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Small Business Grant Awarded for Artificial Pancreas Insulin

Diabetes Test (NIH)

(National Institutes of Health)

Biodel Inc., a biopharmaceutical company in Danbury, Connecticut, has received a Small Business Innovation Research (SBIR) grant to develop concentrated faster-acting insulin formulations for use in an artificial pancreas. The two-year grant totaling $582,473 was awarded by the National Institute of Diabetes and Digestive and Kidney Diseases of National Institutes of Health (NIH).

Biodel notes that the first-phase release of insulin in a person without diabetes occurs within several minutes of glucose’s entry into the bloodstream after a meal.  Injected human insulin, however, enters the bloodstream slowly, with peak insulin levels occurring within two to three hours following the injection. And even the fastest acting insulin analogs, says the company, take from 50 to 70 minutes to reach peak levels.

The SBIR grant will support Biodel’s research to develop a much faster acting insulin product at high concentrations to provide the quantities of insulin needed in an external artificial pancreas pump device that has a limited volume capacity. The company says insulin at concentrations of 500 units per milliliter is now used to treat extremely insulin resistant diabetes patients, more concentrated than normal administrations of insulin, but they can also have a prolonged duration that would be undesirable with an artificial pancreas.

Biodel’s research under the grant is expected to produce an insulin formulation that works much faster and can be absorbed more rapidly than existing concentrated insulin formulations. The company is developing diabetes control products including an injectable faster-acting human insulin for meal-time use, and an oral insulin supplement that mimics first-phase insulin-release signaling, thus reducing the production of glucose by the liver and maintaining normal glucose levels.

NIH sets aside 2.6 percent of its extramural (outside-organization) research funds for SBIR, research and development with commercial potential by small businesses in the U.S. Eleven federal departments and agencies government-wide participate in the SBIR program.

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