BioWorld International Correspondent
Intercell AG aims to start booking its first revenues for its two-shot Japanese encephalitis virus vaccine, IC51, in late 2007, with sales volume ramping up in earnest in 2008.
The Vienna, Austria-based company is on track to gain U.S. approval for IC51 during 2007, following the initiation of the filing procedure. "It's not an official rolling [biologics license application] process. It's an agreed process with the FDA, which is similar to it," CEO Gerd Zettlmeissl told BioWorld International. There is, he added, "no essential operational difference" between the two.
Intercell already submitted the full report on the vaccine's immunogenicity, based on a pivotal trial involving some 860 subjects. Data from a safety trial involving 2,300 participants will follow in the next month or two, Zettlmeissl said. Chemistry, manufacturing and controls will be filed early next year, as will data from an ongoing consistency trial that is comparing three commercial batches.
The regulatory submission will be completed by early 2007. The FDA confirmed the company's filing schedule at a pre-BLA meeting held Sep. 19, Zettlmeissl said. Intercell also will file for approval at the London-based European Medicines Agency in the first quarter of 2007. "They will get everything in one piece," he said.
The company has upped forecasts for sales of the product, following a market assessment conducted by its sales and marketing partner, Basel, Switzerland-based Novartis AG. Based on a top-down exercise, Intercell had predicted revenues of €200 million (US$250.1 million) to €300 million for the product. "They did it bottom up and came out with even better numbers than we had," Zettlmeissl said. The revised sales estimate is now between €250 million and €300 million.
Intercell reported a net loss of €25 million on revenues of about €8.5 million in 2005. It has guided that it will attain revenues of €15 million in 2006. Should IC51 gain approval, the company expects to receive its first order from the U.S. Army in late 2007. The company should enter the black shortly afterward.
"Based on current spending and R&D, 2008 would be feasible," Zettlmeissl said. However, investment decisions could push that point further out, he added.
Intercell acquired rights to IC51 in early 2003 from its original developers, Seoul, South Korea-based CJ Corp. (formerly Cheil Jedang) and the Walter Reed Army Institute, of Silver Spring, Md. It comprises an inactivated, attenuated virus grown in Vero monkey kidney cell culture.
The approved product, JE-Vax, which is manufactured by Biken, the Research Foundation for Microbial Diseases of Osaka University in Japan, and distributed by Sanofi Pasteur SA, the vaccines arm of Paris-based Sanofi-Aventis Group, is grown by inoculating the brains of mice. Although immunogenic, it has a high incidence of allergic reactions.
Cambridge, UK-based Acambis plc is developing a single-shot live attenuated vaccine, ChimeriVax-JE, based on a chimeric yellow fever viral vaccine. A Phase III clinical trial is due to report in the fourth quarter, but the marketing plans for the product still are unclear, Zettlmeissl said.