Post by lakers on Dec 16, 2015 21:09:47 GMT -5
Business Spotlight: Lessons Learned
By Jana Adkins
SCVBJ Editor
October 27, 2014 12:00 p.m.
How MannKind Would Change How They Conduct Clinical Trials in the Future
Hakan Edstrom, President, COO and board member of MannKind. Originally from Sweden, Edstrom is a longtime resident of the Santa Clarita Valley.
SCVBJ: Would you briefly describe the history of MannKind in bringing Afrezza from concept, to development, to R&D and then to FDA approval? And how many years long was that journey?
MannKind history dates back to early 1990s, however, at that time we were known as PDC – Pharmaceutical Development Corp. The focus on diabetes began in the late 1990’s when Chairman Al Mann got exposure to the technology in one of the earlier companies he had founded. In 2001 MannKind focused on the development of diabetes treatment Afrezza. It’s been a costly development.
I’m really happy to say that through the persistence of our people the FDA advisory committee gave us an overwhelming approval in April, and in June we successfully brought Afrezza through the FDA approval process. So many patients from the clinical trials lined up to speak at the FDA panel meeting that they had to be restricted to three minutes each. Those patients spoke based on their own initiative and paid their own way to speak before the FDA panel. It was very compelling and very inspirational to hear how Afrezza made a difference in their lives.
SCVBJ: How big is the market for Afrezza?
Diabetes is such a humongous market. We expect this to be a multi-billion dollar product. In the U.S. alone, about $7 billion is spent on insulin therapy alone.
It is a disease that unfortunately has reached epidemic proportions on global basis. The belief is that by 2050, one in three Americans might be suffering from diabetes. Those states are very scary. As a society we can’t afford to take care of big portion of the population with such a chronic disease.
Insulin therapy Has always been a treatment of last resort, and there are some issues with insulin injections. Afrezza addressed those issues and makes the therapy more attractive to patients and doctors which can result in higher compliance.
Our product’s ease of administration and faster-acting is quite a therapeutic benefit to the patient – and there are no needles involved. Using the inhaler, Afrezza gets into the blood very fast meaning patients can sit down at use it at meal time. Today, injections require patients thinking about what time they will start eating and how to time their injections 30 to 45 minutes in advance for the insulin to reach full concentration in the blood. There’s a risk to injecting it too early or too late.
Afrezza also works for children with diabetes. They don’t want to inject themselves and today most schools don’t have school nurses or places where they can go and inject themselves in privacy. This helps children stay compliant and it's easier for them to administer and control.
SCVBJ: What was the wait for FDA approval like?
The regulatory process has been long and has been hard, as can be expected for products to be used for lifetime chronic therapy. Part of the delay was that there was another inhaled product a few years back, but unfortunately it really didn’t have any clinical benefits over existing therapies at the time and it was a lot more expensive. That created a little bit of bias about our product.
And dealing with the FDA was always a challenge. They certainly have strict requirements. It’s expensive and usually takes a long time. Our product is a combination product of a drug and a device, so even more complicated, and it had to be reviewed by several divisions and bureaus of the FDA. One meeting I attended had 22 FDA representatives. It was a bigger challenge than we had expected and took longer. We had more than 6,340 patients involved in our clinical trials lasting from one to two 2 years. It was very comprehensive and very expensive but we really felt we had something that could make a change in peoples’ lives. The tenacity was there; there conviction was there in our employees.
SCVBJ: How did it feel when the company had to lay off employees in 2011?
It was very unfortunate and difficult in 2011 when we had to lay off employees while we waited for approval. Particularly when you feel like you have very committed, talented people sitting in ‘regulatory hold’ until you know exactly how to move forward. But now we’re in an aggressive hiring mode, especially at our Danbury, Connecticut manufacturing site. But a lot of the people that we had to let go, we’re re-hiring. It’s a sign that we must have been doing something right that people were willing to come back and work with us again. We’re very proud of that.
SCVBJ: Now that Afrezza is approved, what did success feel like?
