A False Noise Alert or Update on the Pot and the Tea Kettle:
Hello, with you being so enamored with what MannKind executives say about MannKind, Afrezza, and, therefore, their technology. Let me share the long history of what I might call BS Walks as Per MannKind Executives. Could it simply be that we are hearing False Noise from the kettle?
Let me start at the head of the food chain for this category of executives—AL MANN.
As excerpted from the LA Times:
“It would be in large part due to the efforts of Alfred Mann, CEO, founder and patron of MannKind, the Valencia, California-based biopharma, if Afrezza finally receives FDA approval next year. (1) But an equally important question is whether, if Afrezza is approved, it will actually be prescribed by physicians and used by patients.
On August 14, MannKind presented the results of its two Phase 3 Affinity trials, both of which FDA requested in a Complete Response Letter issued in 2010. Now that the dust has more or less settled around those data – on August 26 the company posted an unusually frank FAQ, in response to analyst questions on a conference call – the consensus from the analyst community on Afrezza’s approval likelihood seems to rest somewhere between yes and perhaps.
(My aside comment about the FAQ link. MannKind opted to remove this particular content from their corporate website----because it was so disastrous for Mann’s story.)
Al Mann was less ambiguous, in a phone conversation with PharmExec. “I would expect it to be approved in mid-April [2014],” says Mann. “On our schedule it looks like April 14, but it could be a few days before or after.”(2) Mann says his company will file in Europe shortly after completing the US submission. Mann says other markets are looking to the FDA and EMA as a guide on this product; however, “a number of countries are talking about approving [Afrezza] simultaneously…and one country is even talking about doing it before the US.” Which country is that? Mann wouldn’t say.
As for the question of whether physicians and patients, and payers, for that matter, will be keen to trade a syringe for an inhalation powder, (3)Mann is typically optimistic that many patients will want to switch, although other opportunities exist as well. Hakan Edstrom, MannKind’s president and chief operating officer, says the company has done “extensive research in both Europe and the US” on physician preferences, confirming that physicians see Afrezza “as an additional tool in the armamentarium of treatment options. It doesn’t necessarily have to replace something else” to be successful, says Edstrom.
(4) On the payer side, Edstrom says MannKind is currently working with Kantar Health, a data firm. Kantar recently presented findings internally to MannKind, which confirmed the company’s belief that Afrezza would be reimbursed at a premium on par with any insulin product, says Edstrom. Mann himself went further, citing discussions from two years ago with “reimbursement gatekeepers from companies that cover around 30% of American lives” indicating that Afrezza, if approved, would command a “five to 10 percent premium” over rapid-acting injectable insulins, and would achieve a Tier 2 placement alongside injectable insulin products within six months.
(5) Despite Mann’s persistence and undying enthusiasm for Afrezza, he’s something of a bull in a bear cave, with respect to inhaled insulin. Nothing shows confidence more than putting your own money at stake, but there’s no successful product forebear to offer guidance, despite a consistent interest in non-needle insulin delivery going back decades. But Afrezza comes with some very novel attributes, not least of which being an improvement on hyperglycemic events, and a convenience factor for patients who’d rather not inject themselves in public before meals. (6) If Afrezza does win approval, in Western markets and in Asian markets like China, where the population count of adults with diabetes was recently tallied at 114 million, MannKind could potentially end up with the blockbuster drug a lot of people thought it had five years ago.
My Questions with Reference to each issue I’ve numbered in the article and the fact that it has been more than ten years for investors to see how their investment in MNKD has done for them. Is the ‘pot calling the kettle black’ when talking about FALSE NOISE?
1)Now that Afrezza has been approved, have physicians prescribed and patients used Afrezza in quantities that have solely produced a profit for MannKind?
(2) (a) Has Mannkind filed in Europe for Afrezza to be marketed? (b) Has one single European country simultaneously approved Afrezza for use in their country? (c) Do you have any idea what country Al Mann was talking about approving Afrezza before it was approved in the USA?
(3) How do you feel about Al Mann and Hakan’s extensive research in Europe and the US having confirmed that physicians can hardly wait to prescribe Afrezza for their patients?
(4) Do you think Kantar Health was BSing Al and Hakan. Are you satisfied with the insurance coverage that Al and Hakan told you about ten years ago? Or could it have been False Noise coming from MannKind executives?
(5) Are you a member of the group that is still concerned with non-needle insulin delivery?
(6) Now that Afrezza is approved here in the US, could you update me on how many of the 114 million Asian citizens are using Afrezza and whether Afrezza is a BLOCKBUSTER drug and a Noisemaker?
