Medical Device Daily Washington Writer

MannKind Corp. (Valencia, California) is well under way with the pivotal development of its inhaled insulin product, Technosphere Insulin (TI), with two additional Phase III studies now started.

Patient enrollment began in the trials to evaluate the product's efficacy by assessing changes in both HbA1c levels and blood glucose levels after a standardized meal. Also, new data will soon come from two recently completed Phase III trials, a three-month study in Type 1 diabetes patients and a six-month study in Type 2 diabetes patients.

Noting the company's “very extensive program“ for TI, Peter Richardson, MannKind's chief scientific officer, told Medical Device Daily's sister publication, BioWorld Today, that the latest studies are designed “to confirm the sustained efficacy“ of the product. Both randomized trials are scheduled to last a year.

The first, Study 009, will include 500 Type I patients and compare TI to subcutaneous injections of a rapid-acting insulin analogue. Patients in both arms also will receive a basal insulin regimen. The second, Study 102, is the subject of a special protocol assessment by the FDA. It will include 500 Type 2 patients and compare TI plus basal insulin to subcutaneous injections of premixed insulin, including a rapid-acting insulin analogue.

Both studies are being conducted in the U.S., Europe and Latin America, and are meant for regulatory clearances here and abroad. Richardson said MannKind is aiming to file for FDA approval by the end of 2008, with a similar timeline planned for other territories as well.

The FDA recently approved the first inhaled insulin product, Exubera. Marketed by Pfizer (New York), it was developed in collaboration with Nektar Therapeutics (San Carlos, California). It was cleared earlier this year (Medical Device Daily, Jan. 31, 2006).

That approval laid a path for MannKind to follow, and Richardson noted that its product is different from Exubera in several ways.

He said the Technosphere technology creates particles with a “unique pharmacokinetic profile,“ and that the use of TI leads to a quicker insulin absorption rate than that seen with other insulin products, injectable and inhaled. Therefore, TI better mimics a body's first-phase insulin spike. He added said the particles' 2.5 micron size is “optimized“ to allow good dispersion on the lung's surface. In addition, TI's half-life is somewhat shorter, reducing chan-ces of hypoglycemia, and TI patients have not exhibited weight gain in studies to date.

The delivery system pumps out a dry powder Technosphere formulation of insulin that is inhaled into the deep lung using the biopharmaceutical company's MedTone inhaler. Prior studies have demonstrated TI's ability to improve glycemic control in a dose-dependent manner, as measured by decreases in HbA1c levels and reductions in glucose excursions following a meal.

MannKind owns all rights to TI, and last year raised $175 million through a private stock and warrant sale to shore up its balance sheet as the TI's pivotal program began moving forward. A fifth and final Phase III trial, Study 103, is scheduled to begin this summer in Type 2 patients. It will last somewhat less than a year, Richardson said.

Beyond the inhaled insulin program, the company is preparing to file an investigational new drug application to begin clinical studies of a cancer vaccine, and other efforts are focused on developing therapies for dysfunctional B-cells and T-cells in the immune system.

HealthTronics to delay earnings release

HealthTronics (Austin, Texas) said it would delay its fourth quarter and year-end earnings release. The release and call are being delayed to provide additional time for HealthTronics' independent auditors to complete their an-alysis and determination of whether certain items in its financial statements should be adjusted.

Company management said it believes that, if any such adjustments are required, they “would have a positive impact on HealthTronics' financial statements.“ HealthTronics will announce the date of its earnings release and investor conference call at a later date.

HealthTronics provides healthcare services primarily to the urology community.