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• Nabi makes deal for smoking vaccine 

The Rockville maker of an experimental nicotine vaccine has signed a licensing deal with pharmaceutical giant GlaxoSmithKline that could produce a huge payday if the anti-smoking drug can be successfully brought to market.

Nabi Bioparmaceuticals outlined the terms of the deal Monday. It said a unit of GlaxoSmithKline has agreed to pay $40 million initially for the exclusive worldwide licensing rights to the drug, called NicVax.

Nabi would receive additional money if it meets certain developmental and regulatory milestones, including the development of follow-up nicotine vaccines. Nabi would also earn double-digit royalties from sales if the product reaches the market.

All told, Nabi could collect more than $500 million from the development and sale of the vaccine and its successors, the company said.

"It's the biggest deal we've ever had," said Raafat Fahim, Nabi's president and chief executive. He added that NicVax would become the company's flagship product if it successfully passes final rounds of testing.

Nabi says its vaccine causes a body's immune system to produce antibodies that bind to nicotine molecules, making them too large to reach the brain's receptors.

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• Trial drug may help smokers kick butts 

STORY HIGHLIGHTS

* Drug maker given $10 million grant to take anti-nicotine vaccine to Phase III clinical trial

* "Smoker's high" comes from release of dopamine in brain, triggered by nicotine

* NicVAX stimulates immune system to prevent nicotine from entering brain

* In theory, it would help smokers quit for good by reducing pleasure

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• U.S. backs vaccines for drug, nicotine addiction  

Convinced of the need for new and better treatments for addiction, the government is focusing its efforts on vaccine development as a new way to treat and possibly prevent addiction to a range of addictive substances.

"It's a perspective that is very different from what we've operated on in the past," Dr. Nora Volkow, director of the National Institute on Drug Abuse told reporters this week at the Society for Neuroscience meeting in Chicago.

Volkow said the agency intends to piggyback on the frenetic investment by drug companies in vaccine development, spurred by the need for new products and the runaway success of products like Merck's Gardasil vaccine to prevent the virus that causes cervical cancer.

"There is an enormous amount of research and development in vaccines for cancers and a wide variety of disorders," she said. "We can take advantage of those developments."

But first Volkow has to tempt drug companies to develop the vaccines by funding costly clinical trials.

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• Stop-Smoking Vaccine in the Works  

The National Institute on Drug Abuse has given a $10 million grant to a Maryland company to help it in the final phases of research regarding a possible anti-nicotine vaccine.

Nabi Biopharmaceuticals of Rockville will launch a phase III study of a potential vaccine called NicVAX. The study, which could be the last step of research if the vaccine works, represents the most advanced investigation of a smoking-cessation vaccine.

The vaccine is designed to help people quit smoking and not relapse. According to a statement by institute director Dr. Nora D. Volkow, the vaccine has received "fast track" designation from the U.S. Food and Drug Administration and has survived a successful "proof-of-concept" study.

There's no guarantee that the study will prove that the vaccine works, nor is it clear whether it will get federal approval if it does. But researchers are hopeful.

The vaccine works by making the immune system kick into action when it detects nicotine. The idea is that antibodies will bond to nicotine molecules and prevent them from entering the brain, where they give smokers the high that they crave.

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• Study Counters Warnings on Quit-Smoking Drug  

The smoking cessation drug varenicline (Chantix) does not increase the risk for self-harm or depression, according to a new British study.

In July, the U.S. Food and Drug Administration mandated that the drug carry a "black-box warning" on its packaging, indicating that people who use it face increased risk for "serious neuropsychiatric symptoms," including changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior and attempted suicide.

In the new study, British researchers analyzed database information on 80,660 men and women, ages 18 to 95, who were prescribed a smoking cessation product between September 2006 and May 2008. Prescriptions were for varenicline, the antidepressant bupropion (Zyban) or nicotine replacement products, such as a patch, inhaler, gum, tablet or lozenge. People were followed through the period of the prescription and for three months after the date of their last prescription.

No clear evidence emerged that varenicline or bupropion increased the risk for self-harm, suicidal thoughts or depression, the study reported.

However, the researchers added that "the limited power of the study means we cannot rule out either a halving or a twofold increased risk."

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• So you've tried, and tried, and tried, AND TRIED to quit  

Somehow, this time - maybe it was the nicotine-replacement patch, maybe the counseling - Collins resisted the call of the cigarette. But there is no denying: The stranglehold nicotine places on smokers can sometimes prove insurmountable.

Ask Jerry Remy, the Red Sox TV analyst who acknowledged last month that, despite enduring lung cancer, he still falls prey to the occasional impulse to smoke.

