Emergent Biosolutions

Emergent Biosolutions’ agreement to buy the influenza vaccine FluBlok indicates a continued interest in expanding its infectious diseases portfolio, following acquisitions related to anthrax vaccination. This latest addition, once approved, will enable entry into the expanding influenza sector, which is predicted to reach total sales of almost $5 billion by 2016 across the seven major markets.

Emergent BioSolutions (EBS) and Protein Sciences Corporation (PSC) have entered into an asset purchase agreement, pending shareholder approval, under which EBS will acquire PSC’s ongoing operations, including FluBlok, a Phase III recombinant influenza vaccine candidate. If the deal is approved, FluBlok would add to EBS’s infectious diseases portfolio, following recent acquisitions of a Phase II anthrax vaccine candidate from Vaxgen, and a group of anthrax monoclonal antibodies from Avanir Pharmaceuticals.

FluBlok is a trivalent recombinant hemagglutinin influenza vaccine, currently in Phase III development, that the FDA has granted both fast track and priority review status. This reflects the unmet need in the influenza market, despite the availability of six other marketed vaccines. The clinical program for FluBlok has included four trials and more than 6,000 participants, in which the vaccine has demonstrated promising immunogenicity, even in the elderly.

PSC recently submitted a Biologics License Application (BLA) to the FDA for FluBlok and a decision is expected in the fourth quarter of 2008, in time for the flu season. The vaccine is manufactured using PSC’s proprietary Baculovirus Expression Vector System (BEVS) technology, which enables rapid upscaling and straightforward production of large amounts of FluBlok, and can also be applied to develop other vaccines and therapeutics. PSC’s other product candidates are also based on the BEVS platform and include a SARS vaccine, which is in preclinical development.

If FluBlok is successfully approved it will be the seventh flu vaccine to reach the US market. Although it is likely to face significant competition, recommendations for the upcoming flu season in the US have recently been revised to include flu vaccine coverage for teenagers in addition to the elderly, chronically ill and small children. As a result, the demand for influenza vaccines is likely to increase substantially. To take advantage of the expanded coverage, EBS could make the teenage population a focal point for future trial design, given the promising results already seen in the elderly. The acquisition of FluBlok could be hugely profitable, as the influenza market is predicted to reach total sales of almost $5 billion by 2016, across the seven major markets.