The compound may be investigated in the future for additional potential indications. EXCELLENCE, a pivotal Phase III clinical trial to evaluate the efficacy and safety of both single and repeated doses of TLC599, is nearing completion, with the last patient's last visit having taken place in January 2022. No serious or unexpected treatment related adverse events were reported, and most of the treatment related adverse events were mild to moderate in severity. Over half of the patients in the TLC599 group had a durable response, maintaining at least 30% pain reduction in both WOMAC and VAS pain scores at all visits through the 24 weeks. In a Phase II clinical trial, a single injection of TLC599 resulted in statistically significant and clinically meaningful improvement in WOMAC Pain and Function Subscales, and VAS Pain scores over placebo at 12, 16 and 24 weeks. Preclinical toxicity studies showed no marked cartilage damage after single and multiple doses of TLC599 when compared to current treatments. Single and repeated doses of current intraarticular anti-inflammatory treatments for OA have potentially toxic side effects and may lead to the destruction of cartilage filler proteins. TLC 599 is an extended and controlled release liposomal formulated dexamethasone for chronic knee osteoarthritis (OA) pain. 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 as the transaction was signed after the date of the second quarter earnings release. TLC 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. 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. Upon receipt of regulatory approval, Endo will have exclusive rights to manufacture, market, sell and distribute the product in the United States. Under the terms of the agreement, TLC will primarily be responsible for the development of the product and EVL will primarily be responsible for obtaining regulatory approval and commercialization of the product in the United States. "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."Įndo currently expects to launch the differentiated branded product in the United States in 2025. "We are thrilled to be partnering with Endo once again," said George Yeh, President of TLC. "This investigational product is highly synergistic with our existing orthopedic commercial capabilities and complements our current on-market and in-development orthopedic-focused opportunities." "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.
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