Medical Device Daily Washington Editor

WASHINGTON – Gatherings such as the American Dia-betes Association 's (ADA; Alexandria, Virginia) 66th an-nual scientific sessions, held here over the last several days, demonstrate that the market for diabetes-related products continues to expand. And a multitude of firms are offering an ever-widening range of products and delivery vehicles to fill the various niches, with devices occupying some of these spaces.

Among the most important of these is Exubera, the first inhalable insulin approved by the FDA from Nektar (San Carlos, California) and Pfizer (New York), making its first entry to the diabetes market after earning the FDA's seal of approval this past January (MDD, Jan. 31, 2006).

Nektar made sure that attendees to the annual ADA gathering got a close look at the new offering, which followed FDA approval by six months – the delay in commercial release required by sufficient ramp-up of production to avoid any potential shortages, according to the company.

The road to market for this product began with Nektar – maker of the inhaler portion of the therapy – roughly 15 years ago, and its arrival to market has a lot of people at the firm very pumped up.

Chris Searcy, Nektar's vice president for corporate development, told Medical Device Daily that “many of us cannot wait to see the first patient using it outside clinical trials,” and he insisted that the firm's tenacity in the product development effort is not especially common in the industry. “Lots of companies would have folded up their tents long ago,” as a result of development glitches and costs, he remarked.

Learning to turn insulin into a powder was the toughest part of the project.

Nektar started with “an old process called spray-drying,” according to Searcy, but the company had to come up with a few modifications of the typical process in order to “work in the range of less than five microns,” which mandated the development of a proprietary nozzle and collection process.

But all that work paid big dividends. The delivery method achieved is “a one-pop process and very efficient,” Searcy said.

Getting the dried insulin into and then out of the inhaler was nearly as much work as developing the spray-dry equipment. The inhaler is roughly the length of an eyeglass case and slightly smaller around the middle, but Nektar had to come up with an inhaler that would dispense a very carefully measured dose of insulin at just the right rate to avoid the natural variance in individual use. Searcy said that Exubera is of a finer grain than talcum.

The company's decision to work with Pfizer, Searcy said, was not particularly unusual, but also not reflecting the entire business strategy for Nektar.

He indicated that Pfizer was a huge help in getting the products through the FDA mill as well as on some of the financing, the total cost of which has been nearly $3 billion. At present, Nektar makes roughly half the powder and all the inhalers, whereas Pfizer handles the balance of the work. This frees up resources at Nektar to examine other opportunities.

Searcy noted that while the partnership with Pfizer has done quite well, “our business model is changing from partnership to some partnerships and some sole product development.”

He indicated that the company, as a solo enterprise, also is working on an inhalable product to treat lung infections.

Pfizer and Nektar already have an endocrine “home run” in their joint-development bag in the form of Somavert, a treatment for acromegaly that goes by the trade name of pegvisomant. Acromegaly is caused by an excess of growth hormone in adulthood (in childhood, such a state induces a linear growth spurt known as pituitary gigantism).

Several of the firm's developing products are other inhalables, including five partnered products and two that Nektar is working through solo, including the treatment for lung infections.

Diabetes treatments make up a large portion of the business plan, but while Nektar is willing to diversify from a value standpoint, “insulin will continue to be a key component of the business,” Searcy said.

The clinical end of product development offered few surprises. In studies, Exubera users did slightly better than controls in terms of fasting serum glucose levels, but the results may or may not have much clinical meaning.

On the other hand, Exubera subjects did much better on weight control than controls, picking up less than two pounds, compared to the more than four pounds on average for the subjects in the control arm. Searcy said that the data do not currently offer an explanation for this difference.

As for patient safety, trial data do not suggest any lung problems in connection with the new drug. Searcy noted that the lungs are exposed to some insulin under normal conditions, albeit in much lower concentrations.

“We don't think it damages the lungs,” he said. “Trials have shown a small drop” in pulmonary function, but two-year data shows no difference in pulmonary capacity.

Use of Exubera offers another device opportunity, besides the inhaler. Patients will have to undergo a spirometer test for lung function to commence with therapy and again six months after starting. If all is still well at that point, the spirometer test can be repeated annually to ensure continued safety.

Unsurprisingly, the drug is contraindicated for smokers.

The market for the product is not yet fully defined, but Searcy said that Pfizer and Nektar are confident of its place in the constellation of diabetes treatments, especially since a truly closed-loop system (glucose meters tied to insulin pumps) is a long way off in terms of everyday patient acceptance.

“Insulin pumps have been successful in a narrow segment of the market, but they're very complicated,” he said, and offer large up-front costs. He added that some patients simply would not care for the sensation of having this equipment tied to the torso.

On the other hand, Searcy said he does not expect to see any sales of Exubera and the inhaler as a backstop emergency treatment for severe episodes.