Avelox in TB

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Exciting News! Found it from Bloomberg.com
This computer won't allow me to copy and past link. I'll post the link later.


By John Lauerman

Sept. 17 (Bloomberg) -- Bayer AG's Avelox, set to become the first new type of medicine for tuberculosis in 30 years, may shorten treatment time by two months and slow the development of deadly, drug-resistant strains.

Combining the antibiotic with three other therapies might cure the disease in four months instead of six, according to research funded by the Gates Foundation and the U.S. government. As a result, the number of patients who stop treatment too early may fall, slowing the spread of a disease that infects about 2 billion people, scientists say.

TB approval for Avelox, already used to treat pneumonia, may help contain lethal multidrug-resistant TB, the germ carried by Atlanta lawyer Andrew Speaker when he boarded a flight to Paris in May. Doctors at an infectious disease meeting this week in Chicago will hear results of a clinical trial. The findings will be crucial to the drug's approval as early as 2011.

``We're waiting on the edge of our chairs for the tests to get finished,'' said Charles DeGraw, TB controller for Louisiana, who has used Avelox experimentally. ``All of us think this drug is going to be a huge benefit.''

Bayer's American depository receipts, each equal to one ordinary share, rose 92 cents, or 1.2 percent, to $78.81 at 10:50 a.m. in New York Stock Exchange composite trading.

Avelox grabs onto bacterial DNA and stops germs from unwinding their genetic material, a crucial step in reproduction, said Martin Springsklee, vice president of global medical affairs for Bayer Healthcare, a unit of Leverkusen, Germany-based Bayer, in a telephone interview last week.

Efficient Entry

The chemical structure of the drug, also known by the generic name moxifloxacin, can attach to both fatty and watery molecules, allowing it to penetrate TB efficiently, he said.

``The drug reaches levels inside the cell that are two to four times higher than older compounds,'' Springsklee said. ``Because of these features, it acts very rapidly.''

The findings to be presented tomorrow at the Interscience Conference on Antimicrobial Agents and Chemotherapy have implications for fighting tuberculosis in poorer nations, where total annual costs reach $2.5 billion each year, according to the World Health Organization in Geneva. Bayer agreed to make the drug available in poorer nations at ``affordable'' prices.

``We have to protect shareholder money,'' Springsklee said. ``We also have a moral obligation to ensure our drugs are being made available to people who need them.''

Avelox Costs

Avelox costs about $200 for a two-week treatment and generated sales of about 396 million euros (US$551 million) last year. Bayer officials said they can't estimate what the price as a TB treatment would be. The drug's U.S. patent expires in December 2011. Bayer shares have risen 44 percent to 56.08 euros in German trading in the past 12 months.

While Avelox sales were just 1.4 percent of Bayer's 2006 revenue, they exceeded the $370 million worldwide market for all TB drugs, according to the Global Alliance for TB Drug Development in New York. The nonprofit group is preparing Avelox for approval to treat TB.

The Seattle-based Gates Foundation, the world's largest charitable fund, has given $140 million to the Global Alliance to develop new TB drugs. Without that support and direction, along with funds from the U.S. Food and Drug Administration for trials of Avelox, new TB drugs would never get approval, public researchers said. The market is small and treatment trials are so expensive and lengthy that most companies won't touch them.

``There is no room for profit in the world of TB,'' said Mel Spigelman, the Alliance's director of research and development, in an interview. Available drugs are cheap enough now that a full, six-month course of treatment can cost less than $20 in poorer nations, he said.

Plodding Pace

Most patients carry TB in a dormant, non-infectious form. Even when active, the germ grows slowly, dividing about once a day, compared with other bacteria that might replicate every 20 minutes. The plodding pace gives antibiotics few opportunities for bacterial sabotage, and the organism also has a fatty outer coat that keeps most drugs out entirely.

Multi-drug resistant TB affects about 400,000 people worldwide. Speaker, the lawyer who put hundreds of airline travelers at risk of exposure by taking transatlantic flights, underwent surgery in a Denver hospital to remove infected tissue.

Public health officials have spent decades trying to find the best ways to make sure TB patients finish their typical six- month treatments, which once lasted at least 18 months.

Skipping doses allows resistant strains to thrive and spread to other people, said David Ashkin, the tuberculosis controller for Florida. Ashkin confines dozens of TB patients to a secure hospital in Lantana annually to make sure they take all their drugs and don't spread germs.

`Shorter Regimen'

``Six months of therapy is very hard for some patients,'' Ashkin said. ``With a shorter regimen, more people might complete therapy.''

About a third of patients drop out in the final two months of treatment, the TB alliance's Spigelman said. His group will use Gates Foundation support to begin testing four-month treatment with the Bayer drug later this year. He plans eventually to test whether other drug combinations can beat TB in three months or even two.

Trimming months off treatment might also slash TB costs, health officials said. Standard treatment for tuberculosis, using doctors' first and cheapest choices, costs about $8,162 a patient in the U.S., according to an estimate by the Atlanta- based U.S. Centers for Disease Control and Prevention. A four- month treatment might cut the cost to $6,536, the agency said.

To contact the reporter on this story: John Lauerman in Boston at [email protected] .
 
You couldn't have just typed out the link??? :meanie:
 
I will not let you threadjack. Keep it clinical please. btw, Golden Colorado is very nice.

someone's sensitive today...
Fine.

I have a few questions:
1. What happens when pneumonia is no longer controlled by this medication, because it's being used to treat TB?
2. Should this medication be used for "local" strains or should it be limited to "foreign" strains? Basically, who gets to use it for TB exclusive infections?
3. How are they going to come down on the price so that the poorer countries can utilize the medication?
 
someone's sensitive today...
Fine.

I have a few questions:
1. What happens when pneumonia is no longer controlled by this medication, because it's being used to treat TB?
2. Should this medication be used for "local" strains or should it be limited to "foreign" strains? Basically, who gets to use it for TB exclusive infections?
3. How are they going to come down on the price so that the poorer countries can utilize the medication?

I have answers for all three.

But not going to give it to you... but let's turn it around and I'm asking those questions to you. How would you answer it.

btw, I was kidding about threadjack stuff. Somone didn't get enough sleep studying.
 
I have answers for all three.

But not going to give it to you... but let's turn it around and I'm asking those questions to you. How would you answer it.

btw, I was kidding about threadjack stuff. Somone didn't get enough sleep studying.

Well...I'll accept your challenge, but I'm a rookie, so don't be too disappointed.
1. We hope that more people in countries with devastating TB problems get vaccinated for pneumonia.
"Worryingly, the development of resistance[of moxifloxacin] can appear in as short a time as seven days.[6] This calls into question the first line use of moxifloxacin and other respiratory quinolones first line for the treatment of community-acquired pneumonia in populations where TB is still endemic." -Wiki
2. I think both types of strains should be treated. Eradication is essential if we want to stop further mutations.
3. Since drugs are usually cheap to make after they've done all of the research, the makers of Avelox can just give the poorer countries a break on the price. They'll make enough money in the US and Europe to offset their "losses" in the poor countries. The drug's new indication should be profitable enough.

I never get enough sleep the night before an exam.
 
damn i am allergic to quinolones.
 
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