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Mannkind, Game-Chancer in Sachen Diabetik?


ISIN: US56400P7069 | WKN: A2DMZL | Symbol: MNKD
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Bald steht die Entscheidung an ob das zu inhalierende Insulin von Mannkind von der FDA zugelassen wird und aufgrund der nadelfreien Anwendung könnte es ein Game-Chancer werden:

Mannkind ...Afrezza approval is a good bet 15 comments
Jan 7, 2011 5:19 PM | about stocks: MNKD
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Share0 Mannkind is a pharmaceutical company with one product close to approval, Afrezza, an inhaled insulin. In my opinion, Afrezza will be approved around January 21, 2011. The FDA is concerned with safety, efficacy, and clinical need.

1) Let's examine efficacy first. In several major trials spanning thousands of patients and almost a decade, Afrezza has shown that HBA1C, i.e. blood glucose level over an average period of time, was as good as rapid acting injected insulin, i.e. lispro. Primary end points of all of these trials were met. Importantly, all of the secondary end points were also met. Afrezza usage was characterized by substantially fewer hypoglycemic events, lower post prandial glucose (PPG), lower fasting blood glucose (FBG), and less weight gain and even weight loss. A recent study also shows that Afrezza works in a different way than lispro such that Afrezza is safer because efficacy is maintained without hypoglycemia regardless of carbohydrate intake at meal time. This will require more study; but it is important.

2) Now let's examine safety. Does Afrezza result in significantly lower lung function over time? Four years of trial data show that the old inhaler resulted in lower lung function than the control group, but that this lower lung function was not statistically significant. Recent data submitted to the FDA shows that the new inhaler actually results in no lung function difference; however, the trial was very short term. More studies will be need to show this. Either way, the trial end points were met. The second question is does Afrezza cause tumors and is there residual insulin buildup in the lungs? Two studies (106 and 52 week rat and mouse studies) and patient CT scans revealed no tumor or carcinogenic effect or surfactant action or insulin buildup. Finally, does Afrezza adversely impact cardio function? QT trial data showed that Afrezza causes no QT delay.

3) Patient need? One of the biggest issues with injected insulin is patient compliance. There are several issues. Many patients have difficulty with the rigors of carb counting, injection and glucose monitoring. The bottom line is that patients who take Afrezza will tend to remain more compliant because all of these are less difficult while using Afrezza. That's a big big, really really good thing in the diabetes world. Furthermore, because injected insulin peaks too late after meal time and remains in the system at higher levels than needed long after the meal is digested, patients are prone to hypoglycemia. Afrezza solves this problem by peaking early during the meal and moving out of the system after three hours.

4) In March 2010, Mannkind received a CRL in which the FDA asked for clarification as to how Afrezza fits into the armamentarium of diabetes treatment. The FDA asked that the bioequivalency trial data comparing inhalers be resubmitted ina new format. The FDA also asked for certain packaging label clarification. The FDA did not ask for new efficacy or safety data. Indeed, this was a CRL "light" so to speak. Mannkind met with the FDA June 2010 and submitted a class 2 resubmission which the FDA typically handles in about 6 months. Now the FDA in December stated that it would need about four more weeks in order to make a decision, but did not ask for more data. January 21, 2011 is about 6 months after the FDA originally accepted the resubmission. That is a good sign.

It's not easy to predict FDA approvals, but it could be worth it here because many people are still skeptical, meaning that if Afrezza is approved the stock could increase in price substantially. Increasing that return could be a partnership which Al Mann (Mannkind's billionaire CEO, COB and 43% owner) has stated will probably happen after approval. This could be a very good time to own Mannkind shares.

JR

Themes: biotech, diabetes, insulin, inhaler, pharmaceutical, drug Stocks: MNKD
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Antwort auf Beitrag Nr.: 40.838.712 von Magnetfeldfredy am 11.01.11 13:02:26Heute gibts eine spannende Webcast Präsentation von Mannkind,kurz vor der Entscheidung:

MannKind to Present at the JP Morgan 29th Annual Healthcare Conference

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{"s" : "mnkd","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: MannKind Corporation On Tuesday January 4, 2011, 5:21 pm EST

VALENCIA, Calif.--(BUSINESS WIRE)-- MannKind Corporation (Nasdaq:MNKD - News), focused on discovering, developing and commercializing treatments for diabetes and cancer, announced today that it will present at the JP Morgan Healthcare Conference on Wednesday, January 12, 2011 at 3:00 PM (PT) at the Westin St. Francis Hotel in San Francisco, California.



Interested parties can access a link to the live webcast of the presentation from the News & Media section of the Company's website at http://www.mannkindcorp.com.



