In 2004 Pre-Pen®[penicilloyl polylysine] was voluntarily withdrawn from the US and Canadian markets by Hollister-Stier, and in 2005 Allergopharma ceased production of a penicilloyl-polylysine reagent in Europe. Currently there are no licensed sources of this pivotal penicillin skin testing reagent in North America or Europe.

In 2005 Allerquest obtained the legal rights to Pre-Pen® including the FDA license to manufacture this reagent in the US and Canada. Since then we have been aggressively engaged in arranging the necessary FDA-approved filling and packaging facilities needed to produce an approved product for the US and Canadian market.

AllerQuest is now proceeding to build its own manufacturing facility in Plainville, Connecticut. This facility has been built out to meet FDA requirements, and we anticipate a pre-licensure inspection this summer. All required equipment has been acquired, and is installed. Synthesis of the first commercial lot of Pre-Pen will take place in July 2008. We expect no more production delays now that the new FDA-compliant manufacturing space is available.

The management team for AllerQuest met with the relevant FDA review group for Pre-Pen on June 3, 2008 and received tentative approval for our manufacturing plans and stability program. It is now planned that the official application for transfer of the manufacturing license will be submitted in August 2008. FDA review must be completed within a 4 month period.

This timeline indicates that Pre-Pen® will not become available in North America until late in the fourth quarter of 2008. AllerQuest continues to explore every possibility for advancing this schedule, but regulatory approval of our manufacturing site transfer is necessary and beyond our control.

We will continue to update our progress toward the re-introduction of Pre-Pen on this website, and will notify by email allergists and others who have made inquiries when Pre-Pen returns to market.

AllerQuest is grateful for the encouragement and support from our professional colleagues in this venture. We are committed to bringing Pre-Pen back to market as quickly as possible, and then turning our attention to companion skin test reagents such as the "minor determinant mixture."


Updated as of June 8, 2008