why haven't we found a partner in the u.s.a. yet?

[kc]

I believe it’s an issue of publication integrity with the ADA. That in order to be published in the journal’s that are tied to the convention you have to withhold your information for that convention publication.
Deals with the intellectual properties of the publications tied to the ADA.

[sportsrancho]

Jan 6, 2018 9:37:09 GMT -5 kc said:

I believe it’s an issue of publication integrity with the ADA. That in order to be published in the journal’s that are tied to the convention you have to withhold your information for that convention publication.
Deals with the intellectual properties of the publications tied to the ADA.

I think that is correct. And I don’t think we have to wait. Unless we choose to.

[boca1girl]

Jan 6, 2018 8:31:42 GMT -5 sportsrancho said:

Jan 6, 2018 8:10:20 GMT -5 agedhippie said:

That's the problem, it's not our trial so we don't own the results. University of Colorado spent the money to perform the trail so the results are theirs.

So what do they get out of it? Do we pay them for the results?

MNKD does not pay for the results.  

Universities do research and publish in journals.  That’s what they do.  I don’t know how they got the funding for this specific STAT study.  It is a state run public university with a medical school, so the funding could have come from the state or from an endowment or from a US government grant (CDC), etc. Maybe the funding source is published somewhere, i’m just not aware.

[brotherm1]

Appears to me it could very well be funded by the CDF:


”Welcome to the Barbara Davis Center for Diabetes (BDC)

Mission:
Our mission is to provide state-of the-art care to children and adults with type 1 diabetes and to teach our patients how to prevent or delay complications. Our research is devoted to finding prevention, cure, and most effective treatment of diabetes and associated disorders.
Marian Rewers, MD, PhD
Executive Director 

The Barbara Davis Center for Diabetes (BDC) specializes in type 1 diabetes research and care for children and adults. It is one of the largest diabetes institutes in the world. The Center is part of the University of Colorado School of Medicine and has its dedicated building on the Anschutz Medical Campus  (map) in Aurora, Colorado. The Center was funded by Marvin Davis, in 1978, and is generously supported by the Children’s Diabetes Foundation (CDF) .
Clinicians, clinical researchers, and basic biomedical scientists work at the BDC to find the most effective treatment, prevention, and cure for type 1 diabetes. The Center provides state-of-the-art diabetes care to 3600 children and 2400 adults with diabetes from the Rocky Mountain Region as well as receiving national and international referrals. We also provide inpatient care to patients who are seen at the Children’s Hospital Colorado with any type of diabetes.
The Center’s faculty teach the medical, physician assistant, nursing, and dental students on campus. Residents and endocrinology fellows train at the Center on elective rotations. Basic science faculty members provide mentorship to pre-doctoral students and post-doctoral fellows from around the world”.

www.barbaradaviscenter.org/

[brotherm1]

CDF Mission Statement
The Children’s Diabetes Foundation was established by Barbara and Marvin Davis in 1977 in Denver as a non-profit organization dedicated solely to the support of research in diabetes and to provide the best possible clinical and educational programs for people with the disease. The Foundation’s mission is to raise funds to support the Barbara Davis Center for Diabetes, where thousands of patients of all ages from all over the world receive the finest diabetes care available. Since 1978, the Children’s Diabetes Foundation has contributed $100 million dollars to the Barbara Davis Center.
The Guild Mission Statement
The Guild is the auxiliary volunteer group of the Children’s Diabetes Foundation and the Barbara Davis Center for Diabetes. The Guild raises funds for research, promotes diabetes awareness and education, assists families in need, provides continuing education scholarships, and sponsors social activities for children and their families. The Guild, with its more than 400 dedicated members and volunteers, continues with fundraising efforts in the tireless fight against diabetes. Since inception in 1979, The Guild has contributed more than $2 million to the Barbara Davis Center.

www.barbaradaviscenter.org/

[mnholdem]

Jan 6, 2018 9:50:36 GMT -5 boca1girl said:

Jan 6, 2018 8:31:42 GMT -5 sportsrancho said:

So what do they get out of it? Do we pay them for the results?