We felt like what we’ve been fighting for, for such a long time, and our tenacity for our conviction and our commitment that we were able to convince the FDA product was safe – that feeling was great. We partied at individual sites and we’re planning to have our biggest party during the first quarter of 2015 when our global partner, Sanofi, will launch the product. They are working very hard to come out with the product and launch the product in the United States and on a global basis.
SCVBJ: What lessons were learned along the way about how to bring a new drug to market?
In hindsight it’s always a learning process as to how to benefit going forward. Going forward, we would conduct some of the clinical studies in a different manner if we did it again. We would probably do comparative clinical studies with other therapies for patients and show the superiority or benefit of Afrezza over competitive products.
We probably did not give ourselves the optimum ‘label’ (product description) that the product deserves where you can show and differentiate your product from other therapies – showing the incidence of hyperglycemia, high blood sugar, or the recipe of how you can use the product and what you can expect from it, like a prescription advisory to doctors and patients.
The benefit would been an even stronger differentiation of benefits for Afrezza as compared to parallel therapies for Type I and type II therapies. It makes it easier to sell the product and presents stronger arguments to present to doctors and patients; why they should use our product as opposed to alternative. It eventually gives you a stronger franchise and better opportunity for higher sales.
When you do clinical studies for the FDA you’re trying to prove you have a worthy product and show overall safety and efficacy. We were more focused on the clinical side of our studies given history with Pfizer’s (diabetes) medication and other studies than comparing our treatment to others on the market; we wanted a really clean study. The studies are very expensive and we were being careful about how we managed shareholder investments.
Now with an approved product we can do all of the studies and we’ll certainly turn our focus to showing the superiority of the product in therapy.
[Sny should/could have started this last year. JAC was admittedly asleep at the wheel.]
We are certainly very happy to have a company like Sanofi, which is represented in 120 countries worldwide. It’s a tremendous opportunity to expand to many parts of the world.
Editor’s Note: The license agreement between MannKind and Sanofi will give MannKind an upfront payment of $150 million and potential milestone payments of up to $775 million. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65 percent and MannKind receiving 35 percent.
www.signalscv.com/m/section/434/article/129140/
By Jana Adkins
SCVBJ Editor
October 27, 2014 12:00 p.m.
How MannKind Would Change How They Conduct Clinical Trials in the Future
Hakan Edstrom, President, COO and board member of MannKind. Originally from Sweden, Edstrom is a longtime resident of the Santa Clarita Valley.
SCVBJ: Would you briefly describe the history of MannKind in bringing Afrezza from concept, to development, to R&D and then to FDA approval? And how many years long was that journey?
MannKind history dates back to early 1990s, however, at that time we were known as PDC – Pharmaceutical Development Corp. The focus on diabetes began in the late 1990’s when Chairman Al Mann got exposure to the technology in one of the earlier companies he had founded. In 2001 MannKind focused on the development of diabetes treatment Afrezza. It’s been a costly development.
I’m really happy to say that through the persistence of our people the FDA advisory committee gave us an overwhelming approval in April, and in June we successfully brought Afrezza through the FDA approval process. So many patients from the clinical trials lined up to speak at the FDA panel meeting that they had to be restricted to three minutes each. Those patients spoke based on their own initiative and paid their own way to speak before the FDA panel. It was very compelling and very inspirational to hear how Afrezza made a difference in their lives.
SCVBJ: How big is the market for Afrezza?
Diabetes is such a humongous market. We expect this to be a multi-billion dollar product. In the U.S. alone, about $7 billion is spent on insulin therapy alone.
It is a disease that unfortunately has reached epidemic proportions on global basis. The belief is that by 2050, one in three Americans might be suffering from diabetes. Those states are very scary. As a society we can’t afford to take care of big portion of the population with such a chronic disease.
Insulin therapy Has always been a treatment of last resort, and there are some issues with insulin injections. Afrezza addressed those issues and makes the therapy more attractive to patients and doctors which can result in higher compliance.
