Glaxo Jumps Into U.S. Swine Flu Race

GlaxoSmithKline Plc, which has taken orders around the world for 440 million doses of swine flu shots, is finally getting some business in the U.S.

The Food and Drug Administration approved a Glaxo vaccine, making the British company the fifth drugmaker cleared to sell here.

Despite being one of the world's biggest flu-vaccine makers, Glaxo is doing a relatively small amount of business in America. The U.S. government ordered 7.6 million doses from Glaxo, or about 3 percent of the 250 million total doses secured. The U.S. is behind in distributing the vaccine.

Glaxo also is joining the party here late. European rivals AstraZeneca Plc, Novartis AG, Sanofi-Aventis SA, and Australia's CSL Ltd. are producing the vaccine for the U.S. after being approved in September.

The delay for Glaxo relates to a regulatory issue. The vast majority of the vaccine made by the company includes an additive that boosts potency and isn't approved for use in the U.S. So Glaxo is making an American vaccine without the ingredient in its Quebec plant.

Worldwide, flu vaccines are huge for Glaxo. The drugmaker predicts it will sell around 1 billion British pounds ($1.66 billion) of swine flu vaccine this quarter. That's more than three times the $500 million in sales Sanofi-Aventis forecasts for the quarter.

AstraZeneca, which sells a nasal-spray vaccine, estimates its U.S. swine flu contract is worth $453 million and the bulk of those sales will be booked in the fourth quarter. Novartis predicts a range of sales for its vaccine between $400 million and $700 million in the quarter.