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Lou Gehrig’s Disease May Bring Biogen $1 Billion Payoff - Bloomberg

Biogen Idec Inc. (BIIB) Chief Executive Officer George Scangos was skeptical when he learned company researchers were pursuing a new treatment for Lou Gehrig's disease. No one knows the cause of the illness that killed the famous baseball player more than 70 years ago, and no medicine for it has been shown to slow its advance for long.

Scangos changed his mind after he took charge two years ago and reviewed data about dexpramipexole. The compound, which may slow disease progression, is now in the final stages of clinical trials required for U.S. Food and Drug Administration approval, with results expected this year.

"I don't know any disease that's in more need of therapy than ALS," said Scangos, whose company is the world's largest maker of drugs for multiple sclerosis, in a telephone interview. "It's certainly risky, but the data speaks for itself. So we made a calculated bet."

ALS, or amyotrophic lateral sclerosis, affects about 30,000 people at any time in the U.S., causing nerve damage that leads muscles to shut down progressively over three to five years until most patients die from respiratory failure. Lou Gehrig, who played for the New York Yankees, retired from baseball in 1939 when he was diagnosed with the disease, and died two years later, bringing wider awareness to ALS yet hardly any treatments.

Sanofi's Rilutek

There's one drug on the market, Paris-based Sanofi's Rilutek, and it provides only a modest benefit in reducing ALS's progression. Rilutek has U.S. sales of about $ 50 million, according to Eric Schmidt, an analyst with Cowen & Co. in New York.

The market for dexpramipexole, if it's approved, may top $ 1 billion a year, Schmidt estimates. The company paid $ 80 million in cash and stock for a licensing deal in August 2010 with closely held Knopp Biosciences, which first developed the drug, and will pay an additional $ 265 million if certain regulatory and sales goals are met.

The compound looked promising enough in earlier trials by Knopp to attract the attention of Al Sandrock, Weston, Massachusetts-based Biogen's head of neurology research and a former physician who worked with ALS patients. It's designed to improve functioning of the mitochondria, the energy producers in cells, and to provide protection to neurons under stress.

Trial Results

Phase 2 trials showed that after 12 weeks, people on the highest dose of dexpramipexole had about a 35 percent slowing of ALS progression compared with patients taking a placebo, said Merit Cudkowicz, principal investigator of the phase 2 and phase 3 trials and director of the ALS Multidisciplinary Clinic at Massachusetts General Hospital in Boston.

Patients given higher doses of the medicine got better results, Cudkowicz said in a telephone interview. "It was a nice dose-dependent effect. We didn't expect that at 12 weeks."

Biogen's phase 3 trial, generally the last stage before review by regulators, enrolled its first patient in March 2011, and the study was filled within four to five months. That's half the time a trial this size, involving about 900 patients, would normally take, Cudkowicz said. It was the fastest study enrollment in Biogen's history.

This doesn't guarantee the treatment will work, researchers and others caution. There have been as many as 20 consecutive failed studies of experimental medicines for ALS, Cowen's Schmidt wrote in a February research note, citing physician consultants.

Lithium's No Benefit

In 2010, data published in the journal Neurology showed that lithium -- thought to be helpful for ALS patients after a small Italian study -- didn't provide any benefit. In 2003, a study published in the Annals of Neurology showed that creatine, an over-the-counter supplement taken by many for the disease, doesn't help. Cephalon Inc. (CEPH), the biotechnology company purchased last year by Teva Pharmaceutical Industries Ltd. (TEVA) for $ 6.2 billion, struggled for years in the 1990s to get a drug called Myotrophin approved before giving up as trial results failed to persuade regulators.

For some patients, Biogen's medicine is their best hope. "I'd be waiting at the pharmacy for it as soon as it's FDA- approved," said Laura Tuttle, a registered nurse who was diagnosed with ALS in 2009, too long ago to be eligible for Biogen's phase 3 study.

Her first hint of the disease came in April 2009, when she was walking through an airport and noticed her left foot "wasn't cooperating." She wasn't diagnosed though until the end of that year, after she'd started tripping and falling. Having worked with ALS patients, she'd already guessed she had the disease. Tuttle said she finally told her physicians, "'What's it going to take for us to call it what it is?' It was almost as if they were afraid to tell me."

Power Wheelchair

Tuttle now gets around in a power wheelchair and occupies only the first floor of her house outside Boston. Her husband is her primary caregiver. She has participated in studies for two experimental treatments for ALS, including ceftriaxone, an antibiotic in phase 3 trials. It had to be administered intravenously twice a day, and infusions took about two hours every morning and evening, she said.

