Novartis said Monday that it will exercise its option to license rights to Akcea Therapeutics' investigational antisense therapy TQJ230, formerly known as AKCEA-APO(a)-LRx, under a deal entered into in 2017. The drug, discovered by Akcea's affiliate company Ionis Pharmaceuticals, is being developed to reduce risk of cardiovascular disease in people living with elevated levels of inherited lipoprotein(a).
John Tsai, head of global drug development at Novartis, remarked "no treatments are currently available to substantially lower Lp(a)," adding "we're excited about the novel, RNA-targeting approach that could be a game-changer for people with elevated Lp(a)." Assuming the company can eventually secure regulatory approvals for TQJ230, Tsai suggested the therapy could be launched by around 2024, but "I'll be pushing the teams aggressively to see if we can't accelerate that timeline." He also indicated that while the initial market would be for high-risk patients who have already had a previous cardiovascular event, "down the road, there would be opportunities to think about whether we would go into the primary prevention population."
Results from a Phase II study presented last year at the American Heart Association (AHA) scientific sessions showed that TQJ230 significantly reduced Lp(a) in patients with high Lp(a) and pre-existing cardiovascular disease. Having exercised its option, Novartis will be responsible for worldwide development and commercialisation of TQJ230, with the company indicating that it plans to conduct a Phase III cardiovascular outcomes trial of the therapy "with the potential of addressing the Lp(a) patient community's unmet need for effective treatment."
Akcea noted that under its agreement with the Swiss drugmaker, it will receive a $150-million license fee that will be split equally with Ionis. Under the original deal, Novartishad made a $75-million upfront option payment and a $100-million equity investment in Ionis. At the time, Ionis noted that along with the license fee for TQJ230, it was eligible to receive development and regulatory milestone payments of $315 million, as well as commercialisation milestone payments of up to $285 million.
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