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Post by mnholdem on Sept 21, 2017 8:19:03 GMT -5
A study published by McKinsey & Company in Sept 2014 presents the advantages of being first-to-market in the pharmaceutical industry. With a label upgrade by the FDA apparently imminent, from which Afrezza Inhalable Insulin (insulin human) could be elevated into a new Ultra Rapid-Acting classification of insulin for the treatment of Type 1 and Type 2 diabetes mellitus, investors may be interested in researching what advantages, if any, a first-to-market drug in a new classification may give MannKind Corporation.
Advantages of being first
To evaluate the value of first-to-market advantage, we analyzed 492 drug launches in 131 classes over a 27-year period (1986–2012). We filtered for those drugs that generated more than $100 million in annual sales and had one or more competitors during its patented life. Then, to assess the impact of order of entry on a class, we analyzed market share (measured by sales) for each entrant in the tenth year after the launch of the first drug.
Our analysis shows that first-in-class players on average achieve a greater-than-fair market share, defined as 100 percent market share divided by number of entrants (Exhibit 1). Overall, first-to-market players have a 6 percent market-share advantage over later entrants (Exhibit 2), but they achieve market-share leadership in less than 50 percent of the drug classes we evaluated. The relative disadvantage of later entries (up to the fifth entrant) is also roughly the same, meaning it is not meaningfully worse to be fifth than second to market. Yet first-to-market advantage is highly dependent on several market contexts (Exhibit 3).
- Prescriber characteristics. First-mover advantage is more pronounced in specialty areas with small numbers of prescribers and patients. In primary care, the first-mover effect is weaker, as the market opportunity and coverage requirements can be significantly larger, which provides an opening for later entrants to claim market positions.
- Route of administration. Injectable drugs have stronger first-mover effects than oral preparations, which is consistent with the specialty/primary-care dynamic described above.
- Competitive dynamics. In two-horse races, the first mover generally garners greater advantage than the late entrant. In more crowded markets with more than five players, however, we find the first-mover advantage is much weaker, as more late entrants have opportunity to take share from the first player.
- Capabilities. When the first mover is a large pharma company, it has a significant advantage (worth greater than ten market-share points); when the first mover is not a large pharma company, we find that the first mover performs worse than fair share of the market. Furthermore, experience matters. Companies with prior experience in a therapeutic area have almost twice the first-to-market advantage than companies with no experience.
- Lead time. The longer a first-in-class drug has to establish a standard of care, the greater the market-share advantage. We find that a lead time of three years or more offers a fairly sizable advantage; a gap between first and second entrant of one year or less is meaningless.
- Product label. When the first mover expands indications faster than later entrants within the first five years of launch, the first-mover effect is strongest across all dimensions we evaluated—13 percentage points above fair market share.
Despite these circumstances, it is important to note that late movers win in more than 50 percent of the drug classes we evaluated. And we find that the odds are greatly improved for late entrants when they are second entrants to the market, fast followers (launched within the same year or one year after the first entrant), and marketed by a large pharma company.
Source: www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/pharmas-first-to-market-advantage
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Post by mnholdem on Sept 21, 2017 8:50:53 GMT -5
Another excerpt from the study posted above:
- The value of being first should not be overestimated, particularly when the lead time is short (less than two years) and a market is expected to be crowded with more than two players.
- While first-mover advantage can be difficult to surmount when it comes to well-resourced and experienced players with long lead times, being first isn’t always as important as being best. That means that clinical development and commercial strategy can be just as important as the timing of the initial regulatory approval in determining market advantage.
- Smaller companies that lack experience and scale should seriously consider partnering with large pharma companies
- With increasing hurdles to commercializing “me too” drugs, these first-mover effects have intensified. The first-mover advantage in earlier-era launches (1986–2000) was five percentage points in market share; in more recent launches (2000 onward), that advantage has doubled to ten percentage points.
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Point 2 observation: With an URAI label, MannKind would have a distinct advantage of both being first AND being best, IMO. The onus would be on MannKind to market Afrezza in a manner where prescribers will understand the science and significance of this new class of insulin.
Point 3 observation: Having replaced its CEO, CMO and CFO with individuals who have pharmaceutical experience gives MannKind Corporation higher marks in its potential to effectively market its FDA-approved drug, technology and pipeline. Now they must deliver, even though the company currently lacks the resources that large pharmaceutical companies enjoy, which currently may place limits on the speed of clinical development and effective coverage of their commercial strategy.
MannKind needs a significant cash infusion, a commercial partner or both. As an investor, I'm looking forward to learning how CEO Castagna addresses this critical need.
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Post by madog365 on Sept 21, 2017 10:42:53 GMT -5
MannKind needs a significant cash infusion, a commercial partner or both. As an investor, I'm looking forward to learning how CEO Castagna addresses this critical need.
Yes, stay tuned. |
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Post by ghochr on Sept 21, 2017 10:47:12 GMT -5
MannKind needs a significant cash infusion, a commercial partner or both. As an investor, I'm looking forward to learning how CEO Castagna addresses this critical need.
Yes, stay tuned. That chapter has closed with Matt. 😜 Need a new phrase for Mike . Is it " I get it " or is it We are making progress? |
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Post by sportsrancho on Sept 21, 2017 14:24:15 GMT -5
That chapter has closed with Matt. 😜 Need a new phrase for Mike . Is it " I get it " or is it We are making progress? Its, "You will thank me later:-)) |
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Post by dreamboatcruise on Sept 21, 2017 16:24:07 GMT -5
If MNKD can only convince doctors that there is advantage in the first of a kind nature of Afrezza... if that can be done it's a gold mine because there isn't any fast follower, or even slow follower on the horizon now. Though, assuming they can do that, which I do assume, what lies between here and success with regard to company finances and existing equity structure.
