News (Updated January 31, 2009)

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TB, substance abuse closely linked in U.S.: CDC

Mon Jan 26, 2009 4:33pm EST

By Will Dunham

WASHINGTON (Reuters) - About a fifth of people with tuberculosis in the United States report abusing drugs or alcohol, and the figure is even higher when only U.S.-born patients are included, government researchers said on Monday.

The substance abusers were more contagious than others with the disease and remained contagious longer, the U.S. Centers for Disease Control and Prevention researchers wrote in the journal Archives of Internal Medicine.

About a third of people worldwide are infected with the bacterium that causes TB. Only a small percentage of people ever develop the disease. But the effect of substance abuse on the body may raise the chances that the latent infection turns into active disease, and substance abusers may be less likely to be screened for TB, the researchers said.

The researchers tracked 153,268 people with TB in the United States from 1997 to 2006, accounting for nearly everyone age 15 and older with the disease during that span.

Overall, 19 percent of them reported that they abused drugs and/or alcohol, according to the study. Among the 76,816 U.S.-born people with TB, 29 percent reported substance abuse.

The United States has very low rates of TB compared to many other parts of the world, and about half of the people with TB were born elsewhere.

"The most commonly reported risk factor for TB was substance abuse," CDC epidemiologist Eric Pevzner, one of the researchers, said in a telephone interview.

It was greater than are other leading risk factors such as HIV infection or homelessness, the researchers said.

TB is an infectious bacterial disease typically attacking the lungs. It can be spread by breathing in droplets from a cough or sneeze of an infected person.

Pevzner said the findings had important public health implications as the United States attempts to lower its TB rates even further, Pevzner said.

"We can't treat the TB in isolation," Pevzner said. "We have to bring in people who are experts in substance abuse and also treat the life circumstances that people are facing so that we can help cure this disease and help end a chain of transmission."

Substance abusers are less likely to complete TB treatment, the researchers said. They also may have TB diagnosed later and have less access to routine medical care.

 

Microbicide can help avoid herpes infection: study

Thu Jan 22, 1:58 PM

WASHINGTON (AFP) - A new external vaginal treatment works to protect against genital herpes infection for as long as a week, a new study has found.

The topical microbicide works by "silencing" two genes, and was shown effective in mice, the study released Wednesday by Albert Einstein College of Medicine of Yeshiva University and Harvard Medical School found.

The treatment backed by Alnylam Pharmaceuticals Inc. protected mice from simplex 2, which causes genital herpes, according to Dr Deborah Palliser of Harvard University in Cambridge , Massachusetts , one of the study's co-authors.

Their results were published in the January 22 issue of Cell Host and Microbe.

Harvard Medical School professor of pediatrics Judy Lieberman, also a senior investigator at the Immune Disease Institute, oversaw development of the treatment.

Her team used a lab technique called RNA interference, or RNAi, the treatment cripples the virus in a molecular double hit: it disables its ability to replicate, as well as the host cell's ability to take up the virus.

"People have been trying to make a topical agent that can prevent transmission, a microbicide, for many years," Lieberman said. "But one of the main obstacles for this is compliance. One of the attractive features of the compound we developed is that it creates in the tissue a state that's resistant to infection, even if applied up to a week before sexual exposure. This aspect has a real practicality to it. If we can reproduce these results in people, this could have a powerful impact on preventing transmission."

And that also could help in reducing HIV transmission, the authors noted, as herpes sores can help ease HIV transmission.

Some 536 million people worldwide are infected with herpes simplex virus type 2 (HSV-2), the most common strain of this sexually transmitted disease, World Health Organization data show.

Infection rates are strikingly high in the United States , with an estimated one in five US adults infected with HSV-2.

 

Merck seeks new medicine uses, cutting jobs again

Friday January 30, 3:49 pm ET  

WHITEHOUSE STATION, N.J. (AP) -- Merck & Co., a Dow component and the world's No. 8 drugmaker by revenue, reports earnings for the fourth quarter on Tuesday morning. The following is a summary of key developments and analyst opinion related to the period.

OVERVIEW: Merck is in the process of eliminating about 7,200 jobs, or nearly 13 percent of its workforce, as sales of some key products have been flat or slumping, including blockbuster osteoporosis treatment Fosamax, which got generic competition early last year.

It's also been plagued by a variety of production problems with its vaccines, troubles that have limited supplies and reduced revenue. Shingles vaccine Zostavax remains back-ordered, although many orders were filled in December, while hepatitis A vaccine Vaqta is only being shipped for children. It is expected to become available for adults in the second quarter. Shortages hit hepatitis B vaccine Recombivax in January, due to the need to upgrade some manufacturing equipment, with only a version for children available now.

Sales of the cholesterol drugs Merck jointly sells with partner Schering-Plough Corp. have been hammered for a year by reports questioning their efficacy and safety.

