This conference call WAS different

[mnholdem]

Finally! We hear specific plans for ramping up the Technosphere pipeline. Thank you, Hakan!

Hakan Edstrom, MannKind's new CEO, stated that the criteria used for Technosphere-delivered drugs selection, presented and accepted by the Board of Directors, is as follows:

1. Drugs that meet an unmet medical need;
2. Drugs that have short development time / lower cost development;
3. Drugs that offer significant advantage via Technosphere inhalation;
4. Drugs that have large markets.

Hakan stated that MannKind is also in discussions with other companies regarding the development of their own API's, but he reminded everyone that MannKind is developing its own drugs, reminding listeners that "we are a product development company".

Three drugs markets / areas have been selected for Technosphere pipeline development and (this is important) Hakan stated that the API*  for each HAS ALREADY BEEN SELECTED:

1. Pulmonary
2. Pain
3. Oncology

So whadda 'ya know? Hakan talked to us about company developments regarding the Technosphere pipeline.

In addition, 4Q earnings were in line with expectations.

Excellent!

*API = Active Pharmaceutical Ingredient

[bradleysbest]

Don't know why I am not excited as you.....

[liane]

In starting with inhaled insulin, MNKD picked one of the hardest hardest drugs to develop on the Technosphere platform. These other applications should go a lot quicker.

[savzak]

I thought the call was fine. I thought they told us what they realistically could tell us. I thought what they told us demonstrated that they are making real progress with the pipeline. I just don't think we could expect much more than that at this stage. Sure, IF they had a partnership in hand, they would have issued a presser and had a big discussion about it. But they don't. All they can tell us is what is happening. They can't make things up just to placate shareholders

The key for me is that they demonstrated real progress in developing the pipeline. As for Afrezza, there really wasn't much to say at this point. But I did take the fact that samples were underestimated by SNY to be a positive sign and I think it was clear from their tone that management sees it the same way.

[dreamboatcruise]

In addition to the nice news of high demand for samples, we also got the news that the 12u cartridge was submitted a full 2 months ago with availability expected Q2.

And I was excited about the inventory level that appeared on balance sheet, though not 100% confident it is what I'm assuming it is.

[wkndplyr]

I think what was importantly discussed was the potential value of the technosphere technology.  They mentioned some areas that can easily be tested and potentially marketed rather quickly.  There was also mention that technosphere has the potential to transfer small proteins.  This to me is another big frontier and whole set of applications that can it can be used for ie, cancer, vaccines, gene therapy etc.  I just hope that the the side effect profile will not bring this technology down.  Lots of people can benefit from it.

Afrezza is the start, we just have to wait and see how sales will go and it's safety profile.  With all the other potential uses in the pipeline, I don't think it matters whether Afrezza is a bust or not.  If using technosphere improves safely the quality of life for individuals, then this will be a good if not great technology.

haha

if Afrezza is a hit, SNY or some big device company better buy it before the other pipelines are released.

[otherottawaguy]

If technosphere has the potential that they are always reiterating, I for one, do not want to see a buyout. No real way of valuing the company.

OG

[mnholdem]

from MannKind Patent application title: DIKETOPIPERAZINE MICROPARTICLES WITH DEFINED SPECIFIC SURFACE AREAS

Read more: www.faqs.org/patents/app/20140271888#ixzz3ShzRHlfo

Disclosed herein are diketopiperazine microparticles having a specific surface area of less than about 67 m2/g. The diketopiperazine microparticle can be fumaryl diketopiperazine and can comprise a drug such as insulin.
Claims:

1. A method for forming diketopiperazine microparticles comprising: a) dissolving a diketopiperazine in a water-based solution; b) adding an acid solution to the water-based solution to form a mixture; c) adjusting manufacturing conditions to target production microparticles with a specific surface area (SSA) of about 52 m2/g; d) precipitating the diketopiperazine microparticles out of the solution by adding aqueous ammonia forming a microparticle suspension, and e) collecting the precipitate after washing with deionized water; wherein the precipitate comprises FDKP microparticles having a SSA of about 35 m2/g to about 67 m2/g .

2. The method of claim 1, further comprising a step for adsorbing an active agent to the microparticles.

3. The method of claim 2, wherein the microparticles have a SSA of about 35 m2/g to about 62 m2/g within a 95% confidence limit

4. The method of claim 1, further comprising the step of incubating the suspension at a temperature of about 14.degree. C. to about 18.degree. C.

5. The method of claim 2, wherein the step for adsorbing an active agent to the microparticles comprises adding a solution comprising an active agent to the microparticle suspension.

6. The method of claim 5 wherein the active agent comprises at least one of proteins, polypeptides, peptides, nucleic acids, organic macromolecules, synthetic organic compounds, polysaccharides and other sugars, fatty acids, lipids, or antibodies and fragments thereof.

