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Post by savzak on Apr 10, 2014 22:20:18 GMT -5
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Post by otherottawaguy on Apr 11, 2014 8:30:44 GMT -5
MNKD excerpt from article:
TLSR: This makes me think of a name in your active coverage— MannKind Corp. (MNKD:NASDAQ), with its inhalable insulin product Afrezza (human insulin of recombinant DNA origin delivered via Technosphere particles). It had an AdCom meeting on April 1 and the PDUFA date is now set at July 15. Sometimes the FDA doesn’t have an AdCom meeting, but in the case of Afrezza, I’m thinking it was necessary because the agency made MannKind jump through so many hoops during the drug approval process, including extra trials and years of added development. Do you think that’s the FDA’s reason for holding an AdCom meeting? To finally pull all that information together?
KM: Yes. It’s a rather complex drug application. Insulin is a biologic, and we clearly know how it functions, but it’s being delivered attached to a unique particle MannKind calls Technosphere, through a route of administration that is not typical—pulmonary absorption. Also, the inhalation delivery device, called Gen-2 or Dreamboat, is brand new, as it had to be specifically created for this particular drug. I suppose the FDA felt that this AdCom was the best way to be certain that all factors and data were being addressed. And indeed, that was the case—the advisory committee weighed the merits of the drug thoroughly. I think the experts’ near-unanimous support of Afrezza for both type 1 and type 2 diabetes was a strong signal to the FDA in favor of approval.
TLSR: Keith, no one could deny that the approval vote on Afrezza was anything but a positive event. Yet, looking at the relative strength of MannKind shares over the past six months, I get the feeling that some investors are looking at opportunities to sell. What do you think?
KM: I hate to say it, but that attitude certainly exists. There are a number of people who have made a fair amount of money shorting MannKind stock over the years, partly because of the amount of time that it’s taken to develop the drug and take it over the various hurdles of the regulatory process. There are still a number of people out there who are betting against it, simply because they have made a fair amount of money on it in the past, and probably feel that they can do the same again. It’s hard to know exactly where the stock is going to be when the next news breaks, but it’s possible that there could be corrections along the way to commercialization.
TLSR: Your target price on MannKind is $13/share. That’s more than a 100% implied return on this stock. At this point, and given what you’ve just said, are we now looking at MannKind as a market penetration and revenue story?
KM: It depends on how far out you’re looking. I think a couple of things are going to have to take place before we get to a true revenue-and-earnings story. We still have to get FDA approval, and we expect to see MannKind partner with a major drug company to market the product. It will need to be a company with a strong and experienced sales force dedicated to the family/general practitioner (GP) segment of the medical community.
The last time I spoke with Al Mann, MannKind founder and CEO, he said that his goal would be to find a good partner experienced in promoting drugs to the GP. Al knows that most diabetics are going to be treated first in the primary care setting, whether they are type 1 or type 2 diabetics. The more difficult cases will obviously be handed off to endocrinologists, who will be the key opinion leaders on uptake of the drug. For that reason, I think it will be equally crucial for MannKind to have some success penetrating that specialty-clinician market. After finding a marketing partner, it will probably take about six months from approval to launch. So, if we get the approval by July 15, the PDUFA date, that would place the launch in Q4/14 or early 2015.
In that interim, between approval and launch, we may have a relatively quiet period. The two companies—the partner pharma and MannKind—will start to work together while inventory builds. But that kind of work doesn’t really generate any news, and so investors will probably just have to sit tight for the actual revenue-and-earnings story to begin.
TLSR: Back in 2007, Pfizer Inc. (NYSE:PFE) didn’t even last a year with its inhalable insulin product Exubera (recombinant human insulin with particle diameters between1–5mm), which was developed by Nektar Therapeutics (NKTR:NASDAQ). Exubera’s inhalation device was an inconvenient and cumbersome bonglike device that was not really usable in a public place such a restaurant, and Pfizer eventually dumped the product and gave it back to Nektar. Clearly, MannKind’s palm-size Dreamboat inhalation device, designed for Afrezza, is a huge improvement over Exubera’s delivery device. But could Exubera’s failure be an overhang on MannKind’s shares?
KM: To a certain extent, I think it has been an overhang, because when people in the investment community hear “inhalable insulin,” they immediately think of Exubera. It has taken a fair amount of time to educate some investors about the difference. I imagine there’s also an overhang within some of the other major pharmaceutical companies that have watched Afrezza’s development, but remember what happened with Pfizer and Exubera. I don’t know exactly where MannKind is in the partnering process, but I know that it has been talking to multinational corporations and some regional companies in various parts of the world, and it may have had to overcome some reluctance to even discuss Afrezza. We may also see some overhang in the adoption by the medical community. The important thing is, I don’t think that the individual consumer—the diabetic patient—is going to care one iota about what happened with Pfizer and Exubera seven or eight years ago. I imagine, in their eyes, Afrezza offers a distinctly new approach to treating this chronic disease.
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Post by otherottawaguy on Apr 11, 2014 11:59:03 GMT -5
Just hate seeing articles disappear...with no way to reference them in the future.
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