Big Vaccine Plans for Glaxo - TheStreet

GlaxoSmithKline

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said Thursday it would double its annual flu vaccine production by 2008 as it seeks to enter the U.S. market and expand its efforts worldwide.

The announcement was part of a broad review of its vaccine strategy, as GlaxoSmithKline discussed its vaccine plans for the developing world -- including diseases like malaria and dengue fever -- as well as for competing with giant peers such as

Sanofi-Aventis

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and

Merck

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on multiple disease fronts in the U.S. and Europe.

Much of Thursday's vaccine discussion isn't new, but taken together, the projected launching of five new vaccines in the next five years could add $11 billion to $18 billion in revenue by 2010. And that doesn't count another 15 products in earlier stages of development. "

Our vaccines business is set for rapid growth," said David Stout, president of pharmaceuticals for the company, which is based in London and Philadelphia.

More important than the higher sales or potentially higher stock price is the public health impact of more vaccines.

The doubling of flu vaccine production should, among other things, provide greater predictability and stability to the U.S. flu vaccine supply, which has fluctuated over the years.

Last year, U.S. public health officials had expected about 100 million doses to be available, but the number was drastically reduced when manufacturing problems at a

Chiron

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plant in the U.K. caused the canceling of some 48 million to 50 million doses.

Although Chiron has received the go-ahead from British health regulators to resume production, it still must get approval from the U.S. Food and Drug Administration to sell vaccine for the upcoming flu season. The FDA should make a decision in a few weeks.

Even if the FDA gives the go-ahead, Chiron has warned that

it won't provide as much vaccine as it had planned to provide during the previous flu season. Sanofi-Aventis will provide most of the U.S. flu vaccine for the 2005-2006 season.

The uncertainty over Chiron probably won't affect GlaxoSmithKline this year. If the FDA approves its application for Fluarix, GlaxoSmithKline will supply about 10 million flu shot doses for the upcoming flu season. It provided about 1.2 million doses on an emergency basis for the previous season.

The company also is working on an improved flu vaccine, adding that preliminary clinical trial data involving 360 elderly patients shows the experimental product is as well tolerated as Fluarix. Large, late-stage clinical trials will start next year, and the company expects to seek approval in 2008 in the U.S., Europe and other markets. Fluarix is licensed in 102 countries, producing 2004 sales of $144 million.

Showdown With Merck

Perhaps the most closely watched vaccine issue on Wall Street is the competition between GlaxoSmithKline and Merck for a vaccine against human papilloma virus, or HPV, which can cause cervical cancer. The worldwide HPV vaccine market could be worth $4 billion to $7 billion by 2010, GlaxoSmithKline says.

GlaxoSmithKline said the worldwide toll of cervical cancer is enormous -- one death every two minutes from the second-leading cancer-killer of women.

Merck says about 20 million American men and women are infected with HPV. In addition to cervical cancer, HPV has been linked to abnormal Pap tests and genital warts. "Because males can become infected themselves and spread the virus unknowingly, they contribute to the risk of cervical cancer and are at risk of developing genital warts and, rarely, some cancers," Merck says.

In the U.S., an estimated 10,370 new cases of cervical cancer will be diagnosed this year, and there will be an estimated 3,710 deaths from cervical cancer, Merck says. In addition, there will be 500,000 to 1,000,000 new cases of genital warts per year in the U.S.

Merck says late-stage clinical trials are being conducted worldwide with more than 25,000 participants. Results should be available later this year. Merck plans to seek FDA approval for its vaccine later this year.

GlaxoSmithKline said Thursday it plans to submit an application for Cervarix in Europe during the first half of 2006 and other international markets during 2006. "Discussions on filing with

the FDA are ongoing," the company says.

The vaccine has been granted "fast track status," which means that when the agency accepts the Cervarix application, it will be subject to an accelerated review. Some analysts say the application will probably come in 2007.

GlaxoSmithKline and Merck are competing on other fronts. On Wednesday, Merck said the FDA had agreed to review two experimental vaccines, Rotateq, for rotavirus gastroeneteritis, which causes severe diarrhea and dehydration in children, and Zostavax, for preventing shingles and nerve pain.

On Thursday, GlaxoSmithKline said it continues discussing an application with the FDA for its rotavirus gastroenteritis vaccine called Rotarix. The vaccine has been approved in seven countries, and applications have been filed in Europe and 50 other markets. The company predicts the market for rotavirus vaccines could be between $1.8 billion and $2.4 billion by 2010.

More Products, More Competition

In early May, GlaxoSmithKline won FDA approval for Boostrix, the first combination vaccine that provides immunization against whooping cough, tetanus and diphtheria for adolescents. Boostrix received the FDA's clearance just two months before the agency approved a similar booster vaccine called Adacel from Sanofi-Aventis.

The next competitor in sight is

Wyeth

(WYE)

, maker of the vaccine Prevnar to protect infants and children against pneumococcal diseases such as pneumonia and meningitis. Prevnar accounted for $1.1 billion in sales last year.

GlaxoSmithKline claims its experimental vaccine Streptorix can prevent more types of pneumococcal disease than can Prevnar. GlaxoSmithKline says it expects to file applications for approval in Europe and other markets during 2007. "Discussions on a U.S. filing are ongoing," the company says.

GlaxoSmithKline also is taking on Sanofi-Aventis in preventing meningitis. Sanofi-Aventis received FDA approval in mid-January for Menactra, which is designed to fight four major types of this bacterial disease. The vaccine was approved for people aged 11 to 55, and Sanofi-Aventis is seeking FDA approval to expand coverage to children ages 2 to 10.

GlaxoSmithKline expects to file an application with the FDA in 2008 for its Menitorix vaccine that would include the treatment of infants. The company is awaiting approval in the U.K., and the product would be available in other European countries once the U.K. endorses it. Regulatory filings in other worldwide markets will be made in 2006 and 2007.