FluGen secures exclusive rights to novel vaccine-delivery technology

7 April 2009

Flugen Inc., has secured exclusive rights to a novel, patent-protected vaccine-delivery technology being commercialized by Ratio Inc. Terms of the license agreement were not disclosed.

The easy-to-use, disposable micro-device painlessly delivers seasonal and pandemic influenza vaccines. At the press of a button, a miniature fluidic pump distributes the vaccine to a set of microneedles. These microneedles deliver the vaccine intradermally, or into the skin, but not through it and into the muscle, like the traditional needle and syringe do.

The micro-device holds the potential to significantly increase vaccine effectiveness. Seasonal influenza vaccines have shown as little as 20 to 40% efficacy in some patients. Intradermal delivery like that which will be enabled by the micro-device has been shown to increase vaccine efficacy, particularly among those 65 years and older, for whom the disease is the most deadly.

The vaccine-delivery technology also may improve vaccination rates because of the pain-free, easy-to-use delivery it affords. More than a third of those 65 years and older do not receive vaccinations each year, despite higher influenza mortality rates due to age-related immune deficiencies. The vaccination rate is even lower in younger populations.

FluGen this year will begin pre-clinical testing of the micro-device with the company’s cell-based trivalent influenza vaccines, or TIVs. The company anticipates submitting an investigational new drug (IND) application for its vaccine-loaded micro-device to the US Food and Drug Administration during the second half of 2010 and hopes to enter a Phase I clinical trial upon its approval, by the end of 2010.

“This exciting vaccine-delivery technology from Ratio is an important expansion of FluGen’s product pipeline,” said Paul V Radspinner, president and chief executive of FluGen. “It will allow the company to offer the $6-billion influenza vaccine market not only superior vaccines, but an easy-to-use, painless delivery technology that increases vaccine effectiveness. FluGen looks forward to advancing this valuable product through our pipeline with one or more TIVs.”

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