WASHINGTON
(AFP) – The Bill and Melinda
Gates Foundation awarded 100,000 dollars each on Wednesday to scientists
in 22 countries including funding for a Japanese proposal to turn mosquitos into
"flying syringes" delivering vaccines.News (Updated October 26,
2008)
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WASHINGTON
(AFP) – The Bill and Melinda
Gates Foundation awarded 100,000 dollars each on Wednesday to scientists
in 22 countries including funding for a Japanese proposal to turn mosquitos into
"flying syringes" delivering vaccines.
The charitable foundation created by the founder of software giant Microsoft said in a statement that the grants were designed to "explore bold and largely unproven ways to improve global health."
The grants were awarded for research into preventing or curing infectious diseases such as HIV/AIDS and tuberculosis and limiting the emergence of drug resistance.
They are the first round of funding for the Gates Foundation's "Grand Challenges Explorations," a five-year 100-million-dollar initiative to "promote innovative ideas in global health."
The funding was directed to projects that "fall outside current scientific paradigms and could lead to significant advances if successful," the Gates Foundation statement said.
"We were hoping this program would level the playing field so anyone with a transformational idea could more quickly assess its potential for the benefit of global health," said Tachi Yamada, president of global health at the Gates Foundation.
The Gates Foundation said 104 grants were awarded from nearly 4,000 proposals. The recipients included universities, nonprofit organizations, government agencies, and six private companies.
"It was so hard for reviewers to champion just one great idea that we selected almost twice as many projects for funding as we had initially planned," Yamada said.
Among the proposals receiving funding was one from Hiroyuki Matsuoka at Jichi Medical University in Japan.
"(Matsuoka) thinks it may be possible to turn mosquitoes that normally transmit disease into 'flying syringes,' so that when they bite humans they deliver vaccines," the Gates Foundation said.
It said Pattamaporn Kittayapong at Mahidol University in Thailand received a grant to "explore new approaches for controlling dengue fever by studying bacteria with natural abilities to limit the disease."
Founded in 1994, the Seattle, Washington-based Gates Foundation is the largest private philanthropical organization in the world.
WASHINGTON (Reuters) - Earlier treatment may be better when it comes to taking drugs for the AIDS virus, researchers reported on Sunday.
Patients were more than 70 percent less likely to die when they started taking cocktails of HIV drugs earlier than currently recommended, they told a meeting of infectious disease specialists.
There is no cure for the human immunodeficiency virus that causes AIDS but combinations of drugs can keep the virus from replicating and damaging the immune system.
It has not been entirely clear when patients should start taking them, though, and most doctors wait until there is some evidence of damage, measured by counting the number of immune cells called CD4 T-cells.
Current treatment guidelines call for patients to start highly active antiretroviral therapy, or HAART, when they have fewer than 350 CD4 cells per milliliter of blood.
U.S. and Canadian researchers led by Dr. Mari Kitahata of the University of Washington in Seattle looked at information in International Epidemiology Databases to Evaluate AIDS, a global network of HIV clinics from 1996 to 2006.
They compared the records of 8,374 healthy HIV patients with CD4 counts of 351 to 500 who had never taken HAART.
During the time studied, 30 percent of them started HAART while the rest waited until their CD4 counts fell below 350.
Those who waited were 71 percent more likely to die of something during the study period than those who took the drugs early, Kitahata's team told a joint meeting of the American Society of Microbiology and the Infectious Diseases Society of America.
A study released earlier this month showed that patients infected with HIV who take breaks from HAART are more likely to die of heart attacks, strokes and other deadly blood clots.
An estimated 33 million people globally are infected with the AIDS virus. About a 1.1 million Americans are, but the U.S. Centers for Disease Control and Prevention estimates that one in five do not know it, which means they cannot be treated.
The CDC estimates that more than 56,000 Americans are newly infected with HIV annually.
(Reporting by Maggie Fox; Editing by Bill Trott)
WASHINGTON (Reuters) - A new class of HIV drugs can help control the virus in untreated patients, researchers reported on Sunday.
Merck and Co. hopes the findings will open a new market for its drug Isentress, the first drug on the market in a new class called integrase inhibitors.
Isentress worked slightly better than an older HIV drug called efavirenz in suppressing levels of the AIDS virus, the researchers told a meeting of the American Society of Microbiology and the Infectious Diseases Society of America.
Last October, the U.S. Food and Drug Administration cleared Isentress for use in HIV patients whose infection has begun to resist the effects of other drugs.
This problem, called resistance, is common in AIDS virus infections and is one reason why companies continue to develop new drugs to fight HIV.
Companies want their drugs to be approved for first-line treatment against HIV, as well. The human immunodeficiency virus that causes AIDS has no cure, but a cocktail of various drugs can control the infection and keep patients healthy.