But earlier this month, the Food and Drug Administration said patients should not stop taking Vytorin, Zetia or other cholesterol-lowering drugs, based on its review of a controversial study that hammered Vytorin and Zetia sales.

In December, Merck ended its partnership with Dynavax Technologies Corp. on an experimental hepatitis B vaccine that ran into safety problems.

BY THE NUMBERS: Analysts polled by Thomson Financial expect, on average, earnings per share of 74 cents and revenue of $5.98 billion. In the year-earlier period, Merck posted a net loss of 75 cents per share, mainly due to a $4.85 billion charge to settle thousands of lawsuits over withdrawn painkiller Vioxx; revenue that quarter was $6.24 billion.

In the third quarter, earnings per share fell to 51 cents on a charge for restructuring, from 70 cents in the 2007 period.

ANALYST TAKE: Deutsche Bank analyst Barbara Ryan, who has a "Buy" rating on Merck, expects fourth-quarter revenue to be down about 7 percent because of slight declines in sales of vaccines, cholesterol drugs and asthma drug Singulair, plus Fosamax generic competition and unfavorable currency exchange rates, which hurt all major U.S. drugmakers in the quarter. But with the planned job cuts, she believes Merck can increase earnings per share in the mid-single digits through 2011. She writes that the management team seems committed to creating a company with a lower and more flexible cost structure.

Credit Suisse analyst Catherine Arnold sees Merck cutting marketing and administrative costs by a few hundred million dollars in 2009, boosting research spending by $100,000 or more and facing a slightly higher tax rate.

WHAT'S AHEAD: Merck has asked federal regulators to approve use in males of Gardasil, its vaccine against the human papillomavirus, which causes cervical and other sexually transmitted cancers and genital warts. Gardasil was launched in 2006 for girls and young women. Last June, the Food and Drug Administration rejected its use for older women, but in January it asked for more data on that issue. Merck also is seeking FDA approval to market its HIV drug Isentress in new patients, not just ones already treated with other medicines.

STOCK PERFORMANCE: Shares fell 37 percent to $30.40 during the fourth quarter. Over 2008, shares fell 48 percent.

 

Gilead Sciences profit rises on HIV drug sales

Tuesday January 27, 5:57 pm ET  

FOSTER CITY , Calif. (AP) -- Biotech drugmaker Gilead Sciences Inc. said Tuesday its profit soared more than 40 percent in the fourth quarter on higher sales of its HIV-controlling treatments.

For the period ended Dec. 31, Gilead reported net income of $568.2 million, or 60 cents per share, compared with $401.6 million, or 41 cents per share, in the same period last year.

Excluding one-time items, including stock-based compensation, Gilead said it would have earned $598.5 million, or 63 per share.

Wall Street analysts polled by Thomson Reuters predicted earnings of 55 cents per share.

The company's revenue surged 30 percent to $1.43 billion for the quarter, up from $1.09 billion in fourth quarter 2007.

Sales were mainly driven by Gilead 's anti-HIV drugs, including Atripla and Truvada. Atripla sales grew 79 percent to $465.5 million on continued prescription growth in the U.S. , as well as product launches in Europe .

Full-year 2008 earnings grew to $2 billion, or $2.10 per share, from $1.6 billion, or $1.68 per share, in 2007. Revenue advanced to $5.34 billion from $4.23 billion.

Analysts expected earnings of $2.04 per share.

The company benefited from a lower annual tax rate, which fell to 26.5 percent from 28.9, thanks to the resolution of certain tax audits, among other reasons.

Shares of Gilead Sciences Inc. fell 96 cents Tuesday, or 2 percent, to $47.27 in after-hours trading. In the regular session, the stock fell 16 cents to close at $48.23.

 

Myriad Pharma buys Panacos's HIV drug bevirimat

Wednesday January 21, 7:24 am ET

NEW YORK (AP) -- Myriad Pharmaceuticals on Wednesday agreed to buy Panacos Pharmaceuticals Inc.'s HIV drug candidate bevirimat for $7 million.

Myriad will not owe Panacos any milestone or royalty payments on bevirimat, which is currently in mid-stage clinical testing. Myriad said it will handle all clinical and commercial development of the drug. Bevirimat is being studied in both tablet and liquid formulations.

Myriad said it will include the payment in its results for the fiscal third quarter, which ends March 29.

The companies said Watertown, Mass.-based Panacos has completed 15 studies on bevirimat, involving more than 100 HIV patients and a total of about 650 people.

In December 2007, Panacos reported disappointing trial results for bevirimat, as a 350 mg dose of the drug appeared to be less effective than a 300 mg dose. The company later concluded that patients who have few mutations on a protein called HIV Gag are more likely to have a strong response to bevirimat.

Myriad Pharmaceuticals is a unit of Salt Lake City-based Myriad Genetics Inc. The pharmaceutical business is being spun off into a separate publicly traded company, a process expected to be complete by the end of the second quarter.

The remaining Myriad Genetics business will focus on predictive and personalized medicine.


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