Glaxo, Novartis And Their New Flu Vaccines: Just Another ‘Stupid Investment?’

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huh1.jpgHave Glaxo and Novartis stumbled yet again? That’s the question raised in a look at Protein Sciences, a much smaller company using a DNA technology to develop flu vaccines that may prove faster than the methods being used by its much bigger rivals, Bloomberg News reports.

Losing the flu-shot race may be the latest in a series of setbacks for both drugmakers, which are building plants that are part of a $1 billion US initiative to produce millions of inoculations within six months of an outbreak of a deadly flu. But Protein Sciences, with just 40 employees, is close to winning approval for a method that would cut the time at least in half.

Novartis is investing $600 million to build a cell-based flu-shot plant in North Carolina, and has won a $221 million US government grant for clinical trials. And Glaxo, which is getting $275 million in US funding, is building a Pennsvlvania factory in a facility acquired from Wyeth for an undisclosed sum. Both are growing influenza virus in animal cells as an advance over the decades-old technique of making flu shots using chicken eggs.

But cell culture “is an amazingly stupid investment to make for the future,” argues Manon Cox, Protein Sciences’ chief operating officers. “It’s as if we’re still living 100 years ago and recombinant DNA was never developed.”

“The advantages of recombinant DNA are speed of production and volume of production,” notes Dave Fedson, a former director of medical affairs for Sanofi-Aventis, the world’s biggest vaccine producer.

The world market for seasonal influenza vaccines amounts to $2 billion a year. The US has stepped in with research grants, supply contracts and higher payments to encourage suppliers. Governments are trying to reduce the threat posed by a global pandemic of a deadly virus such as the H5N1 strain. Health officials say a worldwide outbreak among humans is inevitable. Fifty million people died in a 1918 influenza pandemic.

Now, the US is preparing another round of funding for companies including Protein Sciences and Novavax to develop flu shots using recombinant DNA. “We were told they could produce a vaccine in less than 12 weeks after the start of a pandemic,” Robin Robinson, director of pandemic influenza countermeasures for the US Health and Human Services Department, tells Bloomberg.

Fedson estimates that factories around the world using Protein Sciences’ recombinant DNA approach could make two doses of vaccine in three months for 3 billion people, almost half the world’s population. That’s 10 times as much as could be made in conventional egg-based flu- shot plants, he says.

Protein Sciences inserts flu genes into cells from a corn eating caterpillar. The cells are then induced to make proteins that when injected into humans trigger a protective immune response. In the technique Glaxo and Novartis are developing, mammal cells are used to generate whole flu viruses, which are then modified to make influenza vaccine.

Protein Sciences may get US market clearance for a seasonal vaccine next year. The FDA has offered an expedited, six-month review, a process that usually takes a year. Making the vaccine is “simple, straightforward, and it’s a very established technique,” says John Treanor at the University of Rochester in New York, who has tested the Protein Sciences vaccine in humans.

The little company, which is based in Meriden, Connecticut, founded to produce pesticides, is owned by 450 shareholders, including Wyeth, according to Manon Cox, Protein Sciences’ chief operating officer. The chief executive officer, Dan Adams, 67, was a co-founder and the first CEO of Biogen.

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  1. [...] developer Protein Sciences is all over the blogosphere today (see, for instance, items on Pharmalot and the WSJ health blog), thanks to a breathless Bloomberg piece on the little Meriden, Conn., [...]

  2. Well Novartis may not be so far off track. The Medimmune story today suggests that Novartis are pretty much aware of the need to use more modern technology. What about GSK? Also, can we assume that this means AZ don’t have any intentions of using their newly acquired technology to develop their own vaccine business, or could they simply not get out of this deal (that must have been in the works for a while)? Either way, AZ are going to get benefits from vaccines and might, in the process, cause additional problems for GSK. Nice plan or just the way it worked out?

  3. May drive AZ takeover by GSK?

  4. [...] Glaxo and Novartis making stupid investments in vaccines? A 40-person company thinks [...]

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