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Post by mnkdmorelong on Jan 14, 2016 5:27:21 GMT -5
There are three drug candidates for TS under consideration. Palonsetron (for Chemo), Epinephrine, and a third for pulmonary hypertension. All three put together are only a fraction of the insulin market. Except for Epinephrine, the drugs will have full clinical trials. Missing from the list is MNKD's pain med. Also missing are large volume drugs. I think this is why it has taken so long to get a TS deal. MNKD went through the list of high volume drugs and found no buyers. Now they are down to the orphan drug volume level.
I can't see any of the opportunities generating a large up front payment. MNKD needs cash now.
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Post by anderson on Jan 14, 2016 6:42:15 GMT -5
If you can get one of those Priority review voucher it might be worth chasing an orphan drug. Last one sold for $350 million.
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Post by vestful on Jan 14, 2016 8:08:57 GMT -5
There are three drug candidates for TS under consideration. Palonsetron (for Chemo), Epinephrine, and a third for pulmonary hypertension. All three put together are only a fraction of the insulin market. Except for Epinephrine, the drugs will have full clinical trials. Missing from the list is MNKD's pain med. Also missing are large volume drugs. I think this is why it has taken so long to get a TS deal. MNKD went through the list of high volume drugs and found no buyers. Now they are down to the orphan drug volume level. I can't see any of the opportunities generating a large up front payment. MNKD needs cash now. No mention of ts pain doesn't mean it's off the table. They may have mentioned the other 3 as a way of dangling a carrot to attract other interests and companies. |
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Post by harryx1 on Jan 14, 2016 9:05:18 GMT -5
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Post by peppy on Jan 14, 2016 9:23:19 GMT -5
There are three drug candidates for TS under consideration. Palonsetron (for Chemo), Epinephrine, and a third for pulmonary hypertension. All three put together are only a fraction of the insulin market. Except for Epinephrine, the drugs will have full clinical trials. Missing from the list is MNKD's pain med. Also missing are large volume drugs. I think this is why it has taken so long to get a TS deal. MNKD went through the list of high volume drugs and found no buyers. Now they are down to the orphan drug volume level. I can't see any of the opportunities generating a large up front payment. MNKD needs cash now. from the JPM healthcare conference call. Matt: Technosphere pipeline is something that's important to us. It’s going to be important from a licensing standpoint. This is probably not huge upfront dollars, but I think and in fact I think, if that were very close to when I or I think my predecessor promised me we have in this quarter. I actually thought we have one today. That didn’t happen, but I think it will happen soon.
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Post by peppy on Jan 14, 2016 9:28:35 GMT -5
from the jpm healthcare conference call. regarding Epinephrine. Ray: 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. screencast.com/t/ybMhTDbx
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Post by kpm1028 on Jan 14, 2016 10:53:51 GMT -5
is the common thought that oxytocin and pain technosphere were not talked about as those are drugs mannkind wants to develop on house rather than license out?
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Post by matt on Jan 14, 2016 11:00:13 GMT -5
Epinephrine is hardly an orphan; it is the active ingredient in almost all asthma inhalers and has been administered in an inhaled form for decades. It is going to be very hard to show that a TS delivered dose of epinephrine is more effective than an inhaled micro-droplet dose so it will be back to the same reimbursement nightmare as with Afrezza vs insulin pens.
The key is finding drugs that are delivered BETTER through the lung than via other routes but which do not presently have a lung delivery method. Every TS application will required a separate approval from the FDA's Office of Combination Products and requires the support and participation of both MNKD and the drug manufacturer. The hunt should begin by identifying those manufacturers that are looking for a competitive advantage rather than looking for a molecule that happens to work with TS. If the manufacturer is not fully engaged in the process they may decide to change their formulation for whatever reason and MNKD loses the combination product approval until all the testing is redone.
You can do a lot of preliminary development work only to find out the manufacturer isn't willing to play ball, which is the death knell for any combination product. Money will be very tight; they need to avoid putting the cart before the horse.
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Post by mnkdmorelong on Jan 14, 2016 11:09:11 GMT -5
Epinephrine is hardly an orphan; it is the active ingredient in almost all asthma inhalers and has been administered in an inhaled form for decades. It is going to be very hard to show that a TS delivered dose of epinephrine is more effective than an inhaled micro-droplet dose so it will be back to the same reimbursement nightmare as with Afrezza vs insulin pens. The key is finding drugs that are delivered BETTER through the lung than via other routes but which do not presently have a lung delivery method. Every TS application will required a separate approval from the FDA's Office of Combination Products and requires the support and participation of both MNKD and the drug manufacturer. The hunt should begin by identifying those manufacturers that are looking for a competitive advantage rather than looking for a molecule that happens to work with TS. If the manufacturer is not fully engaged in the process they may decide to change their formulation for whatever reason and MNKD loses the combination product approval until all the testing is redone. You can do a lot of preliminary development work only to find out the manufacturer isn't willing to play ball, which is the death knell for any combination product. Money will be very tight; they need to avoid putting the cart before the horse. By orphan, I mean business opportunity. All of the drugs pale in market size as compared to insulin. The goal is up front money - I don't see a pony here. I think MNKD wants to use epinephrine in cases of allergy attacks (anaphylaxis). Here speed of drug delivery is important. It would compete with the Epipen. |
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Post by suebeeee1 on Jan 14, 2016 11:57:03 GMT -5
I'm still very, very interested in that pain medications. Our country is getting older every day. And while not everyone needs a heavy duty pain killer, more and more people do. I've posted the figures before. There are millions of people in our country alone who require long acting, base pain relief. Most of these folks also use meds for breakthrough pain. Would Technosphere possibly limit some of the dangers associated with these drugs?. Short acting?. Possibly?
