Clanotech Receives Orphan Drug Designation in the EU
News Nov 04, 2014
Clanotech AB has announced that its anti-fibrotic and anti-angiogenic candidate drug CLT-28643 received orphan drug designation by the European Medicines Agency (EMA) for prevention of scarring post glaucoma filtration surgery. Karolinska Development has an 80 percent ownership in Clanotech.
Clanotech’s lead substance, an α5β1-integrin antagonist, has anti-angiogenic, anti-fibrotic and anti-inflammatory properties that are expected to benefit the wound healing processes following glaucoma surgery. The orphan drug designation will significantly shorten a future market approval process and reinforce market exclusivity for a launched product.
“We’re delighted by the positive response from the EMA, which underpins the great need for products that can improve the outcome of glaucoma surgery“, said Patrizia Caldirola, CEO, Clanotech.
“Therapies with potential for use in specialized care and orphan diseases are at the core of Karolinska Development’s investment strategy. The medical need for a safe and specific anti-fibrotic therapy in glaucoma surgery is substantial and the orphan drug designation will add significant value to this exciting pharmaceutical project”, said Bruno Lucidi, CEO, Karolinska Development.
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