Eli Lilly re-enters alliance with Adocia to develop ultrarapid-acting insulin lispro Concentrated formulation of insulin lispro included in the collaboration Under the terms of the agreement, Eli Lilly is responsible for future development, manufacturing, and commercialisation of an ultrarapid-acting formulation of Humalog (insulin lispro), BioChaperone Lispro. Adocia will receive a total upfront fee of USD 50 million with the potential for future payments of up to USD 520 million in development, regulatory and sales milestones.
The companies have previously collaborated on developing ultrarapid-acting insulins but the collaboration was terminated in July 2013 for undisclosed reasons. Since then, Adocia has continued development of a variety of insulin formulations including ultrarapid-acting insulin lispro. Eli Lilly is currently initiating two phase 1 trials comparing 1) a novel insulin, LY900014 new formulations of lispro with Humalog. One of these trials might be evaluating BioChaperone Lispro.
BioChaperone Lispro has demonstrated faster onset of action and shorter duration than Humalog A PK/PD study in T1DM (n=36) demonstrated 30% faster onset of action, a 70% increase in glucose lowering effect during the first hour and 20% increase during the first two hours vs Humalog. Late glucose lowering effect was significantly lower with BioChaperone Lispro than with Humalog. Further, Adocia has shown proportional dose-exposure and linear dose-response with BioChaperone Lispro. Comment: Adocia's formulations comprise a reversible complex of insulin and a polysaccharide polymer based on the company's BioChaperone technology.
A concentrated formulation of BioChaperone Lispro is also part of the agreement Comment: Adocia has concentrated a U300 lispro formulation in preclinical development and has demonstrated faster onset of action vs Humalog U100. BioChaperone Lispro U300 is planned to enter clinical testing in H1 2015. Eli Lilly has also developed a concentrated version of insulin lispro, Humalog U200 KwikPen. The product was recently approved in EU, 24 April 2014) but intends to resubmit to the FDA in Q4 2014, most likely pending completion of another bioequivalence study for two lispro formulations.
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