Mannkind vor Explosion?

https://finance.yahoo.com/news/...mannkind-corporation-141800891.html  

Zweite Arznei in der Pipline die in klinische Studie geht:

https://finance.yahoo.com/news/...s-enrollment-phase-1-210100931.html  

Weiß noch nicht recht was ich davon halten soll! auf der einen Seite natürlich cool, dass MNKD das nächste Produkt anstrebt. Jedoch erst in Phase 1. d.h.geht noch X-Jahre und auch dieses Produkt wird wieder die Kohle auffressen bis es auf den Markt kommt. Jedoch benötigen wir diese für Afrezza! hmm... wie weiter?  

https://expertgazette.com/2018/03/12/...soar-to-7-in-a-year-analysts/  

bin echt mal gespannt wan hier der Dreck endlich mal steigt,also so etwas hab ich noch nie erlebt so wie hier manipuliert wird ohne worte  

 

So, da hat Mannkind nun wohl eine zweite Substanz in der Mache.

Irgendwie haben die Verantwortlichen bei Mannkind ein Talent, sich mit ihrem Therapieangebot Erkrankungen auszusuchen die nicht so recht passen.

Eine Inhalation, als Applikationsweg eines Medikamentes, bei Pulmonaler Hypertonie anbieten zu wollen ist schon sehr optimistisch.

Eines der größten Probleme dieser Patienten ist die Dispnoe (Atemnot), also Kurzatmigkeit.
Dies betrifft 60-100% der Patienten, je nach Stadium der Erkrankung.

Es gibt hier zwei große Gruppen (von 5 WHO Einteilungen) bei der PH
(1.) pulmonal arteriellen Hypertonie und PH aufgrund Linksherzerkrankung.
(2.) chronisch obstruktive und fibrosierende Lungenerkrankungen die zu einer PH führt.

Wie man bei solch einem Klientel eine Therapie in Erwägung zieht, die auf eine gute Resorption des Wirkstoffes über die Atemwege angewiesen ist, kann ich nicht nachvollziehen.

Nun, warten wir´s mal ab.

Wen das Thema interessiert......
http://flexikon.doccheck.com/de/Pulmonale_Hypertonie#WHO-Einteilung

https://www.aerzteblatt.de/archiv/186048/Pulmonale-Hypertonie

http://flexikon.doccheck.com/de/...mboembolische_pulmonale_Hypertonie

 

http://markets.businessinsider.com/news/stocks/...offering-1020653402  

und wie die Idioten hier alle gleich Übertreiben echt zum Kotzen..die Amis lachen sich einen ab  

 

https://seekingalpha.com/news/...cent-fda-clears-risk-hurdles-afrezza  

Riesenschritt in Richtung bessere Vermarktung, bessere Versicherungsabdeckung, bessere Ärzteüberzeugung, Verpartnerung ........ die Kinderstudie ist viel einfacher..... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 022472/S-017 SUPPLEMENT APPROVAL MannKind Corporation Attention: Robyn Walsh, M.S. Senior Manager, Regulatory Affairs One Casper Street Danbury, CT 06810 Dear Ms. Walsh: Please refer to your supplemental New Drug Application (sNDA) dated and received April 19, 2018, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Afrezza (insulin human) inhalation powder. This Prior Approval sNDA provides for proposed modifications to the approved Afrezza risk evaluation and mitigation strategy (REMS). This supplement is in response to our April 17, 2018, REMS Modification Notification letter. We have completed our review of this supplemental application. It is approved effective on the date of this letter. RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS The REMS for Afrezza (insulin human) inhalation powder was originally approved on June 27, 2014, and the most recent REMS modification was approved on April 20, 2015. The REMS consists of a communication plan and a timetable for submission of assessments of the REMS. In order to minimize burden on the healthcare delivery system of complying with the REMS, we determined that you were required to make the REMS modifications outlined in our REMS Modification Notification letter dated April 17, 2018. Communication Plan: We have determined that the communication plan is no longer necessary as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder outweigh its risks because the communication plan has been completed and the most recent assessment demonstrated that the communication plan has met its goals. No further assessments are necessary to assess the current communication plan. Therefore, because the communication plan is no longer necessary to ensure the benefits of the drug outweigh the risks, a REMS is no longer required for Afrezza (insulin human) inhalation powder. Reference ID: 4252859 NDA 022472/S-017 Page 2 REQUIRED PEDIATRIC ASSESSMENTS Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients (which includes new salts and new fixed combinations), new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable. Because none of these criteria apply to your supplemental application, you are exempt from this requirement. REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81). If you have any questions, call Michael G. White, Ph.D., Regulatory Project Manager, at (240) 402-6149. Sincerely, {See appended electronic signature page} Jennifer Rodriguez Pippins, M.D., M.P.H. Deputy Director for Safety Division of Metabolism and Endocrinology Products Office of Drug Evaluation II Center for Drug Evaluation and Research