Emergency room possibilities are endless as are military. Abuse and accidental overdoses are real concerns. I think there are HUGE markets here yet to be tapped.
My guess, since this is the one that was left off the power point during preparation, there were real expectations that it was going to be the one announced.
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Post by mnholdem on Jan 14, 2016 13:05:24 GMT -5
Source: www.medgadget.com/2015/05/auto-injectors-market-expected-reach-usd-2-5-billion-globally-2020.html
According to a new market report published by Transparency Market Research “Auto-injectors Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2014 – 2020”, the global auto-injectors market was valued at USD 665.0 million in 2013 and is expected to grow at a CAGR of 18.6% from 2014 to 2020, to reach USD 2,503.4 million in 2020.
The injectable devices market has witnessed a paradigm shift from traditional devices administered by skilled personnel to self-injection devices. Auto-injectors, initially used as accessories, have evolved into life saving medical products and are currently a major medical device segment. Auto-injectors have emerged as one of the fastest growing drug administration solutions, driven by factors such as allowance for at-home drug administration, reduction in the number of hospital visits (thereby reducing the cost of health care), rise in prevalence of anaphylaxis and others. Acceptance of auto-injectors under insurance reimbursement by governments is further encouraging patients to switch from manual injections and prefilled syringes to auto-injectors, thereby boosting the market for auto-injectors.
Auto-injectors used for the management of anaphylaxis dominated the market in 2013, with a share of around 95%. Rising prevalence of anaphylaxis in developed economies coupled with the corresponding purchasing parity in these nations are the major factors driving the market for anaphylaxis auto-injectors. Additionally, major players such as Mylan, Inc. and Ypsomed AG are spreading awareness about the use and effectiveness of auto-injectors.
Geographically, North America held the largest share of 70% of the auto-injectors market in 2013. High prevalence of anaphylaxis and multiple sclerosis, availability of favorable reimbursement options and awareness about novel medical devices are the major factors that drive the auto-injectors market in North America. However, Asia Pacific is estimated to be the fastest-growing market for auto-injectors during the forecast period. High prevalence of anaphylaxis in New Zealand and Australia is the major factor that is likely to fuel the growth of the auto-injectors market during the forecast period in the region.
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We're all focusing on the API, but don't forget that there is a device side to the equation. 
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Post by james on Jan 14, 2016 15:28:10 GMT -5
Having used Epipen once, I can tell you it was quite rapid acting, so I don't know whether there's much benefit on that front. However, it is also an incredibly obnoxious experience which lasted longer than I would have liked. The pen is expensive ($2-300?) and has to be replaced every year or so. Many of these are used by pediatrics and while I was not bothered by the needle aspect, it could certainly be intimidating. If any of that is addressed in an inhaled powder form, it could be a win.
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Post by kpm1028 on Jan 14, 2016 15:53:05 GMT -5
hopefully it comes in cricket pre loaded device to alleviate the idea of having to load a cartridge in the event of anaphylaxis
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Post by stevil on Jan 14, 2016 15:54:10 GMT -5
There are three drug candidates for TS under consideration. Palonsetron (for Chemo), Epinephrine, and a third for pulmonary hypertension. All three put together are only a fraction of the insulin market. Except for Epinephrine, the drugs will have full clinical trials. Missing from the list is MNKD's pain med. Also missing are large volume drugs. I think this is why it has taken so long to get a TS deal. MNKD went through the list of high volume drugs and found no buyers. Now they are down to the orphan drug volume level. I can't see any of the opportunities generating a large up front payment. MNKD needs cash now. Was hoping some of the more established docs could speak up to what they think about the potential here. I find myself in the same camp, unfortunately. All of the medications on here are already on the market, some in somewhat cheap formulations. I thought I remembered seeing vancomycin on the list? This would be helpful because they wouldn't require an IV, but aren't patients usually admitted anyway if they're infected with an agent that would require them to take it? I don't know enough to know if it would be as simple as writing a script and then allowing them to go home. It's one of those things that sounds good on paper, but doesn't really fill a need. Unless someone on here can speak up and correct me? Then, the vast majority of these are niche drugs. These are great to develop the pipeline, but horrible right now if we're counting on them to get us through our financial crisis. It sounds to me like Matt's greatest hope is that these will simply instill confidence in the company and raise the share price to do another offering. I didn't get the impression that he was counting too much on upfront payments, although I'm sure he's hoping for them ha. I was really hoping MNKD would develop their own novel medications. Really, after I think about it, there aren't too many medications that need quick absorption. Mainly cardiac related meds. Epi would be one of them, but as another posted added, it worked quickly in the pen. And I raised the issue in another thread that a few of the biggest problems with anaphylaxis is a swollen tongue/throat and difficulty breathing. I'm not really sure I would want to prescribe an inhaled medication as the sole means of treating anaphylactic shock. I think I'd still want a pen as a backup just in case they didn't take it soon enough before their tongue/throat swell, and bronchioles close up. Unless there is a study that shows it's just as effective under those scenarios... |
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Post by james on Jan 14, 2016 16:02:37 GMT -5
hopefully it comes in cricket pre loaded device to alleviate the idea of having to load a cartridge in the event of anaphylaxis It should be single use for sure. You don't want to do it twice if you don't have to! The whistle cost would be irrelevant. Looking into pricing, Epipen looks like it can be up to $500 retail. Folks are definitely motivated to keep these past the expiration date, but bioavailability does drop over time and it will eventually form a precipitate which is visible through a window in the pen. I was taking allergy injections and they required that I carry one and periodically checked the expiration date, so this is a definite issue. The injection form is intramuscular (usually the thigh), so nearly direct access to the blood stream and results are very fast. |
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