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Novartis donates data in effort to jump-start antibiotic development

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Pharmaceutical giant Novartis will publish research on developing drugs to treat some of the deadliest antimicrobial-resistant pathogens as part of an initiative aimed at promoting further scientific efforts within the field.

The effort is being led by the Pew Charitable Trusts, which in September launched the Shared Platform for Antibiotic Research and Knowledge, an open-access research program that will make information from past published studies and unpublished data available to all researchers at no cost.

Wes Kim, senior officer for Pew’s Antibiotic Resistance Project, hopes sharing data in this format will encourage increased development of new antibiotics that will be effective against drug-resistant pathogens since the number of available treatment options has diminished.

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Novartis is the second drugmaker to donate data for the project. The company will share research collected while experimenting with antibiotics to treat against Gram-negative bacteria. Novartis announced last July it was shutting down its antibacterial research projects. In October, San Francisco-based biopharmaceutical firm Achaogen announced plans to provide the Pew project with data from its own discontinued antibiotic research program.

Kim said Pew was currently in discussions with a “handful” of others, including some from academia and other drugmakers, over the prospect of donating their data to the program.

“We hope the scientific community recognizes that sharing data doesn’t mean they’ll lose their competitive advantage,” Kim said. “There’s some data that is so far upstream in the early discovery efforts that if a company decides not to proceed with these types of compounds, then we hope that they see the value in sharing the data with the broader scientific community.”

The initiative’s main focus is on developing antibiotics to combat the growing prevalence of the Gram-negative class of pathogens, a highly resistant type of bacteria that only a handful of current medications are effective against.

The rate of infections that contain Gram-negative strains of bacteria such as E. coli and Klebsiella—two of the most commonly acquired infections in healthcare settings—has grown over the past two decades. Providers worry there will soon come a time when all current medications fail.

Experts say novel antibiotics are needed to overcome Gram-negative bacteria, which can be resistant to multiple drugs. A recent Pew analysis found 17 antibiotics were in development as of last September that have potential to treat Gram-negative infections. Historically, only one out of five drugs that reach the human testing stage of clinical trials receive approval from the Food and Drug Administration.

Since 2017, the agency has approved only two antibiotics to treat Gram-negative bacteria, but both products are either combinations or modifications of existing classes of antibiotics. The last discovery of a new class of antibiotics that works against Gram-negative bacteria was in 1968.

Efforts to develop new antibiotics have faced several challenges. Kim said the science around developing a new antibiotic is incredibly difficult and expensive to conduct. Antibiotics are not lucrative like products to treat cancer and diabetes. Clinicians are told to use antibiotics sparingly to reduce the likelihood of pathogens becoming resistant, which diminishes the prospect of repeat sales.

A 2017 study from Duke University’s Margolis Center for Health Policy found median annual sales of brand-name antibiotics ranged from $24 million to $75 million between 2011 and 2015 compared to more than $500 million for most brand-name oncology drugs approved during the same period.

Over the past few years, Novartis, along with fellow large drugmakers AstraZeneca and Allergan have dropped their antibiotic development programs, while GlaxoSmithKline, arguably the largest maker of such drugs, has stated it was considering a similar move.

But companies are exiting antibacterial research at a time when current antibiotics are losing effectiveness at a faster pace.

“We know that the time to resistance for antibiotics keeps on getting shorter and shorter because of the lack of novel drugs,” Kim said. “It’s not a question of if but when.”

Source: ModernHealthCare.com