BioWorld International Correspondent

Intercell AG brought its eighth year in business to a successful conclusion by completing the biologics license application filing for its lead product, a cell-culture-based vaccine against Japanese encephalitis virus (JEV), just before Christmas. The Vienna, Austria-based firm also has just completed a marketing authorization application (MAA) for the same product in Europe.

"It's a major milestone for us. This is our first BLA. Two weeks ago, we had our first European submission," CEO Gerd Zettlmeissl told BioWorld International. "It shows we have built our processes, functions and, most importantly, a product that is close to the market."

Intercell expects to launch that product, IC51, sometime during the second half of 2008. "There is a chance we could have a very fast review," Zettlmeissl said. There is no longer a licensed JEV vaccine on the market, as Biken - the Research Foundation for Microbial Diseases of Osaka University, of Osaka, Japan - has ceased manufacturing its product, JE-Vax, which had been distributed in the U.S. by Sanofi Pasteur, the vaccines arm of Paris-based Sanofi-Aventis Group.

JE-Vax was, by modern standards, a crude product. It was made by inoculating the brains of suckling mice with JEV. The brains were then harvested and homogenized, and the vaccine was purified and sterilized. It was associated with a relatively high frequency of adverse events.

Basel, Switzerland-based Novartis AG will be responsible for the marketing and distribution of IC51, which Intercell will manufacture at its facility in Livingston, Scotland.

"They get an industry standard royalty for doing the marketing and distribution work," Zettlmeissl said. "We keep the major part of the profit."

The company has forecast peak sales of about €250 million (US$359 million) to €300 million. "We think that next year, depending on timelines, we will get some first sales, coming mainly in the United States," he said. The U.S. military is expected to be a source of early demand for the product.

IC51 was developed over a 10-year period under a Collaborative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research in Silver Spring, Md. Intercell acquired rights to the product in early 2003 from its original developer, Seoul, South Korea-based CJ Corp. (formerly Cheil Jedang).

Acambis plc, of Cambridge, UK, has a rival product in development, ChimeriVax-JE, a single-shot, live, attenuated vaccine that has completed several Phase III clinical trials. Sanofi Pasteur has acquired marketing, distribution and certain manufacturing rights in a number of territories, including Europe and Asia, apart from the Indian subcontinent. Acambis has stated that it anticipates a first license application in 2009.

Intercell, meanwhile, is now in the black and is entering 2008 with about €300 million in cash on its balance sheet, following a major alliance it concluded with Novartis earlier this year, which will deliver €270 million in guaranteed payments. (See BioWorld International, July 4, 2007.)

The company's main priority in 2008 will be to execute its current business plan, Zettlmeissl said, although it also will be open to acquisition or in-licensing opportunities that would enable it to expand its pipeline, revenues or technology portfolio.

The company is maintaining its focus on developing prophylactic and therapeutic vaccines against bacterial and viral pathogens, as well as antibacterial antibodies. It also will seek partnering opportunities in oncology for its T- and B-cell boosting IC31 adjuvant, although it does not plan to enter that space directly. "We don't consider ourselves to be specialists in cancer vaccines. It's another kind of know-how you would need," Zettlmeissl said.