CoDa Therapeutics Receives Orphan Drug Designation for Nexagon^® for the Treatment of Persistent Corneal Epithelial Defects

25 Sep 2008

Company preparing to initiate Phase 2 clinical trial

May 11. 2009 - CoDa Therapeutics, Inc. today announced that its lead drug product candidate, Nexagon^® , has received Orphan Drug Designation from the U.S Food and Drug Administration for the treatment of persistent corneal epithelial defects. The Company initiated a Phase 2 clinical trial for this indication in April 2009.

Persistent Epithelial Defect (PED) is a condition where the epithelium (thin layer of surface cells) covering the cornea of the eye fails to re-grow over a defect within the expected time period. PED is extremely difficult to treat and a common occurrence after traumatic abrasions and chemical injury. If unresolved the outcome for patients can lead to severe visual impairment or even blindness in the affected eye.

"Receiving orphan drug designation for Nexagon^® for the treatment of PED is an important milestone for CoDa and provides meaningful benefits as we move our lead program through clinical development" commented Bradford J. Duft, President and Chief Executive Officer of CoDa.

"In acute eye injury from chemical burns a successful outcome for patients is often challenging. In recent cases of PED from ocular burns, where we received compassionate use approval from New Zealand regulatory authorities, we have seen dramatic improvement in epithelial re-growth and a positive result for patients following treatment with Nexagon^® "commented Professor Charles McGhee, Director of the New Zealand National Eye Centre, University of Auckland. "This designation will assist CoDa’s clinical advancement of Nexagon^® which has the potential to significantly improve clinical outcomes in patients with PED."

Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. Orphan Drug Designation entitles CoDa to seven years of market exclusivity in the treatment of PED patients in the event of market approval for this indication. Additional incentives for orphan drug development include tax credits related to development expenses, reduction in FDA user fees, and FDA assistance in clinical trial design.