Nabi Smoking Vaccine

December 3, 2009 by · Leave a Comment 

By Mike Musgrove, Washington Post Staff Writer

Raafat Fahim
CEO Raafat Fahim, of Nabi Pharmaceuticals.

Smokers have tried a long list of ways to quit: cold turkey, counseling, gum, patches and more.

Now, a small Rockville company is hoping it can make millions of dollars by creating a vaccine for people who want to kick the habit. Nabi Biopharmaceuticals, which is in the late stages of testing its experimental vaccine, called NicVax, took a big step toward its goal last week by striking a deal with pharmaceutical giant GlaxoSmithKline.

Under the agreement, GlaxoSmithKline will pick up the cost of developing and marketing the vaccine if Nabi successfully completes the Phase 3 trials now underway.

“GSK is one of the preeminent pharmaceutical companies with worldwide commercialization reach,” Raafat Fahim, Nabi president and chief executive, said in a conference call with investors last week. “GSK has particular strength in the development and marketing of both vaccines as well as smoking-cessation therapies.”

For many years, the standard treatment for breaking a smoker’s dependence on nicotine has been patches or gum that contain declining dosages of the substance in an effort to wean addicts off their dependence.

Nabi’s experimental vaccine, a decade in the works, tries a more direct approach: It shuts down nicotine’s access to the brain. Smokers may light up a cigarette while on NicVax, but if the drug works as intended, they won’t feel any of the stimulating effects they crave from nicotine.

NicVax causes the immune system to create antibodies that bond with the nicotine molecule if it enters the bloodstream. The result is a molecule too large to pass along to the brain. In short, the vaccine seeks to make the body immune to nicotine.

If smokers can’t get a buzz from lighting up a cigarette, the thinking goes, there’s no reason for them to continue the habit. Since the antibodies created by NicVax stay in the body for a long period of time, the chances of a smoker quickly returning to the habit are low.

“It breaks the cycle of addiction,” Fahim said.

So far, the vaccine has completed its early and middle rounds of testing. The company plans to have the results of its recently commenced final round in 2011.

“At first blush, it sounds crazy,” said Norman H. Edelman, chief medical officer of the American Lung Association. After all, creating a vaccine against a small nicotine molecule is a large challenge, he said, “but it’s not beyond the realm of belief.”

Cheryl Healton, president and chief executive of the American Legacy Foundation, a public health nonprofit, said it’s the long-term effects of NicVax as a smoking cure that make it revolutionary. Smokers don’t usually quit successfully on the first try — on average there are eight to 11 failed attempts, she said.

Under the terms of the deal with GlaxoSmithKline, Nabi will receive $40 million initially for the exclusive worldwide licensing rights to the drug. The company stands to make as much as $500 million from the deal with GSK if the company meets a number of developmental and marketing milestones in the coming years.

That figure doesn’t include double-digit royalties the company would earn if the product makes it to market. An estimated 45 million people in the United States are smokers.

“Needless to say, I’m very pleased with the agreement with GlaxoSmithKline, which provides not only for the development and potential commercialization of NicVax, but also for the development of its second-generation nicotine vaccines,” Fahim told investors.

David Moskowitz, an equity analyst with Caris and Co., said the new anti-smoking drug Chantix, which entered the market in 2006, is already worth about $800 million in sales.

“There is a large opportunity in the smoking-cessation market,” he said. The GSK deal for NicVax is a good one, he said, because the new partner has “deep enough pockets to maximize its value.”

Nabi isn’t the only firm trying to defeat the smoking habit with this type of vaccine, but it appears to have a head start on the competition, said Stephen Dunn, managing director of life science research at Jesup & Lamont.

An experimental drug from Swiss pharmaceutical firm Novartis and Cytos Biotechnology recently failed a middle round of testing, casting doubts on whether it will reach the market.

And the market remains quite large. While the percentage of adults who use tobacco has been on a steady decline over the past few decades, recent years have seen that trend flatten out. Last year, the Centers for Disease Control and Prevention found that 20.6 percent of U.S. adults count themselves as smokers, a figure that’s virtually unchanged since 2004, when it was 20.9 percent.

Edelman said there are about seven products on the market to combat smoking; most of them are nicotine-delivery devices, such as gum or patches.

