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Boehringer and Lilly close in on empagliflozin filing

But amend diabetes alliance after Boehringer drops basal insulin

Empaglifozin moleculeBoehringer Ingelheim and Eli Lilly have moved a step close towards filing for approval of their new diabetes drug candidate empagliflozin after reporting positive data from four out of eight phase III trials.

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor, a new class of type 2 diabetes treatment that works independently of insulin and appear to provide sustained improvements in blood glucose whilst also alleviating the weight gain seen with other oral anti-diabetic agents (OADs).

In all four of the phase III studies, empagliflozin given at a dose of 10mg and 25mg once daily was able to achieve the target reductions in haemoglobin A1c (HbA1c), a measure of blood glucose control over time, putting the drug on target for regulatory filings later this year.

The trials supported the efficacy and safety of Boehringer and Lilly's drug as a monotherapy and in combination with other OADs - including metformin, sulfonylureas and Takeda's Actos (pioglitazone) - as well as in patients with renal impairment.

The most common side effects were urogenital infections, which are a class effect of the SGLT-2 inhibitors and thought to be a consequence of their mechanism of action, which promotes excretion of glucose via the urine.

Empagliflozin is lagging behind in a race to market with two other SGLT-2 inhibitors, namely Bristol-Myers Squibb and AstraZeneca's Forxiga (dapagliflozin) - which has already been approved in the EU but delayed in the US - and Johnson & Johnson's canagliflozin which has been filed for approval in the US and Europe.

Analysts have predicted peak sales of each of the drugs in the class could knock on the door of $1bn a year, given their attractive clinical profiles, although the prospects for Forxiga may be weakened after an FDA request for additional data amid concerns of liver damage and a link to breast and bladder cancer.

Boehringer hands back rights to basal insulin

Meanwhile, Lilly has taken back sole development and marketing rights to LY2605541 - a basal insulin product - that was also covered under the terms of its diabetes alliance with Boehringer

LY2605541 was one of four compounds which Lilly and Boehringer agreed to co-develop under the 2011 collaboration, along with empagliflozin, Tradjenta (linagliptin) and LY2963016, a second basal insulin analogue. 

The decision to hand back LY2605541 to Lilly has been out down to "independent strategic portfolio considerations" and does not appear to reflect any development issues with the project. Lilly said it would press on with planned phase III clinical trials of the basal insulin product.

8th January 2013

From: Sales

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