MNKD Patents

[mango]

Robin Offord of Mintaka Foundation speaking about MannKind and inhaled oxytocin at the Global Healthcare Innovation Academy on August 26, 2016 start @ 40:00. They won Third Place & People's Choice Award

[peppy]

Sept 18, 2019 7:54:48 GMT -5 mango said:

Robin Offord of Mintaka Foundation speaking about MannKind and inhaled oxytocin at the Global Healthcare Innovation Academy on August 26, 2016 start @ 40:00. They won Third Place & People's Choice Award

I watch what is going on, the homeless, the social security cut back talk, the senate majority leader.
I don't really believe the world wants to help the 3rd worlds maternal pregnancy problems.
So, in a sense, it is all lip service.
In this country we have refrigeration and oxytocin is available. 
What color is your skin?

[mango]

Sept 18, 2019 8:11:22 GMT -5 peppy said:

Sept 18, 2019 7:54:48 GMT -5 mango said:

Robin Offord of Mintaka Foundation speaking about MannKind and inhaled oxytocin at the Global Healthcare Innovation Academy on August 26, 2016 start @ 40:00. They won Third Place & People's Choice Award

I watch what is going on, the homeless, the social security cut back talk, the senate majority leader.
I don't really believe the world wants to help the 3rd worlds maternal pregnancy problems.
So, in a sense, it is all lip service.
In this country we have refrigeration and oxytocin is available. 
What color is your skin?

In the video Robin Offord details what the economics are and what the manufacturing costs would be. It would be extremely cheap to produce it and a ROI would be seen rather quickly, all while helping solve a serious unmet medical need. 

I agree, no one wants to help. 

[mango]

Some 98% of our formulation of oxytocin survives 8 months at 40°C, and the inhaler has proved a highly efficient means of delivery. The next step is to design and then execute a clinical safety trial in a developed county (medicines should not be safety-tested on fragile populations). If our expectation that there will be no safety issues proves justified, the way will then be open to forming a product development partnership to take the product to market.

www.mintakafoundation.org/our-projects/maternal-health/

[paul]

Johnson and Johnson are also working on inhaled oxytocin: www.jnj.com/johnson-johnson-joins-forces-with-monash-university-led-partnership-to-advance-novel-technology-aimed-at-saving-lives-of-women-in-child-birth

"Formulated as a dry powder, inhaled oxytocin would eliminate the need for refrigerated storage conditions, while delivering oxytocin via a powder inhaler could ease its administration allowing for its use by frontline health workers, birth attendants and mothers themselves."

A phase 1 trial was completed a couple of years ago -- www.oindpnews.com/2017/03/positive-results-for-phase-1-study-of-inhaled-oxytocin -- but for some reason it hasn't any further forward since.

[mango]

New MannKind Granted Patent 9/24/2019


Microcrystalline diketopiperazine compositions and methods

Abstract: Disclosed herein are DKP microcrystals made by an improved method where they do not irreversibly self-assemble into microparticles. The microcrystals can be dispersed by atomization and re-formed by spray drying into particles having spherical shell morphology. Active agents and excipients can be incorporated into the particles by spray drying a solution containing the components to be incorporated into microcrystalline diketopiperazine particles. In particular, the microcrystalline particle compositions are suitable for pulmonary drug delivery of one or more peptides, proteins, nucleic acids and/or small organic molecules.

Assignee: MannKind Corporation
Inventors: Bryan R. Wilson, Joseph J. Guarneri, Marshall L. Grant


patents.justia.com/patent/10421729

[mango]

New MannKind Patent Application Published 9/26/2019 (looks like a continuation/priority patent)


METHOD OF DRUG FORMULATION BASED ON INCREASING THE AFFINITY OF CRYSTALLINE MICROPARTICLE SURFACES FOR ACTIVE AGENTS

Abstract: Methods are provided for coating crystalline microparticles with an active agent by altering the surface properties of the microparticles in order to facilitate favorable association on the microparticle by the active agent. Types of surface properties that are altered by the disclosed methods include electrostatic properties, hydrophobic properties, and hydrogen bonding properties.


Assignee: MannKind Corporation
Inventors: Keith A. Oberg, Joseph Sulner, Marshall L. Grant


patentscope.wipo.int/search/en/detail.jsf?docId=US252244373&_cid=P12-K12E39-05328-1

[mango]

New MannKind Patent Application Published 10/10/2019


Use of Ultrarapid Acting Insulin

Application Date:
16.04.2019

Publication Date:
10.10.2019

Applicants:
MannKind Corporation

Inventors:
Anders Hasager Boss
Richard Petrucci

Abstract:
Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.



patentscope.wipo.int/search/en/detail.jsf?docId=US254124818&_cid=P22-K1TLHN-25227-1

[churchmouse]

Has Afrezza been granted the designation of Ultra rapid?  

[mango]

Oct 16, 2019 14:04:35 GMT -5 churchmouse said:

Has Afrezza been granted the designation of Ultra rapid?  