Isentress, known generically as raltegravir, is sold as a twice-daily pill.
Cowen & Co analysts have forecast that the drug could reap up to a $1 billion in sales by 2012. The drug could compete with another integrase inhibitor called elvitegravir being tested by Gilead Sciences.
Merck estimates about 500,000 patients in the United States are getting these drug cocktails and that between 30 and 40 percent of them have developed resistance.
The U.S. Centers for Disease Control and Prevention estimates that about a million people in the United States are infected with HIV. Globally, 33 million are infected with the fatal and incurable virus.
Merck's phase III study -- the last stage of testing before seeking FDA approval -- found that Isentress reduced HIV viral load to undetectable levels in 86 percent of patients compared to 82 percent of patients treated with efavirenz.
The 500 patients were also taking the HIV drugs tenofovir and emtricitabine.
(Reporting by Maggie Fox, editing by Will Dunham)
By Amy Norton
NEW YORK (Reuters Health) - Electronic "postcards" may offer a new way to alert the partners of patients with sexually transmitted diseases that they may have been exposed, according to a new report.
Partner notification has long been a cornerstone of controlling the spread of STDs like gonorrhea, chlamydia and HIV. Traditionally, it's been done over the phone, by mail or in person, with the help of a public health worker.
In some cities, however, high numbers of STD-infected patients, many of whom have had multiple sexual partners, make it difficult to track down all the individuals who are at risk.
In 2004, a San Francisco-area non-profit called Internet Sexuality Information Services (ISIS) developed an Internet-based program to aid in partner notification. Called inSPOT, the service uses "e-cards" to help STD patients reach their partners.
Web site users choose one of six e-cards, type in recipients' email addresses and either send the postcard anonymously or include their own email addresses. The e-cards alert recipients that they might have been exposed to an STD, and also provide them with links to STD information and a map of clinics where they can be tested.
Early data, published in the online journal PLoS Medicine, indicate that the service is proving useful.
The program began in San Francisco, where it was targeted toward gay and bisexual men, but has since expanded to more than a dozen U.S. states. Since 2004, more than 30,000 people have sent nearly 50,000 e-cards to their sexual partners.
The percentage of recipients who click on the e-card links varies by city, according to the PloS report -- ranging from 20 percent in Los Angeles to a high of nearly 50 percent in Idaho.
The results suggest that inSPOT represents "one more tool in the toolkit" to cut STD transmission rates, study co-author Deb Levine, the executive director of ISIS, told Reuters Health.
"E-cards do not replace in-person communication," she said, "but for those people who are diagnosed with an STD, e-cards can enhance sexual communication and help with community responsibility and easing a process of disclosure that can be extremely difficult."
Still unknown is the percentage of e-card recipients who ultimately seek STD testing. Levine said she and her colleagues are now seeking funding to study the full impact of inSPOT nationally.
SOURCE: PLoS Medicine, October 20, 2008.
NEW YORK (Reuters) – U.S. drug makers Bristol-Myers Squibb Co (BMY.N) and Eli Lilly and Co (LLY.N) posted better-than-expected third-quarter profits on double-digit sales gains, although results were marred by special charges related to either government probes or soured investments.
Both drug makers also gave improved forecasts for the rest of the year, and their shares rose.
Drug makers have largely surpassed expectations this quarter, despite some setbacks, proving their potential value as defensive investments during the economic turmoil.
"The whole drug group has broadly exceeded expectations in the quarter, to a large extent because of restructuring and cost cutting each company has implemented," Deutsche Bank analyst Barbara Ryan said.
Still, like most of their rivals, Bristol and Lilly both face questions over their long-term profitability because of patent expirations to top products and uncertainty with their pipelines of experimental drugs.
Bristol's blood-clot treatment Plavix and Lilly's schizophrenia drug Zyprexa -- the companies' respective top-selling products -- will lose U.S. patent protection in the next few years, and the companies face skepticism that they will be able to make up for the lost revenue.
For the quarter, Bristol said it earned $2.58 billion, or $1.29 per share, compared with $858 million, or 43 cents per share in the year-ago quarter. The results reflect a $2 billion after-tax gain from the sale of the ConvaTec unit in August.
Excluding special charges, Bristol-Myers said its third-quarter earnings from continuing operations was 46 cents per share. Analysts on average expected 42 cents per share, according to Reuters Estimates.
"It was a very strong quarter for Bristol," Ryan said, citing strength in its core franchises, including Plavix, schizophrenia drug Abilify and its HIV drugs, as well as improved profit margins.
Bristol revised its 2008 forecast to the upper end of its previous range, forecasting earnings per share of $1.65 and $1.70, excluding items, from its prior range of $1.60 to $1.70.
