Thermalin Diabetes raises $1.9M to commercialize new types of insulin

Startup Thermalin Diabetes Inc. has raised $1.9 million in equity to commercialize new forms of insulin developed at Case Western Reserve University, according to a regulatory filing.

Startup Thermalin Diabetes Inc. has raised $1.9 million in equity to commercialize new forms of insulin developed at Case Western Reserve University, according to a regulatory filing.

The company is developing several “insulin analogs” — new proteins engineered to act like insulin in the body. The insulin analogs are heat resistant, unlike the natural hormone, which must be refrigerated. Resistance to heat makes the analogs especially useful in insulin pumps worn outside the body or in locations, like disaster sites, where there is no refrigeration.

The company is hoping to bring the latest round of funding, which it considers its Series A, to $3 million, CEO Rick Berenson said. Including $350,000 from Cleveland-based economic development group JumpStart Inc., the round currently stands at about $2.2 million. Aside from JumpStart, the funding for the Series A round comes from angel investors, Berenson said.

Thermalin is working to commercializing the discoveries of Dr. Michael Weiss, chairman of the Biochemistry Department at Case Western Reserve University School of Medicine. Weiss is founder and chief scientific officer for Thermalin.

Thermalin recently signed a licensing agreement with Case that gave the company exclusive worldwide rights to develop a portfolio of more than 100 insulin analogs. The company is in the midst of large-animal tests that it hopes to wrap up next year, Berenson said.

Thermalin will use the investment to continue animal testing and scale up manufacturing, according to Berenson.

Some time next year, Thermalin officials expect to meet with the Food and Drug Administration to plan the regulatory path the company’s products should follow to land on the market. Thermalin expects to file with the FDA an Investigational New Drug (IND) Application, which is required to begin testing a drug on humans, in 2012, Berenson said.

Also next year, the company plans to begin raising a Series B round of funding that Berenson pegged at between $4 million and $8 million.

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 in March. 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.

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