lung cancer usd billion product potential

Huge news: Fast track status granted for TG4010 Lung Cancer Treatment by US FDA
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Virax Holdings Limited (ASX:VHL) advises that Transgene SA of Strasbourg, France have announced that the US Food
and Drug Administration (FDA) have granted Fast Track development designation for TG4010 treatment of Non-small-celllung
cancer (NSCLC).
Transgene stated that the Fast Track Program “is designed to facilitate the development and expedite the review of new
drugs that are intended to treat serious or life threatening conditions and demonstrate the potential to address unmet
medical needs”.
TG4010 utilises Virax’s Co-X-Gene™ technology which Transgene access under a License Agreement with Virax. Under
the terms of the agreement Virax will benefit from milestone and royalty payments upon Transgene achieving relevant
development milestones and sale of product. Virax’s CEO, Dr. Larry Ward stated: “The granting of fast-track status for
TG4010 is significant for the potential future success of the product. This recognition by the FDA confirms the importance
of the product in a very large market area of unmet medical need. Peak sales for such a NSCLC product have been
estimated at over USD 1 billion per annum. The fast track status will also shorten the time required for TG4010 to reach
the market”.
Transgene’s Chief Executive Officer, Philippe Archinard is noted as saying “We are actively preparing the next
development steps for the product and look forward to working closely with the FDA. Discussions for the partnering of
TG4010 have progressed and we hope to reach a collaborative agreement around year-end 2009”.
Virax’s Co-X-Gene™ sub licence provides that a percentage of milestone moneys received by Transgene are payable to
Virax.