BioWorld International Correspondent

ProBioGen AG entered its first human vaccine development deal involving its avian cell line, AGE1.CR, with an undisclosed U.S. biotechnology company. Financial terms were not disclosed but the deal covers the use of AGE1.CR in vaccines against both seasonal and pandemic influenza and in three other undisclosed disease areas.

Berlin-based ProBioGen will receive what it called "significant" up-front and milestone payments for development programs in each of the four indications, plus royalties on eventual product sales. The deal is the second product development agreement it has secured with the AGE platform. Earlier this year, it completed a licensing agreement with animal health firm Virbac SA, of Carros, France, for the production of unidentified biological products.

ProBioGen was established in 1994 and initially concentrated on providing contract manufacturing services, particularly for Phase I and Phase II clinical trials, as well as cell line development and process development services. It altered its business model in 2000, CEO Michael Schlenk told BioWorld International, to build a business based around a proprietary cell culture platform as well.

Its AGE1.CR cell line is derived from retinal tissue isolated from a single duck embryo. It has been developed to conform to the FDA's "combined risk" strategy, Volker Sandig, vice president of vector and cell biology, told BioWorld International.

It differs in that respect from rival platforms, such as an avian cell line developed by Nantes, France-based Vival SA, which is derived from avian stem cells. "When you take a stem cell, you have to grow the stem cell on a layer of [murine] feeder cells," Sandig said. "Those mouse cells are not very well characterized," he added.

"We believe our cell line is the only one that has been developed from day one in a GMP environment," Schlenk said.

ProBioGen is positioning its avian cell line as an eventual replacement for the embryonated chicken eggs and chicken embryonic fibroblasts that currently are used in the manufacture of influenza vaccines. Although they have provided a cheap and, for the most part, reliable technology for several decades, the process is cumbersome and cannot provide surge capacity, which would be required in the event of a pandemic flu strain.

Basel, Switzerland-based Novartis AG gained European Union approval for the world's first cell culture-based influenza vaccine earlier this year. The product, OptaFlu, which is grown in MDKC mammalian cell culture platform, is expected to be submitted to the FDA next year.

Others engaged in developing cell-culture-based influenza vaccines include: DynPort Vaccine Company LLC, of Frederick, Md., and its partner Baxter International, of Deerfield, Ill.; Brussels, Belgium-based Solvay SA; Paris-based Sanofi-Aventis Group and partner Leiden, the Netherlands-based Crucell NV; and London-based GlaxoSmithKline plc. The U.S. Department of Health and Human Services is subsidizing all of these efforts, including that of Novartis, with aggregate funding of approximately $1.1 billion. Meriden, Conn.-based Protein Sciences Corp. is also in the game, with a late-stage seasonal vaccine called FluBl0k, which is produced in a baculovirus expression system that is grown in the insect species Spodoptera frugiperda.

"There is always room for later development because there are multiple ways to attack the influenza virus from a vaccine perspective," Sandig said.