A clinical stage pharma company specializing in developing nanomedicines will receive $30 million in exchange for rights to an injectable treatment for osteoarthritis (OA).
In one of the largest deals in Taiwan’s biotech sector, TLC Biosciences will receive the upfront payment with potential to earn a further $110m if the treatment targeting knee pain is a success.
The funds will come from Endo International plc for the rights in the US to TLC599, a proprietary BioSeizer sustained release injectable, which is in phase 3 development.
TLC599 is an extended and controlled release liposomal formulated dexamethasone, which means the active drug is contained within small fat particles, making it easier to absorb for chronic knee OA pain.
Knee osteoarthritis
OA is the most common joint disorder in the U.S. Symptomatic knee OA occurs in 10% of men and 13% of women aged 60 years or older. The number of people affected with symptomatic OA is likely to increase due to the aging of the population and the obesity epidemic.
Toxic side-effects
Single and repeated doses of existing intraarticular anti-inflammatory treatments for OA have potentially toxic side effects, and may lead to the destruction of cartilage filler proteins.
Blaise Coleman, president, and CEO, at Endo said: “We see tremendous opportunity in TLC599 to potentially address an unmet medical need in patients with osteoarthritis arthritis knee pain. If approved, we expect to launch this differentiated branded product in 2025.”
Under the terms of the agreement, signed with Endo’s subsidiary Endo Ventures Limited (EVL), TLC will develop the product and EVL will primarily be responsible for obtaining regulatory approval and commercialization of the product in the U.S.
Upon receipt of regulatory approval, Endo will have exclusive rights to manufacture, market, sell and distribute the product in the U.S.
Treatment milestones
The additional $110m will be paid based on the achievement of certain development, regulatory, and manufacturing milestones related to the initial indication for the treatment of osteoarthritis knee pain.
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 U.S. Additionally, TLC will be eligible to receive certain milestone payments for potential future indications.
George Yeh, president of TLC said: “We are thrilled to be partnering with Endo whose proven capabilities in the orthopedic space complement TLC’s expertise in developing novel nanomedicines. Together, we hope to deliver life-enhancing therapies to meet an unmet need with a large patient base.”
Other treatments
In 2019, researchers at the University of Twente, in the Netherlands, devised a potential treatment based on tissue engineering. The group intended to inject hydrogels into the joint to help to stabilize it and stop it from deteriorating. The hydrogels are also able to encourage new cartilage cells to grow and mend the joint.
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