Boehringer Ingelheim and Eli Lilly and Company will modernize their current alliance as of 1 January 2020 and focus its combined expertise and investment on the continued development and commercialization of Jardiance® (empagliflozin) in type 2 diabetes, heart failure, and chronic kidney disease. Trajenta® (linagliptin) and Basaglar® (insulin glargine) continue to be part of the Alliance, with primary responsibility for development and commercialization led by the innovator company. Boehringer Ingelheim will continue as strategic lead for Trajenta®, and Lilly for Basaglar®.
Under the amended and restated agreement, there will be a revised margin sharing structure for ongoing payments starting 1 January 2020. There are no changes to Lilly's 2019 financial guidance or 2020 financial goals as a result of this amendment. The specific impact on the upcoming year will be incorporated into Lilly's 2020 guidance, currently scheduled to be issued on 17 December 2019. The net result of the revised margin sharing structure is not expected to be financially material over the duration of the agreement.
"The Alliance has experienced significant success since its formation in 2011, with Jardiance®, Trajenta® and Basaglar® becoming strong brands and continuing to grow in their respective classes globally," said Carine Brouillon, Head of Global Therapeutic Areas, Boehringer Ingelheim. "As the versatility of the SGLT2 inhibitor class continues to be realised, focusing our combined expertise and investment to support this important treatment will not only result in greater value for both companies but better enable us to help more people with and without type 2 diabetes."
Jardiance® is the most prescribed SGLT2 inhibitor in many markets worldwide, including the US. It is also the first type 2 diabetes medicine approved by regulatory authorities to significantly reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, or to include data on the reduction of the risk of cardiovascular death in the label. Furthermore, the cardiovascular benefits of empagliflozin in type 2 diabetes and established cardiovascular disease have been endorsed in more than 60 guidelines worldwide. The American College of Cardiology (ACC) Expert Consensus Decision Pathway recommends empagliflozin as the preferred SGLT2 inhibitor for its proven benefit in reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
"Building on EMPA-REG OUTCOME®, a number of important clinical trials are ongoing to evaluate the safety and efficacy of Jardiance® in people with heart failure or chronic kidney disease, including in people with and without type 2 diabetes. The results from these trials will help us understand how to further improve quality of life for these populations. Jardiance® has a bright future, and the Alliance is absolutely committed to its success," said Mike Mason, senior vice president, Lilly Connected Care and Insulins. Mason will become president of Lilly Diabetes starting 1 January 2020.
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More than 425 million people worldwide have diabetes, of which over 212 million are estimated to be undiagnosed. By 2045, the number of people with diabetes is expected to rise to 629 million people worldwide. Type 2 diabetes is the most common form of diabetes, responsible for around 90 percent of diabetes cases in high-income countries. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
Due to the complications associated with diabetes, such as high blood sugar, high blood pressure and obesity, cardiovascular disease is a major complication and the leading cause of death associated with diabetes. People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. In 2017, diabetes caused four million deaths worldwide, with cardiovascular disease as the leading cause. Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease.
Having a history of diabetes at age 60 can shorten a person's life span by as much as six years compared with someone without diabetes. And having both diabetes and a history of heart attack or stroke by age 60 can shorten a person's life span by as much as 12 years compared with someone without these conditions.
Worldwide, more than 60 guidelines have been updated to endorse type 2 diabetes agents with proven cardiovascular benefits since 2016, including a Consensus Report initiated by the American Diabetes Association® and European Association for the Study of Diabetes, recommending that, in patients with type 2 diabetes and established atherosclerotic cardiovascular disease, SGLT2 inhibitors (such as empagliflozin) or GLP1 receptor agonists with proven cardiovascular benefits are recommended as part of glycaemic management.
Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in the label in several countries.
Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels leads to excretion of excess sugar in the urine. In addition, initiation of empagliflozin increases excretion of salt from the body and reduces the fluid load of the body's blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME® trial.