Our product’s ease of administration and faster-acting is quite a therapeutic benefit to the patient – and there are no needles involved. Using the inhaler, Afrezza gets into the blood very fast meaning patients can sit down at use it at meal time. Today, injections require patients thinking about what time they will start eating and how to time their injections 30 to 45 minutes in advance for the insulin to reach full concentration in the blood. There’s a risk to injecting it too early or too late.
Afrezza also works for children with diabetes. They don’t want to inject themselves and today most schools don’t have school nurses or places where they can go and inject themselves in privacy. This helps children stay compliant and it's easier for them to administer and control.
SCVBJ: What was the wait for FDA approval like?
The regulatory process has been long and has been hard, as can be expected for products to be used for lifetime chronic therapy. Part of the delay was that there was another inhaled product a few years back, but unfortunately it really didn’t have any clinical benefits over existing therapies at the time and it was a lot more expensive. That created a little bit of bias about our product.
And dealing with the FDA was always a challenge. They certainly have strict requirements. It’s expensive and usually takes a long time. Our product is a combination product of a drug and a device, so even more complicated, and it had to be reviewed by several divisions and bureaus of the FDA. One meeting I attended had 22 FDA representatives. It was a bigger challenge than we had expected and took longer. We had more than 6,340 patients involved in our clinical trials lasting from one to two 2 years. It was very comprehensive and very expensive but we really felt we had something that could make a change in peoples’ lives. The tenacity was there; there conviction was there in our employees.
SCVBJ: How did it feel when the company had to lay off employees in 2011?
It was very unfortunate and difficult in 2011 when we had to lay off employees while we waited for approval. Particularly when you feel like you have very committed, talented people sitting in ‘regulatory hold’ until you know exactly how to move forward. But now we’re in an aggressive hiring mode, especially at our Danbury, Connecticut manufacturing site. But a lot of the people that we had to let go, we’re re-hiring. It’s a sign that we must have been doing something right that people were willing to come back and work with us again. We’re very proud of that.
SCVBJ: Now that Afrezza is approved, what did success feel like?
We felt like what we’ve been fighting for, for such a long time, and our tenacity for our conviction and our commitment that we were able to convince the FDA product was safe – that feeling was great. We partied at individual sites and we’re planning to have our biggest party during the first quarter of 2015 when our global partner, Sanofi, will launch the product. They are working very hard to come out with the product and launch the product in the United States and on a global basis.
SCVBJ: What lessons were learned along the way about how to bring a new drug to market?
In hindsight it’s always a learning process as to how to benefit going forward. Going forward, we would conduct some of the clinical studies in a different manner if we did it again. We would probably do comparative clinical studies with other therapies for patients and show the superiority or benefit of Afrezza over competitive products.
We probably did not give ourselves the optimum ‘label’ (product description) that the product deserves where you can show and differentiate your product from other therapies – showing the incidence of hyperglycemia, high blood sugar, or the recipe of how you can use the product and what you can expect from it, like a prescription advisory to doctors and patients.
The benefit would been an even stronger differentiation of benefits for Afrezza as compared to parallel therapies for Type I and type II therapies. It makes it easier to sell the product and presents stronger arguments to present to doctors and patients; why they should use our product as opposed to alternative. It eventually gives you a stronger franchise and better opportunity for higher sales.
When you do clinical studies for the FDA you’re trying to prove you have a worthy product and show overall safety and efficacy. We were more focused on the clinical side of our studies given history with Pfizer’s (diabetes) medication and other studies than comparing our treatment to others on the market; we wanted a really clean study. The studies are very expensive and we were being careful about how we managed shareholder investments.
Now with an approved product we can do all of the studies and we’ll certainly turn our focus to showing the superiority of the product in therapy.
[Sny should/could have started this last year. JAC was admittedly asleep at the wheel.]
We are certainly very happy to have a company like Sanofi, which is represented in 120 countries worldwide. It’s a tremendous opportunity to expand to many parts of the world.
Editor’s Note: The license agreement between MannKind and Sanofi will give MannKind an upfront payment of $150 million and potential milestone payments of up to $775 million. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65 percent and MannKind receiving 35 percent.
www.signalscv.com/m/section/434/article/129140/
