Novartis retreats on antibiotics

The fight against life-threatening infections suffered another blow when one of the world's biggest drugmakers waved the white flag.

Novartis AG is the latest drug giant to end antibacterial and antiviral research, joining the likes of AstraZeneca PLC, Sanofi, Allergan PLC and Medicines Co. GlaxoSmithKline PLC has put some antibiotics assets under review.

The pullback revives concern about a world in which routine infections again become lethal as bugs develop resistance to existing drugs. Sales of new antibiotics are too low for big pharmaceutical companies to recoup their investments, and public measures to encourage more activity aren't moving the needle.

"The market is broken," said David Shlaes, a former pharmaceutical executive and consultant. "We're at a point now where resistance is moving a lot faster than our ability to provide new antibiotics. This is just another in a long string of really bad news."

The latest retreat comes after a brief period when industry leaders appeared willing to take a risk on the field. Merck & Co. spent $8.4 billion on antibiotics leader Cubist in 2014. Novartis, Glaxo and other companies pledged at the World Economic Forum in 2016 to fight the threat of drug-resistant bacteria. The U.S. government offered longer patent protection and subsidies, potentially worth hundreds of millions of dollars, to companies willing to invest.

But the new antibiotics just haven't sold. Only five of the 16 brand-name drugs approved from 2000 through last year were able to generate sales of more than $100 million annually, according to a study from Duke University's Margolis Center for Health Policy. That's a pittance compared with the billions of dollars for new cancer treatments.

The problem for drugmakers is that new antibiotics are usually held in reserve and are not used unless they're needed because patients develop resistance to an older medicine. Even the most expensive antibiotics, at around $1,000 a day, are cheap compared with a cancer medicine that will be given for months instead of a few days or weeks.

Meanwhile, developing new antibiotics is becoming more expensive, said Gabrielle Breugelmans, director of research for the Access to Medicine Foundation. The roughly 275 research projects going on around the world might yield two or three medicines, she said.

"Novartis pulling out makes us a little worried, because they had a relatively large pipeline" of new antibiotics, Breugelmans said. "Now it is not clear what will happen."

Faced with the prospect of drug-resistant bacteria killing 10 million people a year by 2050, according to a U.K. report, governments are considering more aid. In the U.S., Congress is considering legislation that proposes an exclusivity voucher for companies that develop badly needed new antibiotics -- a voucher that can be transferred to another product or sold. And in India, where drug-resistant microbes kill nearly 60,000 newborns every year, the government has provided early research funding to homegrown startups including Bugworks Research India Pvt. Ltd.

"We think the tide may be turning from a scientific, as well as a regulatory and pricing, perspective," said Kasim Kutay, CEO of Novo Holdings A/S in Denmark, which started a $165 million fund in February to combat antimicrobial resistance.

Information for this article was contributed by Ari Altstedter and John Lauerman of Bloomberg News.

Business on 07/14/2018

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