Biogen's dexpramipexole is a pill, another reason patients are so excited by it. The last study turned up no major safety concerns.

Some patients want to know why a medicine that's shown safety and some efficacy in earlier trials isn't being made available immediately, said Lucie Bruijn, chief scientist at the ALS Association. She cautions that although dexpramipexole is promising, "this is nowhere near a cure." Still, patients who've seen Biogen's success with multiple sclerosis, a disease of the central nervous system that can cause limb numbness, hope the company can accomplish the same in ALS, she said.

FDA Application

Biogen applied for FDA approval earlier this year for BG- 12, its first pill for MS, which may draw as much as $ 3 billion in annual revenue if approved, according to estimates from Cowen's Schmidt and other analysts. The company also makes Avonex, an injectible treatment for MS that had revenue of $ 2.7 billion last year, and Tysabri, an intravenous therapy that sold $ 1.1 billion.

Biogen declined less than 1 percent to $ 127.82 at 4 p.m. New York time. The shares have gained 74 percent in the last 12 months.

The data from Biogen's phase 3 trial in ALS are expected in the second half of this year, and the medicine is on a fast- track path with the FDA.

"This is far from a long shot," CEO Scangos told investors at JPMorgan Chase & Co. (JPM)'s annual health-care conference in January. "We are genuinely hopeful that we will be able to provide meaningful therapy for the thousands, tens of thousands, of ALS patients who right now have very little to help them."

To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Crime Patrol - 8 Year Old Aashish Gets Assassinated - Episode 27 - 29th July 2011

8 year old Aashish lives with his parents in Maharoli, New Delhi. Aashish's father use to often stop his communication with vegetable sellers and other several shop owners. On May 2011, a worst nightmare occurs as Aashish goes missing. He wanted to see the procession. Aashish's Parents files a police complaint. Cops follow the procession. Where has Aashish gone? Who kidnapped Aashish? Police Patrol coming back in its 4th season attempts to bring stories of crime happening all around the country. Polices that tell us, we need to be careful, we need to be watchful. Polices that tell us lives could have been saved.Every crime we hear of, either warns us to be careful or scares us, it could happen to us. Every crime ignites a feeling, "It should not have happened".Would knowing the "Why" behind a crime, help in stopping a crime from happening?"I don't like the way he looks at me", "I don't like the way he/she is behaving", "I think he/she is out of his/her mind", "I think he/she has gone crazy". That gaze, that quirky smile, that persistent stare which unnerves. It is difficult to understand the intentions but the hints are there.In a house a husband and wife argue, fight. A vessel comes flying, a glass breaks. Husband is angry and the wife is upset. That hatred, that ego. The distance that keeps growing. It is difficult to comprehend the damage, but the cracks are there.Feelings... expressions. Misunderstood, unresolved callings of the heart. The cracks are there. Too wide to ...

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THE ACCIDENTAL HERO
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A ruthless hitman confronts his destiny in a startling tale of redemption.THE ACCIDENTAL HERO
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Retiring Detroit FBI chief says Wayne County probe will be unaffected

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Pozi - FBI

broma completa de Manolito "PoZí" en la pelicula FBI

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FBI denies fears of sexy spy success in 2010

The FBI is denying a report that a top counter intelligence official, in a interview with the BBC, was suggesting that a Russian sleeper spy ring was shut down in 2010 because one of the alleged spies -- Anna Chapman -- was edging closer to President Obama's inner circle.

USA TODAY's Kevin Johnson says the FBI has issued a statement saying the British report regarding Chapman is untrue.

The statement:

Mr. Figliuzzi's comments to BBC were consistent with and confined to the information outlined in the criminal complaint that was filed nearly two years ago. There is no allegation or suggestion in the complaint that Anna Chapman or anyone else associated with this investigation attempted to seduce a U.S. Cabinet official.

Original report: The FBI moved to shut down a Russian sleeper spy ring in 2010 because of fears that one member -- the glamorous Anna Chapman -- was getting "closer and closer" to President Obama's inner circle, a top FBI counterintelligence official tells the BBC.

According to the British newspaper The Independent, Frank Figliuzzi, assistant FBI director for counterintelligence, tells the BBC2 series Modern Spies that the FBI feared Chapman would compromise an unidentified senior U.S. official in a "honey trap."

