Date: 2014-10-29
Type of information: Development agreement
Compound: portfolio of diabetes compounds including linagliptin, BI10773 and two basal insulin analogues—LY2605541 and LY2963016
Company: Boehringer Ingelheim (Germany) Eli Lilly (USA - IN)
Therapeutic area: Metabolic diseases
Type agreement: development
commercialisation
Action mechanism:
Disease: diabetes
Details: * On January 7 , 2011, Boehringer Ingelheim and Eli have announced a global agreement to jointly develop and commercialize a portfolio of diabetes compounds currently in mid- and late-stage development. Included are Boehringer Ingelheim’s two oral diabetes agents—linagliptin (dipeptidyl peptidase-4 (DPP-4) inhibitor for type 2 diabetes) and BI10773 (sodium-dependent glucose co-transporter-2 (SGLT-2) inhibitor that block tubular reabsorption of glucose in the kidney)—as well as Lilly’s two basal insulin analogues—LY2605541 and LY2963016 as well as the option to co-develop and co-commercialize Lilly’s anti-TGF-beta monoclonal antibody. The agreement also includes an option for Boehringer Ingelheim to co-develop and co-commercialize another Lilly diabetes molecule, an anti-TGF-beta monoclonal antibody, which is currently in Phase II of clinical testing in patients with diabetes with chronic kidney disease.
Financial terms: Under the terms of the agreement, Lilly will make an initial one-time payment to Boehringer Ingelheim of €300 million. Boehringer Ingelheim will be eligible to receive up to a total of €625 million in success-based regulatory milestones for linagliptin and BI10773. Lilly will be eligible to receive up to a total of $650 million in success-based regulatory milestones on its two basal insulin analogues. Should Boehringer Ingelheim elect to opt-in to the Phase III development and potential commercialization of the anti-TGF-beta monoclonal antibody, Lilly would be eligible for up to $525 million in opt-in and success-based regulatory milestone payments. The companies will share ongoing development costs equally. Upon successful regulatory approval of any product resulting from the alliance, the companies will equally share in the product’s commercialization costs and gross margin. Each company will also be entitled to potential performance payments on sales of the molecules they contribute to the collaboration.
Latest news: * On October 29, 2014, Boehringer Ingelheim and Eli Lilly announced that they are changing the operational and financial structure of their diabetes alliance in certain countries. Under the revised agreement, 17 countries representing more than 90 percent of the alliance's anticipated market opportunity will continue their co-promotion work. In all other countries, the companies will exclusively commercialize the respective molecules they brought to the alliance. The changes will be implemented starting January 1, 2015. The scope of the alliance will remain unchanged in the following 17 countries: United States, Germany, Italy, Spain, France, United Kingdom, Republic of Ireland, Portugal, Canada, Japan, China, Australia, New Zealand, South Korea, Taiwan, Brazil, and Mexico. Under a revised agreement, Boehringer Ingelheim and Lilly will exclusively commercialize the respective molecules they brought to the alliance in all other countries under revised financial terms that will include an upfront payment and ongoing payments paid to Lilly in lieu of commission payments in those markets. Lilly plans to communicate the impact to its 2014 financial guidance in its third quarter Form 10-Q report to the U.S. Securities and Exchange Commission. To date, three new treatments for diabetes have been launched by the alliance: Trajenta® (linagliptin), Jardiance® (empagliflozin), and Jentadueto® (linagliptin/metformin HCI). Additionally, the alliance's new insulin glargine product has been tentatively approved in the U.S. and approved in Europe. Other potential treatments, including fixed-dose combinations, continue being developed by the alliance. * On January 7, 2013, Eli Lilly and Boehringer Ingelheim have announced they will adjust the scope of their diabetes alliance with respect to LY2605541, Lilly's investigational novel basal insulin analog, with Lilly reassuming sole worldwide development and commercialization rights to LY2605541. While Lilly and Boehringer Ingelheim will continue to jointly develop and commercialize the other assets in the alliance, Boehringer Ingelheim elected to terminate the collaboration with Lilly with respect to LY2605541 given independent strategic portfolio considerations. Lilly also announced plans for the 2013 and 2014 initiation of the remainder of the pre-planned clinical trials for LY2605541. In addition to supporting regulatory submissions, these studies will be conducted to evaluate safety, efficacy and differentiation of this novel basal insulin analog. These studies are in addition to the five ongoing IMAGINE clinical trials. If the Phase III trials for LY2605541 are successful, Lilly could submit its novel basal insulin analog to regulatory authorities as early as 2014, as previously communicated.