Ask Barack Obama . . .

The failure to quit, research has shown, has nothing to do with weakness of will. Nicotine, the primary addictive agent in tobacco, steals into the brain, setting on fire circuitry that regulates our sense of pleasure. At the same time, cigarettes acquire a sort of social permanence in smokers' lives - a way to start the day, to end a meal, to celebrate good times, to muddle through bad times.

So specialists who treat smokers now emphasize a double-barreled approach that combines counseling and medication, including patches, gum, and other nicotine substitutes along with drugs designed to thwart nicotine's addictive effects. There's even a nicotine vaccine being tested that would prevent the substance from reaching the brain.

Still, it's estimated that while roughly 70 percent of smokers want to quit, fewer than 10 percent succeed each year. . . .

Her first major attempt to quit was in 2000, when she went to group counseling at Mass. General. "I'd go there and I'd talk. And I'd leave immediately and have a cigarette.'' She tried again and again to stop smoking for good. Finally, last year, she decided, "This is ridiculous.'' She again sought counseling and wore the most potent nicotine patch available.

Her last drag on a cigarette, she said, was last October.

"No one can tell you to quit smoking. No one can make you feel like a social miscreant to make you quit smoking,'' said Collins, who lives in Belmont. "You have to summon it up from inside. You really, really do.''

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• CHAPMAN: Pfizer’s campaign to drug as many smokers as possible  

Pharmaceutical giant Pfizer is in the middle of a major campaign to convince Australian smokers that they should not try to quit without taking anti-smoking medication.

The company sells over-the-counter nicotine replacement therapy (NRT) and prescription drug varenicline (brand name Champix). A Pfizer brochure "what makes you think you can quit this time?" and website stress that "only 3-5% of people who try to outsmart cigarettes without treatment succeed", that "a serious quit attempt needs a plan" and that most smokers "require help from a health-care professional".

Each of these claims is highly contestable. Pfizer and other pharmaceutical companies see cold turkey as the enemy of their efforts to medicate as many smokers as possible. Smoking cessation has become increasingly pathologised to the point that public awareness of its natural history has become heavily distorted.

For years, cold turkey has been denigrated as a hopeless strategy and ignored in public campaigns. But ask 1000 ex-smokers how they stopped and you get a very different answer. As occurs with personal efforts to stop problem drinking, gambling and narcotics use, population studies consistently have shown that a large majority of smokers who permanently succeed in quitting do not use any form of assistance. . . .

Pfizer’s claim that "most require help" is not only nonsense, but contrasts with a reference it cites in its own brochure, which states "about one-third of smokers now use a medication when they try to stop", meaning that two-thirds don’t. Its claim that smokers need a plan is also highly debatable. A recent study (Nicotine Tob Res 2009;11(7):827-32) of unplanned cessation found that unplanned cessation attempts were twice as successful as planned attempts and significantly, that most unplanned quit attempters do not use any assistance.

The emphasis about the futility of people trying to stop smoking unaided acts to exclude popular understanding of what is the most common story of cessation: doing it without professional or therapeutic help. When citizens have common, ordinary and self-limiting ailments, traits and behaviours constantly redefined as needing treatment, avoidable iatrogenic consequences and burgeoning health-care expenditure can follow. But the steady erosion of human agency and self-belief as people lose confidence in their ability to recover or change unhealthy practices is perhaps of greater concern.

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• Chantix Lawsuit Blames Drug for 2007 Death of Dallas Musician 

The parents of Carter Albrecht, a Dallas musician who was shot to death during a bizarre episode that was allegedly fueled by Chantix side effects, have filed suit against Pfizer, Inc. According to a CBS 11 report, the lawsuit claims Pfizer did not disclose the risks of Chantix or provide adequate warning of possible side effects when Albrecht began taking it in an effort to quit smoking.

Albrecht's death occurred in September 2007, just a week after he began taking Chantix. Shortly after beginning Chantix therapy, Albrecht began complaining of vivid dreams. According to a Dallas Morning News article published after his death, Albrecht had lashed out violently towards his girlfriend on the night he died – something she said had never occurred before. Albrecht’s girlfriend told the Morning News that he seemed confused and terrified, and looked at her as though he did not recognize her. Somehow, Albrecht ended up at the home of a neighbor, banging violently on the back door. A call was made to 911, but before the police arrived the terrified neighbor had fired a warning shot from his rifle, which accidentally hit and killed Albrecht.

