Radius Health Announces Commercial Agreement With Paladin Labs
Radius Health, Inc. recently announced it has entered into definitive agreements with Endo Ventures Limited, a subsidiary of Endo International plc 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 terms of the agreements, Paladin will pay Radius upfront and milestone payments up to approximately $8 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-US 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 US FDA 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.
Abaloparatide-TD was developed in a collaboration between Radius and Kindeva Drug Delivery (formerly 3M Drug Delivery Systems) with the application of Kindeva’s innovative microstructured transdermal patch technology. The Phase 3 wearABLe abaloparatide-TD study is the first pivotal study to evaluate treatment using a novel non-injectable delivery of an anabolic therapy. The wearABLe Phase 3 study is a pivotal, randomized, open label, active-controlled, bone mineral density (BMD) non-inferiority bridging study that will evaluate the efficacy and safety of abaloparatide-TD versus TYMLOS (abaloparatide) injection in approximately 500 patients with postmenopausal osteoporosis at high risk for fracture. The primary endpoint of the study is the percentage change in lumbar spine BMD at 12 months.
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. For more information, visit www.radiuspharm.com.
Endo is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from a global team of passionate employees collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. Paladin has a focused marketing and sales organization that has helped it evolve into one of Canada’s leading specialty pharmaceutical companies. Paladin is an operating company of Endo International plc. For more information visit: www.endo.com or www.paladin-labs.com.
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