Battling Deadly Diseases--13 Antibiotic Makers

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Top Antibiotic Makers:

Trius Therapeutics--(TSRX)
Forest Labs--(FRX)
Optimer Pharmaceuticals--(OPTR)

These stocks haven't necessarily done extremely well this year, but the high cost of Clinical Trials leads to debt.  Once the clinical trials are approved and these antibiotics go on the market these should have noticeable gains.  I think these could have potential to invest in the long term futures.

Another company of note is SIGA Technologies (SIGA).  SIGA makes bioweapons vaccines for the government and recently announced a government contract for small pox treatment.  From Marketwatch:  SIGA soars on government contract. 
 
Hope In The Grim Fight Against Drug-Resistant Germs



The little girl had 30 sores on her chest caused by methicillin-resistant staphylococcus aureus bacteria, also know as MRSA.

Pediatrician Jennifer Shu put the child on powerful antibiotics and told the girl’s father to bathe her in diluted bleach and squeeze the pus from the sores. Shu, the medical editor of the American Academy of Pediatrics’ HealthyChildren.org web site, just felt lucky her patient avoided being hospitalized.

Drug resistant bacteria, once confined to hospital wards, are now commonplace in pediatrician’s offices. David Pollock, of the Children’s Hospital of Pennsylvania’s health network, says strains like MRSA have forced him to use potent drugs he would have avoided a decade ago because of their side effects. And what happens when those, too, stop working? “There hasn’t been a new antibiotic developed in kids for 10 years,” he says.

It’s no better for grown-ups. MRSA alone kills 18,650 Americans annually, more than HIV. Yet the field of antibiotic development has been at a standstill for two decades. Now executives, analysts, and researchers see a potential resurgence for bacteria-fighting drugs even as more germs evolve defenses to one or more antibiotics.

The shortage of new bacteria-killers is the result of a “vicious cycle,” says Pedro Lichtinger, a former Pfizer executive who since May has headed antibiotic developer Optimer Pharmaceuticals. The success of previous generations of antibiotics led companies to de-emphasize the drugs. Those firms that pursued germ killers ran into regulatory hurdles that further dissuaded new entrants.

“Resistance to antibiotics doesn’t emerge over a day, a week, or a month,” says Lichtinger. “New products are unattractive financially until the problem is so big. But if you don’t develop the medicines early, people are dying.”

Optimer is one of a cadre of antibiotic developers whose drugs are either nearing FDA review or entering the last stages of clinical trials. Its lead drug, fidaxomicin, targets the Clostridium difficile bacteria, which causes 500,000 cases of diarrhea every year and is frequently resistant to first-line drugs. He boasts that 50% fewer patients get the diarrhea again when they are treated with fidaxomicin instead of the current standard, vancomycin. The product could hit the market next year; the investment bank Needham & Co. forecasts worldwide sales of $170 million in 2013.

Will these drugs hit a wall at the FDA, just as their predecessors did? Standards for new antibiotics were already tightening in 2007 when the use of Ketek, a much-hyped antibotic from Aventis, had to be restricted because the pill caused liver damage. Congressional hearings painted Aventis’ studies of Ketek as sloppy, and criticized FDA officials. In 2008, three antibiotics went before an FDA advisory panel, and only one made it. That drug, Vibativ from Theravance and Astellas, has been a commercial disappointment so far, partly because it was not approved for pneumonia, which most experts see as its most obvious niche. Johnson & Johnson abandoned its attempts to get antibiotics developed by partner Basilea. Pfizer stopped work on a drug it acquired as part of its $1.9 billion purchase of Vicuron in 2005.

Acinetobacter baumanii

The standard-bearer to put an end to this trail of failure is ceftaroline, from Forest Laboratories. On Sept. 8 a panel of advisors voted unanimously that it should be marketed. Analysts at Credit Suisse forecast sales of $138 million in 2015.

"There’s no way that drug is not going to be approved,” says Jeffrey Stein, chief executive of a company called Trius Therapeutics, which is developing its own anti-MRSA drugs.

