The company also announced that it was recently notified by its clinical research provider, BattelleCRO that Battelle Memorial Institute has decided to shut down BattelleCRO by June 30, 2008. As a consequence, Dyax is required to transfer BattelleCRO’s clinical database to another clinical research service, a process which is underway with a global clinical research organization.
After completion of the transfer, the newly housed database can be verified, locked and analyzed, and then prepared for filing as part of Dyax’s rolling biologics license application (BLA). This process is expected to move the completion date of the company’s rolling BLA to the FDA for approval of DX-88 in hereditary angioedema (HAE) to the early fourth quarter of 2008. The company will disclose topline data from the Edema4 study prior to completion of the BLA, once the data becomes available.
Henry Blair, chairman, president and CEO of Dyax, said: “While we are disappointed by the untimely closure of BatelleCRO, we have taken immediate action to transfer our clinical database and finalize the BLA sequence. We expect these final steps to be completed in a timely manner, while making certain that the BLA meets the highest regulatory standards.”