Nope

[uflawdog]

Patent applicants are free to be their own lexicographers. They can use whatever terms they choose so long as any special meaning assigned to a term is clearly set forth in the specification.  Link.  Also, it would be a stretch to call a patent application an advertisement under FDA guidelines.  Link.

[mango]

METHOD FOR IMPROVING THE PHARMACEUTIC PROPERTIES OF MICROPARTICLES COMPRISING DIKETOPIPERAZINE AND AN ACTIVE AGENT

Application Date:
26.06.2019

Publication Date:
17.10.2019

Applicants:
MannKind Corporation

Inventors:
Bryan R. Wilson
Marshall Grant

Abstract:
Methods are provided for drying a particle. Specifically, there is provided a spray-dried diketopiperazine-insulin particle formulation having improved aerodynamic performance and in which the active agent is more stabile and efficiently delivered as compared to that of the lyophilized diketopiperazine-insulin formulation. The dry powders have utility as pharmaceutical formulations for pulmonary delivery.



patentscope.wipo.int/search/en/detail.jsf?docId=US254716882&_cid=P20-K20PJD-01839-1


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5. The inhalable dry powder of claim 1, wherein the active agent is insulin, calcitonin, parathyroid hormone 1-34, bioactive fragment of parathyroid hormone, octreotide, leuprolide, RSV peptide, felbamate, cannabinoid antagonists and/or agonists, muscurinic antagon and/or agonists, heparin, low molecular weight heparin, cromolyn, sildenafil, vardenafil, tadalafil, growth hormone, AZT, DDI, GCSF, lamotrigine, chorionic gonadotropin releasing factor, luteinizing release hormone, .beta.galactosidase, GLP-1, exendins 1-4, or ghrelin.

6. The inhalable dry powder of claim 1, wherein the active agent is a peptide or protein.

7. The inhalable dry powder of claim 1, wherein the active agent is vardenafil or an analogue thereof.

8. The inhalable dry powder of claim 1, further comprises a stabilizing agent.

9. The inhalable dry powder of claim 8, wherein the stabilizing agent is sugars, surface modifying agents, surfactants, hydrophobic amino acids such as tryptophan, tyrosine, leucine, phenylalanine, pharmaceutical carriers, excipients or a combinations thereof.

10. The inhalable dry powder of claim 1, wherein the one or more pharmaceutical acceptable carriers are fructose, galactose, glucose, D-mannose, sorbose, lactose, trehalose, raffinose, maltodextrins, glycine, sodium citrate, tromethamine hydrochloride, human serum albumin, mannitol or a combinations thereof.

[mango]

4 New Ones...Special close attention to #3 and the inventors...


1) DIKETOPIPERAZINE MICROPARTICLES WITH DEFINED ISOMER CONTENT

Application Date:
11.06.2010

Publication Date:
23.10.2019

Applicants:
MANNKIND CORP

Inventors:
SOMERVILLE KARLA
KRAFT KELLY S

Abstract:
Disclosed herein are fumaryl diketopiperazine (FDKP) compositions and microparticles having a specific trans isomer content of about 45% to about 65%. The FDKP microparticles can be used as a delivery system for drugs or active agents in the treatment of disease or disorders, for example, those of endocrine origin, including diabetes and obesity.

patentscope.wipo.int/search/en/detail.jsf?docId=EP260717302&tab=NATIONALBIBLIO&_cid=P11-K2EZ3G-20049-1



2) COMPOSITION AND METHOD FOR INHALATION

Application Date:
07.06.2019

Publication Date:
24.10.2019

Applicants:
MannKind Corporation

Inventors:
Joseph J. Guarneri
Nikhil Amin
Marshall L. Grant
John J. Freeman
Kelly S. Kraft

Abstract:
A prostaglandin composition and method for treating pulmonary arterial hypertension is disclose. The composition is based on diketopiperazine for pulmonary inhalation.


patentscope.wipo.int/search/en/detail.jsf?docId=US260703981&tab=NATIONALBIBLIO&_cid=P11-K2EZ3G-20049-1



3) METHOD AND COMPOSITION FOR TREATING OBESITY

Application Date:

Publication Date:
31.10.2019

Applicants:
MANNKIND CORPORATION

Inventors:
CASTAGNA, Michael
KENDALL, David
KRAFT, Kelly
SMUTNEY, Chad, C.
GRANT, Marshall

Abstract:
A method for treating obesity associated to Prader Willi Syndrome and/or binge eating is disclosed. The method utilizes a rapid drug delivery system which delivers small molecules and peptides to the lungs by oral inhalation.


patentscope.wipo.int/search/en/detail.jsf?docId=WO2019210083&_cid=P11-K2EZ3G-20049-1



4) APPARATUS, SYSTEM AND METHOD FOR DETECTING AND MONITORING INHALATIONS

Application Date:

Publication Date:
31.10.2019

Applicants:
MANNKIND CORPORATION

Inventors:
POCREVA III, John, J.
ADAMO, Benoit
LAURENZI, Brendan
SMUTNEY, Chad, C.
KINSEY, Spencer, P.

