The small private company Protein Sciences skirted bankruptcy, fought off a hostile takeover bid, spent three years angling for a sorely-needed government contract, and survived a four-year dialogue with the FDA before winning approval this year for the first influenza vaccine made with genetic engineering and without eggs.
Now comes the hard part.
The 115-employee business, based in Meriden, CT, must build a customer base for its the vaccine, which it markets as Flublok, in a $1 billion US market dominated by drug industry giants, including Sanofi Pasteur, Novartis, and GlaxoSmithKline.
“These are big guys, and it’s hard to inch in and get a bit of market share,” says Ramya Kartikeyan, lead analyst on infectious diseases for GlobalData, a research and consulting firm.
Protein Sciences CEO Manon Cox says the company is in the process of developing marketing channels for its flu vaccine. The vaccine, the company’s first product, is called a “recombinant” vaccine because its production in a cell culture is directed by a genetically engineered virus whose genes have been combined with certain influenza virus genes. Traditionally, flu vaccines have been made by culturing the flu virus itself in chicken eggs.
“I believe that a recombinant protein vaccine is just a higher quality product,” Cox says. “Many people are aware of this product, and many people want it.”
Manufacturers made about 145 million doses of flu vaccine for this winter, according to the Centers for Disease Control and Prevention. Protein Sciences is now gearing up to produce at least 500,000 doses of its version at its Meriden plant for the 2013-2014 flu season, and may manufacture as much as 3 million more if the FDA approves the plant it is expanding in Pearl River, NY.
Meanwhile, though, Protein Sciences’ big pharma competitors have been fielding innovations of their own with new flu shot formulations, manufacturing processes, and methods of administering the drugs. The flu vaccine business—once a stodgy, low-margin enterprise—has been stimulated by an influx of money from the federal government, which was gobsmacked in 2004 by an influenza scare much worse than the current winter’s severe flu season.
Nearly half the U.S. flu vaccine supply—about 50 million doses—had to be scrapped in 2004 due to contamination at the Liverpool, England, plant then run by Emeryville, CA-based Chiron, which was later acquired by Novartis. Few other companies had the capacity to fill the supply gap. Most flu vaccine at the time was produced in eggs, a decades-old method with long lead times. On top of that, epidemiologists were tracking the spread of an often-lethal new strain of avian flu that they feared could escalate into a pandemic while nations lacked the means to make vaccines against it.
A bout with the seasonal flu may be no more than an annoyance for most people, but it can be deadly in more vulnerable populations, such as the elderly. Protein Sciences was one of the beneficiaries of government funding programs designed to draw new companies into the vaccine business, and to support new vaccine technologies to supplement the more cumbersome egg-based method.
Protein Sciences’ vaccine is produced in reactors full of cells derived from an insect, the fall armyworm. These cells are each turned into small factories to churn out copies of the proteins that make up the vaccine.
Like other flu vaccines, Protein Sciences’ version will consist of different proteins each year, depending on which influenza virus strains are expected to circulate commonly for that winter season. Each flu virus strain produces characteristic proteins, or antigens, that the human immune system recognizes and tries to attack.
This is where the genetic engineering comes in. Protein Sciences induces the armyworm cells to make copies of the antigen proteins by infecting the cells with a genetically modified insect virus containing the genes that code for the flu virus proteins. In the older method, fertilized chicken eggs are infected with a live flu virus strain, which multiplies during an incubation period and then, typically, undergoes many purification and inactivation steps. Assembling an uncontaminated egg supply is a major strategic endeavor for vaccine makers, and some flu strains don’t grow well in eggs, the FDA says. By contrast, cell cultures can be frozen to stand ready for a quick manufacturing start.
The development of a recombinant flu vaccine is a “big deal,” says Kartikeyan, the GlobalData analyst. It reduces manufacturing time, and generates the exact proteins needed for the vaccine by using the genetic code for the protein as a blueprint, she says.
This rapid manufacturing capability is a boon for emergency