MNKD does not pay for the results.  

Universities do research and publish in journals.  That’s what they do.  I don’t know how they got the funding for this specific STAT study.  It is a state run public university with a medical school, so the funding could have come from the state or from an endowment or from a US government grant (CDC), etc. Maybe the funding source is published somewhere, i’m just not aware.

MannKind likely provided the Afrezza at no charge. Whether that gives them a look at the trial data and/or results in advance of publication is part of the negotiations related to sponsorship. Certainly there is an agreement in place.

[matt]

The reason there is no US partner is the difficulty of penetrating the diabetes market. It takes a sales force dedicated to the indication that calls on both primary care offices and specialists like endos. Lilly and Novo would be great partners but they will look at Afrezza net of the impact to their existing product lines, and while some companies are happy to make their own products obsolete the economics are not always there. Fact is, Sanofi was a logical choice for the partnership but that did not turn out as either side had hoped, and there are no other pharma companies eager to spend a lot of money trying to displace Humalog or Novolog just so that they can get kicked around by the PBMs. People are dancing in the street now that weekly Afrezza scripts have hit 500, while Novolog and Humalog each do more than 140,000 scripts weekly. To get those scripts the price for Afrezza would have to come down below what Novolog and Humalog sell for to the PBM. You can argue all you want that Afrezza is a better mousetrap, but until there is a FDA label claim approved for superiority the PBM is going to carry the cheapest non-inferior drug they can find, and with Afrezza's higher manufacturing cost the company can't play hard ball by lowering the selling price.

The problem is not what MNKD would get out of the partnership, the problem is that the industry lacks a partner that wants to spend serious money to get into a price competitive space like insulin that already has to very successful players. Big pharmas have lots of opportunities presented to them every year and they have to pick and choose the therapeutic areas where they want to invest and the particular projects they want to pursue within those therapies. The financial press covers the 1% of opportunities that turn into partnering deals, but they never know about the 99% that get turned down due to a poor fit or insufficient economic potential for the partner. It is the same reason Mannkind does not have more international deals; unless the numbers add up for the partner they are not going to be interested.

[pat]

Isn't that the 'rub'?

All evidence seems to point to afrezza being the 'best'

Is demand driven by the consumer

Or is it driven by available financing (insurance coverage)

If it's truly the latter we have a long slog ahead.

Assuming that endos and other docs are the group think sheeple that they are often portrayed as.

[Deleted]

matt "To get those scripts the price for Afrezza would have to come down below what Novolog and Humalog sell for to the PBM."

From what I have read, the product that is preferred by PBMs is not the lowest prices but the highest rebates. Is that true or false?

[cjm18]

What conclusions can we draw If fiasp passes afrezza sales in 6 months without a superiority trial? Has there been a superiority trial done for Apidra?

[liane]

FYI - any posts referencing Sierra Equity will immediately be removed. This is pure trash.

[MnkdWASmyRtrmntPlan]

Jan 6, 2018 13:31:54 GMT -5 matt said:

The reason there is no US partner is the difficulty of penetrating the diabetes market. It takes a sales force dedicated to the indication that calls on both primary care offices and specialists like endos. Lilly and Novo would be great partners but they will look at Afrezza net of the impact to their existing product lines, and while some companies are happy to make their own products obsolete the economics are not always there. Fact is, Sanofi was a logical choice for the partnership but that did not turn out as either side had hoped, and there are no other pharma companies eager to spend a lot of money trying to displace Humalog or Novolog just so that they can get kicked around by the PBMs. People are dancing in the street now that weekly Afrezza scripts have hit 500, while Novolog and Humalog each do more than 140,000 scripts weekly. To get those scripts the price for Afrezza would have to come down below what Novolog and Humalog sell for to the PBM. You can argue all you want that Afrezza is a better mousetrap, but until there is a FDA label claim approved for superiority the PBM is going to carry the cheapest non-inferior drug they can find, and with Afrezza's higher manufacturing cost the company can't play hard ball by lowering the selling price.

