With tens of millions of patients at higher risk of cardiovascular events from high LDL-C, we believe that inclisiran could contribute significantly to improved patient outcomes and help healthcare systems address the leading global cause of death. The prospect of bringing inclisiran to patients also fits with our overall strategy to transform Novartis into a focused medicines company and adds an investigational therapy with the potential to be a significant driver of Novartis' growth in the medium to long term.'
Novartis announced today that it has entered into an agreement and plan of merger with
'Novartis has a longstanding history of delivering breakthrough cardiovascular treatments for patients, and I am very excited about the opportunity to add inclisiran to our cardiovascular portfolio,' said
Transaction fits long-term strategic goals
The planned acquisition of
Financial highlights and updated IM Division margin outlook guidance
The offer price represents a premium of approximately 41% over
The transaction is expected to create significant value for patients, payers and Novartis shareholders. Assuming completion in the first quarter of 2020, Novartis expects inclisiran to start to contribute to Group and IM Division sales from 2021. It is also expected to further drive growth of the Cardiovascular-Renal-Metabolism franchise with the potential to become one of the largest products by sales in the Novartis portfolio, leveraging Novartis' global cardiovascular commercial capabilities.
The acquisition is expected to modestly dilute core EPS versus a no deal scenario during the next few years as the company invests for a successful launch of inclisiran. Novartis expects the transaction to be significantly accretive to Group core operating income and core EPS in the medium term, driven by sales growth and operational synergies, leveraging the worldwide footprint of the cardiovascular business.
Novartis expects to continue to expand IM Division core margins to reach mid-thirties in the near term, and mid to high-thirties in the medium term, while investing in launches, including inclisiran. This guidance assumes that no Gilenya generics will enter the US market in 2020.
The core margin expansion for IM Division is driven by the continued sales momentum of key growth drivers, expected new launches as well as previously announced productivity programs. Novartis believes these factors will offset investments in new launches including inclisiran as well as the impact of generic erosion.
Transaction details
The transaction is expected to close in the first quarter of 2020, subject to the satisfaction or waiver of all closing conditions. Until closing,
Under the terms of the agreement and plan of merger, Novartis will, through a subsidiary, commence a tender offer to purchase all outstanding shares of
Novartis plans to finance the transaction through available cash and short- and long-term borrowings.
About Novartis in Cardiovascular-Renal-Metabolism
Bending the curve of life requires 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. In addition to essential treatment Entresto (sacubitril/valsartan), Novartis has a growing pipeline of potentially first-in-class molecules addressing genetic cardiovascular risk factors, rare renal diseases and metabolic disorders.
About atherosclerotic cardiovascular disease
Atherosclerotic cardiovascular disease is the leading cause of death worldwide6. ASCVD results from a thickening and loss of elasticity in the arterial wall. It is a severe disorder and the leading cause of morbidity (sickness) and mortality (death) in most developed countries7. High levels of LDL-C build up on the walls of blood vessels. This buildup is called 'plaque.' As blood vessels build up plaque over time, the insides of the vessels narrow. This narrowing blocks blood flow to and from the heart and other organs and eventually causes heart disease or stroke8.
About familial hypercholesterolemia
Familial hypercholesterolemia (FH) is a genetic condition that leads to high cholesterol. People with FH have high levels of LDL-C as a result of a mutation in one gene that controls the way cholesterol is cleared by the body. High levels of LDL-C build up on the walls of the blood vessels and over time, the vessels narrow. This can lead to increased risk of heart attack or stroke. While lifestyle factors are important, for people with FH this isn't sufficient to control LDL-C9.
About inclisiran
Inclisiran, potentially the first and only cholesterol-lowering therapy in the siRNA (small-interfering RNA) class, is
About ORION clinical development program
Durable and potent LDL-C reduction with twice-yearly administration was demonstrated in three pivotal Phase III trials. ORION-11: showed a 54% LDL-C lowering with time-adjusted reductions of 50% sustained over 18 months of treatment2. ORION-10: showed a 58% (observed) LDL cholesterol lowering with time-adjusted reductions of 56% sustained over 18 months. ORION-10 met all primary and secondary endpoints, with profound, durable efficacy and excellent safety of inclisiran that were at least as favorable as observed in ORION-113,4. ORION-9: met all primary and secondary efficacy endpoints, including durable and potent efficacy and excellent safety in a patient population where cardiovascular disease is most severe4.
In addition, inclisiran has a highly attractive dosing regimen. After an initial 3-month lead in, twice-yearly subcutaneous dosing thereafter applicable to all tested patients and subgroups. A clean long-term safety profile across a broad range of patient groups was observed. The benefit of inclisiran on cardiovascular outcomes is being assessed in an on-going 15 000 patient 5-year clinical trial (ORION-4)5.
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as 'to be commenced,' 'to purchase,' 'to acquire,' 'to transform,' 'potential,' 'expected,' 'offers,' 'future,' 'ongoing,' 'would,' 'potentially,' 'believe,' 'can,' 'hopefully,' 'excited,' 'ambition,' 'priorities,' 'confidence,' 'to strengthen,' 'opportunity,' 'pending,' 'will,' 'expects,' 'subject to,' 'planned,' 'soon to launch,' 'transformational' or similar expressions, or by express or implied discussions regarding the potential outcome of the tender offer for the shares of
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 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world.
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