Some have been using AFREZZA for 6+ years with no ill effects reported.
So Pfizer has some knowledge of AFREZZA. If no ill effects after 6+ years that's a good sign. Anybody know the size of this population?
Apparantly some patients have been using AFREZZA since 2008.
Check out Pfizer press release dated Septembe 15, 2008 and entitled
MannKind and Pfizer Announce Collaboration for Certain Exubera Patients to Transition to MannKind's Inhaled Insulin Therapy
In February 18th Earnings Call Transcript, Dr. Mann states:
"Given the imminent PDUFA date, it is important that we proceed in preparing for commercialization of AFREZZA. We are making excellent progress preparing for post-launch manufacturing. The second and third [fill/finish] machines are now being installed in our Danbury facility and when completed and validated soon after launch, should give us a capacity to produce up to 350 million cartridges per year, as Hakan has noted, with later addition of equipment and factories that have an annual capacity of about 2 billion cartridges"
Discuss results and "other Company developments"
MannKind Corporation to Hold 2013 Fourth Quarter and Full Year Financial Results Conference Call on February 18, 2014
MannKind Corporation February 4, 2014 5:00 PM
VALENCIA, Calif., Feb. 4, 2014 (GLOBE NEWSW
IRE) -- MannKind Corporation (MNKD) will release its 2013 fourth quarter and full year financial results on Tuesday, February 18, 2014 and its management will host a conference call to discuss the fourth quarter and full year financial results and other Company developments at 5:00 PM (Eastern Time) on February 18, 2014.
On Sept 15, 2008 Pfizer issued a press release entitled: MannKind and Pfizer Announce Collaboration for Certain Exubera Patients to Transition to MannKind's Inhaled Insulin Therapy (cann find press release by going to the Pfizer website and searching for Mannkind.
Thus it appears there are a body of patients that may have been on AFREZZA for over 5 years. One assumes if there were any ill effects they would have shown up by now.
Wonder what this is all about -
United States Patent (16) Patent No.: US 8,623,87 B2
Richardson et al. (44) Date of Patent: January 7, 2014
Method of treating Diabetes Type 2
By administering ultrarapid acting insulin
Assignee: Mannkind Corporation, Valencia, CA (US).
1/16/2014 January 15, 2014, MannKind Corp. Announces
Launch of AFREZZA
MannKind Corp. announced launch of AFREZZA. AFREZZA
is the ultra-acting insulin that will change the therapy of
diabetes. It's the first one that really significantly matches the
physiology of normal pancreatic insulin. It's had proven
reductions in HbA1c, which is the primary target of the Food
and Drug Administration. There is substantially lower risk of
hypoglycemia and probably what remains is not from
AFREZZA, less weight gain and probably even weight
neutrality, but people gain weight from other reasons. It's a
very small and discrete device to deliver it, and its
injection-free delivery. And we've had no safety signals that
we've seen of any kind, and we'll talk more about that later.
The first thing that needed is prandial control, but they don't
use it because of the deficiencies of current prandial insulins.
It's a very tiny little device, easy to use and no injection and
no indiscernible. It's breath-powered. Even a 4-year old child
can do it. Efficient delivery to the deep lung and hardly any
Should note each warrant allows you to buy ,6 of a share of Mannkind for 2.40 until 2916. So 10 warrants allows you to buy 6 shares of Mannkind for 2.40 a share. So with Mannkind at 5.83, each warrant has an intrinsic value of 2.058, if I did the math correctly. So you're paying a slight premium. But they are a better deal than the Jan 15 2.50 calls that are going for around 3.70.
A Step Back for MannKind?
MLV remains upbeat on diabetes drug Afrezza despite an AdCom meeting.
MannKind (MNKD: Nasdaq)
By MLV & Co. ($7.08, Jan. 10, 2014)
MannKind announced that the Food and Drug Administration has called for an April 1, 2014, Advisory Committee meeting to review Afrezza.
This comes as a surprise to us, as in our view, this adds a new level of regulatory risk to MannKind (ticker: MNKD) that we hadn't previously contemplated. After all, our view is that when it comes to Advisory Committees (AdComs), you just never know, but for perspective, we provide a concise review of 2005 AdCom for Exubera (for which there was a seven to two vote in favor of approval). At this stage, we remain confident not only in the phase III program that MannKind conducted for Afrezza, but also the data announced from the phase III trials last August. We'd expect the stock to be weak on this news, but given our positive view on Afrezza's approvability, we think this presents a buying opportunity.
We maintain a Buy rating on MannKind and $10 price target.
