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Post by tchalaa on Jan 27, 2016 5:23:49 GMT -5
DANBURY — Shares of MannKind spiked after a report that the local pharmaceutical company may be on the selling block. Citing unnamed sources, Reuters reported on Tuesday afternoon that MannKind — which earlier this month lost its marketing partner for the inhaled insulin Afrezza — is in talks with investment bankers about a potential sale and other options. Matt Pfeffer, the company’s CEO, wasn’t made available to respond to the rumor late Tuesday, though one analyst refuted the report. “I don’t know where a story like this comes from, but I really don’t give it much credence,” said Keith Markey, an analyst with Griffin Securities who is bullish on the stock. The shares closed up 17 cents to 92 cents and reached as high as 96 cents after the Reuters report was posted. Markey said the company made a clear and convincing presentation about its direction last week at a J.P. Morgan health care conference, which included marketing Afrezza on its own and developing other uses for its proprietary inhaler. MannKind’s stock plunged more than 50 percent on Jan. 5 after French drug giant Sanofi backed out of a deal to market Afrezza, the company’s only FDA-approved drug, which became available nearly a year ago but has had limited commercial success. In an interview with the News-Times on Tuesday before the Reuters report broke, Pfeffer said he sees broad potential for Technosphere — MannKind’s inhaler system that gives insulin-dependent diabetics an alternative to injections — to deliver a host of other medications currently administered via needle. One of its most promising uses, he said, could carry epinephrine to a patient experiencing anaphylactic shock, the life-threatening allergic reaction.
“One of the advantages of the Technosphere particle is the speed at which it can deliver a drug into the blood stream,” he said. “There is a huge market carrying the EpiPen who hope they never have to use it. But people are sometimes reluctant to inject themselves if they believe they can handle the condition.”MannKind last week announced an agreement with Receptor Life Sciences, a newly formed company based in California, to study how Technosphere might be able to deliver treatment for chronic pain, neurological diseases and inflammatory disorders using proprietary compounds owned by Receptor. And while MannKind is taking up the marketing of Afrezza on its own, at least until another partner can be found, there will be additional costs associated with the sales effort. Pffefer, who last week conceded that cost reductions may be necessary to offset the additional expenses, said Tuesday he hopes no additional job cuts would be needed at the company’s manufacturing facility on Casper Street, which employs about 170 people. “While we are continually looking at ways to be more efficient, I wouldn’t expect anything as dramatic in terms of layoffs at the Danbury plant,” he said. “If we are successful at what we are doing then we’ll be fine.” m.newstimes.com/business/article/Report-MannKind-may-be-looking-to-sell-6785625.php |
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Post by matt on Jan 27, 2016 9:36:24 GMT -5
I doubt Matt has ever seen a patient with anaphylaxis. Before I went to college, I spent a few years working as a paramedic based out of a Level 1 trauma center so I saw my share of reactions from bee stings to shell fish to various unknown causes. The classical symptom is that the patient can't breathe due to bronchospasm, edema in the upper airway, inability to communicate, and sheer panic. The goal of emergency treatment is to take the edge off the attack so that the physician can do a proper work-up and figure out the root cause. In such circumstances you need absolute certainty that you can get a measured dose into the patient in seconds, and injected drugs properly administered in a beating heart patient get to where they need to be in under 30 seconds. EpiPens are normally injected into muscle and are not much slower than IV.
While I have no doubt epinephrine can be administered orally, that is (was) the active ingredient in Primatene Mist, it is a stretch to think that is the best way to administer any medication in an emergency. Can asthma patients with pulmonary distress due to bronchospasm use an inhaler? No question that they can. Patients with anaphylaxis and an upper airway obstruction, absolutely not. When seconds count nothing is as reliable as a needle, and with a patient gasping for oxygen they never complain about being stuck; most of them can't talk anyway. Anaphylaxis is not like Type I diabetes where the patients need to get stuck multiple times per day, every day. Severe allergic reactions should be an extremely rare event.
I know Matt is trying to keep the company afloat, but this idea is an ill-conceived distraction and poor use of company resources. There are better therapeutic targets and markets for inhaled drugs.
