Santaris Pharma wins milestone payment from Enzon Pharmaceuticals after US FDA grants IND approval to SPC/ENZ2968, an RNA antagonist of HIF-1a (hypoxia-inducible factor 1alpha)
Santaris Pharma, the Danish biopharmaceutical company, has received a milestone payment of US$5 million from Enzon Pharmaceuticals, its oncology partner, coinciding with the acceptance by the US 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 18 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.
Commenting on the FDA's IND approval, Keith McCullagh, president and CEO of Santaris Pharma, said: "This is the second RNA Antagonist based on Santaris Pharma's LNA chemistry to receive IND rapid review and acceptance by the FDA.
"We are delighted to be supporting Enzon's work on this and other development projects.
"Their experience and dedication to quality and efficiency in new oncology drug development has been exemplary".
HIF-1a is an exciting new drug target in cancer and vascular biology.
HIF-1a is a key regulator of a large number of genes important in cancer biology, such as angiogenesis, cell proliferation, apoptosis and cell invasion.
HIF-1a is low in normal cells, but reaches high intracellular concentrations in a variety of cancers and is strongly correlated with poor prognosis and resistance to therapy.
Drugs targeting HIF-1a thus have the potential to target multiple cancer processes.