“We don’t have an ideal pharmaceutical yet,” Edelman said. After all, “if one was superior to the others, we wouldn’t have all those others out there.”

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Community News (V11-I50)

December 3, 2009 by · Leave a Comment 

Dr. Omar Ali develops cancer vaccine

CAMBRIDGE, MA–A team Harvard bioengineers and biologists have developed a cancer vaccine that eradicates melanoma tumors in mice and slows their reoccurrence. The study which was published in the journal Science Translational Medicine, used a plastic disk implant carrying the vaccine to recognize and eliminate tumor cells, the Harvard Crimson reported.

The new vaccine specifically attacks cancerous cells, avoiding the collateral damage on healthy cells that other cancer treatments often cause. This approach may also build long-term resistance within the immune system, the researchers said.

Dr. Omar  A. Ali, a researcher at the School of Engineering and Applied Sciences is the co-author of this study.

He holds a Ph.D. in Engineering and Applied Sciences from Harvard University (2008). His research focuses on developing cell-instructive materials to study immune processes. His research has resulted in publications, patents and the foundation of a start-up company, InCytu, which aims to develop regenerative methods for vascular disease and vaccine delivery systems.

He has also contributed to the Encyclopedia of Islam in the United States published by the Greenwood Press.

Saving by cutting back on Halal food ?

DEARBORN, MI–The Dearborn school district has one of the largest concentration of Muslim students. The students have been offered the option of eating halal hot dogs and chicken nuggets for a number of years. But if the teacher’s union have their say the choice will no longer be made available.

The union had listed halal foods among the list it presented to the district which it said could lead to potential savings.

While most of the other items on the list had a value attached the union did not provide any such details for eliminating Halal foods from the lunch program.
However, better sense prevailed and the school district did not even consider the option. While this a relief it also brings into question the real intentions of the teacher’s union.

Hertz sued for accommodating Muslim employees

ATLANTA, A–Hertz Global Holdings Inc., the second-largest U.S. rental car company, was sued by former employees who say its policy of allowing Muslims to take daily prayer breaks discriminates against non-Muslim workers, according to press reports.

Katie Barkley and Shirley Harris, who worked as part-time drivers moving Hertz cars from Hartsfield-Jackson Atlanta International Airport to other locations, claim Muslim employees were given as many as three paid, 15-minute prayer breaks each shift while non-Muslim employees were denied equal time off, according to the suit filed Nov. 30 in federal court in Atlanta.

Barkley and Harris lost their jobs in February when Hertz fired all 120 drivers at Hartsfield and replaced them with contract drivers, according to the lawsuit, which seeks class-action status as well as back pay and other damages.

A similar suit filed in 2007 is pending before the same court. In August, Hertz said in court documents filed in that case that it allows Muslim employees at the Atlanta airport to take prayer breaks and that they aren’t required to clock out. A non-Muslim worker “has no need for such an accommodation,” Park Ridge, N.J.-based Hertz said in the court documents.

Slaughterhouse proposal rejected

ALMA,TX–Ellis County commissioners last week rejected a proposal to build a halal slaughterhouse on a 200 acre property. The property is owned Shamsul Ahmed who runs a grazing ranch and wanted to build a 4,000 square-foot slaughterhouse for specialty processing.

The halal facility would have hired 20 people. Ahmed said it would be run according to the state and federal rules, as well as the Halal requirements, which adds up to cleanliness first. An estimated 25-30 steers or heifers a well, and up to 400 goats a week were to be slaughtered there.

The country commissioners rejected the plan by saying it wouldn’t fit into the growing residential area in southern Ellis County. Despite the refusal Ahmed is not giving up. He is hoping to locate his plant near    Interstate 45 since his primary customers will be businesses in North Dallas.

Texas has a growing Muslim population of more than 400,000 and their needs are not met by the current businesses which cater to them.

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Indonesia Minister, Clerics Clash over Hajj Swine Vaccine’ Requirement

June 18, 2009 by · Leave a Comment 

JAKARTA, June 15 — The Indonesian Council of Ulema (MUI) and the health minister are now at odds over a requirement for hajj pilgrims to take an anti-meningitis vaccine which allegedly contains a swine enzyme before travelling to the Holy Land, Antara news agency reported.