The auburn-haired Chapman, now 30, was getting "closer and closer to higher and higher ranking leadership ... she got close enough to disturb us," he says.

"They were getting close enough to a sitting U.S. Cabinet member that we thought we could no longer allow this to continue," Figliuzzi says.

Chapman was among 10 people arrested in 2010 in Yonkers, Boston and Northern Virginia for allegedly living under false names and deep cover in a scheme to penetrate what one coded message called American "policy making circles," The New York Times reported.

They were deported and swapped for four people held in Russian prison.

The Times quotes U.S. officials as saying the FBI had been watching some members of the ring for as long as a decade. At the time, officials said they swooped down on the alleged spies because some of them were about to leave the country.

Chapman returned to Russia as a celebrity, posing for sexy photos in the Russian edition of Maxim and taking a post in Vladimir Putin's political party.

The series began airing Monday night.

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FBI feat BLAZ "ce qu'il faut", clip rap francais

FBI feat BLAZ "ce qu'il faut", clip rap francais

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FBI's Arena retiring from post, to lead Detroit Crime Commission

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Ministers want the Crime to lead, not just help

Local ministers want a meeting with the mayor's representatives.

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FBI: Russian Honeypot Tried To Sex Obama Cabinet Official

Russian Spy Anna Chapman may have been trying to sexually entice a U.S. cabinet member, an FBI official says. Photo: Facebook/EnglishRussia.com

UPDATE, 3:55 p.m., April 3: The FBI says Figliuzzi was misquoted by the Independent, and the Bureau appears to be right. Read our follow-up story here.

If the arrest of Russian spy Anna Chapman seemed abrupt, it's because the FBI began to fear she was out to sexually ensnare a member of President Obama's cabinet.

That seems too crazy to be true, even in a case as bizarre as Chapman's. But the FBI's counterintelligence chief tells a BBC interviewer that Chapman was getting "closer and closer to higher and higher ranking leadership."

"They were getting close enough to a sitting U.S. cabinet member that we thought we could no longer allow this to continue," says C. Frank Figliuzzi, the assistant FBI director for counterintelligence, according to the Independent. That alleged — repeat: alleged — sexual "closeness" prompted Figliuzzi's agents to shift from monitoring Chapman's crew of ten spies to arresting them in 2010.

Figliuzzi doesn't say which "serving" cabinet official was thisclose to shtupping Anna Chapman. It would be irresponsible to speculate. But it's so, so, so hard not to. (I'm guessing that you can erase ex-Defense Secretary Robert Gates, a former CIA kremlinologist, from Anna Chapman's little black book.)

Chapman will not go down in history as the world's ugliest agent, and the history books are littered with politicians who convinced themselves that the rewards of power include extracurricular, extramarital sex. But Anna Chapman appears to have been a pretty incompetent spy. Her crew used what intelligence reporter Jeff Stein termed "primitive radio techniques" and hid loosely encrypted messages in plain sight on the Internet. She traded in "routine political gossip and policy talk," as the New York Times put it, rather than real secrets. Bedding a cabinet official would seem to be past her means, comely as they are.

These days, you're likely to find Chapman on the Russian celebrity circuit, boosting Vladimir Putin's political machinations, or expressing ambitions for designing bizarre fashions. So she's probably unlikely to spill. But if Figliuzzi is anywhere even close to correct, maybe Chapman left clues to her little black book online somewhere.

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Fugitive of the Week convicted, sentenced, missing

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 PDF Document: Delno Clayton Wanted Poster

LORAIN -- A man convicted and sentenced for robbery and kidnapping took off before he could be jailed.

Because Delno Clayton failed to self-surrender as ordered, he has been named Fugitive of the Week by the Northern Ohio Violent Fugitive Task Force.

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Clayton, 27, of Lorain, broke into a home in 2010 and tied up the residents before stealing their valuables.  He was charged with robbery and kidnapping, was convicted, and was setenced to 4 years in prison.

He had been out on bond during his case and was ordered to surrender following his conviction, but never showed up.  He has been on the run since 2010.

Clayton had been living in the 1100 block of West 14th Street in Lorain, and is thought to still be hiding on the west side of the city.  A reward is being offered for the information which leads to his capture.

Tips can be called into the U.S. Marshal's Fugitive Hotline at 1-866-4-WANTED.  Information can also be texted to 847411 (tip411).  Use the keyword WANTED followed by the information about Clayton.

WKYC-TV

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