Medical Device Daily

On the heels of Pfizer's (New York) FDA approval last Friday of Exubera, an inhaled insulin product delivered via a device by Nektar Therapeutics (San Carlos, California), at least one other company is making it known that it intends to follow suit with a similar product.

The difference between the Pfizer/Nektar insulin delivery device and Kos Pharmaceuticals (Cranbury, New Jersey) is that Kos is leveraging the asthma inhaler model, whereby an aerosolized liquid is inhaled using a device similar to that used for the asthma rescue drug Albuterol.

Kos' device, however, is much smaller, fitting in the palm of one's hand “like a cellphone,” according to Ralf Rosskamp, MD, executive vice president, research and development at Kos. According to Kos, Rosskamp was involved in the worldwide approval of Lantus, the most-prescribed injectable insulin, and was involved in planning Phase III studies for Exubera.

“In comparison to Exubera, they need the device, and then they need the blister packages of the insulin,” requiring a lot more handling to push a button on something like an airgun to blow the powder into the lungs, Rosskamp said, comparing it to the Kos paradigm of a “device, plus the can,” or canister.

Kos developed its own aerosolized formulation at its aerosol R&D facilities, Rosskamp said.

“The can, for instance, for our inhaled insulin has like 120 puffs for the patient, so this will bring them over the next two to three weeks,” he said. “[The patient] doesn't need any additional supplies. And when he has used and exhausted the can, he throws it away and gets another can.”

Unlike asthma inhalers, the Kos device is “breath-activated,” Rosskamp said.

With asthma inhalers, the squeezing of the device and breath intake have to be coordinated. But with the Kos insulin device, it is inserted into the mouth, and the inhalation activates the device to dispense insulin.

Another “nice feature” of the device, Rosskamp said, is a dose counter, so the patient can see if he has taken a dose or not, as well as how many doses he has left before needing a new canister.

Kos is gearing up for Phase III trials, scheduled to begin in late 2006 with the first dosing in early 2007. The company is in the process of identifying manufacturers for both the device and the aerosol can, since it is too small to do it on its own. And, as Rosskamp pointed out, the FDA prefers to have companies in Phase III trials, operating with essentially what will be the final product, and have the ability to produce it at commercial scale.

Pfizer/Nektar does have the advantage of being the first approved, but as Rosskamp sees it, Pfizer also has the tall order of paving the way for inhaled insulin in the marketplace and convincing both physicians and patients that it is a product both good and safe.

“For the next three, four years, I think they will have the advantage because they will be the only one in the market,” he said. “But that's one of the few times when I think it is good not to be the number one . . .” He added: “I personally believe Pfizer will do a tremendous job in educating people on what inhaled insulin does mean.”

Rather than just a “convenience product,” he said inhaled insulin could help patients who don't want to take injectable insulin take the inhaled form and thereby get better metabolic control, which could help with complications of diabetes long-term.

As the FDA pointed out in its announcement to report the approval of Exubera, that product is not meant for smokers or people who have quit smoking in the last six months. It is also not meant for people with asthma, COPD or emphysema. The FDA also is recommending baseline tests for lung function before patients begin treatment with Exubera and are recommended to be repeated every six to 12 months thereafter.

Other companies also are working on inhaled insulin products.

MAP Pharmaceuticals (Mountain View, California) is developing an insulin/haler system and is also working to commercialize two inhaled drugs: one for pediatric asthma, the other for migraine. It just closed a $25.25 million Series C preferred stock financing to support Phase II trials (Medical Device Daily, Jan. 26, 2006).

Among the big pharmas working on inhaled insulin products is Novo Nordisk (Bagsvaerd, Denmark). And Eli Lilly (Indianapolis) and Alkermes (Cambridge, Massachusetts) also have said that they are in Phase III trials with an inhaled insulin product, according to Rosskamp.

In September, Alkermes and Eli Lilly presented detailed results from a Phase II trial of inhaled insulin in people with Type 1 diabetes at the 41st annual meeting of the European Association for the Study of Diabetes in Athens, Greece. Data showed that patients using the Lilly/Alkermes inhaled insulin system achieved blood sugar levels similar to patients treated with injected insulin. Also, 80% of patients in the study preferred the inhaled insulin system at mealtime over-injected insulin, they said.

In July, Alkermes and Eli Lilly reported they had entered Phase III trials with an inhaled insulin product, targeted for patients with Type 1 or Type 2 diabetes.

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