U.S. Food and Drug Administration Approves Humulin R U-500 KwikPen

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Humulin^® R U-500 KwikPen^®(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than standard U-100 insulin. This insulin is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day. The safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered by an insulin infusion pump has not been determined.

Until now, Humulin R U-500 was only available in a vial, administered with either a U-100 insulin syringe or a volumetric (tuberculin) syringe that requires conversion to respective syringe "unit markings" or volume markings. Although each U-500 KwikPen holds 1500 units of insulin (the amount in five U-100 insulin pens), it is the same size as other KwikPens and dials in five-unit increments. The U-500 KwikPen has a unique aqua-colored pen body to clearly differentiate it from other insulin pens.

Humulin R U-500 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Humulin R U-500 or any of its additives or components. Hypoglycemia (low blood sugar) is the most common side effect associated with all insulins, including Humulin R U-500. The Humulin R U-500 Savings Card Program offers eligible, commercially insured patients the opportunity to pay as little as $25 per prescription for up to 12 redemptions over a 12-month period.

Lilly supports global Dementia Discovery Fund

Eli Lilly and Company announced it will be a key collaborator in the $100 million Dementia Discovery Fund (DDF), which aims to accelerate the discovery and development of new treatments for dementia. This first-ever global dementia research fund - recently launched after securing backing from investors including Lilly, the UK Government's Department of Health, Alzheimer's Research UK and a number of other global pharmaceutical companies - will invest in research into treatments for the condition. 

 

"Lilly is delighted to be a partner in the Dementia Discovery Fund. Alzheimer's disease is one of the most significant challenges the world faces, and we welcome the UK Government's leadership in this area. The UK is a great place for science and discovery, and we believe this fund will provide the resources to help advance vital research," said Jan Lundberg, Ph.D., executive vice president of science and technology, and president of Lilly Research Laboratories for Eli Lilly and Company. "Our investment in this fund reflects Lilly's commitment to innovation and our history of collaboration. We look forward to working as part of this collaboration to speed the discovery of new medicines to treat one of the world's most devastating diseases."

The DDF collaboration seeks to identify and foster promising new global research in the field of dementia and supports Lilly's commitment to explore innovative approaches to scientific discovery. By providing financial support and its scientific expertise to this venture, Lilly hopes to accelerate the development of innovative new treatments for this disease.

The DDF today announced that SV Life Sciences has been appointed as Fund Manager and will be supported by a Scientific Advisory Board made up of some of the world's leading scientists. This group will identify potentially innovative projects in which the fund can invest, with the aim of speeding development of medicines that both improve symptoms and treat dementia.    

Dementia affects more than 47 million people worldwide at a cost of over $604 billion a year. Every year, there are more than 7.7 million new cases. Alzheimer's disease is the most common cause of dementia and may contribute to 60 to 70 percent of cases. While current treatments can temporarily alleviate or slow down symptoms for a limited period of 6 to 12 months or longer, there is currently no cure for Alzheimer's disease, making it one of the world's greatest unmet medical needs.

Eli Lilly and Company Announces Expansions its Headquarter

Eli Lilly and Company revealed plans to expand its global research and development (R&D) headquarters in Indianapolis, Indiana.  Adding 130,000 square feet to Lilly's existing complex, the new $70 million building will feature a multi-disciplinary laboratory that facilitates collaboration across multiple research functions. The new building is part of Lilly's continued growth of its Indianapolis footprint, which included a $400 million expansion initiated in 2013 to increase its insulin manufacturing capacity.

Upon completion in 2017, the new building will enable organic chemists and engineers to work side-by-side in a collaboration-centric workspace with modelling, analytical and formulation scientists. Key to this success will be flexible laboratories that can adapt as research and technology needs evolve, as well as open, interactive meeting spaces that are meant to spark creativity and multi-disciplinary problem-solving. The laboratory will focus its efforts on small molecules - treatments typically taken orally - which currently comprise about half of Lilly's investigational medicines portfolio. 

Lilly and Sanofi Reach Settlement Agreement

Eli Lilly and Company has entered into a settlement agreement to resolve patent litigation with Sanofi regarding its insulin glargine product, Basaglar®. As a part of the agreement, Lilly and its alliance partner, Boehringer Ingelheim, will have the ability to launch Basaglar in the U.S. on December 15, 2016. 

 Under the terms of the agreement, Sanofi has granted Lilly a royalty-bearing license so Lilly can manufacture and sell Basaglar in the Kwikpen® device globally. Further details regarding the settlement are confidential. The U.S. Food and Drug Administration tentatively approved Basaglar in August 2014. With this resolution, Lilly plans to request final approval of Basaglar from the FDA.