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www.fdanews.com/articles/63409-dna-coated-pellets-may-be-pfizer-s-golden-ticket-to-vaccine-market

DNA-COATED PELLETS MAY BE PFIZER'S GOLDEN TICKET TO VACCINE MARKET

October 18, 2006

Pfizer is joining the ranks of vaccine manufacturers, with the purchase of a company developing technology that boosts the immune system by shooting microscopic DNA-coated gold particles into the skin.

Pfizer announced Oct. 9 it will purchase PowderMed, a UK company that specializes in DNA-based vaccines and developed the Particle Mediated Epidermal Delivery technology. Pfizer CEO Jeffrey Kindler called the acquisition a "strategic opportunity to enter the vaccine market" and said it was part of the company's effort to broaden its product line.

The needle-free device shoots microscopic gold particles into the skin at more than 1,500 miles per hour using pressurized helium gas. These DNA-coated particles enter the epidermis, which is inaccessible using a needle and syringe, and activate cells that trigger an immune response. Vaccines based on this technology have been shown to elicit both antibody and cell-mediated immune responses, which could lead to improved efficacy over both egg-based vaccines and the cell-based technology currently being developed, Pfizer said.

The current vaccine-manufacturing system is constrained by insufficient manufacturing capacity and a limited ability to quickly adapt vaccines to emerging strains of influenza, the release said. The FDA stated recently that as demands for vaccines for influenza and other infectious diseases, such as SARS, increase, greater flexibility is needed to allow surge capacity in an emergency.

The "user-friendly" device, referred to as a "Gene Gun" on PowderMed's website, requires "minimal medical training and may allow for self-administration," according to Pfizer's statement. The company is also developing vaccines in formulations stable at room temperature, which would eliminate the need for cold storage.

PowderMed is part of a "scientific effort to overhaul" an outdated vaccine manufacturing system, which uses a 50-year-old technique to produce influenza vaccines inside chicken eggs -- a process that can take up to nine months. The company has several proprietary vaccine candidates for influenza and chronic viral diseases in the pipeline, according the release.