With influenza season a few months away, Sanofi is giving its vaccine operations a shot in the arm by acquiring Protein Sciences, a company that has a commercial vaccine, Flublok, and manufactures it using genetic engineering and cell culture instead of the traditional method that relies on millions of chicken eggs.
According to the companies, Sanofi (NYSE: [[ticker:SNY]]) will pay privately held Protein Sciences, of Meriden, CT, $650 million up front. The deal puts Flublok in the hands of a big company with resources to market the product globally. Protein Sciences stands to gain an additional $100 million if its vaccine hits certain unspecified milestones under Sanofi.
Most influenza vaccine is produced by a decades-old process of culturing the virus in chicken eggs. Vaccine makers have been trying to move beyond it for years; egg production requires long lead times and is susceptible to many factors, like contamination and chicken illnesses, that can create shortages.
Conversely, cell cultures can be frozen until needed, notes the FDA. This feature gives vaccine makers more flexibility to match demand. Cell culture has other advantages. Some flu strains grow better and faster in cell culture, which allows vaccine makers to produce vaccines and bring them to the market more quickly, the FDA says.
FluBlok, which got an FDA green light in 2013, is a “recombinant vaccine,” which means Protein Sciences uses genetic engineering to make the single protein from the influenza virus that is needed for protection. The vaccine is then produced in cell culture. This approach, Protein Sciences says, matches the viral strain that is circulating in a given flu season. Last year, the FDA approved a quadrivalent version of Flublok, a version of the Protein Sciences vaccine developed to protect against four flu strains.
Despite the speed advantages of cell culture production, as well as Protein Sciences’ ability to match its vaccine to circulating viral strains, the approach does have some challenges. Like egg culture, cell culture vaccine production faces contamination risks. Also, making vaccines from cell culture is a more expensive way to produce vaccines.
Nonetheless, pharma companies are pursuing cell culture production to diversity their vaccine portfolio mix. In some cases, companies have constructed vaccine manufacturing plants as part of a Biomedical Advanced Research and Development Authority initiative to build the capability to respond to a viral outbreak. BARDA formed the plan following the 2009 H1N1 influenza pandemic. One site constructed under this plan operates in North Carolina. Under a government contract, Novartis (NYSE: [[ticker:NVS]] built a vaccine production site in Holly Springs, NC, capable of quickly responding to a viral emergency. That site is now operated by Seqirus, a division of Australian company CSL formed through the 2015 acquisition of Novartis’ influenza vaccine business.
Protein Sciences’ facility in Pearl River, NY, will give Sanofi a fifth site for seasonal vaccine production. The Paris-based company currently produces flu vaccine in northwestern France, Mexico, China, and Pennsylvania.
The boards of directors of both Sanofi and Protein Sciences have approved the acquisition, which still needs the approval of regulators. The companies expect to close the deal in later this quarter.
Image of H1N1 influenza by Flickr user NIAID via a Creative Commons license.
