Rick Berenson knows startups.
The CEO of Cleveland’s Thermalin Diabetes LLC has worked as CEO or COO for 11 different startups over the last 25 years, and Thermalin is his latest venture. But he didn’t land his spot with Thermalin through the vast professional network that he’s built up from all that time working in the startup community.
A call from his former undergraduate roommate at Harvard University, Michael Weiss, got the ball rolling with Thermalin. Weiss, the chairman of the Biochemistry Department at Case Western Reserve University School of Medicine, has developed several insulin analogs: proteins that are engineered to act like insulin in the body and offer several advantages over traditional insulins.
Weiss is the scientific mind behind Thermalin, and Berenson was brought on to develop the business. So far, the company has raised more than $3 million to support its efforts to develop and commercialize the analogs. Berenson is hoping to close another investment round between $4 million and $8 million by the end of the year that would fund clinical studies of Thermalin’s insulin analogs, which thus far have been tested only in animals.
Thermalin is aiming to take advantage of the exploding worldwide diabetes market. Worldwide insulin sales are expected to grow from $12 billion to $54 billion over the next 20 years, one of the company’s investors said last year. In 2030, there are expected to be 366 million diabetics worldwide ’ more than double the amount in 2000, according to the World Health Organization. Several drugmakers, including Eli Lilly & Co., and Sanofi-Aventis, have received FDA approval to sell insulin analogs in the U.S.
Berenson, a Boston resident, still devotes some of his time to other ventures, but about three-quarters of his work is focused on Thermalin. Berenson spoke with MedCity News about Thermalin’s plans to bring its insulin analogs to market and what advantages they might offer over what’s available now.
Q. What’s the most important thing for Thermalin to accomplish in 2011?
A. We need to select a compound to begin our first formal preclinical studies so we can get ready for clinical studies in 2012. Depending on how you count, we’ve licensed between 80 and 150 compounds from Case Western Reserve University. It’s likely that just two or three will make it to market.
Q. What makes Thermalin’s insulin analogs different from other companies’ insulin analogs that are in development or on the market?
A. The first thing to know is that diabetes patients take insulin for two purposes. First, to ensure they have at least a minimum level of insulin throughout the day, they inject a long-acting insulin once a day. Second, to have enough insulin to deal with blood sugar spikes after meals, they also often inject a meal-time insulin. The main difference between these two is their speed of action or “kinetics.”
For meal-time insulins, even existing insulin analogs, which are improved forms of regular insulin, are not fast enough in starting to work and wearing off to deal with the rapid up-and-down spike of blood sugar after a meal. For long-acting insulins, existing analogs often do not last a full day. Long-acting insulins can also have a different challenge — they have a side-effect of signaling cells to grow which some studies have suggested could, over the long term, increase cancer risk.
We have new insulin that will come on and off faster, or will last longer and have less cancer risk. It is interesting to note that currently marketed insulin analogs are going off patent in the next three or four years. Regular human insulin has been off patent for awhile. This means that the companies in the insulin market today will have to find new, superior insulin analogs or become generics companies.
Q. Do your insulin analogs offer other major advantages over insulin?
A. We also have insulins that don’t need refrigeration, which would be a boon for mail-order delivery in the U.S. and for the developing world.
Q. Talk a little about the current market for insulin analogs. Are there a lot of players? Is there a market leader?
A. There are three leading companies today in insulin: Novo Nordisk, Eli Lilly, and Sanofi-Aventis. They’ve been in the market for many years, had significant innovations, and hold significant market share. A number of other companies want to get in the market, too. Pfizer bought rights to what will soon be generic insulin analogs. Merck recently announced a deal to acquire SmartInsulin, a new insulin formulation which releases insulin in response to high glucose but which hasn’t been tested in people yet. So there are at least five players with more maybe to come.
Q. What has to happen for Thermalin to be an attractive partner to a Big Pharma company?
A. The key is going to be in our data. We need to run high-quality Phase 1 and Phase 2 trials that show that our analogs perform in a superior and advantageous way.