Swiss pharmaceutical giant Novartis has announced it has exercised the option to license its right to develop and commercialise TQJ230, a targeted cardiovascular (CV) therapy, from Akcea Therapeutics’ affiliate Ionis Pharmaceuticals.
This makes Novartis responsible for the global development and commercialisation of TQJ230. In return, Akcea will receive a $150m license fee to split equally with Ionis.
TQJ230 was previously known as AKCEO-APO(a)-LRx and was developed by the two companies using Ionis’ ligand conjugated antisense technology.
Novartis entered into an exclusive option agreement with Akcea and Ionis in January 2017 for two drugs being investigated for their ability to reduce CV risk in patients with elevated lipoprotein(a) (Lp(a)) levels; the other drug is known as AKCEA-APOCIII-LRx.
TQJ230 works by inhibiting the production of apolipoprotein(a) (Apo(a)), and so reducing Lp(a).
In a Phase II study, which was completed in December 2018, TQJ230 significantly reduced the levels of Lp(a) in patients with high Lp(a) and pre-existing CV disorders.
Akcea chief executive officer Paula Soteropoulos said: “We are very pleased that Novartis, an established global leader in drug development and commercialization, will now shepherd this landmark therapy through late-stage clinical development and toward the market.”
“The Phase 2 study results presented last year at AHA showed that AKCEA-APO(a)-LRx significantly reduced Lp(a) levels below the recognized threshold for cardiovascular risk in patients living with cardiovascular disease and elevated Lp(a) levels with a favourable safety and tolerability profile. AKCEA-APO(a)-LRx is the first and only medicine to do this.
Novartis plans to conduct a Phase II CV outcomes trial. The company’s chief medical officer and global drug development head John Tsai said: “No treatments are currently available to substantially lower Lp(a).
“People with this inherited risk factor are facing cardiovascular risks that cannot be addressed effectively with lifestyle changes.
“We’re excited about the novel, RNA-targeting approach that could be a game-changer for people with elevated Lp(a). If our Phase III trial succeeds, we expect that TQJ230 will become the leading treatment option and another pillar of our longstanding commitment to re-imagining cardiovascular medicine.”