“Health Minister Siti Fadilah Supari’s statement that MUI has no right to decide whether meningitis vaccine is ‘halal’ (allowed in Islam) or ‘haram’ (banned) can mislead and create unrest among Muslims,” MUI Chairman Amidhan, said yesterday.

According to the MUI chairman, the health minister as a state official should not have made the statement as it would create unrest among Muslims. The minister made the statement at a meeting of the Aisyiyah women wing of the Muhammadiyah Muslim organisation in Yoyakarta yesterday.

“I read her statement in the running text of a television broadcast Sunday morning,” Amidhan said.

MUI has the authority to decide whether or not a product is halal or haram based on Law No. 7 / 1996 on Food. One of its articles clearly stipulates that the halal certification of a product would be issued by MUI.

MUI is equipped with two institutions in this case. One is the Institute for Assessment of Food, Drug and Cosmetics (LPPOM) and the other one is the Commission on Edicts and Legal Affairs.

“Before MUI decides whether a product is halal or haram, its team will check it in the field and test it in a laboratory, the results of which would be taken to and discussed with the edict commission. We have the experience to handle such a problem for 20 years,” Amidhan said.

At the Aisyiyah meeting, Health Minister Siti Fadilah Supari said that Indonesian would-be hajj pilgrims were obliged to receive a meningitis vaccine before they left for Saudi Arabia because the Saudi government had decided to oblige pilgrims to have one.

“The Saudi government obliges all hajj pilgrims to have meningitis vaccine in order to protect them from cerebral membrane inflammation,” the minister said. She was responding to a rejection by a hajj pilgrim organiser group to provide meningitis vaccine as the vaccine was suspected to contain swine enzyme.

The minister said that the requirement set by the Saudi government to have meningitis vaccine for would-be hajj pilgrims was final. Pilgrims should be injected with the vaccine if they wanted to travel to Saudi Arabia.

“I have told the Saudi health minister about the pros and cons on the use of the meningitis vaccine which was suspected to contain swine enzyme but the Saudi government maintained its policy and required meningitis vaccination for hajj pilgrims,” the minister said.

Therefore, Indonesia’s would-be hajj pilgrims should receive meningitis vaccine injection in the first place before they could depart to Saudi Arabia. Without taking the meningitis vaccine, a would-be hajj pilgrim would not be allowed to go to the Holy Land.

“So far, there is only one kind of meningitis vaccine used by hajj pilgrims. This vaccine is produced by a US pharmacy. So far, no other pharmacy has produced meningitis vaccine,” the minister said.

The minister said that the US company was going to produce another type of meningitis vaccine. They claimed the new product was an innovative version of the previous one.

“Therefore, the price of the new vaccine which was claimed to be free from pig enzyme is far higher than that of the previous vaccine,” the minister said.

With regard to the present vaccine, the minister said that the institution that had the right to assess the substance of the vaccine was the ministry of health, not the MUI. So, MUI had neither right nor authority or competence to assess the substance of the meningitis vaccine and decided that it was halal or haram.

“MUI may decide that swine is halal or haram, but as far as a vaccine is concerned, the institution which has the right and competence to assess its substance is the health ministry,” Minister Supari said.

However, it was reported that MUI had received the very information on the swine enzyme substance in the meningitis vaccine from the health ministry itself, namely its Advisory Council on Health and Religious Legal Affairs (MPKS).

Amidhan said that MUI had the information from the MPKS which held a meeting with the meningitis vaccine producer. It was learnt from the results of a meeting between MPKS and the vaccine producer Glaxo Smith Kline (GSK), that the vaccine contained swine enzyme.

The producer even admitted that the meningitis vaccine contained swine enzyme.

“That is why we say that the vaccine is haram,” the MUI chairman said. MUI has sent a letter to the Saudi government with regard to the requirement for pilgrims to have meningitis vaccine.

The highest Islamic regulating council took the step because all parties involved in the organization of hajj pilgrimage in the country had agreed that the vaccine contained pig substance.

“We are waiting for a response from the Saudi government. However, if the Saudi government insists on its decision to require pilgrims to take meningitis vaccine, then we will use it based on the principle of emergency. Of course this would continue to create unrest,” Amidhan said. — Bernama

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