September 18, 2008
Development-stage drugmaker and Motley Fool Hidden Gems Pay Dirt pick MannKind (Nasdaq: MNKD ) had a busy day the other day. The announcements: results from one of several phase 3 studies for its inhaled insulin diabetes treatment Technosphere, a new partnership of sorts with Pfizer (NYSE: PFE ) , and the brand name of Afresa for Technosphere if it's approved for marketing.
For any diabetes treatment, the gold standard for measuring a compound's effectiveness is how well it works to lower a patient's long-term blood sugar level (what are known as HbA1c levels). In this one-year study, Technosphere performed at least equally as well at controlling diabetics' blood sugar levels as long-approved insulin treatment Novolog from Novo Nordisk (NYSE: NVO ) . No matter how you slice the data about its effectiveness, Technosphere succeeded. That's good news.
Even more important considering what happened earlier this year, MannKind didn't report any lung neoplasms (tumors, benign or not) in the study. This is the suspected adverse event that affected Exubera -- Nektar Therapeutics (Nasdaq: NKTR ) and Pfizer's inhaled insulin product -- last spring. Many worry that this effect could be part of all inhaled insulins. While it's good news that MannKind didn't report any neoplasms in this study, a significantly larger and longer clinical trial is probably needed to tease out any possible relationship or lack of relationship between Technosphere and a rarely occurring issue such as lung neoplasms.
Overall, though, this study can be considered a success on the efficacy side. It is only the first of three phase 3 trials for which MannKind will be announcing data over the coming months. MannKind still expects to file a marketing application for Technosphere with the FDA late this year or early next year, so investors won't have to wait much longer for the rest of the pivotal phase 3 data to come in.
It's hoped a clearer picture of Technosphere's safety profile will emerge by the end of the year. That will make or break the whole deal.