FDAnews Drug Daily Bulletin


April 6, 2006

Biotechnology firm SGX Pharmaceuticals has signed an agreement with Novartis to develop and market new BCR-ABL inhibitors, which are used to treat patients with chronic myelogenous leukemia (CML).

Under the deal, SGX will receive a $25 million up-front payment from Novartis. Total payments -- excluding royalties -- could exceed $515 million, including a minimum of two years of research funding.

The collaboration aims to develop new drugs for CML patients who have become resistant to Novartis' Gleevec (imatinib), which was approved in May 2001 and is used to treat both CML and gastrointestinal stromal tumors, a type of stomach cancer. In 2005, Gleevec generated $2.2 billion in sales, a 33-percent increase over 2004.

SGX noted that some patients develop resistance to Gleevec or cannot tolerate the therapy. "For these patients, there are currently no other approved treatment options," the company said.

Under the agreement, SGX will complete preclinical development of its lead drug candidate and submit an investigational new drug application with the FDA. SGX also will be responsible for completion of an initial Phase I clinical study, after which Novartis will be responsible for conducting further clinical development and commercialization of the compound.