Endo’s subsidiary Endo Ventures Limited is partnering with Taiwan Liposom, a clinical-stage specialty pharmaceutical company, to commercialize TLC599, an injectable compound in Phase 3 development for the treatment of osteoarthritis knee pain.
"TLC599 is fully aligned with our commitment to providing differentiated nonsurgical options to healthcare providers and their appropriate patients," said Patrick Barry, executive vice president and president, global commercial operations at Endo. "This investigational product is highly synergistic with our existing orthopedic commercial capabilities and complements our current on-market and in-development orthopedic-focused opportunities."
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"We are thrilled to be partnering with Endo once again," said George Yeh, president of TLC, a company that develops novel nanomedicines to target areas of unmet medical need. "Endo's proven capabilities in the orthopedic space complement TLC's expertise in developing novel nanomedicines, and together, we hope to deliver life-enhancing therapies to meet an unmet need with a large patient base."
Endo currently expects to launch the differentiated branded product in the United States in 2025.
Under the terms of the agreement, TLC will be responsible for the development of the product and EVL will be responsible for obtaining regulatory approval and commercialization of the product in the United States. Upon receipt of regulatory approval, Endo will have exclusive rights to manufacture, market, sell and distribute the product in the United States.
TLC will receive an upfront payment of $30 million and will be eligible to receive up to an additional $110 million based on the achievement of certain development, regulatory and manufacturing milestones related to the initial indication for the treatment of osteoarthritis knee pain. The company also will be eligible to receive payments based on the achievement of certain commercial milestones and royalties based on the product's net sales in the United States. Additionally, TLC will be eligible to receive certain milestone payments for potential future indications, the companies said.
The upfront payment of $30 million will be expensed in the second quarter as acquired in-process research and development. This expense was not reflected in Endo's second quarter 2022 financial guidance provided on May 5, 2022, as the transaction was signed after the date of the second quarter earnings release.