7. The method of claim 5 wherein the active agent comprises at least one of vasoactive agents, neuroactive agents, hormones, anticoagulants, immunomodulating agents, cytotoxic agents, antibiotics, antiviral agents, antigens, infectious agents, inflammatory mediators, hormones, and cell surface antigens.

8. The method of claim 7 wherein the active agent comprises at least one of a cytokine, a lipokine, an enkephalin, an alkyne, a cyclosporin, an anti-IL-8 antibody, an IL-8 antagonist including ABX-IL-8; a prostaglandin including PG-12, an LTB receptor blocker including LY2931 1, BIIL 284, CP105696; a triptan, insulin or analogs thereof, growth hormone or analogs thereof, parathyroid hormone (PTH) or analogs thereof, parathyroid hormone related peptide (PTHrP), ghrelin, an obestatin, an enterostatin, a granulocyte macrophage colony stimulating factor (GM-CSF), amylin, an amylin analog, 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 and vasoactive intestinal peptide.

[dreamboatcruise]

mnholdem... I've been wondering how long it would be before we could all start inhaling our "Texas Red".

[mnholdem]

Ooops... I switched patents, having posted the wrong one to begin with. I have no idea what Texas Red is (highlighted below) but I do know for a fact that the triptan class of drugs is what's used for treating migraines and that triptan was specifically mentioned in the more recent patent displayed above.

Excerpt from the earlier posting:

Agents to be Delivered

[0028] The substance to be coated onto the crystalline microparticle is referred to herein as the active agent. Examples of classes of active agent include pharmaceutical compositions, synthetic compounds, and organic macromolecules that have therapeutic, prophylactic, and/or diagnostic utility.

[0029] Generally, any form of active agent can be coated onto the surface of a crystalline microparticle. These materials can be organic macromolecules including nucleic acids, synthetic organic compounds, polypeptides, peptides, proteins, polysaccharides and other sugars, and lipids. Peptides, proteins, and polypeptides are all chains of amino acids linked by peptide bonds. Peptides are generally considered to be less than 30 amino acid residues, but may include more. Proteins are polymers that can contain more than 30 amino acid residues. The term polypeptide as is know in the art and as used herein, can refer to a peptide, a protein, or any other chain of amino acids of any length containing multiple peptide bonds, though generally containing at least 10 amino acids. The active agents used in the coating formulation can fall under a variety of biological activity classes, such as vasoactive agents, neuroactive agents, hormones, anticoagulants, immunomodulating agents, cytotoxic agents, antibiotics, antiviral agents, antigens, and antibodies. More particularly, active agents may include, in a non-limiting manner, insulin and analogs thereof, growth hormone, parathyroid hormone (PTH), ghrelin, granulocyte macrophage colony stimulating factor (GM-CSF), glucagon-like peptide 1 (GLP-1), Texas Red, alkynes, cyclosporins, clopiogrel and PPACK (D-phenylalanyl-L-prolyl-L-arginine chloromethyl ketone), antibodies and fragments thereof, including, but not limited to, humanized or chimeric antibodies; F(ab), F(ab)2, or single-chain antibody alone or fused to other polypeptides; therapeutic or diagnostic monoclonal antibodies to cancer antigens, cytokines, infectious agents, inflammatory mediators, hormones, and cell surface antigens. Non-limiting examples of antibodies to tumor antigens include anti-SSX-241-49 (synovial sarcoma, X breakpoint 2), anti-NY-ESO-1 (esophageal tumor associated antigen), anti-PRAME (preferentially expressed antigen of melanoma), anti-PSMA (prostate-specific membrane antigen), anti-Melan-A (melanoma tumor associated antigen), anti-tyrosinase (melanoma tumor associated antigen), and anti-MOPC-21 (myeloma plasma-cell protein).

Read more: www.faqs.org/patents/app/20140308358#ixzz3Si0AawXi

[dreamboatcruise]

Hopefully someone will review the info about what size molecules can be used on Techosphere before tomorrow's RBC healthcare conference.

[oracle]

Other significant points made were, the new production lines are on schedule for completion, that current production is meeting the very aggressive shipping schedule and that production line is more efficient than they thought possible.

[kball]

Also a sample pack was said to be a 10 day supply of Afrezza

[babaoriley]

For the longer term, I liked the call, for the shorter term, well:

The shorts are gonna have their day
Tonight.
The Shorts are gonna have their way
Tonight.
The loyal longs all mumble,
“Good call.”
But when the market opens,
They’ll hit a stone wall.

Hope I've got that all wrong.

[dreamboatcruise]

Feb 24, 2015 19:57:58 GMT -5 kball said:

Also a sample pack was said to be a 10 day supply of Afrezza

If the analyst asking that was on top of things he would have already seen the pictures of the sample box posted online and known the answer.