Inhaled Insulin NDA Submitted
MannKind has submitted a new drug application to the Food and Drug Administration for its own version of inhaled insulin, Afresa, the company announced. In a statement, the company downplayed the drug's method of delivery, trying to distance itself from Exubera, Pfizer's version of inhaled insulin that is no longer on the market. “The feature that distinguishes Afresa from all other insulin products is not the route of administration—it is the pharmacokinetic profile,” the statement said. MannKind is seeking approval for treating adults with type 1 or type 2 diabetes. Pfizer gave up on Exubera in the fall of 2007, blaming resistance from patients and physicians to earlier initiation of insulin therapy. MannKind believes Pfizer's failure with Exubera was due mainly to the clunky device and the drug's high cost—50% above ordinary insulin—as well as residual powder apparently left in the lung after Exubera use. MannKind's Afresa powder transforms into mist when it hits the lung, reducing pulmonary-function problems.
Inverness Buys Rest of Acon
Inverness Medical Innovations will pay $200 million to acquire the rest of Acon Laboratories' worldwide lateral flow immunoassay rapid diagnostics business under a March 19 agreement. In March 2006, Inverness bought the business for territories limited to the United States, Canada, Western Europe, Australia, Israel, Japan, and New Zealand for $175 million. The newly acquired territories include China, Asia Pacific, Latin America, South America, the Middle East, Africa, India, Pakistan, Russia, and Eastern Europe; those markets generated about $45 million in sales in 2008. San Diego-based Acon notes that it will retain its other worldwide in vitro diagnostics businesses, including its diabetes, clinical chemistry, and immunoassay products. The firms expect the deal to close by April 30.
Novo Nordisk, ADA Announce Grant
Novo Nordisk has issued a $1.2 million grant to the American Diabetes Association to support researchers studying the effects of intestinal hormones on obesity and prediabetes. The researchers will study the role of glucagon-like peptide 1 (GLP-1) and other incretin hormones in people at risk for, or with, diabetes. The money, to be divided into two $600,000 grants, will fund investigation in two areas: understanding the role of incretins, including GLP-1, in the progression of obesity, prediabetes and type 2 diabetes; and the role of incretins in regulating weight, satiety, and cardiovascular risk factors. “Studying the role of GLP-1 and other incretin hormones in people with type 2 diabetes and those at risk holds much promise,” said Scott Campbell, Ph.D., American Diabetes Association vice president of research programs. “Emerging science shows us that GLP-1 treatments can positively affect glucose metabolism and may increase beta cell mass, two important elements that could someday lead to a cure for type 2 diabetes.”
Alogliptin Faces Added Hurdle
Takeda Pharmaceutical Co. announced that alogliptin, the DPP-4 inhibitor for which the company has submitted a new drug application for the treatment of type 2 diabetes, will be required to meet the new cardiovascular guidelines issued by the FDA last December for type 2 diabetes drugs, even though the new drug application was filed about a year before the guidelines were issued. The company noted that the agency is open to discussions regarding the design of additional cardiovascular studies with alogliptin. Alogliptin's Prescription Drug User Fee Act (PDUFA) date of June 26, 2009—the date by which the FDA must act on the application—remains unchanged. —From staff reports
Reporters and editors from Elsevier's “The Pink Sheet” contributed to this column.