The problem is not what MNKD would get out of the partnership, the problem is that the industry lacks a partner that wants to spend serious money to get into a price competitive space like insulin that already has to very successful players. Big pharmas have lots of opportunities presented to them every year and they have to pick and choose the therapeutic areas where they want to invest and the particular projects they want to pursue within those therapies. The financial press covers the 1% of opportunities that turn into partnering deals, but they never know about the 99% that get turned down due to a poor fit or insufficient economic potential for the partner. It is the same reason Mannkind does not have more international deals; unless the numbers add up for the partner they are not going to be interested.

Thanks for that insight, Matt.
Wow, just imagine Afrezza selling 140,000 scripts per week!!!

[racedog]

Jan 6, 2018 13:31:54 GMT -5 matt said:

The reason there is no US partner is the difficulty of penetrating the diabetes market. It takes a sales force dedicated to the indication that calls on both primary care offices and specialists like endos. Lilly and Novo would be great partners but they will look at Afrezza net of the impact to their existing product lines, and while some companies are happy to make their own products obsolete the economics are not always there. Fact is, Sanofi was a logical choice for the partnership but that did not turn out as either side had hoped, and there are no other pharma companies eager to spend a lot of money trying to displace Humalog or Novolog just so that they can get kicked around by the PBMs. People are dancing in the street now that weekly Afrezza scripts have hit 500, while Novolog and Humalog each do more than 140,000 scripts weekly. To get those scripts the price for Afrezza would have to come down below what Novolog and Humalog sell for to the PBM. You can argue all you want that Afrezza is a better mousetrap, but until there is a FDA label claim approved for superiority the PBM is going to carry the cheapest non-inferior drug they can find, and with Afrezza's higher manufacturing cost the company can't play hard ball by lowering the selling price.

The problem is not what MNKD would get out of the partnership, the problem is that the industry lacks a partner that wants to spend serious money to get into a price competitive space like insulin that already has to very successful players. Big pharmas have lots of opportunities presented to them every year and they have to pick and choose the therapeutic areas where they want to invest and the particular projects they want to pursue within those therapies. The financial press covers the 1% of opportunities that turn into partnering deals, but they never know about the 99% that get turned down due to a poor fit or insufficient economic potential for the partner. It is the same reason Mannkind does not have more international deals; unless the numbers add up for the partner they are not going to be interested.

With the problems Celgene has been having lately, I am wondering if there could be interest here.

[MnkdWASmyRtrmntPlan]

Here is one of Mike's slides from his Qtr 3 presentation:

Sources of Capital
 Afrezza® product revenue
 ATM
 Co-promote opportunities
 Debt options
 Equity
 International Licensing
 Partnership(s) for pipeline assets

[radgray68]

Jan 5, 2018 21:27:53 GMT -5 yash said:

Jan 5, 2018 19:02:08 GMT -5 radgray68 said:

Founded in 1991, Mannkind is almost 27 years in the making. 2 years ago, our U.S. sales and marketing partnership with one of the Big 3 almost bankrupted us, causing us to drop from $11 to 50 cents. I think we can take a couple extra quarters or even years doing it ourselves to avoid that kind of criminal usury again.

Also, the stat study results will help us sell the insurance companies on us.

Until which year Afrezza patent is valid before other companies come up with Generic drug replacing Afrezza?

At this point, losing half the patent exclusivity period is not the first thing on Al's.er..uhmmm Mannkind's mind. The fight in front of us today is simply getting this treatment to the most patients as possible to save it before it goes away for good, lost to the annals of the what could have been.

Btw, as excited as I am about the stat study, I think the Levin study could be bigger. I have been waiting five years for something to recognize the possibility of Afrezza first and only in T2's.