Genzyme and Sunway sign PAH drug deal

US biotechnology firm Genzyme and Shanghai-headquartered Sunway Biotech have signed an agreement to develop and commercialize the former's experimental gene therapy candidate, Ad2/HIF-1a, in China. The drug, which is currently being examined in Phase II clinical trials in Europe and the USA, is an artificial form of the alpha subunit of the hypoxia-inducible factor 1 gene. It utilizes an adenovirus-based delivery vector and is intended to stimulate blood vessel growth and improve circulation in patients with peripheral arterial disease.

Under the terms of the agreement, Genzyme will hand over all manufacture of Ad2/HIF-1a to Sunway, enabling the Chinese firm to begin production of the agent for assessment in clinical trials. Sunway will then be responsible for all aspects of the Phase I and II development program in the country, and has said that it will initially focus on examining the drug in PAH patients. The firms also said that have agreed to share the cost of any future Phase III development program, and added that they "envision" jointly commercilializing Ad2/HIF-1a in China if it gains regulatory approval.

Genzyme said that its collaboration with Sunway, which was one of the first companies in the world to successfully commercialize a gene therapy product (the anticancer treatment H101 in 2005), is a key step in furthering its involvement in China's dynamic biotechnology sector.