Big pharma: Few new antibiotics in the works

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Thirty years ago, when the world faced the terrifying prospect of an untreatable disease known as AIDS, big drugmakers saw an opportunity and raced to develop new medicines.

Today, as the world confronts the crisis of antibiotic resistance, the industry is cutting research in a field that offers scant financial rewards.

The overprescription of antibiotics has created resistant bacteria they no longer can defeat. These "superbugs" are dangerous but not yet widespread, so the costly research needed to combat them is not worthwhile.

Developing weapons that can save the lives of infected patients will require both faster approval of last-resort drugs and new ways to guarantee rewards for companies, according to industry leaders and public health officials.

"The market for a new antibiotic is very small, the rewards are not there and so the capital is not flowing," said Paul Stoffels, pharmaceuticals head at Johnson & Johnson. "In cancer, people pay $30,000, $50,000 or $80,000 (per patient) for a drug, but for an antibiotic it is likely to be only a few hundred dollars."

In December, Stoffels' company won regulatory approval for a new treatment for drug-resistant tuberculosis — a growing issue in many countries. But Johnson & Johnson is not developing any more antibiotics.

Pfizer, once the leader in antibiotics research and development, closed its dedicated center in Connecticut in 2011, to the dismay of many scientists. The company now focuses its anti-bacterial work on vaccines.

Others to have quit include Roche, Bristol-Myers Squibb and Eli Lilly, leaving only a handful of firms like GlaxoSmithKline, AstraZeneca and Merck & Co. in the game. But with basic research providing few new leads for drug targets, they are finding it tough.

Facing difficult decisions about where to invest, AstraZeneca on Monday said it would put less money into developing anti-infectives. "We have to make choices, and we have to focus our investments where we think we can make a substantial difference," CEO Pascal Soriot said.

The number of new systemic antibiotics approved by the U.S. Food and Drug Administration has plunged from 16 between 1983 and 1987 to just two in the past five years, according to the Infectious Diseases Society of America.

Meanwhile, the superbugs are spreading. One of the best known is methicillin-resistant Staphylococcus aureus, or MRSA, which is estimated to kill about 20,000 people every year in the U.S.

For any company weighing its investment in research and development, the regulatory bar for drug approval is a key consideration. The bar for antibiotics is high, partly because of a scandal over the approval of Sanofi's drug Ketek in 2004, which U.S. officials said later should be reserved for serious diseases because of the risk of side effects.

The head of FDA's drug wing, Janet Woodcock, last year pledged a complete "reboot" of the approval process, aware of the stifling effect that recent official caution has had on the development of new drugs.

The Generating Antibiotic Incentives Now Act, which took effect last October, will also help by offering an extra five years of market exclusivity.

Still, the Infectious Diseases Society believes more legislation is needed to set out a clear path by which new antibiotics can be approved for a limited population after much smaller and faster clinical trials.

Just as in the early years of HIV, it argues, the world must accept riskier new drugs for incurable infections when there are no alternatives and patients' lives are on the line.

GlaxoSmithKline — the company that developed AZT, the first HIV drug — is one of the few big pharma companies still actively researching antibiotics. CEO Andrew Witty said he thinks the antibiotic problem can be cracked, given sufficient political will — but it won't happen overnight.

"This is a long-cycle-time business," Witty said. "Even if we get this absolutely brilliantly tuned up, it is going to be a five- to 10-year journey."