Alkermes catching leaders in inhaled insulin?

US drug delivery specialist Alkermes surged late last week on the news that its partner Eli Lilly had agreed to take their inhaled insulin product into Phase III testing. The news came just as further doubts have been raised about the prospects of a rival product from Pfizer, Aventis and Nektar Therapeutics getting approved.

With the number of patients with diabetes currently estimated at about 25 million in Europe alone - and escalating every year - the rewards for a company that can come up with a safe alternative to injections look assured. Analysts have predicted that the first inhaled insulin product to reach the market could achieve sales upwards of $1.5 billion a year.

Earlier this month, shares in Nektar fell through the floor after rumours surfaced that the product, called Exubera, was to be rejected for approval by regulators in Europe. An application to market the drug in the US had been withdrawn after experiments suggested that it may be associated with a decline in lung function over time.

And as diabetes requires chronic dosing with insulin, the concern is that patients taking the drug in this way could have complications later in life.

Despite the problems associated with Exubera, US-based multinational Lilly has decided to proceed with a full Phase III trials programme after encouraging results in a Phase II study of the product, which is based on Alkermes' AIR drug delivery technology.

Alkermes also said it had made progress in developing commercial versions of the powdered insulin and the inhalation technology that form its product.

Alkermes started its collaboration with Lilly in 2001, although the terms of the agreement were modified in December 2002 with Lilly agreeing to purchase $30 million of Alkermes stock. This move left Alkermes with funding for the complete development programme for inhaled insulin during calendar years 2003 and 2004.

Analysts at Datamonitor said that the news about Exubera was no surprise, as submission for approval in Europe was viewed by many as a ploy by Aventis to assure investors that its pipeline could produce continued earnings growth, in its effort to fend off the then recently launched takeover bid by Sanofi-Synthelabo.

If Exubera is not approved however, it is likely that other inhaled insulins in earlier phases of development will find it much harder to gain regulatory approval, since the authorities will require robust and conclusive data proving the efficacy and safety of such medications in the lack of precedent.