Abstract:
Described herein are an interactive apparatus and methods for sensing and measuring real-time characteristic patterns of a subject's use of a dry powder inhalation system. The inhaler device can be used in a wireless communication mode to communicate with a display to assess the subject's usage of the inhalation system concurrently as the inhalation is performed and thus the subject's inhalation can be evaluated as well as the performance of the inhalation system. The system can also detect the identity of the medicament, its dosage, lot, expiration, etc. and the characteristic profile of a dry powder formulation emitted from the inhalation system in use and allows effective delivery of powder doses. Data obtained can be transmitted to a digital application and can be analyzed for optimal therapeutic utility.


patentscope.wipo.int/search/en/detail.jsf?docId=WO2019209994&_cid=P11-K2EZ3G-20049-1

[peppy]

patentscope.wipo.int/search/en/detail.jsf;jsessionid=68B84616414079E0863AFC49F254B673.wapp2nB?docId=WO2019210083&tab=PCTDESCRIPTION

The application date is missing.
Edit: Publication Date: 31.10.2019  International Filing Date: 25.04.2019


Formula

and an peptide hormone, including, amylin, an amylin analog, or an amylin mimetic, including, Symlin® or pramlintide acetate, and administering to the subject the dry powder composition from an oral dry powder inhaler. In this embodiment, the dry powder composition can be administered either alone, and/or in combination with a dry powder composition comprising insulin and fumaryl dikepiperazine. In certain embodiments, a combination therapy with insulin comprises administering an insulin composition separately, subsequently, or concurrently with the Pramlintide administration, wherein the insulin composition is a rapid acting insulin for rapidly reducing blood glucose levels, and wherein the subject’s hyperglycemia can be more tightly control. In this embodiment, blood glucose levels in the subject to be treated are greater than 120 mg/dL, or greater than 140 mg/dL and the insulin can be administered by inhalation or by other routes of administration.

===========================================================================

"Amylin is a peptide hormone that is cosecreted with insulin from the pancreatic β-cell and is thus deficient in diabetic people. It inhibits glucagon secretion, delays gastric emptying, and acts as a satiety agent."

diabetes.diabetesjournals.org/content/53/suppl_3/S233

[mango]

New MannKind Patent Application Published 11/07/2019


HIGH CAPACITY DIKETOPIPERAZINE MICROPARTICLES AND METHODS

Abstract: Disclosed herein are diketopiperazine microparticles having high capacity for adsorbing a drug or active agent. In particular, the diketopiperazine microparticle are formed using fumaryl diketopiperazine and can comprise a drug in large doses for the treatment of disease or disorders by pulmonary delivery via oral inhalation.

Type: Application
Filed: June 26, 2019
Publication date: November 7, 2019
Applicant: MannKind Corporation
Inventors: Marshall Grant, Paul Menkin, Grayson W. Stowell


patents.justia.com/patent/20190336606



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9. An inhalable dry powder of claim 1, wherein the drug or active agent is a vasoactive agent, neuroactive agent, hormone, anticoagulant, immunomodulating agent, cytotoxic agent, antibiotic, antiviral agent, antigen, infectious agent, inflammatory mediator, hormone, cell surface antigen, cytokine, lipokine, enkephalin, alkyne, cyclosporin, anti-IL-8 antibodie, IL-8 antagonist including ABX-IL-8; prostaglandin including PG-I2, LTB receptor blocker including LY29311, BIIL 284 and CP105696, triptan such as sumatriptan and palmitoleate, insulin and analogs thereof, growth hormone and analogs thereof, parathyroid hormone (PTH) and analogs thereof, parathyroid hormone related peptide (PTHrP), oxytocin, leuprolide, interferon-alpha, RGD peptide, DDAVP peptide, GHR peptide, detirelex human growth hormone, albumin, cyclosporine, ghrelin, obestatin, enterostatin, granulocyte macrophage colony stimulating factor (GM-CSF), granulocyte colony stimulating factor (GCSF), amylin, amylin analogs, glucagon-like peptide 1 (GLP-1), clopidogrel, PPACK (D-phenylalanyl -L-prolyl-L-arginine chloromethyl ketone), oxyntomodulin (OXM), peptide YY(3-36) (PYY), adiponectin, cholecystokinin (CCK), secretin, gastrin, glucagon, motilin, somatostatin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), IGF-1, growth hormone releasing factor (GHRF), integrin beta-4 precursor (ITB4) receptor antagonist, nociceptin, nocistatin, orphanin FQ2, calcitonin, CGRP, angiotensin, substance P, neurokinin A, pancreatic polypeptide, neuropeptide Y, delta-sleep-inducing peptide or vasoactive intestinal peptide.

10. An inhalable dry powder of claim 1, wherein the drug or active agent is a neurotransmitter agonist, a neurotransmitter antagonist, a pain inhibitory agent, a vaccine, an anti-inflammatory agent, an anti-cancer agent, a cell receptor agonist molecule, a cell receptor antagonist molecule, an immunosuppressant, a statin, or an anti-infective agent.