The company affirmed it expects compounded annual earnings growth from continuing operations of at least 15 percent from 2007 through 2010.
Bristol said its net earnings from continuing operations fell 21 percent, primarily due to a charge of $224 million in the quarter related to losses on auction rate securities.
Ryan said the company, which took its first charge for depressed auction rate securities in January, has shifted its investments into U.S. Treasury bonds. "They're definitely playing safer," she said.
Lilly said it lost $466 million, or 43 cents per share, as it booked $1.48 billion in charges for probes of its Zyprexa schizophrenia treatment. That compared with a year-earlier profit of $926 million, or 85 cents per share.
But excluding special items, earnings rose 14 percent to $1.04 per share, 2 cents ahead of estimates.
Sales rose 14 percent to $5.21 billion, topping analysts's forecast of $5.09 billion, as sales of its depression treatment Cymbalta soared 40 percent to $716.4 million.
"Lilly's business looks good; their sales growth looks very nice," said Mike Krensavage, principal of Krensavage Asset Management.
Lilly raised its 2008 forecast, excluding items, to $3.97 to $4.02 per share, from its previous range of $3.85 to $4.00.
Although the company's near-term earnings prospects are bright, Krensavage said he was concerned whether the company will win approvals for enough big drugs to offset looming generic competition for Zyprexa, Cymbalta and cancer drug Gemzar.
WASHINGTON,
Oct 22 (Reuters) - U.S. health regulators have expanded approval for Johnson
& Johnson's <JNJ.N> Prezista in combination with other drugs to treat
HIV patients who are just beginning to take medication for the virus, the
company said on Wednesday.
Prezista,
or darunavir, had already been approved for use along with other HIV drugs in
patients who were already taking protease inhibitors but had developed
resistance.
Patients
new to HIV therapy should take the drug with ritonavir and food to get the best
results, the company said. Ritonavir, sold by Abbott Laboratories <ABT.N>
under the name Norvir, helps boost the concentration of Prezista in the body by
slowing its breakdown.
The
approval offers another option to treat the human immunodeficiency virus, or
HIV, the company said in statement. Protease inhibitors help prevent the
AIDS-causing virus from replicating.
Common
side effects include diarrhea, nausea, headache and serious skin rashes, the FDA
has said. Reports of hepatitis and liver failure have also been found in
Prezista patients, the company said.
Johnson
& Johnson also said the FDA finalized its approval of the drug for patients
used to taking HIV medications. When the FDA cleared the use in 2006 it required
follow-up studies to verify its benefits.
The
agency said on Wednesday the company's additional studies supported Prezista,
the company said.
First-time
HIV drug patients should take two 400-milligram tablets once a day. Those who
have been on medication before should still take 600-milligrams. The drugmaker
added it was discontinuing its 300-milligram tablet since it began manufacturing
a 600-milligram version earlier this year.
The drug
is marketed in the
Shares of
Johnson & Johnson were off 2.6 percent, or $1.64 at $62.02 in morning trade
on the New York Stock Exchange. (Editing by Dave Zimmerman)
WASHINGTON (Reuters) – The AIDS virus, HIV, may cause blood clots and other problems with blood vessels that can kill patients prematurely even if they are relatively healthy, researchers reported on Monday.
They found that patients given breaks from their HIV prescriptions had higher levels of blood proteins associated with inflammation, an often dangerous immune response.
The international study showed why it may be risky to give patients "breaks" from the drug cocktails that suppress the virus, the researchers reported in the Public Library of Science journal PLoS Medicine.
The findings come from an international study into whether it would be truly beneficial to let patients take their HIV drug cocktails only intermittently after research had shown this was safe, would save money, and limit side-effects from the drugs.
But the study was stopped early, in 2006, because patients who took breaks from their drug therapy were far more likely to die early than patients who took treatment continuously, and not from conditions usually associated with AIDS, the researchers found.
James Neaton of the University of Minnesota and colleagues looked at 85 of the patients who died early, and compared their blood samples to 170 patients who did not.
They found three so-called biomarkers, or blood proteins, that are linked with inflammation were higher in the people who died. They were high-sensitivity C-reactive protein, interleukin 6 (IL-6), and D-dimer.
"IL-6 and D-dimer were strongly related to all-cause mortality. Interrupting (HIV drugs) may further increase the risk of death by raising IL-6 and D-dimer levels," the researchers wrote.
"The magnitude of the increased risk of death associated with elevations of these biomarkers is clinically relevant," Neaton said in a statement. "Research aimed at understanding whether treating elevated levels of these markers is beneficial and is now needed."
The researchers said it may be possible to develop drugs that fight this inflammation.
Inflammation in general is linked with a range of heart conditions, cancer and possibly diabetes.