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Post by mnholdem on Jan 27, 2016 9:55:16 GMT -5
Treatments and drugs
By Mayo Clinic Staff
During an anaphylactic attack, an emergency medical team may perform cardiopulmonary resuscitation (CPR) if you stop breathing or your heart stops beating. You may be given medications including:
• Epinephrine (adrenaline) to reduce your body's allergic response
• Oxygen, to help compensate for restricted breathing
• Intravenous (IV) antihistamines and cortisone to reduce inflammation of your air passages and improve breathing
• A beta-agonist (such as albuterol) to relieve breathing symptoms
Source: www.mayoclinic.org/diseases-conditions/anaphylaxis/basics/treatment/con-20014324
---
The information posted by matt should be seriously considered. However, my father-in-law may still be alive today if he had only had an emergency kit with him when he was stung by a bee.
People who KNOW that they are deathly allergic, also know that they have only minutes to administer epinephrine before succumbing to the sting/bite and that they risk becoming incoherent if they don't act immediately. I think that an inhalable epinephrine is a viable option to be carried in a purse or pocket, as it will be used immediately by anybody who knows they are at risk.
Whether by injection or inhalation, the sting/bite victim has time to immediately administer their emergency epinephrine. If they must wait for EMT personnel arrive, it may be too late. Then you may have no choice but to use IV.
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Post by suebeeee1 on Jan 27, 2016 10:00:33 GMT -5
matt , I respect that you have seen many people suffering from serious allergic reactions and by the time they reached you, they were gasping like fish out of water. With anaphylactic shock, it is suffocation that generally kills a person. That is the end stage. Given that you saw them many minutes after the allergic event, I understand your reaction. In the early minutes after a bee sting or snake bite, a person absolutely is inhaling well enough to inhale a drug that will bring their reaction to a halt. I can see this item being in everyone's medicine chest.
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Post by pktrump on Jan 27, 2016 10:00:39 GMT -5
TS Epi would be an interesting application, but certainly is not an urgent need given the effectiveness of the epipen. If the shelf life is long, the price is right, can see it
being utilized/carried around by those who have h/o anaphylaxis e.g. peanut allergy, bee stings, etc.. in addition to or as a replacement to the epipen.
More urgently needed are more effective routes to treat pneumonias, whether it be tough to treat Fungal infxs, mycobacteria, MRSA, viral influenza, Adeno and RSV in the pediatric group; the acute pain market, migraines, and pulmonary arterial HTN where there is a much greater need and hence opportunity IMHO. Not to mention, there would seem to be many drugs near their patent expiry that certainly might be entertaining the TS platform.
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Post by Deleted on Jan 27, 2016 10:19:03 GMT -5
TS Epi would be an interesting application, but certainly is not an urgent need given the effectiveness of the epipen. If the shelf life is long, the price is right, can see it being utilized/carried around by those who have h/o anaphylaxis e.g. peanut allergy, bee stings, etc.. in addition to or as a replacement to the epipen. More urgently needed are more effective routes to treat pneumonias, whether it be tough to treat Fungal infxs, mycobacteria, MRSA, viral influenza, Adeno and RSV in the pediatric group; the acute pain market, migraines, and pulmonary arterial HTN where there is a much greater need and hence opportunity IMHO. Not to mention, there would seem to be many drugs near their patent expiry that certainly might be entertaining the TS platform. ROI is quicker as there are no trials as per presentation by Ray and Matt |
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Post by mnholdem on Jan 27, 2016 10:50:36 GMT -5
TS Epi would be an interesting application, but certainly is not an urgent need given the effectiveness of the epipen. If the shelf life is long, the price is right, can see it being utilized/carried around by those who have h/o anaphylaxis e.g. peanut allergy, bee stings, etc.. in addition to or as a replacement to the epipen. More urgently needed are more effective routes to treat pneumonias, whether it be tough to treat Fungal infxs, mycobacteria, MRSA, viral influenza, Adeno and RSV in the pediatric group; the acute pain market, migraines, and pulmonary arterial HTN where there is a much greater need and hence opportunity IMHO. Not to mention, there would seem to be many drugs near their patent expiry that certainly might be entertaining the TS platform. ROI is quicker as there are no trials as per presentation by Ray and Matt I can confirm this from the JPM conference transcript and slidedeck made available by MannKind Corporation.
