Press Release : World-first agreement between -2-

Inclisiran (KJX839) is the first and only small interfering ribonucleic acid (siRNA) therapy for the reduction of low-density lipoprotein cholesterol (LDL-C) levels via an RNA interference (RNAi) mechanism of action(7,8,9) . It works, in combination with maximally-tolerated statins and a lipid-lowering diet, by preventing the production of the target protein in the liver, increasing hepatic uptake of LDL-C and clearing it from the bloodstream. Inclisiran is dosed initially, again at three months and then once every six months thereafter(1) (6) . In three clinical trials, patients taking inclisiran maintained LDL-C reduction throughout each six-month dosing interval(8,9) . Inclisiran is administered by a healthcare professional as a subcutaneous injection.

In the Phase III trials, inclisiran was generally well-tolerated(8,9) . The most common adverse events reported (>=3% of patients treated with inclisiran and occurring more frequently than placebo) were injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity and dyspnea. Among those, injection site reactions were the most frequent ones. Those were generally mild, and none were severe or persistent(8,9) .

Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.

Inclisiran was granted marketing authorization by the European Commission on December 9, 2020.

About the Global Novartis Population Health Management Approach

The Novartis population health management approach is anchored in building partnerships between Novartis and systems of care around the world that accelerate patient access to a therapy, with the goal of improving the CV health of the system's defined population at speed and scale.

Novartis is committed to co-creating innovative solutions, anchored in an LDL-C lowering approach, that can address public health needs and deliver responsible budget impact and return on healthcare-spending investment. Optimizing cholesterol levels can be done through a central management model for which inclisiran is a suitable candidate, thereby helping to reach a large number of at-risk patients(6,7,8) .

About Novartis in Cardiovascular-Renal-Metabolism

Novartis is committed to addressing some of society's biggest public health concerns. Novartis has an established and expanding presence in diseases covering the heart, kidney and metabolic system. Novartis is committed to researching molecules with the potential to address cardiovascular, metabolic and renal diseases.

About Novartis

As a leading global medicines company, we use innovative science and digital technologies to create 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 nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

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References

   1. National Institute for Health and Care Excellence. Inclisiran for 
      treating primary hypercholesterolaemia or mixed dyslipidaemia [ID1647] 
      https://www.nice.org.uk/guidance/indevelopment/gid-ta10703. 
 
   2. Mach F. et al. European Heart Journal. 2020;1(41):111--188. 
 
   3. British Heart Foundation. CVD Factsheet. Available 
      at: https://www.bhf.org.uk/-/media/files/research/heart-statistics/bhf-cv 
      d-statistics-uk-factsheet.pdf?la=en [Last accessed: August 2021]. 
 
   4. NHS England. Cardiovascular disease (CVD). Our ambition for CVD 
      prevention. Available at: 
      https://www.england.nhs.uk/ourwork/clinical-policy/cvd/ [Last accessed: 
      August 2021]. 
 
   5. Data on file. INC_DOF-014. 
 
   6. NHS long-term plan summary. Available at: 
      https://www.longtermplan.nhs.uk/wp-content/uploads/2019/01/the-nhs-long-term-plan-summary.pdf. 
      [Last accessed: July 2021]. 
 
   7. Stoekenbroek RM, Kallend D, Wijngaard PL, et al. Inclisiran for the 
      treatment of cardiovascular disease: the ORION clinical development 
      program. Future Cardiol. 2018;14(6):433--442. 
 
   8. Raal F, Kallend D, Ray K, et al. Inclisiran for Heterozygous Familial 
      Hypercholesterolemia. N Engl J Med. 2020;382(16):1520--1530. 
 
   9. Ray K, Wright R, Kallend D, et al. Two Phase 3 Trials of Inclisiran in 
      Patients with Elevated LDL Cholesterol. N Engl J Med. 
      2020;382(16):1507--1519. 
 
  10. Mayo Clinic. Arteriosclerosis / atherosclerosis. Available 
      from: https://www.mayoclinic.org/diseases-conditions/arteriosclerosis-ath 
      erosclerosis/symptoms-causes/ [Last accessed: July 2021]. 
 
  11. Goldstein J, Brown M. A century of cholesterol and coronaries: from 
      plaques to genes to statins. Cell. 2015;161(1):161--172. 
 
  12. World Health Organization. Cardiovascular diseases (CVDs): Factsheet 
      [online] May 17, 2017. Available 
      from: https://www.who.int/news-room/fact-sheets/detail/cardiovascular-dis 
      eases-(cvds) [Last accessed: July 2021]. 
 
  13. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke 
      Statistics--2012 update: A report from the American Heart Association. 
      Circulation. 2012;125(1):e2--e220. 
 
  14. Kim H, Kim S, Han S, et al. Prevalence and incidence of atherosclerotic 
      cardiovascular disease and its risk factors in Korea: a nationwide 
      population-based study. BMC Public Health. 2019;19(1):1112. 
 
  15. National Cholesterol Education Program (NCEP) Expert Panel on Detection, 
      Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult 
      Treatment Panel III). Third Report of the National Cholesterol Education 
      Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of 
      High Blood Cholesterol in Adults (Adult Treatment Panel III) final 
      report. Circulation. 2002;106(25):3143--3421. 
 
  16. Inclisiran Summary of product characteristics. 

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See endnotes for further details

++ See 'About inclisiran' section later in release for detail

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(END) Dow Jones Newswires

August 31, 2021 19:01 ET (23:01 GMT)