Other studies have shown that HIV affects the insides of the blood vessels and may make blood more likely to clot. These clots can cause heart attacks, strokes and pulmonary embolisms.
Cocktails of HIV drugs, called highly active antiretroviral therapy or HAART, keep the virus from replicating in the blood and destroying immune system cells. While there is no cure for HIV, these drugs can keep patients healthy.
(Reporting by Maggie Fox; Editing by David Storey)
TRENTON, N.J. – Drugmaker Merck & Co. said Wednesday it will slash 7,200 jobs as part of a new restructuring program that comes as its third-quarter profit plunged 28 percent, due to a hefty restructuring charge and flat sales.
The maker of allergy and asthma treatment Singulair and cervical cancer vaccine Gardasil said it will cut nearly 13 percent of its work force, including many executives, to lower overhead and become more competitive, in its second major restructuring in less than three years.
"It's not a reaction to our performance in 2008 or the economy," Chief Executive Richard Clark said in an interview. "I think it's a competitive advantage" to make the company leaner and more flexible.
Clark said 60 percent of the job cuts will come overseas — a higher rate than in the December 2005 restructuring just wrapping up — and cuts will affect workers in sales and marketing, manufacturing, administration and even research. He said spending on research, the company's future, won't be cut, but more will be shifted to basic-research collaborations at small companies and universities.
Three basic research centers will be closed — in Seattle, Japan and Italy — and the company is still evaluating which manufacturing plants will be closed in a few years as it outsources more "non-core manufacturing."
In afternoon trading, Merck shares were down $1.08, or 3.6 percent, at $28.89.
Whitehouse Station, N.J.-based Merck & Co. took a $612 million charge for restructuring, reducing net income for its third quarter to $1.09 billion, or 51 cents per share. That's down from $1.53 billion, or 70 cents per share, a year earlier.
The after-tax charge includes a $720 million pretax charge for the new restructuring program, much of it for severance costs, plus $127 million for the prior restructuring.
Excluding the $612 million charge, equal to 29 cents per share, earnings per share would have been 80 cents, 1 cent better than Wall Street expected.
"I don't think it's a stunner. I think it's more of what you'll see from all of these (pharmaceutical) companies," David Heupel, pharmaceuticals portfolio manager at Thrivent Large Cap Growth Fund, said of the new restructuring. "They're all looking for ways to grow their top line again but it certainly isn't as easy as cutting costs."
The company narrowed its 2008 earnings forecast, to $3.28 to $3.32 per share excluding one-time items, from April's forecast of $3.28 to $3.38.
Despite a 4 percent boost from the favorable exchange rates, third-quarter revenue was down 2 percent at $5.9 billion. Analysts surveyed by Thomson Reuters were expecting $6.1 billion.
Edward Jones analyst Linda Bannister said she was disappointed Merck reduced its often-repeated financial forecasts for the 2005-2010 time frame, such as dropping from double-digit growth in earnings per share over that period down to mid-to high-single digits. Revenue growth for the period also was reduced, from 4-6 percent annually to 2-4 percent.
Sales were hurt by a further decline in Merck's cholesterol franchise, lower sales for nearly all its vaccines and generic competition for former blockbuster osteoporosis drug Fosamax, which lost U.S. patent protection in February and saw sales cut in half this quarter to $354 million.
Vaccine sales were down because of what Heupel called "disappointing" problems with manufacturing. Merck said several vaccines have been on back order because of nearly-resolved production problems.
The cholesterol drugs Vytorin and Zetia, which Merck jointly markets with partner Schering-Plough Corp., saw sales dip about 15 percent to $1.1 billion in the quarter, cutting Merck's income from the joint venture by 17 percent, to $400 million.
Singulair sales edged up 1 percent, to $1.03 billion, and blood pressure drugs Cozaar and Hyzaar rose 9 percent to $888 million. Some new products, including HIV drug Isentress and diabetes drugs Januvia and Janumet, also sold well.
The new restructuring program, which aims to eliminate the 7,200 jobs by the end of 2011, includes streamlining management layers by eliminating one in four senior and mid-level executives. Merck now has about 56,700 employees.
A massive December 2005 restructuring, nearly complete, cut 10,400 jobs; between the two programs, Merck will have shed just over a quarter of its staff.
The new cuts are expected to produce cumulative pretax savings of $3.8 billion to $4.2 billion from 2008 to 2013, but it will cost between $1.6 billion and $2 billion through the end of 2011.
For the first nine months, net income jumped nearly 26 percent to $6.16 billion, or $2.86 per share, compared with $4.9 billion, or $2.24 per share, in the January-September period of 2007. Much of that improvement was due to one-time items this year, particularly a $2.2 billion gain related to Merck's partnership with AstraZeneca LP. Sales for the first nine months were down about 1 percent, to $17.82 billion.