Das kann der langersehnte Turnaround werden!  

Was denkt Ihr?
Kommt es diese Woche zu zum grossen Plus?

Danke  

Zulassung Brasilien, wichtig für evtl. weltweiten Vertriebspartner, Brasilien hat 12, 5 Millionen Diabetiker, 1 % auf Afrezza und 100.000 Leute

... (automatisch gekürzt) ...

https://www.globenewswire.com/news-release/2019/...ved-in-Brazil.html

 

MannKind Presents Positive Afrezza® Clinical Data from Three Studies at ADA 79th Scientific Sessions
GlobeNewswire•June 9, 2019

WESTLAKE VILLAGE, Calif., June 09, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (MNKD) announced that new data from three different studies of Afrezza® (insulin human) Inhalation Powder were released at the American Diabetes Association’s 79th Scientific Sessions, being held June 7-11, in San Francisco, California.

Poster 1350-P:   Safety and Pharmacokinetics of Technosphere Insulin in Pediatric Patients

MannKind will present a poster with initial information from its ongoing study of Safety and Pharmacokinetics of Technosphere Insulin (Afrezza) in Pediatric Patients ¹ on Monday, June 10.  This study is the first step in preparation for a phase 3 safety and efficacy study.

Poster Highlights:                        

   In pediatric patients, the rapid rise in insulin concentrations corresponded with early postprandial glucose control within the first hour post-dose. The profile is similar to that previously observed in adults.
   Consistent with its safety profile in adults, Afrezza was generally well-tolerated in pediatric patients; most treatment emergent adverse events were of mild severity, and no severe hypoglycemia was observed.
   These data will help guide the finalization of the protocol for a phase 3 safety and efficacy study.

“We are excited to share the progress of the ongoing pediatric study program,” said David Kendall, M.D., Chief Medical Officer of MannKind. “As is well known, type 1 diabetes is often diagnosed in children and adolescents, and these individuals will continue to require insulin therapy throughout their lives. Evaluating as quickly as possible the potential use of Afrezza in children and adolescents as an option for mealtime insulin therapy is a top priority for MannKind.”

Poster 136-LB:   Effective Treatment of T2D Patients Uncontrolled on Multiple Diabetes Medications by Adding Afrezza® Mealtime Ultra-Rapid Insulin

Dr. Philip Levin and colleagues presented data from an independent study supported and funded by MannKind. Dr. Levin presented late-breaking clinical data on interim results of a study² showing how a fixed titration schedule can be implemented to achieve better time in range and reduction of overall A1c.

