Thursday, September 18, 2008

Alseres gets orphan status for spinal cord drug in EU

By Mass High Tech Staff

Alseres Pharmaceuticals Inc. reports that it has won orphan drug designation from the European Commission for its drug Cethrin for the treatment of traumatic spinal cord injury.

Cethrin had already received Orphan Drug designation from the U.S. Food and Drug Administration in 2005 for the treatment of acute spinal cord injury. According to Hopkinton-based Alseres (Nasdaq: ALSE), the drug is being investigated in Phase 2 clinical testing in the U.S. and Canada for its potential to restore motor and sensory function after acute spinal cord injury.

Once a drug has been approved, Orphan Designation provides a drug with market exclusivity for a 10-year period in the European Union and for 7 years in the United States for a particular indication.

Late last month, Alseres joined its Woburn and Hopkinton offices into one new facility in Hopkinton.

In June, Alseres reported that it had raised $5 million through the private placement of a Convertible Promissory Note Purchase Agreement with former board member Robert Gipson.

The company also announced in May that it had received an option to amend its license to Cethrin from BioAxone Therapeutic Inc., potentially reducing Alseres’ milestone fees to BioAxone from $25 million to $7 million.

Alseres Pharmaceuticals is developing therapeutic and diagnostic products primarily for disorders in the central nervous system. The company reported a loss of $19.6 million for 2007 on zero revenue.