Dr. Raymond Urbanski:
"The last slide, the last one of our clinical development candidates is Epinephrine for Anaphylaxis. I think the one point I want to raise here is this can be an incredibly short timeline. No real clinical studies would be required. Obviously you cannot do a clinical study in the Anaphylactic setting. So that would be e-study and some human factor studies would probably suffice. So we're looking at this opportunity as again one of our priority ones."
While I agree with pktrump that epinephrine may not represent an urgent need in the medical community, the needs both for cash to keep MannKind viable and for improving shareholder value and/or better financing leverage are very likely among the reasons why MannKind has prioritized this one among its many choices of API(TS) drugs.
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Post by Deleted on Jan 27, 2016 11:03:18 GMT -5
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Post by sluggobear on Jan 27, 2016 12:11:26 GMT -5
Thanks for the article where Mylan has been gouging for its EpiPen. Another good example that illustrates how out of step our US healthcare system is regarding drug pricing. Epinephrine is so cheap. It's an opportunity for MNKD to take the high ground in the pharma world and offer at an affordable price point while still being very profitable. Mannkind could help reset the bar for drug pricing on this product and Afrezza. |
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Post by pktrump on Jan 27, 2016 12:29:28 GMT -5
IAM2, MNH, and Slug,
Exellent points and very pertinent to MNKD finances.
A quick ROI maybe as important as the TS application at this point.
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Post by dreamboatcruise on Jan 27, 2016 14:24:27 GMT -5
I doubt Matt has ever seen a patient with anaphylaxis. Before I went to college, I spent a few years working as a paramedic based out of a Level 1 trauma center so I saw my share of reactions from bee stings to shell fish to various unknown causes. The classical symptom is that the patient can't breathe due to bronchospasm, edema in the upper airway, inability to communicate, and sheer panic. The goal of emergency treatment is to take the edge off the attack so that the physician can do a proper work-up and figure out the root cause. In such circumstances you need absolute certainty that you can get a measured dose into the patient in seconds, and injected drugs properly administered in a beating heart patient get to where they need to be in under 30 seconds. EpiPens are normally injected into muscle and are not much slower than IV. While I have no doubt epinephrine can be administered orally, that is (was) the active ingredient in Primatene Mist, it is a stretch to think that is the best way to administer any medication in an emergency. Can asthma patients with pulmonary distress due to bronchospasm use an inhaler? No question that they can. Patients with anaphylaxis and an upper airway obstruction, absolutely not. When seconds count nothing is as reliable as a needle, and with a patient gasping for oxygen they never complain about being stuck; most of them can't talk anyway. Anaphylaxis is not like Type I diabetes where the patients need to get stuck multiple times per day, every day. Severe allergic reactions should be an extremely rare event. I know Matt is trying to keep the company afloat, but this idea is an ill-conceived distraction and poor use of company resources. There are better therapeutic targets and markets for inhaled drugs. I certainly don't doubt what you say about those that showed up at emergency room. Don't you think there is some argument that there is a fair amount of time before symptoms get that severe that there would be benefit to having a delivery device that someone might be less reluctant to use early in the symptoms. I don't know what the dangers are of taking epi that might also lead to reluctance to dose on first clue of symptoms. Might the inhaled version be targeted specifically at this and dosed such as to hopefully avoid any negative side effects of epi but yet enough to prevent a life threatening reaction if not totally avoid a reaction? The counter argument to that is that it would seem that a person might then want an epi pen as backup and that gets into the whole aspect of trying to market something that increases health care costs... and hard to do without significant clinical trial evidence of benefit. |
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Post by Deleted on Feb 5, 2016 15:06:57 GMT -5
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Post by peppy on Feb 5, 2016 15:19:37 GMT -5
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Post by Deleted on Feb 5, 2016 15:28:43 GMT -5
so is that good or bad? I guess you misunderstood "Mannkind should have put some of the resources on this ( meaning epinephrine inhaler and not on the doctors injectable )and had been cash flow source" |
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Post by stevil on Feb 5, 2016 15:54:05 GMT -5
Not only is it expensive, but if I'm remembering correctly, I think they expire fairly quickly. I can't remember if they last 1-2 years. So it would be a huge benefit if we could undercut on price as well as have the benefit of not needing to throw away good medicine simply because it expired. |
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