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June 7, 2009)
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Reuters June 5, 2009
WORCESTER, South Africa
(Reuters) - Baby Hisinawa is permanently semi-comatose after TB spread to his
brain, his board-stiff body shivering as a doctor pushes a rubber tube down his
nose to clear away thick phlegm choking him.
Last December, the chubby
two-year-old South African was talking and laughing. Now he has limited use of
all four limbs and cannot swallow.
Hisinawa is a severe
example of the debilitating symptoms of tuberculosis, which kills more people
than any other treatable infectious disease. Trials for a new vaccine start in
Scientists across the
world are seeking a new vaccine against the contagious lung disease, which is
largely under control in developed countries but still haunts the poor in the
developing world. Up to one in three people have it globally.
"The world needs a
new TB vaccine because the current one is not really effective in terms of
preventing TB and that is manifest in the context of an increasing
epidemic," Gregory Hussey, director of the South African TB Vaccine
Initiative (SATVI) told Reuters.
With more resources and
research committed by international and philanthropic organisations like the
World Bank and the Bill and Melinda Gates Foundation, optimism for a new TB
vaccine has reached heights last seen when the current TB vaccine, Bacille
Calmette-Guerin (BCG), was developed in the 1920s.
The most clinically
advanced of the nine vaccine candidates -- called MVA85A -- will be tested in
"All of the clinical
trials conducted to date with this vaccine (MVA85A) have shown that it is safe
and it stimulates high levels of the type of immune response we believe is
protective against tuberculosis," the vaccine inventor Dr Helen McShane of
the University of Oxford, told Reuters.
The World Bank, which
focuses on controlling TB by identifying and curing infectious patients, has
said financial support for its treatment would bring an estimated economic gain
of around $1.6 trillion (996 billion pounds) between 2006 and 2015.
Without financial
intervention, the economic burden of TB in badly hit countries like
STALKING THE POOR
South Africa is a good
place to start: a high rate of infection coupled with the world's largest AIDS
epidemic, where close to an eighth of the population are HIV positive, makes it
particularly vulnerable.
The World Health
Organisation has said the AIDS virus and TB form a lethal combination, each
speeding the other's progress. TB is the leading cause of death in AIDS
sufferers.
"My friend has TB and
I've seen what it does to her," said Esmerenthia Cupido, 35, a resident of
the town of
"She coughs terribly
and is getting very thin. She also lost two of her brothers to the disease, but
likes to party and drink. She doesn't want to listen," Cupido told Reuters
at the Brewelskloof hospital in
"Tering" as it
is known in the local Afrikaans patois, stalks the poor. A lack of proper
nutrition, cramped living conditions and substance abuse aid TB's spread.
In
INEQUALITY
The government said on
Wednesday it would step up measures to improve health care in
"We have set
ourselves the goals of reducing inequalities in health care ... and step up the
fight against the scourge of HIV and AIDS, TB and other diseases," South
Africa's president Jacob Zuma said in his first state-of-the-nation address.
TB, which has infected
people for thousands of years according to the Global Tuberculosis Institute at
the
In the 21st century it has
swamped developing countries across Africa and
"About four months
ago I saw someone in our street die from TB. He got thin and started vomiting
blood. When he coughed, chunks of blood came with it," Monique Wilson, 26,
said as she cradled six-month-old Mercedi. "That scared me and I decided to
take my baby for vaccination."
The TB bacterium commonly
affects the lungs, but can also move through the blood to other organs and the
bones. When the brain is affected, as with baby Hisinawa, patients die or suffer
serious disabilities.
The July tests will be the
first concept trial of a new preventative TB vaccine for infants in close to 90
years, and will be used as a booster to the BCG shot if found to be successful.
Major drug pharmaceutical
companies GlaxoSmithKline, Sanofi-Aventis and Crucell are now also testing TB
vaccines, although there is little incentive to develop an unprofitable vaccine.
"Most of the market
is in developing countries which might not be able to afford an expensive
vaccine," said Dr Tony Hawkridge, Head of the Aeras Global TB Vaccine
Foundation's
"It's never going to
be a Viagra or one of those multi-billion dollar products which rockets a
company into the ranks of the very rich," he said.
