Eli Lilly is remaining optimistic about its yet-to-be-approved inhaled insulin despite the dramatic downfall of Pfizer's Exubera. But is Exubera's fall from grace an indication of things to come for inhaled diabetes treatments?
Following Pfizer's shock departure from the inhaled insulin market last week, Eli Lilly is seen as the next company to take the reins - its AIR Insulin is expected to be submitted for approval in 2009.
Speaking to in-PharmaTechnologist.com, Eli Lilly spokesman Scott MacGregor said the company would not be influenced by Pfizer's decision to withdraw Exubera from the market.
"We don't make our decisions based on what other companies do but we do look at the need of patients and need of the market and the value the product will provide, and we feel confident AIR Insulin will meet an unmet medical need."
Last week, Pfizer, the world's largest pharmaceutical company, announced it would be dropping Exubera - the company's inhaled insulin drug which had been hotly touted as a possible $2bn (€1.4bn) a year blockbuster.
But with second quarter financials noting a "disappointing" $4m in worldwide revenues, Pfizer was forced to cut back on production of the device.
And now, just over a year on from the drug's launch, Exubera has gone belly up.
The question is, can Eli Lilly's drug fill the hole or will it face the same fate as Exubera?
According to Eli Lilly, the company believes it is on to a gem.
"We believe the value of the product will always stand on its own," MacGregor said.
Pfizer had been knocked down by attacks on the cumbersome nature of its inhaler device - it had even started development of two smaller next-generation devices, now both terminated - there were questions about lung function, and uptake of the product by physicians and doctors had been slow. Meanwhile, inhaled insulin does not completely replace the need for insulin injections.
But MacGregor said the poor performance by Exubera was not an indication of the "take" on the inhaled insulin market - if anything, "the launch of Exubera was a positive development".
"We are very supportive of the class of inhaled insulin . . . Exubera did establish inhaled insulin as a safe and effective treatment for diabetes. That's a positive development of the Exubera experience and clearly that will benefit us."
So if not insulin as an inhaled treatment, what was Exubera's downfall?
"It is not our place to comment," MacGregor said.
"A lot of people have speculated about Exubera. We'll leave that speculation to others."
But it is not new news that Eli Lilly's AIR Insulin, developed in conjunction with Alkermes, comes in a nifty little device, about the size of a marker pen.
"We believe our system can fit into a patient's life because it's small, simple, and easy to use," MacGregor said.
He pointed out that in Phase II studies, four out of five patients preferred to use inhaled insulin.
"We know the device does matter. We know the size and simplicity of the device really will matter in inhaled insulin and that really stands across the board for insulin devices . . . You're right in saying our device is different and the size and simplicity will be very important in making this a successful treatment."
The other promise AIR Insulin holds, is it has not yet shown the same questionable effects on lung function that has dogged Exubera.
But both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are keeping a stern eye on trials to see the effect inhaled insulin has on pulmonary function.
Danish drug-maker Novo Nordisk is not far behind Eli Lilly in the race to bring an inhaled insulin to the marketplace, and has just recruited patients for Phase III trials for its AERx insulin Diabetes Management System (iDMS) with the target of launching the device in 2010/2011.
Developed in partnership with Aradigm, the AERx system is the only inhaled insulin in clinical trials that uses a liquid formulation. While trials are using a device that is quiet large - about the size of a paperback book - Novo Nordisk chief science officer Mads Krogsgaard Thomsen said the aim was to bring a much smaller device to the market - just less than half the size, but still smaller than Exubera.
When contacted by in-PharmaTechnologist.com, Krogsgaard Thomsen said he believed there was a market for inhaled insulin but did not believe the market was "of the magnitude" that Pfizer had made it out to be.
"We have to say the size of the market depends on the system, how simple it is to use, the price of the drug, and it has to be dosed at about 10 times the injection amount.
"We are not willing to say inhaled insulin will be a blockbuster product. But in our opinion we have to offer a portfolio of options for the patient."
While Krogsgaard Thomsen gave credit to Pfizer for "paving the way for protein therapies via the lungs" he did question the drug giant's device.
With Exubera's size and the number of steps required to get adequate dosage, "it is not very convenient", Krogsgaard Thomsen said.
"Since inhaled insulin is supposed to be convenient, this sort of negates it. You need simplicity . . . They haven't had the right device for the market."
Meanwhile, diabetes research and treatment specialist Dr Nancy Bohannon told in-PharmaTechnologist.com, Exubera's failure to launch was down to Pfizer's "mismanagement" in the marketing of the product.
"It is my strong belief that the reason Exubera did not do well in the marketplace is that the launch and marketing to both physicians and potential patients was extremely mismanaged.
"This was one of the worst launches I've ever seen and I know that they did not listen to their clinical consultants when it came to market strategies. They seemed to think it would sell itself."
But Bohannon did not see Exubera's fall from grace as a condemnation of the entire class of inhaled insulin.
"I believe that the concerns of most physicians and patients could have been easily addressed and relieved. The smaller devices expected with the other inhaled insulin manufacturers will also greatly improve their likely acceptance by both patients and physicians," she said.
With that in mind and 80 years of diabetes business behind Eli Lilly, Bohannon said she expected AIR Insulin to be much more successful than Exubera.
But it would not be easy for the US company, as it has some legwork to do to shake off the shadow of Exubera and prove AIR Insulin can stand on its own in the inhaled insulin market, Bohannon said.
"I am sure that Lilly would have much preferred that Exubera gained widespread acceptance and use. When Lilly's much smaller inhalation device becomes available, they would have expected many of those prior Exubera users to convert to Lilly AIR Insulin. Their job will now be much harder, creating the demand and doing the legwork which Pfizer should have already done."
Financial services company Credit Suisse has forecast Eli Lilly's Air Insulin to reach sales of $500m in 2012.