FDA approval for Santaris Pharma’s second new cancer drug

The Medicon Valley Academy member Santaris Pharma, announced 26.01.07 that it has received a milestone payment of US$5 million from Enzon Pharmaceuticals Inc., its oncology partner, coinciding with the acceptance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for SPC/ENZ2968, an RNA antagonist of HIF-1a (hypoxia-inducible factor 1alpha), being developed by Enzon for commercialisation outside Europe.

The IND is the result of the first six months of successful collaboration between Santaris Pharma and Enzon and was filed mid-December 2006 and subsequently approved by the FDA on 18th January, 2007. Enzon plans to initiate a phase I trial for the drug in the USA in the first half of 2007. Jeffrey Buchalter, Chairman and Chief Executive Officer of Enzon commented:

“This marks an important milestone for Enzon as we continue to focus our efforts on important oncology therapies. The continued advancement of the HIF-1alpha program demonstrates our commitment to developing a differentiated cancer portfolio.”

Enzon entered into a partnership with Santaris Pharma in July 2006, as part of which it has licensed the non-European rights to the Santaris RNA antagonist of HIF-1a, alongside a similar drug targeting another cancer gene called Survivin, The two companies are also collaborating on six additional proprietary RNA antagonists directed against recognised cancer gene targets selected by Enzon. The $5m milestone payment by Enzon follows a previous $3m milestone achieved in November 2006 which related to the final selection of molecular targets in the Enzon-Santaris drug discovery collaboration.