We're a bit surprised by the news, especially given a view that only novel mechanisms get reviewed and that there's precedent with the 2005 AdCom for Pfizer's (PFE) Exubera. That said, we're fully cognizant of the FDA's right to call an AdCom anytime it sees fit. In this case, given overall safety controversies with diabetes drugs in general (see GlaxoSmithKline's (GSK) Avandia), we think the FDA is just looking to cover its back. At the AdCom, we'd expect the FDA's outside body of experts to opine on Afrezza's efficacy and safety, and ultimately vote on approval. It is important to note, however, that the FDA is not bound by the advice of the panel.
We'd already viewed the April 15 Prescription Drug User Fee Act (PDUFA) as a major stock catalyst, given its binary nature. Not only does the April 1 AdCom set up a new potential catalyst (given the binary outcome of a likely panel vote on a "yay" or "nay" on ap
This is from Barron's site. Not a subscriber so all I can over is this.
MannKind (MNKD: Nasdaq) By MLV & Co. ($7.08, Jan. 10, 2014) MannKind announced that the Food and Drug Administration has called for an April 1, 2014, Advisory Committee meeting to review Afrezza. This comes as a surprise to us, as ...
It is interesting to watch how people try to manipulate the stock price on this Board. Issues that were settled months ago get raised again. Simple facts get ignored. Doubts are planted with no basis in fact.
The nice thing about the stock market is like in a war facts generally triumph. People can create panic and if it works make short term profits. That's okay - have fun make some money. But in the end, facts will out. The FDA will make a decision on AFREZZA. It will probably come in April. You want to create doubt and say it will be later. OK. Doesn't really matter unless you are holding April calls. A safety panel is called for. Okay. Possibly explained by a new FDA official who is said to be much more cautious than his predecessor. Bureaucrats like to cover there behinds, especially ones new to their jobs. But facts are facts. Every study, EVERY study, has found AFREZZA to be safe. Every study has found it to be effective. The FDA has granted waivers to groups allowing use of AFREZZA. If there were negative effects, presumably the FDA would have withdrawn those waivers. Want to deny that okay. Myself, while I'm not adverse to making short term profits, I think for the long term this is a no brainer. By the way MNKDW is probably the best way to profit on MNKD. Those are warrants that expire in 2016. AFREZZA's fate will be settled by then. These Boards sometimes have useful information and posters who are just trying to spread fear and panic are usually pretty obvious. At any rate, facts are facts and time does tell.
Actually there is quite a lot of information available about the company. Even more about AFREZZA. You can even estimate the dilutive effects of the stock that has been issued and the options outstanding. To invest without doing due diligence IS stupid. But to ignore the results of due diligence is also stupid
It is interesting to watch people react to MNKD news. The safety panel is supposedly a negative because it is so close to April 15th date. One could view it as a positive as well. It is so close because it is going to be pro forma. Is AFREZZA dangerous, ineffective, or otherwise unsafe. So far every study, EVERY study, has found it to be safe and effective. In addition, the FDA has granted waiver for certain groups to use it NOW. If the FDA thought there was a real question about it being unsafe, would they have granted the waivers. Or if it were shown to be unsafe, why haven't the waivers been revoked?
From Seeking Alapha post:
Though it has yet to receive FDA approval (it's a low hurdle at this juncture in our opinion), many use it today through a special FDA waiver. This includes individuals and groups like the Junior Diabetes Research Foundation (or JDRF) which uses AFREZZA (bolus) in combination with insulin pumps (basal) to achieve results which virtually mimic the human body. This is an astonishing feat and these results are independent from the studies MannKind has successfully completed. Many AFREZZA users are also active on message boards and other venues discussing their pleasing experience and desire to continue using AFREZZA.
MannKind Corporation (NASDAQ:MNKD), the $1.66 billion market capped development stage biotech has another research and development cap in its crown as of January 2 this year. This was in the form of a new patent being granted to cover its new target compound “which directly inhibit IRE-1.alpha activity in vitro, prodrugs, and pharmaceutically acceptable salts thereof”. This proprietary compound was developed by seven co inventors and the patent rests with MannKind Corporation (NASDAQ:MNKD). MannKind Corporation (NASDAQ:MNKD) shares closed at $5.47 on last trade day, by losing -2.23%. Stock 52 week range is $2.34 – $8.70. Company’s market capitalization is $1.96 billion.
Well if the NSA would just tell us who Dr. Mann and MNKD's General Counsel are calling amd being called by, we could figure out who MNKD is going to partner with. Metadata could be very useful in this endeavor.