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Post by bioexec25 on Sept 21, 2017 16:45:41 GMT -5
That chapter has closed with Matt. 😜 Need a new phrase for Mike . Is it " I get it " or is it We are making progress? Its, "You will thank me later:-)) Yes this is the new legacy saying for sure. The customer facing saying by Mike absent in the past is " How can I help". Leading by example in getting patient issues addressed. |
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Post by mango on Sept 21, 2017 18:14:21 GMT -5
MannKind has not even begun seeing the PCPs yet. Mike is trying to do an honest attempt at educating the Endo community and having happy, healthy patients. Dude has gone above and beyond with trying to help others. I appreciate Mike's commitment to help others and see people get the results they rightfully deserve and need.
Mike has an advantage being a pharmacist and having the connections he does. Pharmacists are gatekeepers. I imagine he has been and continues to try and educate pharmacists about this insulin as they are being implemented into more patient care roles. Majority of the thought leaders within the Endo community are financially tied up with megaglomerates and simply have lost their ways.
I imagine that this label revision will be what they need in order to successfully start seeing the PCPs, but that's just my opinion. That's where majority of diabetics are managed and seen.
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Post by sayhey24 on Sept 21, 2017 18:28:09 GMT -5
I like many here have "stay tuned" and I will be the first in line to say "Thank you Mike" but enough is enough all ready. I see itell post the 118 study which says what VDex is saying in their paper, T2s just don't get hypoglycemia with afrezza. Then Mango posts this video www.youtube.com/watch?v=SvZxYmYPXYQAl starts talking MNKD at 8:30m but it gets interesting at 11:00m and then the MONEY statement at 15:00M "interesting this (afrezza) lowers insulin resistance... this (afrezza) is even likely to slow and even stop the progression of Type 2 diabetes". One thing I knew about Al he always had data to back up what he said. Come on Mike!!! I want to thank you but what are you doing after 18 months??? You have a product which STOPS the progression! Does anybody but Mango know this? All the "experts" will tell you that product DOES NOT exist. Can you get the word out??? Maybe announce a follow-up study to the 118 and Al's claims about stopping the progression!!! Can you sell more than 400 boxes a week? You should be selling 40,000 boxes a week. Can you close some International deals??? The Indians and Arabs both have huge diabetes problems. Mike, I can't wait to say thank you. Please give me the opportunity and sooner is better than later. |
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Post by mango on Sept 22, 2017 5:13:38 GMT -5
Fact of the matter is, to realistically achieve actually mimicking endogenous prandial insulin secretion, everything has to be 100% on point every single time. It will never happen with an injectable insulin formulation. Creating a competing inhaled formulation would require scientific brilliance on par with Al Mann and Co and would need to be achieved within a handful of years—not gonna happen.
Afrezza is the only insulin that currently mimics endogenous prandial insulin secretion like that of a healthy non-diabetic pancreas while also effectively restoring glucose homeostasis, which means it stops the progression of the disease.
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Post by agedhippie on Sept 22, 2017 12:07:26 GMT -5
Come on Mike!!! I want to thank you but what are you doing after 18 months??? You have a product which STOPS the progression! Does anybody but Mango know this? All the "experts" will tell you that product DOES NOT exist. Can you get the word out??? Maybe announce a follow-up study to the 118 and Al's claims about stopping the progression!!! That is what needs to be done. Until there is trial data this remains an opinion and that is hard to sell. A superiority follow-up trial is needed ASAP (months ago actually) and this can be bundled in as a secondary objective. If you really felt brave you could simply do the progression trial since if it works then it can hardly fail to be superior. |
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Post by ghochr on Sept 22, 2017 14:38:39 GMT -5
MannKind has not even begun seeing the PCPs yet. Mike is trying to do an honest attempt at educating the Endo community and having happy, healthy patients. Dude has gone above and beyond with trying to help others. I appreciate Mike's commitment to help others and see people get the results they rightfully deserve and need. Mike has an advantage being a pharmacist and having the connections he does. Pharmacists are gatekeepers. I imagine he has been and continues to try and educate pharmacists about this insulin as they are being implemented into more patient care roles. Majority of the thought leaders within the Endo community are financially tied up with megaglomerates and simply have lost their ways. I imagine that this label revision will be what they need in order to successfully start seeing the PCPs, but that's just my opinion. That's where majority of diabetics are managed and seen. Not visiting PCP means all PCP are excluded? Do you have more details? Management comments? |
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Post by mango on Sept 22, 2017 16:47:17 GMT -5
MannKind has not even begun seeing the PCPs yet. Mike is trying to do an honest attempt at educating the Endo community and having happy, healthy patients. Dude has gone above and beyond with trying to help others. I appreciate Mike's commitment to help others and see people get the results they rightfully deserve and need. Mike has an advantage being a pharmacist and having the connections he does. Pharmacists are gatekeepers. I imagine he has been and continues to try and educate pharmacists about this insulin as they are being implemented into more patient care roles. Majority of the thought leaders within the Endo community are financially tied up with megaglomerates and simply have lost their ways. I imagine that this label revision will be what they need in order to successfully start seeing the PCPs, but that's just my opinion. That's where majority of diabetics are managed and seen. Not visiting PCP means all PCP are excluded? Do you have more details? Management comments? In the recent investor conference Mike talks about it. |
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Post by sportsrancho on Sept 22, 2017 17:37:57 GMT -5
They see them, they just haven't been targeting them. Some have many patients on Afrezza.
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Post by mango on Sept 23, 2017 0:56:05 GMT -5
They see them, they just haven't been targeting them. Some have many patients on Afrezza. You're not kidding either, I didn't get to look at the script count until 7 pm tonight. Whatcha think the year's end will be? |
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