Another encouraging sign, Stein says, is new guidance from the FDA on how companies should conduct studies of new antibiotics aimed at skin and soft tissue infections, one of the biggest problems caused by MRSA. The last such document came 12 years ago.

FDA scientists delved into clinical trial designs going back to the first antibiotics in the 1930s and 1940s, a time before placebo controls were common, says Ed Cox, the director of the FDA’s division of anti-infective drugs. They found that the best data were not for whether or not drugs cured patients, but for whether they shrank the size of lesions on the skin and stopped fever.

Clostridium Difficile

Cox and his staff swam against the medical mainstream, which in other diseases is pushing for harder measures like cure rates or survival. These will still count, Cox says, but they risk missing subtle differences between drugs. This is especially important because antibiotics must be tested in non-inferiority trials, which aim only to prove that the new drug is as good as old options, not that it’s better. Tiny differences matter.


For Stein the guidance is good news because it matches up well with studies Trius has already started on its lead medicine. Trius’ drug, torezolid, is in the same class as Pfizer’s Zyvox, the last antibiotic to reach $1 billion in annual sales, but with better potency and dosing.

Psuedomonas

But are draft guidelines really a step forward? The new guidance “goes partway toward solving some problems,” says Alan Carr, the financial analyst who covers antibiotics for Needham. But he cautions thath there are “still gaps” and that the agency often fine-tunes its draft guidance substantially. In other areas, like pneumonia, he sees concern that he guidance will call for clinical trials that will cost as much as hundreds of millions of dollars – matching the peak sales of most antibiotics. That would certainly put a damper on antibiotic development. The FDA’s Cox says he is very concerned that studies not become too expensive.

The FDA is not alone in trying to work out a regulatory framework in which antibiotics can be approved. The Foundation for the National Institutes of Health has been holding meetings to try and help drive consensus of how new antibiotics should be tested, helping to drive the FDA’s decisions.

Finding a way forward is critical, says Ramanan Laxminarayan, senior fellow at Extending the Cure, has spent years pushing for doctors to pay more attention to not overusing the antibiotics we already have. But new drugs are needed if we’re going to keep the bacteria at bay. “If there’s another approach that will deal with these bugs,” says Laxminarayan, “I haven’t heard of it.”

Antibiotic Army

These 13 companies are working on new ways to battle bacteria.

Company-------How it is fighting the germs

Achaogen This private company is still only in mid-stage trials, but is developing next-generation drugs for gram-negative bacteria, for which there are few treatments.

Advanced Life Sciences ALS is developing oral antibiotic Restanza to treat community acquired pneumonia and inhalation anthrax.

Basilea Spun-out Roche antibiotics division. Lead drug rejected because of problems with clinical trials, and partnership with Johnson & Johnson severed.

Cempra Privately held firm is developing sodium fusidate, which is already used outside the U.S., against MRSA and other bugs.

Cubist Pharmaceuticals Its Cubicin is approaching blockbuster status. Company hoping for next hit.

Durata Team from biotech Vicuron bought stalled antibiotic dalbavancin from Pfizer in hopes they could get it to market.

Forest Laboratories Its ceftaroline passed FDA advisory committee with flying colors in both pneumonia and skin infections

Optimer Pharmaceuticals Its fidaxomicin is targeted against the C. difficile bacteria that causes 500,000 cases of diarrhea in the U.S.

Paratek Pharmaceuticals Developing a new class of antibiotics derived from tetracyclines; partnered with Novartis.

Rib-x Is developing new drugs in the same classes as Cipro and Zyvox.

Tetraphase In the early stages of developing new antibiotics derived from tetracyclines.

Theravance Televancin is approved for skin infections, but not for pneumonia, where potential is greatest because it enters lung tissue.

Trius Therapeutics Searching for heirs to Pfizer’s Zyvox using natural products; in late-stage trials.

Related articles

• Pfizer Fights Deadly Bacteria And Wins (blogs.forbes.com)
• Trius to Participate in Antibiotics Panel Discussion at Citi's 5th Annual ... - PR Newswire (press release) (news.google.com)
• Good News for Optimer Drug (wallstreetpit.com)