About MannKind Corporation



MannKind Corporation (NASDAQ:MNKD - News) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its diabetes pipeline includes AFREZZA® and MKC253. MannKind has submitted a NDA to the FDA requesting approval of AFREZZA for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. MKC253 is currently in phase 1 clinical trials. Other products in MannKind's pipeline include the cancer immunotherapy platform MKC1106, which is currently in phase 2 clinical trials. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website.
Welche Umsatzerwartung hat MannKind denn?
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Antwort auf Beitrag Nr.: 40.850.084 von sdaktien am 12.01.11 19:09:17Der Rapid Acting Insulin Analoga (RAA) Markt hat gegenwärtig ein Volumen von ca. $9Bio. Afrezza als Ultra Rapid Acting Insulin sollte diesen Markt aufrollen.
Hinzu kommt die grosse Anzahl von Diabetikern im Anfangsstadium, welche kein Insulin spritzen obwohl sie es sollten und damit die Krankheit verschlimmern. Hier ergibt sich ein zusätzlicher Markt, der anscheinend sehr gross sein soll.
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Antwort auf Beitrag Nr.: 40.850.326 von logel am 12.01.11 19:40:00Einen Hinweis auf die Umsatzerwartung bietet die Danbury-Fabrik von Mannkind, welche auf $4Bio Umsatz/Jahr ausgelegt ist und langfristig nur die USA abdecken soll. 2016 ist laut Al Mann die nächste Fabrik geplant, falls die firmeneigenen Umsatzschätzungen zutreffen. Ansonsten weitere Fabriken in verschiedenen Ländern der Welt.
Man beachte dass diese Fabrik bereits steht und von Mannkind finanziert und betrieben wird, nicht von einem Big Pharmapartner wie sonst meist üblich.
Eine gewisse Zuversicht in den Erfolg von Afrezza seitens der Firma ist hier nicht zu übersehen.
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Antwort auf Beitrag Nr.: 40.850.426 von logel am 12.01.11 19:53:39Sehe ich genauso und sehe Mannkind als Game-Chancer in Sachen Diabetik!:eek:
Jetzt fehlt nur noch die überfällige Zuslassung und ich rechne mit einer Vervielfachung des Kurses, vielleicht nicht gleich nach der Zulassung sondern nach Bekanntgabe des big Pharma Partners, Merck?:look:
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Antwort auf Beitrag Nr.: 40.851.748 von Magnetfeldfredy am 12.01.11 22:56:59Jan. 12, 2011, 11:28 p.m. EST

MannKind CEO bets big on diabetes drug
Mann has contributed over half of $1.5 billion used on AfrezzaExplore related topics
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|Recommend PrintEmail AlertBy John Letzing, MarketWatch
SAN FRANCISCO (MarketWatch) — MannKind Corp. Chief Executive Alfred Mann has poured a considerable amount of his personal fortune into developing the company’s inhaled insulin treatment for diabetes, contributing well over half of the $1.5 billion invested in the drug so far.

The insulin treatment, Afrezza, is expected to receive a decision on approval from the U.S. Food and Drug Administration later this month.

New chapter for insulinDr. Alfred Mann, CEO of Mannkind Corp., has developed an inhaled form of insulin, which the FDA is expected to decide on later this month. The product, called Afrezza, would be a major breakthrough in diabetes care, as it would greatly reduce the need for needles.
The FDA informed MannKind /quotes/comstock/15*!mnkd/quotes/nls/mnkd (MNKD 9.01, -0.03, -0.33%) late last month that it needed to delay for roughly four weeks its decision on the highly-anticipated treatment, which could provide an inhaled alternative to insulin injections for diabetes patients.

Mann said he’s cautiously optimistic that Afrezza will be approved.

“I have personally invested $925 million of the $1.5 billion that’s been invested in this product,” Mann said during an interview on Wednesday.

Afrezza could be a blockbuster for MannKind, said Mann, who noted that the company has no other commercialized products.

MannKind has in “the order of ten” other products in development, the CEO said, though “they’re years away.”

While other companies have made ill-fated forays into inhaled insulin in the past, including Pfizer Inc. /quotes/comstock/13*!pfe/quotes/nls/pfe (PFE 18.36, -0.01, -0.05%) , Mann said his firm’s treatment is distinguished by its ease of use and effectiveness.

“The only thing Pfizer had was an inhalation which frankly was in a large, inconvenient mechanism that had to be done multiple times, was expensive, and didn’t produce results as good as what you get with injections,” Mann said.

Mann said that delays from the FDA on drug approvals are not uncommon.

During a presentation at the JP Morgan Healthcare Conference in San Francisco later on Wednesday, Mann told an audience that while MannKind has not received specific reasons from the FDA for its delay in deciding on Afrezza, he assumes that it’s attributable to a slowdown during the recent holiday season.

“My guess is they just didn’t have it all done, given the holidays,” Mann said. “They’re being very, very thorough, as they should be.”

Mann previously founded MiniMed Inc., a diabetes therapy developer sold for $3.7 billion to Medtronic Inc. /quotes/comstock/13*!mdt/quotes/nls/mdt (MDT 36.70, +0.18, +0.49%) in 2001.

Last year, Forbes listed Mann as one of the world’s wealthiest individuals, with an estimated net worth of $1.4 billion.
John Letzing is a MarketWatch reporter based in San Francisco.
Mmh. Also die FDA hat die Zulassung um 4 Wochen rausgezögert, was ja nichts bedeuten muss. Warum ist wahrscheinlich nicht zu erfahren, oder?

Der CEO macht aber (schonmal?) drauf aufmerksam, dass man ja noch andere Produkte in der Pipeline hätte.

Zu wünschen wäre, dass die Zulassung durchkommt, denn bislang hat man nur Verluste erzielt.
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Antwort auf Beitrag Nr.: 40.856.162 von sdaktien am 13.01.11 16:10:42Mannkind steht und fällt mit Afrezza, und Alfred Mann, ein Genie, weiß das besser als wir zusammen, inhalierbares Insulin mit super Effektivität und guter Sicherheit kann ein Game-Chancer werden und so was gibts nicht alle Jahre! Hopp oder top!:rolleyes:
Die Börse siehts ja positiv. Dem könnte natürlich ein "sell the facts" Folgen, also der Verkauf von Papieren, wenn die Meldung endlich da ist (wie auch immer die ausfällt).
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