Another serious blow has occurred in the fight against infections that are threatening numerous lives. One of the largest drug manufacturers in the world has just waved the proverbial white flag. According to Novartis, they are ending their research regarding antivirals to prioritize their research. This statement was made on Wednesday after Glaxo or GlaxoSmithKline reviewed some of their antibiotic assets, the medicines sold by the business and the portfolio for Sanofi was shifted to Evotec. According to a statement made by Allergan in May, they will be leaving the field. The former leader was AstraZeneca but they gave up on manufacturing antibiotics approximately two years ago.
These actions have led to concern regarding a world where a simple infection may once again become lethal due to the ability of the bugs to resist the drugs currently in existence. Antibiotic sales have become too small for the big pharma companies to recoup their investments. This is not being changed by any public measures to encourage more activity. David Shlaes is a consultant and a former executive in the pharmaceutical industry. He believe the market has broken and the industry has reached the point where the resistance is moving much quicker than the ability of the pharmaceutical sector to provide the necessary antibiotics. He said this just adds to the long history of very bad news.
The latest retreat by the pharmaceutical industry occured after a short period of time when the leaders in the industry appeared to be willing to take some risks in their industry. In 2014, $8.4 billion was spent by Merck for the antibiotics leader Cubist. Numerous companies including Glaxo and Novartis made pledges in 2016 at the World Economic Forum to fight the threat rising from bacteria resistant to drugs. The government of the United States offered subsidies and longer patent protection to any company willing to make an investment. The potential for this was hundreds of millions of dollars. The issue is the new antibiotics are just not selling so the big pharma companies are not willing to invest.
Between 2000 and the close of 2017, there were sixteen antimicrobials approved carrying a brand name. The Margolis Center for Health Policy at Duke University conducted a study. This revealed only five of these antimicrobials generated sales that exceeded $100 million per year. This does not seem like much when compared to the new cancer treatments that are making billions of dollars for the big pharma companies. The drug makers have stated the problem is any new antibiotics are generally placed in reserve. Unless they are needed, they will not be used due to the resistance developed by patients for older medications. The most expensive antibiotic costs roughly $1000 per day. This is cheap in comparison to cancer medications that are necessary for months as opposed to a few weeks or even days.
Gabrielle Breugelmans works for the Access to Medicine Foundation as the director of research. She stated it has become more expensive to develop new antibiotics. She said only two to three medicines are generally yielded from approximately 275 research projects. She added she was a bit concerned that Novartis had pulled out. She believes their pipeline for new antibiotics was fairly large and admitted she is unsure of what will happen next. Novartis has made claims they will be trying to find partners for their experimental drugs. If they follow the precedent most recently set, the result may be giving their assets to a smaller company. More and more drug manufacturers are abandoning antibiotics and giving their assets to much smaller biotech companies willing to take a higher risk.
The portfolio for Medicines Co. has been sold to Melinta Therapeutics and the research for AstraZeneca went to the small company of Entasis Therapeutics. Any antibiotics remaining were sold to Pfizer’s antibiotics unit. In 2018, the portfolio for Sanofi was taken over by a German company called Evotec. The CEO for the business is Werner Lanthaler. He believes co-developing a €200 million product with a commercial partner makes a lot of sense. He also believes the long term support of the public is necessary for making a strong case for the importance of antibiotics. According to a report from the United Kingdom, the government was faced with the potential of ten million deaths every year from bacteria resistant to drugs by 2050. This had led to the realization more aid is required.
The Congress of the United States is considering drafting legislation for the proposal of a voucher for exclusivity. This would apply to any company developing desperately needed antibiotics. This voucher can be sold or transferred to a different product. Superbugs in India are killing almost 60,000 newborns each year. Early research funding has been provided by the government for homegrown startups such as Bugworks Research India. Kasim Kutay serves Denmark’s Novo Holdings as the CEO. He believes the tide is turning from a perspective of pricing, regulations and science. In February, the company launched a fund for $165 million to combat antimicrobial resistance. This received in excess of fifty European investment proposals and the intent is to make their first investment before 2018 ends.
Merck is the drug maker in the United States that purchased Cubist. The company has stated they remain dedicated to researching antimicrobials. The Swiss cancer specialist Roche said the same thing and has an antibiotic pipeline. The biggest player in the industry is Glaxo. In 2017, the company stated they would review the business for their cephalosporins antibiotics in addition to considering selling their operations. The company also stated they are working on an experimental antibiotic in the later stages of development. They are trying to locate a creative way for rewarding new developments and research in antibiotics.
The hope is pressure will result from so many of the big pharma companies like Novartis leaving the antibiotic research field. As Motif Bio’s CEO, Graham Lumsden believes this may correct some of the failings in the market. A regulatory review in the United States of his experimental antibiotic Iclaprim is underway and may take up some of the current slack.