News (Updated March 18, 2007)

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Wednesday March 14, 6:11 PM

Angered U.S. firm excludes Thailand from new drugs

BANGKOK (Reuters) - U.S. drugs giant Abbott Laboratories said it would stop launching new medicines in Thailand in protest at the army-backed government's move to override international drug patents.

The decision will not affect Abbott drugs already on sale in Thailand, which declared a "compulsory license" in January allowing it to make or buy generic versions of Abbott's Kaletra to treat HIV/AIDS.

"Thailand has chosen to break patents on numerous medicines, ignoring the patent system. As such, we've elected not to introduce new medicines there," Abbott spokeswoman Jennifer Smoter told Reuters.

There was no immediate reaction from the Health Ministry, which argues it needs cheaper, copycat drugs to ensure wider access for Thailand's 63 million people, including 580,000 living with HIV/AIDS.

About 30 AIDS activists and patients protested outside Abbott's office in Bangkok, calling for a boycott of the company's products.

Paul Cawthorne of Medicins Sans Frontieres called Abbott's decision an "immoral act." Other critics accused Abbott of depriving Thailand's poor of lifesaving medicines, particularly a new formulation of Kaletra.

"Abbott has the hubris to blacklist a courageous country like Thailand simply trying to do the right thing for its people. Astounding," Michael Weinstein, president of the AIDS Healthcare Foundation, said in a statement.

The seven withdrawn drugs include the new version of Kaletra, an antibiotic, a painkiller and medicines to fight blood clots, arthritis, kidney disease and high blood pressure.

Abbott is believed to be the first pharmaceutical maker to withhold new drugs from Thailand since the government shocked drug makers late last year with its first compulsory license, for Efavirenz, an HIV-AIDS treatment made by Merck & Co.

Thailand has also issued one for Plavix, a heart disease medicine made by Bristol-Myers Squibb and Sanofi-Aventis, the first time a developing nation as done so for such a treatment.

Although legal under world trade rules, the licenses, which allow governments to make or buy generic versions of medicines needed for public health measures, stunned drug makers who received no prior warning.

Malaysia and Indonesia were the first in Southeast Asia to issue such licenses for AIDS drugs three years ago, but Thailand has gone farther in challenging Big Pharma by targeting other drugs.

Health Minister Mongkol na Songkhla told Reuters last month he was studying whether to issue compulsory licenses for other "essential medicines" to fight cancer, heart disease and other leading causes of death in Thailand.

 

China to use new medicine for drug addicts

China's Ministry of Health will use a new type of medicine to replace methadone in the treatment of some drug addicts in Guangxi and Xinjiang Autonomous Regions.

The drug treatment experts say many drug addicts misuse and become addicted to methadone, while others are allergic to it. This has lead the ministry to offer Suboxoner, a British-made medicine, to treat addicts.

The ministry has urged health departments in the two regions to carefully use the new medicine and study the effectiveness of Suboxoner.

The ministry says the new medicine is supposed to be safer, easier to manage and less likely to be misused.

Local health departments have been asked to sign agreements with the addicts who are to be treated with the new medicine, so the addicts are aware that Suboxoner is experimental.

The addict's personal information will be kept confidential, said the ministry.

Methadone has been used to treat drug addiction in China for years. Some 36,000 addicts have received methadone treatment by the end of 2006, according to statistics from the Ministry of Public Security.

China now has 460,000 registered drug addicts.

Both southwest China's Guangxi Zhuang Autonomous Region and northwest Xinjiang Uygur Autonomous Region have a large number of drug addicts.

Xinjiang has the fourth largest number of HIV/AIDS-infected people on the Chinese mainland. Most of the region's infections are found in Urumqi, the capital of the region.

According to statistics from the Health Ministry, the number of officially reported HIV/AIDS cases had grew to 183,733 nationwide in 2006, up nearly 30 percent from the previous year.

Source: Xinhua

 

 

Trimeris, Roche Amend Deals

Thursday March 15, 6:29 pm ET

MORRISVILLE, N.C. (AP) -- Biopharmaceutical company Trimeris Inc. said Thursday it reached a deal with F. Hoffmann-La Roche Ltd., a unit of Swiss drug company Roche Holding Ltd., over patents of HIV fusion inhibitor peptides.

 

Roche will return the rights to joint patents and other intellectual property related to next-generation HIV fusion inhibitor peptides to Trimeris that fall under the companies' 2000 research agreement, Trimeris said.

In return, Trimeris said it agreed to pay the company a "nominal royalty," which it did not specify, on future sales of TRI-1144, up to a certain limit.

Roche has also agreed to return the rights to all intellectual property that Trimeris originally licensed to the company in 1999, with the exception that Roche retains an exclusive license to manufacture and sell the HIV drug Fuzeon worldwide.

 

GenVec 4Q Loss Widens on Lower Revenue

Wednesday March 14, 11:08 am ET

 

GAITHERSBURG, Md. (AP) -- Biotech drug developer GenVec Inc. said Tuesday that its fourth-quarter loss widened on lower funding for its HIV vaccine.

