Exubera drop creates drug delivery fallout

The COO of US biopharmaceutical company MannKind has said that he would not partner with Pfizer to help sell and market its own inhaleable insulin delivery system.

In an interview with outsourcing-pharma.com, Hakan Edstrom said that the company remained confident about its inhaled insulin product, the Technosphere Insulin System, and its success in forming a partnership, despite Pfizer's abandonment of the inhaled insulin product Exubera, which it had marketed for US drug delivery company, Nektar Therapeutics.

The problem of reduced lung function was the main problem with Exubera, despite extended safety studies. Eli Lilly's partner Alkermes said in an interview with Reuters that it was likely its own AIR Insulin product and other forms of inhaled insulin would suffer from the same problem.

MannKind does not have the sales and marketing clout to help sell the product and thus needs a partner to help bring the product to market. Edstrom added that while Pfizer's action could have a damaging effect on his company's search for a partner, he revealed that there had been no impact so far.

Edstrom revealed that MannKind was in discussions with a number of big pharmaceutical companies, but added that Pfizer was no longer on its list as a potential candidate to help sell and market Technosphere.

Edstrom said in the interview: "I would be very hesitant considering what Pfizer has done with Exubera and certainly there is an opinion within the physician community about the way the launch was conducted. That would be a very long shot at this point in time."

Technosphere Insulin is administered using MannKind's inhaler device, MedTone, which is palm sized, unlike the larger delivery device for Exubera.

MannKind's inhaled insulin product works by loading the active ingredient on pH-sensitive carrier particles and drying the formulation to a powder. When the patient inhales, the powder becomes an aerosol and travels deep into the lungs. Because the particles are sensitive to pH, they dissolve immediately in the neutral pH of the lungs, liquefy and then are absorbed into the bloodstream.

Clinical studies have shown Technosphere Insulin to reach peak levels in the blood within 12 to 14 minutes, equivalent to the post-meal insulin profiles normally seen in healthy individuals. Studies on the Technosphere Insulin System have shown there was no difference in lung function compared with the controls of regular therapies.

Technosphere Insulin System is in phase III trials and MannKind says it will submit a New Drug Application to the FDA in Q4 2008, with a launch anticipated for 2009/2010.