US scientists have uncovered a defence mechanism in bacteria that allows them to fend off the threat of antibiotics.

It is hoped the findings could help researchers boost the effectiveness of existing treatments.

The study published in Science found that nitric oxide produced by the bacteria eliminates some key effects of a wide range of antibiotics.

One UK expert said inhibiting nitric oxide synthesis could be an important advance for tackling tricky infections.

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Antibiotic resistance, for example with MRSA, is a growing problem and experts have long warned of the need to develop new treatments.

The latest research, done by a team at New York University, showed that in bacteria the production of nitric oxide – a small molecule made up of one nitrogen and one oxygen atom – increased their resistance to antibiotics.

They found the enzymes responsible for producing nitric oxide were activated specifically in response to the presence of the antibiotics.

They also showed that nitric oxide alleviates damage caused by the drugs as well as helping to neutralise many of the toxic compounds within the antibiotic.

The researchers then showed that eliminating nitric oxide production in the bacteria allowed the antibiotics to work at lower, less toxic doses.

More effective

Study leader, Dr Evgeny Nudler, said developing new medicines to fight antibiotic resistance, such as that seen with MRSA is a “huge hurdle”.

“Here, we have a short cut, where we don’t have to invent new antibiotics.

“Instead we can enhance the activity of well-established ones, making them more effective at lower doses.

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Dr Matthew Dryden, consultant in microbiology and communicable disease at Royal Hampshire County Hospital and general secretary of the British Society for Antimicrobial Chemotherapy, said if the enzyme which creates nitric oxide could be inhibited, it could suppress the ability of the bacteria to counteract antibiotics.

“This would be a useful therapeutic advance, especially as we are running out of new classes of antibiotics and there is less antibiotic development in general.”

Source: BBC NEWS

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An FDA advisory committee voted unanimously in favour of agency draft guidelines for developing generic versions of ViroPharma’s antibiotic Vancocin (vancomycin) that do not require comparative studies in humans to establish bioequivalence, the company reported on Wednesday.

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The proposed guidelines allow the use of in vitro testing to establish bioequivalence for generic versions of the product, which is approved to treat severe infections of the gastrointestinal tract, Clostridium difficile infection (CDI) and enterocolitis caused by Staphylococcus aureus. Committee member Thomas Moore remarked that given the increase in cases of serious Clostridium difficile infection, “it seems more important than ever to increase access to oral vancomycin.”

The drugmaker argued that “the proposed in vitro test conditions do not mimic the in vivo environment of the CDI patient and the qualitative and quantitative sameness…is inadequate given formulation and critical manufacturing process controls, and lacks correlation with clinical effects.” ViroPharma CEO Vincent Milano said he believes the favourable vote “puts patients seriously at risk.” The FDA is scheduled to render its final decision on whether to adopt the draft guidelines later this year.

Commenting on the news, Deutsche Bank analyst Robyn Karnauskas said investors had anticipated the panel decision and are looking at potential future growth to be driven by the company’s hereditary angioedema drug, Cinryze. Vancocin generated sales of $232 million in 2008.

Source: FirstWord

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We’ve been straining to see inside our congressional crystal ball for hints on what Henry Waxman’s win in the contest for chairman of the powerful House Energy and Commerce Committee means for the drug and device industries.

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The soon-to-be ex-chair John Dingell (D., Mich.) may be a conservative on energy and auto emissions, but he has been one ornery activist for change at the FDA and the industries it regulates. But there may be little comfort for those pining for change. Waxman hasn’t been bashful about bashing the same folks.

The committee under Dingell has more than a dozen ongoing investigations of issues drugs, food and FDA-related issues that have made their targets sweat. His investigations on DTC advertising were particularly bruising. After a May hearing that left pieces of Merck, Schering-Plough, and Pfizer on the floor, PhRMA’s chief Billy Tauzin warned his members to volunteer some DTC restrictions before they had them stuffed down their throats by Dingell & Co.

