Nasal Vaccine Holds Promise Against Swine Flu:

http://www.nytimes.com/2009/07/31/business/31flumist.html

By ANDREW POLLACK
Published: July 30, 2009

As the nation girds for a possible swine flu pandemic, one of the big weapons may come from an unexpected source — a vaccine squirted or dropped into the nose.

MedImmune, which already makes the nasal spray vaccine FluMist for seasonal flu viruses, says it is on track to produce about five times as much swine flu vaccine as it had expected — so much, in fact, that it will run out of nasal spray devices and is looking to administer the vaccines with droppers instead.

A nasal spray vaccine could be a strong weapon against swine flu because makers of conventional flu shots have reported problems producing their vaccines.

If nasal spray vaccines emerge as a central player against swine flu, it would represent a reversal of fortune for MedImmune’s efforts in the field. As a vaccine for seasonal influenza, its FluMist has been a flop from a marketing standpoint, accounting for only a few percent of the inoculations Americans receive each year.

But it appears to have a manufacturing edge. Because its vaccine uses a live but weakened virus, MedImmune uses a different viral strain than the makers of flu shots, which contain an inactivated virus.

Each approach uses chicken eggs as the culture for growing its virus strain, but flu shot makers say the strain of swine flu virus they are using is growing more slowly than expected. MedImmune’s strain, meanwhile, is growing faster than expected.

As a result, MedImmune, a subsidiary of AstraZeneca, says it can make 200 million doses by next March, about five times what it had expected.

Robin Robinson, who heads procurement of the pandemic vaccine for the Department of Health and Human Services, said MedImmune alone accounted for 12 million of the 20 million doses already produced by the five companies under contract to the government.

Dr. Robinson said that the other drug makers were resolving their production problems and would catch up. He said 120 million doses should be available by October, without counting on any extra production from MedImmune. But if the extra nasal spray doses can be used, Dr. Robinson said, “our supply could possibly increase by a very large amount.”

The problem for MedImmune is that the unexpected production surge left the company short of the sprayers used to squirt the vaccine into the nose. It can supply only about 40 million doses in sprayers by March.

“We now are sitting on a surplus of potentially 150 million bulk doses,” Bernardus N. M. Machielse, executive vice president for operations, said in an interview.

BD, supplier of the sprayers, said Thursday that it was running its sprayer factory in Columbus, Neb., round the clock to increase annual capacity to 70 million sprayers — up from 20 million.

But even that will not be enough. So MedImmune wants to use droppers in addition to sprayers. Some early clinical trials of the vaccine were conducted with droppers, so the company hopes to win approval from the Food and Drug Administration to use them.

Pandemic vaccines could bolster the total sales of AstraZeneca, the pharmaceutical giant based in London that acquired MedImmune, a Maryland biotechnology company, for $15.6 billion in 2007.

The government has ordered 12.8 million doses of pandemic vaccine from MedImmune for $151 million, Dr. Robinson said. AstraZeneca might get many hundreds of millions more in sales if the government buys the rest of the 40 million or so doses in sprayers and potentially the some 150 million doses in droppers.

Simon Lowth, AstraZeneca’s chief financial officer, told analysts on Thursday that FluMist had a lower-than-average profit margin and that the pandemic vaccine, being sold under government contract, had margins that are “lower still.”

The pandemic might also allow AstraZeneca to achieve a foothold outside the United States, the only country that has approved FluMist. The company is applying for approval in other countries and is talking to the World Health Organization about supplying some pandemic vaccine to poorer countries, David Brennan, its chief executive, said Thursday.

When MedImmune agreed to buy Aviron, the developer of FluMist, in 2001, executives predicted sales would grow to more than $1 billion a year. But in 2008, the best year yet for FluMist, sales reached only $104 million.

Several missteps nullified any appeal a needle-less vaccine might have. When it was initially sold in 2003, FluMist was priced at about $50, two to six times as much as a flu shot. And FluMist had to be frozen, a problem for some doctors’ offices.

Because of safety concerns FluMist was approved only for healthy people 5 to 49 years old. But those are not typically the people who get flu vaccines.

FluMist is now approved for children as young as 2, it can be refrigerated instead of frozen and the wholesale price is down to $18.95.