Late Breaking Poster Highlights:

   Enrolled adult patients with uncontrolled type 2 diabetes on two or more therapies (orals/ basal/ GLPs) – with the addition of Afrezza at all meals by means of a rapid and ongoing titration protocol
   Observed a mean decrease in A1c of ~1.6% (all subjects with A1c reduction over 12 weeks of study)
   93% (13 of 14 subjects) achieved A1c below 8% (mean baseline A1c 9.1%)
   Reduced hyperglycemia (>250mg/dL) by 74%
   Increased time in range more than 75%; daily glucose decreased by ~50 mg/dL as measured by blinded continuous glucose monitoring
   No significant difference in rates of hypoglycemia with the addition of Afrezza

“We are pleased to share the interim analysis from our independent investigator-initiated trial of Afrezza therapy. These preliminary data significantly advance our understanding of the potential clinical benefits and practical use of Afrezza therapy for those living with type 2 diabetes,” stated Philip Levin, M.D. of Bay West Endocrinology Associates and MODEL Clinical Research in Baltimore, MD. “Data generated to this point are encouraging and support the use of Afrezza as prandial therapy earlier in the treatment of type 2 diabetes.”

Oral Abstract
151-OR: Technosphere Insulin Provides Better Early Postprandial Glucose Control than Subcutaneous Rapid-Acting Analog

MannKind investigators also shared data at an oral presentation³ using mixed meal tolerance testing to assess glucose control, Afrezza dosing and overall safety in a cohort of individuals with type 1 diabetes.

Oral Presentation Highlights:

   When compared to rapid acting injected insulin, Afrezza provided significantly better glucose control in the first two hours following the meal.
   Even when adjusting the dose of Afrezza using up to two times the dose of injected insulin aspart, Afrezza treatment was associated with lower rates of overall and level 2 hypoglycemia - an observation that was particularly evident in the late (>2 hour) post-meal period.

Dr. Anne Peters, Clinical Professor of Medicine at the Keck School of Medicine at USC and Director of the USC Westside Center for Diabetes Care noted that “the improved post-meal glucose levels and lower rates of low blood sugars seen in this study of individuals with type 1 diabetes support my growing clinical experience. The presentation of these data provides further evidence that proper dosing of Afrezza has the potential to safely and effectively get more patients into target range at meal times.”

About Afrezza®

Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.  Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration.  Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels.  For Afrezza doses exceeding 12 units, patients ma  

....mal schauen , wie hoch es heute geht  

was der Tag bringt  

 

https://www.nasdaq.com/symbol/mnkd/real-time  

https://www.nasdaq.com/symbol/mnkd/real-time  

..keine Ahnung  

Aber ich kann es nicht fassen, dass es noch Leute gibt, die an Afrezza glauben.
Dieses Insulin wird nie eine relevante Rolle am Markt spielen.

Die können noch so viele Zulassungen in verschiedenen Ländern erhalten.

Afrezza scheitert nicht an mangelnden Zulassungen, es scheitert an mangelnder Praktikabilität.
Allein die Dosierung ist schon ein Problem, absolut nicht fein genug für viele Typ1er.
Für Typ2er ist prandiales Insulin ohnehin nicht das Mittel der ersten Wahl, da gibt es inzwischen viele Alternativen, die super funktionieren.
Zudem ist die Applikation für viele ältere Typ2er indiskutabel.

Ich verstehe nicht, wie man hier noch auf einen Durchbruch hoffen kann.
Afrezza spielt in Fachkreisen absolut keine Rolle.  

840333  

 

Die UTHR Kooperation schreitet super voran, wieder 12,5 Milionen US Dollar Milestones:

MannKind Receives Second $12.5 Million Milestone Payment From United Therapeutics
GlobeNewswire•November 4, 2019

WESTLAKE VILLAGE, Calif., Nov. 04, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (MNKD) today announced that it has achieved the second of four specified development milestones under its licensing and collaboration agreement with United Therapeutics for the development and commercialization of a dry powder formulation of treprostinil.  Treprostinil Technosphere (“TreT”) is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension.  Pursuant to the agreement, MannKind is eligible to earn additional milestone payments up to $25 million upon the achievement of other defined development milestones.  MannKind will also be entitled to receive low double-digit royalties on net sales of TreT.

About MannKind Corporation

MannKind Corporation (MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S.

For further information, visit www.mannkindcorp.com.

Company Contact:
818.661.5000
ir@mannkindcorp.com