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Novartis, excited by strong Phase II data, is licensing its TQJ230 from Akcea Therapeutics, a treatment to reduce the risk of cardiovascular disease in people living with high levels of hereditary lipoprotein (a).
TQJ230, formerly known as AKCEA-APO (a) -LRx, was discovered by Ionis Pharmaceuticals and has been co-developed to date by Akcea and Ionis.
In one treat Novartis announced in January 2017 that it would work with Ionis to license and develop TQJ230 and another antisense treatment, AKCEA-APOCIII-LRX.
The agreement provided for an initial payment of $ 75 million and short-term payments of $ 225 million, including a $ 100 million investment from Novartis to Akcea.
The license follows Phase II results announced in November that in patients taking the highest dose of TQJ230, 20 mg once a week, 98% had their Lp (a) level fall below the recommended risk threshold.
Novartis is now responsible for the development and commercialization of this badet worldwide.
The company already markets Entresto (sacubitril + valsartan), a recently approved drug for the treatment of heart failure, and the drug for the treatment of diabetes Galvus (vildagliptin) through its cardiometabolic division, and plans to 39, expand its offer in this area.
Lp (a) is a lipoprotein that circulates in the blood. High levels of Lp (a) accumulate in the arteries, narrowing them gradually and limiting the blood supply to the heart, brain, kidneys and legs. This can lead to an increased risk of coronary heart disease, atherosclerosis, thrombosis and stroke.
It is estimated that 20 to 30% of people with CVD have high Lp (a) levels. There is currently no treatment specifically targeting high Lp (a), and changes in diet and other lifestyles are not effective in reducing high rates.
Novartis announced that it now plans to conduct a Phase 3 cardiovascular test to address the unmet need of the Lp (a) patient community for effective treatment.
"There is currently no treatment to significantly lower Lp (a)," said John Tsai, head of global drug development and Chief Medical Officer at Novartis.
"People with this inherited risk factor are facing cardiovascular risks that can not be managed effectively with lifestyle changes.
"We are excited about the novel, the RNA targeting approach that could change the game for people with high Lp (a). If our Phase 3 trial is successful, we expect the TQJ230 to become the treatment option of choice and another pillar of our long-standing commitment to rethink cardiovascular medicine. "
According to Ionis Cardiovascular Development Manager Dr. Sotirios Tsimikas, also director of vascular medicine at the University of California San Diego (UCSD), a drug that reduces Lp (a) could be a "paradigm shift" for the cardiovascular community.
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