The company posted a loss of $5.8 million, or 9 cents per share, from $4.3 million, or 7 cents per share, in the year-ago period.

Revenue fell 55 percent to $3.5 million from $7.8 million in the 2005 period because of reduced funding under an HIV vaccine development program following the completion of clinical vaccine supply production in 2005.

 

Sexually transmitted HPV remains mystery

By MARTHA IRVINE, AP National WriterThu Mar 15, 6:19 PM ET

PhotoNearly every working day, Dr. Elizabeth Poynor encounters anxious young women who come to her New York City office with an HPV diagnosis. The human papillomavirus is the most prevalent sexually transmitted diseases — so common that researchers estimate most people will have some form of it in their lifetime. Young adults are especially at risk because they tend to be the most sexually active group.

And yet Poynor finds that most of her young patients — even if they've heard of a new vaccine aimed at preventing the worst kinds of HPV — know little about the virus and the harm it can do.

Many women find themselves scrambling to understand HPV after a routine Pap smear determines they have it. And that, Poynor and others say, creates angst that could be avoided with more education.

"This is a very common problem, period," Poynor, a gynecological oncologist in private practice, says of HPV. "That's the first thing I try to tell my patients, to put their minds at ease and to potentially take away some of the stigma that a sexually transmitted disease might carry."

The reasons that HPV is so little known are many. Poynor thinks it's been overshadowed by higher-profile STDs, such as HIV and herpes. Others note that, when marketing its vaccine, pharmaceutical company Merck & Co. has chosen to focus on the potential for cervical cancer rather than the virus itself, which also can cause genital warts.

And then there's the gender divide. Both men and women can have high-risk HPV and low-risk types. But, doctors say, high-risk strains pose more problems for women, potentially leading not only to cervical cancer but also to infertility.

Frequently, men are seen as the silent carriers who can unknowingly spread HPV to their sexual partners. And even when people know they have HPV, they often think condoms offer 100 percent protection, when research has shown that they don't.

That was the case for one 24-year-old woman in San Francisco, who recently learned she has one of the high-risk types of HPV. She was one of a few young women with HPV interviewed for this story, all of whom spoke on the condition of anonymity because of the stigma of having an STD.

"I was scared, sad, disappointed and definitely ashamed. It seemed unfair that I should have it when I've had relatively few partners," says the young woman, who's been sexually active for eight years and had four monogamous sexual partners, including her current boyfriend of two years.

She knew little about HPV at the time. But when her doctor uttered the words "pre-cancer," in reference to the abnormal cells found in her cervix, she frantically searched the Internet to educate herself.

"It definitely made me question a lot about my past choices," says the young woman, who plans to soon attend graduate school to study culinary arts.

Certainly, doctors say, having more sexual partners increases a person's chance of contracting HPV. But, they say, HPV also can be contracted from just one partner and even one sexual encounter.

Having a partner get tested for STDs also isn't a guarantee, as one 22-year-old woman discovered.

"I always made getting tested a requirement. Then I would know I wasn't getting anything," says the recent college graduate who lives in Washington Township, Mich., near Detroit.

She has since been diagnosed with HPV and will soon undergo a procedure known as laser ablation to remove precancerous cells in her cervix. Other procedures often include a colposcopy, which is a close examination of abnormal cells in the cervix, and, if need be, a biopsy in which doctors remove a cone-shaped portion of the cervix to test it.

"I've been in to see the doctor five times in the last month — it's just overwhelming," says the young woman, who ended up sharing her diagnosis with her boyfriend and parents.

Having more information and the support of loved ones has helped.

"When you just say STD, people are like 'Ohhh,'" she says. "But when you ask those questions and understand more about it, it's not necessarily as scary."

While some women who have HPV think it's too late for them to be vaccinated against HPV, some doctors say it would still be worth it, since it shields against the worst four types of HPV.

"Even if a young woman has one type of high-risk HPV, there's nothing to say that she cannot be infected with the other three," says Dr. Tina Tan, an infectious disease specialist at Children's Memorial Hospital in Chicago.

Federal officials recently recommended that girls as young as age 9 receive the HPV vaccine. Some parents remain reluctant, though — worried that the vaccine could be considered a license to have sex.

Dr. Gary Rose, head of the Medical Institute for Sexual Health in Austin, Texas, says parents should reconsider, even if they're certain their daughters will wait until marriage for sex.

"There are a couple of things you can't be sure of," he tells those parents. "One is the sexual history of the person your daughter marries." The other, he says, is the risk of abuse or rape.

Because the vaccine does not protect against all types of HPV, Poynor and Tan say regular Pap smears and early treatment remain keys to fighting the virus. And they agree that some protection from condoms is better than none.

One young woman from San Antonio, Texas, who was diagnosed with HPV two years ago, also calls educating men about their role in spreading HPV "crucial."

"I had to tell my boyfriend about it," says the 26-year-old professional, "and he still doesn't get what it is."

 


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