MannKind Corporation needs an outside boost to get its inhaled insulin off the ground, but the likelihood of that partner being Pfizer is a 'very long shot', the president of the company says.
The biopharmaceutical company based in California is one of the players involved in developing an inhaled insulin product. But unlike Eli Lilly and Novo Nordisk, MannKind has a limited sales and marketing force backing the product and currently is in search for a partner to bring the product to global commercial fruition. Despite the recently publicised failings and abandonment of Pfizer's inhaled insulin product Exubera, MannKind remained confident about its state-of-the-art inhaled insulin system, Technosphere Insulin System, and its success in forming a partnership. "It's a very different product to Exubera. Nothing has changed our mind or belief that we have a product that is efficacious to the patient," MannKind president and chief operating officer Hakan Edstrom told in-PharmaTechnologist.com. "I can't say [the dropping of Exubera] won't have an impact [on finding a partner] but there has been no impact up till now. People understand that what we're offering is something very different from Exubera." Edstrom said the company was in discussions with a number of big pharma companies but while there was no mention of whether Pfizer was included as one of the suitors it was clear the US drug giant's position as a potential candidate was way down the list. "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." When asked about the way Pfizer had treated its Exubera partners, Nektar Therapeutics, West Pharmaceuticals and Consort Medical (formerly known as Bespak), Edstrom said: "Would it make me a little worried? Was there a lack of transparency and openness that would make a cautiousness on our part? But that would be based on what we know from the media at this time." While Edstrom said the company could go it alone and market the Technosphere Insulin itself, it was "not our ideal approach" as the company would have to start on a regional level rather than its preferred penetration of the global market.
MannKind's inhaled insulin is based on a very different approach than other products in development. The formulation is centred on pH-sensitive carrier particles. Drugs such as insulin can be loaded onto these particles and dried to a powder, which is then filled into plastic cartridges and packaged. When the patient inhales, the powder is aerosolised and because of the aerodynamic properties of the particles, travels deep into the lungs. As the particles are sensitive to pH, when they come in contact with the neutral pH of the lungs the particles dissolve instantly, becoming a liquid and rapidly absorbed through the lungs. The insulin that is released is in monomeric form which can be readily used by the body. This is in contrast to most pharmaceutical dosages which exist often as hexamers. Clinical studies so far, have shown Technosphere Insulin to reach peak levels in the blood within 12 to 14 minutes which is equivalent to the post-meal insulin profiles normally seen in healthy individuals. Technosphere Insulin is administered using MannKind's inhaler device, MedTone, which is palm sized. The problem of impaired lung function has dogged Exubera, and Eli Lilly's partner Alkermes told Reuters earlier this week it was likely its AIR Insulin and other forms of inhaled insulin would have the same tendency.
But according to Edstrom, studies on the Technosphere Insulin System had shown there was no difference in lung function compared to the controls of regular therapies. "I do not anticipate there will be a problem," he said. Though he expected all eyes on the product to see how it would perform.
The Technosphere Insulin System is currently in Phase III trials and the company was looking at submitting a New Drug Application to the US Food and Drug Administration in the fourth quarter of 2008 with the aim of launching the product in 2009/2010.