Novartis `Gold Mine' Shot May Stop Killer Meningitis

Novartis `Gold Mine' Shot May Stop Killer Meningitis

By Eva von Schaper


July 2 (Bloomberg) -- Novartis AG biologist Rino Rappuoli says he may have found a way to wipe out meningitis B, a disease that can kill children within 24 hours of infection.

Fifteen years after Rappuoli undertook his meningitis project, Basel, Switzerland-based Novartis is set to begin final clinical tests of a preventive vaccine. If the studies are as successful as earlier ones, Rappuoli's treatment will be the first to protect infants from most of the 260 strains of bacteria that cause 80,000 cases of the deadly brain and spinal inflammation each year worldwide.

Rappuoli, 55, initiated his effort in 1993 when he read a scientific report by U.S. researchers who were the first to decipher the genetic code of a bacterium responsible. The advance suggested a new approach that eventually led to a vaccine that may provide a global public health weapon, doctors say. The shot may also bring in more than $1 billion annually for Novartis, according to Graham Parry, a Merrill Lynch & Co. analyst.

``They do have a very, very good market opportunity,'' said Hedwig Kresse, an analyst at Datamonitor Plc, the London-based market research company, in an interview. ``We especially see a large commercial potential in Europe, where meningitis B currently accounts for around 60 percent of all meningococcal meningitis infections.''

The shot may generate $2 billion annually by 2016, with catch-up immunizations adding to that, according to Datamonitor. Rappuoli's vaccine may be active against about 80 percent of the bacteria that cause meningitis, an inflammation of the protective membranes covering the brain and spinal cord, Novartis spokesman Eric Althoff said in an interview.

Return to Vaccines

Novartis rose 3.4 percent, the most in almost four months, to 58 francs at the close of Zurich trading. The stock is down 6.6 percent this year, compared with a 13 percent decline in the Bloomberg Europe Pharmaceutical Index of 13 companies.

Novartis's support for the meningitis product is part of an increase in investment by drugmakers in vaccine research after the success of the pneumonia shot Prevnar, which brought in $2.4 billion last year for Wyeth, based in Madison, New Jersey. Drugmakers largely had abandoned research on vaccines about two decades ago because the products generated low prices and brought increased legal liability, while branded medicines typically produced higher profits.

Now, with a dearth of new drugs coming from research labs and with advances in gene technology, companies are rebuilding vaccine operations. While drugs can be readily copied, few generic drugmakers can make vaccines, Kresse said.

`A Gold Mine'

Last year, U.K. drugmaker AstraZeneca Plc bought MedImmune Inc. for $15.2 billion, gaining the FluMist flu vaccines. In 2006, Novartis paid $5.4 billion for the 67.8 percent of Chiron Corp. it didn't already own, acquiring Rappouli's labs.

The shot may be available in 2010, Novartis says. It may help the drugmaker replace $8 billion in annual sales that will be lost because of generic competition to its heart pill Diovan and cancer treatment Gleevec beginning in 2012.

``This is a gold mine,'' Rappuoli says he remembers thinking when he tested the first experimental batch of the vaccine in 1997. His lab is a 10-minute walk from the unfinished wall of the Siena Cathedral in Italy. Work on it stopped in the 14th century after the Black Plague depopulated the city, leaving the wall as a reminder of the power of infectious diseases, Rappuoli said.

There isn't a shot that allows doctors to protect children against the many strains that cause meningitis B, so infected patients are treated with antibiotics. Because the disease is difficult to diagnose, some patients don't receive help until after the illness has progressed, according to the Geneva-based World Health Organization.

10 Percent Die

At least 10 percent die and as many as one in five are left with permanent effects, such as mental retardation, epilepsy or tissue death leading to limb amputation, says Robert Read of the University of Sheffield in England.

The B strain causes the majority of infections in the U.S, Europe, Canada and Australia. Even though the product isn't available yet, Rappuoli's technology is being used in university labs to develop additional vaccines. Wyeth and London-based GlaxoSmithKline Plc, Europe's largest drugmaker, are working on similar vaccines.

The genetic advances that triggered Rappuoli's effort were critical because scientists were stymied. Injecting a portion of the bacteria into a patient's bloodstream, the approach typically used for vaccines, didn't elicit a protective immune response, the Italian scientist says.

New Effort

Rappuoli found that the shell of the menigococcus bacterium wouldn't provoke an immune protection when given as a vaccine, because it was too similar to a protein in the human brain.

When he read that U.S. researcher Craig Venter -- who later became famous for helping decode the human genome -- deciphered the genome of a related bacterium, Rappuoli says he knew ``this was revolutionary.''

Rappuoli persuaded Venter, then at Celera Corp., a U.S. genetics company, to analyze an additional bacterium. The resulting gene map identified five of the bacterium's protein building blocks, which the Italian scientists then stitched together into a vaccine.

``We started the work in '96 or '97 and only now do we have the final answer that the vaccine works in infants,'' Rappuoli said in an interview. ``The most difficult thing was that conventional technologies failed to make a vaccine for this terrible disease.''
 
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