Orelli: The two studies the FDA wanted to confirm the new device is the same as the old device are supposed to finish up in May and June, which should allow the company to crunch the numbers and share the data in August. If it can put the reply to the FDA together quickly, a new decision in the second quarter of 2014 seems likely.
And then there’s a potential partnership. But maybe we’re getting a little ahead of ourselves with catalysts. What do you think the chances are of that happening?
Macaluso: Without the stamp of approval from the FDA, I don’t think any of the big pharmas would be interested in partnering on Afrezza. They have all been effected by the patent cliff, and I think that has made the industry more risk-averse. And I’ve talked about this before, but big pharmas have long memories, and I’m sure they remember Pfizer Inc. (NYSE:PFE)‘s attempt to bring Exubera to market. I definitely think Afrezza is a better product, but I don’t see a partnership happening before FDA approval.
Orelli: Me neither. The two other pharmas that were working on inhaled insulin — Novo and Eli Lilly — both dropped their products awhile ago. It’s hard to see them picking it up again. I don’t know who is left. Maybe Merck & Co., Inc. (NYSE:MRK) or the AstraZeneca plc (ADR) (NYSE:AZN)–Bristol Myers Squibb Co. (NYSE:BMY) joint venture. I don’t think either sells insulin products, but maybe they want to expand into later-stage type II diabetes?
Seems like they might have trouble finding a partner even with an approval. MannKind might need to market it themselves first to prove to a pharma that it’s a product patients want.
Macaluso: If Afrezza is approved, I think they’ll have to market it themselves, but it won’t be easy. They don’t currently have a marketing and sales team set up, so they’ll either have to create one or outsource it. Also, I think Dendreon Corporation (NASDAQ:DNDN) and VIVUS, Inc. (NASDAQ:VVUS) investors have seen firsthand how hard it can be for a small biotech company to launch a drug.
But, of course, that’s further down the road. The drug still needs to get approved.
Orelli: I think the diabetes market is larger than Dendreon’s prostate cancer market in terms of number of doctors they have to call on. VIVUS has focused on a select number of high-prescribing doctors, but I don’t know if that’s even possible in the diabetes space. Maybe if you only go after type 1 diabetics? But they’ve lived with it their whole lives. Seems like the target audience for inhaled insulin is new-to-insulin type 2 diabetics.
The article What’s Behind MannKind’s Incredible Run? originally appeared on Fool.com and is written by Brian Orelli and Max Macaluso, Ph.D.
Fool contributor Brian Orelli has no position in any stocks mentioned. Max Macaluso, Ph.D. has no position in any stocks mentioned. The Motley Fool owns shares of Dendreon.
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