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December 7, 2012

Danbury's Biodel wins lucrative FDA 'orphan' tag

By Gregory Seay

In a strong finish to a busy 2012, Danbury biopharma Biodel Inc. says the top U.S. drug regulator has granted "orphan drug" status to its treatment for infants born with a rare condition in which their tiny bodies produce too much insulin.

The Food & Drug Administration's orphan designation means Biodel may be eligible for a range of incentives, including FDA grants to cover clinical trial costs; tax credits related to development expenses; waiver of FDA user fees; and a seven-year period of marketing exclusivity in the U.S. following FDA approval, the company said.

The latter tends to be the most coveted aspect among drug developers and their investors.

Cheshire drug maker Alexion Pharmaceuticals Inc., for instance, has grown rich due to its orphan drug, Soliris, that started life as a treatment for a rare form of potentially fatal anemia that affects a relatively slim percentage of the world's population. Its treatment costs each patient more than $300,000 a year.

The FDA grants orphan designation to promote development of therapies to treat rare diseases.

Biodel's "glucagon'' prevents hypoglycemia in newborns and infants with a pancreas that makes too much insulin, which occurs in one out of every 30,000 to 50,000 live births, authorities said.

It's primary advantage, however, is that its glucagon formulation stays stable in liquid longer, avoiding the frequent catheter blockages that plague other commercial formulations, Biodel President and CEO Errol De Souza said.

The FDA designation is but the latest in a series of positive developments for the company this year, De Souza said.

Biodel last January got a positive opinion for orphan drug designation from the European Medicines Agency's Committee for Orphan Medicinal Products – Europe's FDA equivalent -- and orphan designation by the European Commission last March 5.

Despite the orphan glucagon tag, Biodel continues to work on its primary treatment – a fast-acting synthetic insulin for patients with too little insulin or too much blood glucose – the cause for diabetes.

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