The deal – worth $650m (€570m), plus a further $100m upon achievement of certain milestones – sees Sanofi increase its presence in the recombinant vaccine space, adding Protein Sciences’ insect virus-based expression technology and its commercial vaccine Flublok.
“Recombinant vaccines are not new and have already been operated by Sanofi Pasteur for a while. The oldest example of recombinant vaccine is probably Hepatitis B. More recently Sanofi Pasteur’s dengue vaccine is a recombinant vaccine,” Sanofi spokesman Jack Cox told Biopharma-Reporter.
He added the addition of Flublok – the only recombinant protein-based influenza vaccine approved by the US Food and Drug Administration (FDA) – complements Sanofi’s egg-based flu vaccines.
“As soon as Protein Sciences will be integrated, it will benefit from Sanofi’s broad industrial network & resources,” Cox continued.
“Flublok production involves the same steps as a traditional vaccine: seeds & cells production, antigen manufacturing, formulation, filling, packaging, and testing all along the chain. Some of those steps could be supported by Sanofi facilities in a mid-long term horizon.”
Sanofi will take on laboratories and pilot plant at Protein Sciences’ headquarters in Meriden, Connecticut, as well as a manufacturing facility based on a 2,000L bioreactor in Pearl River, New York acquired from Pfizer in 2012 and repurposed to make Flublok within ten weeks.
“They also run manufacturing partnerships with Unigen in Japan for large-scale bulk flu vaccine production and with Adimmune in Taiwan for formulation, filling and packaging activities,” Cox said, though told us the brand-new Unigen plant is not yet FDA-approved.
Insects, not eggs
According to Cox, recombinant vaccines tend to be purer than traditional vaccines.
“They offer more flexibility for research, development and production. In the case of Flu, they also offer a production alternative to traditional egg-based flu vaccines. Moreover, insect cells are easier to grow, compared to traditional mammalian cells.”
Meriden, Connecticut-based Protein Science employs a Baculovirus Expression Vector System (BEVS) to optimise its proprietary Spodoptera frugiperda insect cell line, expresSF+ cells. The reengineered high-density and serum-free cell line generates quantities of a desired recombinant vaccine dramatically faster than using an egg-based platform.
“We can manufacture vaccine in significantly less time – 2-3 months vs. 6 months – and that can be shortened even further to a few weeks if we already have recombinant baculoviruses made/stored that express the desired hemagglutinin protein,” the firm told this publication in 2013.
The acquisition bolsters Sanofi’s position in the highly consolidated vaccine industry.
Speaking at an industry conference earlier this year, Sanofi Pasteur’s head of global research Nicholas Jackson said the number of vaccine makers had dropped to single digits over the past 50 years.
“In the late 60s there were 26 manufacturers who provided an FDA licensed vaccine. Today there are only seven [companies] who produce one vaccine and only eight that have more than one vaccine,” he told a crowd at the BPI European Summit in Amsterdam in April.
He added after years of mergers and acquisitions, on an international level “there are really only five players left: Sanofi Pasteur, GSK, Merck [& Co.], Pfizer and J&J.”
Data from EvaluatePharma supports this view, showing 86% of worldwide vaccine sales in 2015 were for products made by GSK, Sanofi, Merck & Co. and Pfizer.