Boehringer hands back Lilly drug
pharmafile | January 8, 2013 | News story | Research and Development, Sales and Marketing | Boehringer, Tradjenta, diabetes, lilly
Boehringer Ingelheim has handed back one of Eli Lilly’s investigational diabetes drugs as a result of ‘independent strategic portfolio considerations’.
Lilly will now reassume sole worldwide development and commercialisation rights to the novel basal insulin analog LY2605541, and plans to carry out the remaining pre-planned clinical trials this year and in 2014.
The companies said this decision to ‘adjust the scope’ of their diabetes alliance did not affect the other products they jointly signed up to develop two years ago.
These include Tradjenta (linagliptin) tablets, and investigational agents empagliflozin and LY2963016, a new insulin glargine product.
The new studies of LY2605541 will seek to evaluate its safety and efficacy and are in addition to the five ongoing IMAGINE clinical trials.
“We’re encouraged by the pre-clinical, Phase I and II data we’ve seen,” said Gwen Krivi, vice president, diabetes product development at Lilly Diabetes.
Phase III data may be available next year, with a regulatory filing not far behind, the company believes.
“Boehringer Ingelheim is an important partner in our strategy to provide a broad portfolio of diabetes medicines, and our diabetes alliance remains strong,” insisted Enrique Conterno, president of Lilly Diabetes.
As if to affirm that the LY2605541 decision is a blip, the companies have also published topline results from a Phase III study of empagliflozin.
The sodium glucose co-transporter-2 (SGLT-2) inhibitor is in a class that has been shown to reduce blood glucose and is being studied in patients with type II diabetes.
In all four studies, the primary efficacy endpoint – significant change in HbA1c from baseline compared to placebo – was met with once-daily doses of 10mg or 25mg.
The Phase III programme for empagliflozin will enrol over 14,500 patients and comprises eight multinational clinical trials, including a large cardiovascular outcome trial.
Boehringer and Lilly say they are ‘encouraged’ by the results so far and expect to file the drug in the US, Europe and Japan this year.
They also plan to present detailed data from the studies at meetings and in journals this year and in 2014.
Adam Hill
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