So why bring to market another inhalable insulin at an investment of over $1 billion? What are the grounds for you expectations of more than $5 billion in peak sales?“Afrezza is a new insulin formulation, which is closer to natural insulin that the body produces. Inhalable delivery enables the insulin to quickly reach high hormone levels, as well as expediting the insulin’s removal, which takes up to nine hours for regular insulin. In this way, the insulin does not remain in the body after the food has been digested and provides much better control of blood-sugar levels, reduces weight gain and slows tolerance to insulin. The product also prevents hyperglycemia and slows the progression of diabetes.”It sounds like there won’t be any more need for insulin needles, pumps and frequent finger pricking to test blood-sugar levels, or the continuous monitoring of glucose, which are considered the golden fleece of diabetes.“Correct. Injections won’t be needed any more, and measurements will only be necessary every few days. After the 56 trials we conducted, mostly at our own initiative, I can say that I know my product well. We were very cautious. Although the product does not cause weight gain, we told the FDA that it ‘reduces weight gain.’ Although it doesn’t create tolerance to insulin, we said that it ‘creates less tolerance to insulin.’ “Nonetheless, despite all the compromises we made, the FDA is not satisfied. It’s not only about us; there have been a lot of companies this year that couldn’t get their products approved by the FDA on the first attempt and were forced to conduct supplementary studies.“That is the regulatory environment that we operate in, which together with other factors that are burdening the US economy and health system, are simply killing innovation. Fortunately, Israel is still fun. I feel that a new wave of innovation is about to arrive, like in the US 30 years ago.”Bioness, founded in 2007, has undergone several incarnations. It acquired NESS in 2008 and planned a reverse merger with Israeli blank-check company AMEX-listed Advanced Technology Acquisition Corporation, whose founders included former chief scientist Shuki Gleitman. The merger was canceled in mid- 2009, and ATAC was liquidated and returned its money to its investors.“Bioness has $20 million in annual sales,” Mann says. “It has extensive operations in Israel, and its manufacturing is also carried out here. It currently has 90 employees in Israel and 150 in the US.”Why didn’t it merge with ATAC? “Because they had to meet a deadline, and we couldn’t arrange the merger in time.That’s why we’re financing Bioness on our own. I strongly believe in Bioness and predict that it can become a billion-dollar company.”
Alfred Mann to double $100 million Technion donation
Chairman and CEO of medical-devices company MannKind says regulators are killing innovation in the US, but Israel is still fun.
So why bring to market another inhalable insulin at an investment of over $1 billion? What are the grounds for you expectations of more than $5 billion in peak sales?“Afrezza is a new insulin formulation, which is closer to natural insulin that the body produces. Inhalable delivery enables the insulin to quickly reach high hormone levels, as well as expediting the insulin’s removal, which takes up to nine hours for regular insulin. In this way, the insulin does not remain in the body after the food has been digested and provides much better control of blood-sugar levels, reduces weight gain and slows tolerance to insulin. The product also prevents hyperglycemia and slows the progression of diabetes.”It sounds like there won’t be any more need for insulin needles, pumps and frequent finger pricking to test blood-sugar levels, or the continuous monitoring of glucose, which are considered the golden fleece of diabetes.“Correct. Injections won’t be needed any more, and measurements will only be necessary every few days. After the 56 trials we conducted, mostly at our own initiative, I can say that I know my product well. We were very cautious. Although the product does not cause weight gain, we told the FDA that it ‘reduces weight gain.’ Although it doesn’t create tolerance to insulin, we said that it ‘creates less tolerance to insulin.’ “Nonetheless, despite all the compromises we made, the FDA is not satisfied. It’s not only about us; there have been a lot of companies this year that couldn’t get their products approved by the FDA on the first attempt and were forced to conduct supplementary studies.“That is the regulatory environment that we operate in, which together with other factors that are burdening the US economy and health system, are simply killing innovation. Fortunately, Israel is still fun. I feel that a new wave of innovation is about to arrive, like in the US 30 years ago.”Bioness, founded in 2007, has undergone several incarnations. It acquired NESS in 2008 and planned a reverse merger with Israeli blank-check company AMEX-listed Advanced Technology Acquisition Corporation, whose founders included former chief scientist Shuki Gleitman. The merger was canceled in mid- 2009, and ATAC was liquidated and returned its money to its investors.“Bioness has $20 million in annual sales,” Mann says. “It has extensive operations in Israel, and its manufacturing is also carried out here. It currently has 90 employees in Israel and 150 in the US.”Why didn’t it merge with ATAC? “Because they had to meet a deadline, and we couldn’t arrange the merger in time.That’s why we’re financing Bioness on our own. I strongly believe in Bioness and predict that it can become a billion-dollar company.”