Other investigations involve a variety of alleged mistakes and bad decisions at the FDA involving the safety of food, drugs and medical devices—such as its handling of problems with contaminated heparin, dangers with Sanofi-Aventis’s antibiotic Ketek, and the risks of bisphenol A.

With Dingell’s toppling, will Billy Tauzin at PhRMA and drug czar Janet Woodcock at FDA sleep more soundly? We wonder.

For starters, Dingell’s tough Investigations Subcommittee chair, Bart Stupak, another Michigan Democrat, is likely to retain his role, which probably means those investigations will keep rolling.

And Waxman has also been a bulldog on drug issues. He is trying to derail efforts by the FDA and industry that would ease rules against off-label promotion of medicines. Just before Supreme Court arguments, he revealed documents showing internal divisions at the FDA over whether to support “preemption” of product liability suits against drugmakers. He seems unlikely to let that one go.

Waxman also has pending legislation that would allow lawsuits against medical device makers, which would undo this year’s Supreme Court preemption decision affecting them. Waxman’s office didn’t respond to our questions about the congressman’s plans for pharmaceuticals and FDA.

Meantime, give PhRMA credit for quick reaction. Tauzin, a former Republican congressman, hasn’t had as close a relationship with Waxman as he has had with Dingell. But less than an hour after Waxman won, Tauzin and PhRMA sent a public congratulations to him with a big olive branch, touting plans to work with Waxman for Americans.

Source: The Wall Street Journal

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Pfizer is making headlines this week for improving its pipeline, but is it really? While it announced it is ditching the heart disease medication research in favor of working towards advancements in other key clinical areas, some doubt the promise of the pipeline. The company is also backing out of bone health and anemia research, along with several other research areas.

Recently, Pfizer had to withdraw an FDA filing for the antibiotic dalbavancin when it failed to demonstrate sufficient evidence for the efficacy of the drug, although it is taking the antibiotic back into clinical trial. However, the company says it has increased its late-stage pipeline from 16 to 25 projects in the last six months and that it will continue to make advancements with medications aimed at treating cancer, diabetes, immunology, inflammation, pain, schizophrenia and Alzheimer disease. Pfizer shares rose 4.5 percent following the announcements.

The company announced its decision to back out of cardiac and other markets at nearly the same time it announced the improved pipeline, but some in the investment world wonder if shareholders are getting enough R&D bang for their Pfizer bucks–especially since some of the medications in Phase III trials are old drugs looking for a new raison d’être.

As an aside, all this change leaves us wondering if Carl Icahn will announce today that Pfizer is Imclone’s secret bidder.

Source: FiercePharma

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Even as Pfizer is bailing out of drug research for heart disease, the company’s late-stage pipeline has increased to 25 projects from 16 in the past six months.

The new figures come from Pfizer’s regular six-month pipeline update and on the same day as news of its departure from new cardiovascular research.

Overall, the company moved 31 clinical programs to the next stage of development. Pfizer said it made the most progress in six areas: pain, Alzheimer’s, diabetes, inflammation, schizophrenia and cancer.

The company killed 13 other projects across a range of therapeutic areas, and as previously announced, has withdrawn its FDA filing on the antibiotic dalbavancin, acquired with much fanfare three years ago, in order to run an additional clinical trial.

The pipeline update didn’t reflect Pfizer’s decision to stop internal drug development in cardiovascular drugs and other areas. Martin Mackay, the head of R&D, told the Health Blog that the company will decide on a case-by-case basis exactly which compounds in these areas will be terminated — the ones in phase III won’t be touched. Then, in a departure from past Pfizer form, the company may partner with other companies to bring the compounds to market. “Outlicensing will very much come to the fore,” Mackay told the Health Blog.

The pipeline progress wasn’t enough to cheer some shareholders. “I’m not sure that investors are getting their money’s worth for Pfizer’s R&D spending,” said Mike Krensavage, whose money-management firm Krensavage Partners holds Pfizer shares. As explained to the Health Blog, Pfizer spent $3.8 billion on R&D in the first six months of the year, but only one internally developed new chemical entity moved into phase III testing during that time.

Source: The Wall Street Journal

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