Monday, January 27, 2014

Antibiotics will attract pharmaceutical investment

For years, pharmaceutical companies have abandoned the search for new antibiotics, stating that she wasn't worth his time. Now, some are changing their minds.
After having dismantled the team in charge of search in 1999, antibiotics Switzerland Roche Holding AG is hiring a professional to lead and recompose your area of medicines against infections. Last year, Roche has licensed a new biotech company Polyphor antibiotic Ltd. and invested $ 111 million in another company specializing in antibiotics, RQX Pharmaceuticals Inc.
Already the GlaxoSmithKline PLC, United Kingdom, giant recently reported that will receive $ 200 million in u.s. Government funding for its program of antibiotics.
Roche and Glaxo are joining some other large pharmaceutical sector, as AstraZeneca PLC and Novartis AG, in being an effort to discover and develop new antibiotics.
In the last 15 years, Drugmakers have abandoned the mass development of antibiotics, claiming high costs of research, low returns and heavy regulation. In the years 80, 30 new antibiotics were approved in the United States, compared with only one between 2010 and 2012.
Pfizer Inc., one of the pioneers in mass production of penicillin, ceased publication of research of antibiotics in 2011, along with Johnson & Johnson. In 2002, the Eli Lilly co. & left the industry to focus on chronic diseases. Sanofi SA, in turn, closed its anti-infective, Novexel, in 2004.
"We weren't having success developing new approaches to bacterial infections are difficult to be treated," says Charles Knirsch, Vice President of clinical research at Pfizer. "After much evaluation, we decided to increase the focus on prevention of infections would represent a return on investment more prudent."
Fortunately for the public health, the unfavourable economic conditions are changing. The u.s. and European regulators recently took measures to remove obstacles to the development of antibiotics, with the United States giving priority to the review of new drugs.
Funds for research are also beginning to grow. The European Union finances research projects of antibiotics in companies and universities. U.s. Government funds are accessible to companies that develop new promising molecules.
In addition, alternative business models are being discussed as a way to circumvent the problem of the low sales volumes: among them, the sale of new drugs in large quantities to service providers in the area of health so they use them when needed or the levying of a fee fixed licensing for access to medicines.
The need for new antibiotics is huge. Today, antibiotic-resistant infections kill about 50,000 people a year in the United States and Europe, a number that is growing, according to the World Health Organization. In the u.s., two million people per year will contract an infection resistant to medicines, resulting in a cost of $ 20 million in health costs, according to the Center for disease control and prevention in the country.
Overuse of antibiotics increased resistance of bacteria to them, making the current medication less effective. The generalized job in animals bred for cutting introduced more antibiotics in the food chain, which also reduced the effectiveness of them.
With fewer new drugs to prescribe, and the ancients often failing in the fight against drug-resistant strains, doctors are sometimes forced to use older and more toxic drugs.
"The antibiotics that were easy to figure out if exhausted," says Brad Spellberg, an infectious disease specialist at the Institute of biomedical research of Los Angeles.
Even when the antibiotic hits the market, medicines against cancer, for example, are on average three times more profitable. Remedies for the bones and muscles generate a return ten times greater, according to estimates of a 2009 report of the school of Economics and political science from London.
For example, the ceftarolina fosamil, an antibiotic approved in the USA in 2010, costs about $ 600 in the country for a one-week treatment. In comparison, the yervoy, a new drug against melanoma, costs $ 120,000 for a 12-week treatment.
"The society evaluates the antibiotics in the wrong way," says David Payne, head of research of antibacterial GlaxoSmithKline. "These drugs save lives; they not only give the patient a few months more [of life]. "
John Rex, area Director of AstraZeneca's infections, which currently has one of the strongest portfolios of antibiotics in development, admits that his unit is not an economic engine of the same size that the Oncology. "The math is clear," he says. "It is difficult for every anti-infective industry."
Unlike drugs against chronic diseases, antibiotics are taken for a week or two, limiting sales. Those prescribed, including azithromycin and amoxilina, are now sold as low-priced generics.
Charge higher prices could stimulate development. In a recent article published in the scientific journal "Nature", and Rex Spellberg argued that a hypothetical new medication against Acinetobacter baumannii, which cause hospital-acquired infections, could be advantageous to health providers even at a price of $ 30,000 per treatment period.
Aetna and Cigna, large u.s. health insurers, would not comment on a hypothetical price, but the Nice, United Kingdom price Advisory Council, recommends the use of two drugs against cancer that cost more, considering the additional lifetime they provide to patients.
While most Big Pharma continues to invest in other areas, some smaller companies are venturing into the sector. Drugmakers of small and medium respond now for 73% of antibiotics in development, according to statistics of BioPharma.
The Cubist Pharmaceuticals, which is based in Boston and was established in 1992, now has three antibiotics approved and a market value of $ 5 billion.
Another entrant from Boston, the Enbiotix, is talking with several large pharmaceutical companies interested in doing business, including those that do not have a division of anti-infective, said Jeff Wager, CEO of Enbiotix.
"The antibiotics will never be great champions of sale," he says. "Still, the immediate answer is that we need these meds. I don't think a big pharmaceuticals can call herself a great corporate citizen without them. "
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