Sunway and Genzyme to Collaborate on Gene Therapy

Sunway Biotech Co. Ltd. of Shanghai will collaborate with Genzyme (NSDQ: GENZ) on the experimental gene therapy drug Ad2/HIF-1a, a drug that seeks to grow new blood vessels in patients with peripheral arterial disease. Sunway will manufacture the drug in China and undertake the trials necessary to win marketing approval in China from the SFDA. Genzyme is already testing Ad2/HIF-1a in Phase II trials in the US and Europe.

Sunway, founded in 1995, already has a gene therapy drug approved in China. H101 is an adenovirus agent for the treatment of head and neck cancer. H101 is a genetically-modified type-five adenovirus that can selectively replicate inside tumor cells with dysfunctional p53 genes, killing them and stopping the cancer's spread. H101 was approved in 2005 and launched under the name Oncorine in November 2006. So far, sales have been disappointing.

Sunway developed its cancer drug after its scientists read a paper about gene therapy that was written in 1996 by researchers at Onyx (NSDQ: ONXX). At the time, Onyx was leading the field in a promising technology. However, Onyx abandoned the drug after a patient died in the first clinical trial of a gene therapy drug, concentrating its efforts on Nexavar, a more conventional monoclonal antibody that Onyx was developing with Bayer (NYSE: BAY). Although Onyx never patented its gene therapy techniques in China, and even though Sunway pursued development of the drug separately from Onyx, Sunway signed a worldwide license with Onyx to the technology.

SiBiono, which is majority owned by Benda Pharma (NSDQ: BPMA) also has a gene therapy drug, Gendicine, on the market in China for head and neck cancer.

At one point, it was rumored that Genzyme would become the US partner of Sunway for Oncorine, but that never came to pass.

As part of its business plan, Sunway wishes to partner with western biopharmas to bring their products to the market in China.

The Genzyme gene therapy, Ad2/HIF-1a, is an engineered form of the HIF-1a gene. It is designed to promote the growth of new blood vessels and improve circulation in the limbs of patients with peripheral arterial disease. In the Phase II trial, currently underway in the US and Europe, Genzyme is administering Ad2/HIF-1a to patients with intermittent claudication, a form of peripheral arterial disease marked by disabling pain or fatigue in the legs following exercise.

Sunway, using Genzyme’s process for manufacturing Ad2/HIF-1a, will produce the drug in its Shanghai facility for clinical trials. Sunway will be responsible for Phase 1 and Phase 2 studies in China. These trials will enroll patients with critical limb ischemia, a severe form of peripheral arterial disease that often results in amputation of the limb. Genzyme has already completed a Phase 1 study of Ad2/HIF-1a in this population. Sunway and Genzyme will fund the Phase III trial jointly, and they also will co-promote the drug in China, pending approval.

Sunway also acknowledged that it is currently in the process of closing an investment round to build its growing operations. However, financial details of the agreement with Genzyme were not disclosed.