In their lawsuit, Albrecht's parents allege that their son's use of Chantix played a "direct and proximate" role in his death. According to the Dallas Observer, the Albrecht's are hoping that by filing the lawsuit, they will "remind Pfizer they have to keep the public informed of the risks associated with this drug."

Albrecht's parents also acknowledge that Pfizer's attorneys will likely make an issue of their son's alcohol use (his blood alcohol level was three times over the legal driving limit) on the night of his death.

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• Carter Albrecht's family suing Pfizer over stop-smoking drug  

A federal lawsuit has been filed in Dallas on behalf of local musician Carter Albrecht against Pfizer, the maker of the stop-smoking drug Chantix.

Albrecht was shot and killed September 3, 2007 while banging on his neighbor's door. Albrecht had been drinking.

Albrecht's girlfriend, Ryann Rathbone, said he had become increasingly erratic after he started taking Chantix to quit smoking. She said vivid, often frightening dreams were an immediate side effect.

After using the prescription medication for a week, Rathbone said Albrecht began hallucinating, lashing out at her physically and verbally.

A News 8 investigation revealed thousands of similar reports of potentially dangerous psychiatric side effects. Pfizer later added a black box label, warning of serious neuropsychiatric side effects.

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• Pfizer grows R&D work in China 

the world's largest pharmaceutical company is also busy expanding its presence in China to capitalize on the country's growing role in the world's pharmaceutical market. . . .

To tap into the anti-smoking market, Pfizer launched its smoking-cessation Champix product in late 2008.

Pfizer is not the only pharmaceutical maker to recognize the market potential in stop-smoking pills.

Its rivals, Swiss drug maker Novartis AG and US-based Johnson & Johnson, also introduced their quit-smoking products.

Novartis introduced Nicotineel to China in 2008, and Johnson & Johnnson introduced Nicorette to China this year.

It's estimated by Novartis that the smoking cessation market in China is valued at around 30 billion yuan.

"It's still early to comment on the outcome of Champix, but as far as I know, we don't have anything as good as Champix in the smoking cessation area so far, " Mackay said about his company's product.

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• Ban on drugs to help quit smoking 

The Ministry of Health has banned two popular smoking cessation drugs as their side-effects include suicidal tendencies.

The drugs containing varenicline (trade name Champix from Pfizer) and buproprion (Yaba)) were banned after the US Food and Drugs Adminstration (FDA) issued a black box warning – the toughest warning on risks associated with a medicine — on serious mental health risks of the drugs.

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• 'Cruise Ship Virus' Vaccine Stems From Tobacco  

Scientists have developed a vaccine for the common viral infection norovirus from a novel source: a tobacco plant.

The new vaccine was "manufactured" in a tobacco plant using a bioengineered plant virus.

This plant biotechnology opens the door to faster, more inexpensive ways to bring vaccines to the public quickly, especially in times when viruses mutate into unpredictable new strains, said Charles Arntzen, who reported on the vaccine at the American Chemical Society annual meeting, in Washingtopn, D.C.

"The recent outbreak of H1N1 influenza virus has once again reminded us of the ability of disease-causing agents to mutate into new and dangerous forms," Arntzen said.

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• Half of smokers have tried to quit  

A substantial number of smokers have tried - or have good intentions of trying - to give up their cigarette habit, according to a new report by Statistics Canada.

The study, based on 2006 data, indicates almost half of the smokers surveyed tried to butt out in the previous 12 months, and one-third reported intentions to quit in the next month.

"Smokers go through very distinct stages when they're trying to quit, so the plan to do it in the near future is really an important step to take, compared with those who have no plans at all to quit within the near future or ever. So that's good," said Margot Shields, one of the study authors.

A senior policy analyst with the Canadian Cancer Society agreed.

"It's very significant that a third of smokers are considering quitting smoking in the next 30 days, and it just demonstrates how [much more potential progress] we can achieve to reduce smoking rates in Canada," Rob Cunningham said.

"We need to do more in terms of government funding for smoking cessation programs, and we need to do more in terms of stronger legislation that would help motivate successful quit attempts."

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• Smoking--Medicines To Help You 

You are a woman. You are a smoker.

You are not alone. Approximately 18% of adult women smoke. More than half of all smokers want to quit. There is help.

Read this guide … even if you are not ready to quit now. Learn more about products and medicines to help you quit smoking. Read tips to help you make a quit smoking plan that may work for you. Use this guide to help you talk to your pharmacist or doctor.

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• FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban  

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Similar information on mental health events will be required for bupropion marketed as the antidepressant Wellbutrin and for generic versions of bupropion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

Woodcock said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their health care professional if they experience such changes.

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