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. This product is not approved in Canada. In 2019, Radius initiated the wearABLe study, a Phase III clinical trial comparing the safety and efficacy of abaloparatide-TD to abaloparatide-SC. The wearABLe study reached full enrollment in September 2020 and top line results are expected in the fourth quarter of 2021.

About Osteoporosis:

Osteoporosis is a progressive metabolic bone disorder characterized by compromised bone mineral density (BMD) and bone quality, predisposing to an increased risk of fracture. The World Health Organization defines the diagnostic threshold for osteoporosis as BMD measurement 2.5 standard deviations or more below the mean of a young, healthy reference group. Osteoporosis affects primarily women over the age of 50; the rapid decrease in estrogen that follows menopause is one major cause. In more severe cases, osteoporosis can cause recurring fractures of the spine, upper limbs and hip, which are in turn associated with significant morbidity and mortality.

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