• Novartis announced today that it is exercising its option to license the rights to develop and commercialize TQJ230, an investigational agent previously known as AKCEA-APO(a)-LRx, from Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, for targeted cardiovascular therapy   
  • Novartis is now responsible for worldwide development and commercialization of TQJ230 
  • Millions of people have elevated lipoprotein(a) (Lp(a)), an independent inherited cardiovascular disease (CVD) risk factor that cannot be effectively addressed by diet and other lifestyle changes 
  • If approved TQJ230 could be first in class treatment specifically targeting elevated Lp(a) 

BASEL, Switzerland I February 25, 2019 I Novartis announced today that it is exercising its option to license the rights to develop and commercialize TQJ230, an investigational agent previously known as AKCEA-APO(a)-LRx, from Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, for targeted cardiovascular therapy. TQJ230 was discovered by Ionis and has been co-developed to date by Akcea and Ionis. Novartis is now responsible for worldwide development and commercialization of this asset.

Millions of people have elevated Lp(a), an independent inherited cardiovascular disease (CVD) risk factor. It is estimated that 20-30% of people who suffer from CVD have elevated Lp(a).[1],[2] Currently no treatment exists that specifically targets elevated Lp(a), and diet and other lifestyle changes are also not effective at reducing elevated levels.[3] Results of a Phase 2 study presented at AHA in November 2018 showed that TQJ230 significantly reduced Lp(a) in patients with high Lp(a) and pre-existing CVD.[4] Novartis plans to conduct a Phase 3 cardiovascular outcomes trial with the potential of addressing the Lp(a) patient community’s unmet need for effective treatment.

“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,” said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis. “We’re excited about the novel, RNA-targeting approach that could be a game-changer for people with elevated Lp(a). If our Phase 3 trial succeeds, we expect that TQJ230 will become the leading treatment option and another pillar of our longstanding commitment to re-imagining cardiovascular medicine.”

About Lipoprotein(a) (Lp(a))
Lp(a) is a lipoprotein that travels through the blood. Elevated levels of Lp(a) collect in the arteries, gradually narrowing the arteries and limiting blood supply to the heart, brain, kidneys and legs. This can lead to increased risk of coronary heart disease, atherosclerosis, thrombosis and stroke. Additional information is available through Lipoprotein Foundation at www.lipoproteinafoundation.org.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 130 000 people of nearly 150 nationalities work at Novartis around the world. Find out more at www.novartis.com.

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References:
[1]   Buuren, F. V., Horstkotte, D., Knabbe, C., Hinse, D., & Mellwig, K. P. (2017). Incidence of elevated lipoprotein (a) levels in a large cohort of patients with cardiovascular disease. Clinical Research in Cardiology Supplements, 12(S1), 55-59. doi:10.1007/s11789-017-0087-y
[2]   Varvel, S., Mcconnell, J. P., & Tsimikas, S. (2016). Prevalence of Elevated Lp(a) Mass Levels and Patient Thresholds in 532 359 Patients in the United States. Arteriosclerosis, Thrombosis, and Vascular Biology, 36(11), 2239-2245. doi:10.1161/atvbaha.116.308011
[3]   Tsimikas, S. (2017). A Test in Context: Lipoprotein(a). Journal of The American Cardiology, 69(6), 692-711.
[4]   Tsimikas et al. (2018). Late-breaking clinical trial presentation at the American Heart Association Scientific Sessions.

SOURCE: Novartis