(Reporting by Wendell
Roelf; Editing by Farah Master and Michael Kahn)
On Tuesday June 2, 2009,
1:03 pm EDT
Glaxo will gain the rights
to three research programs by privately held Concert -- a protease inhibitor for
HIV due to start Phase I clinical trials this year, a preclinical drug for
chronic kidney disease and a third unspecified product.
Deuterium is a safe,
non-radioactive relative of hydrogen that can be isolated from sea water and has
been used extensively in human metabolic and clinical studies.
As deuterium is heavier
than hydrogen, it forms a stronger chemical bond to a carbon atom of a molecule,
which may substantially improve a drug's metabolic properties, potentially
resulting in better efficacy.
Patrick Vallance, senior
vice president of drug discovery at Glaxo said that Concert's approach to
deuterium modification of medicines "has broad potential to enhance certain
drug properties and result in innovative new medicines."
Lexington,
Massachusetts-based Concert said it would receive $35 million upfront, including
a $16.7 million equity investment.
The company is also
eligible to receive milestone payments and tiered, double-digit royalties based
on deuterium-containing products arising from the Concert pipeline programs and
from any Glaxo pipeline compounds.
Combined with the upfront
payment, Concert said it has the potential to receive in excess of $1 billion.
Concert will retain full
rights to further develop and commercialize its product candidates in any
program that Glaxo chooses not to license.
Thu Jun 4, 2009
By Lisa Richwine
WASHINGTON (Reuters) -
Many of the issues have
been previously disclosed, but remain under review by the Food and Drug
Administration.
The FDA said it was
checking Pfizer Inc's smoking cessation drug Chantix for possible risk of
accidental injury, vision impairment and other issues, and Cephalon Inc's sleep
disorder drugs Nuvigil and Provigil for a potential of serious skin reactions.
Other drugs listed
included orlistat, a weight-loss drug sold by Roche Inc as the prescription
product Xenical and by GlaxoSmithKline Plc as the over-the-counter drug Alli.
The FDA said it was continuing to evaluate liver toxicity reports for orlistat.
The FDA also said Pfizer's
overactive bladder drug Detrol was under investigation for reports of
Stevens-Johnson syndrome, a serious skin reaction.
The FDA releases a
quarterly list of safety probes as part of an effort to inform the public about
early investigations of potential side effects that have been reported. The list
released on Thursday covers October through December 2008.
The problems are potential
safety issues and their appearance on the list "does not mean that FDA has
identified a causal relationship" with the drug, the agency said.
Roche spokesman Terry
Hurley, commenting on the listing of Xenical, said available data "does not
suggest that orlistat is causally related" to liver problems, noting
obesity itself is a risk factor for liver injury.
Glaxo spokeswoman Mary
Anne Rhyne also said "no causal relationship ... has been established"
between Alli and hepatitis, a liver disease.
Pfizer spokeswoman Sally
Beatty said the maker of Chantix evaluates any reports of health problems and
"as with all our medicines, we work with the FDA to ensure our labeling
reflects the latest safety information."
The FDA had said last year
it was taking a closer look at Chantix after reports of accidents, vision loss
and other problems in hundreds of patients
A Cephalon spokeswoman did
not immediately respond to a request for comment on Nuvigil and Provigil.
Serious skin reactions were identified as an issue with the drugs in 2007 and
the FDA continues to study the matter, the agency said.
A spokeswoman for Glaxo
could not immediately be reached for comment on the listing of Alli.
Bristol-Myers Squibb Co's
HIV drug, Sustiva, was listed due to one report of an eye-related birth defect.
A description of the case was added to the drug's prescribing instructions in
March 2009, the FDA said.
Bristol-Myers spokeswoman
Cristi Barnett said the drug's label states it should only be used in pregnant
women, "if the benefit to the patient justifies the potential risk to the
fetus."
The FDA also is probing
pancreatitis with Bayer AG's contraceptive Yasmin, the agency's list said. Bayer
spokeswoman Rose Talarico said the listing "was not prompted by any change
in the existing safety profile" of Yasmin and the company "continues
to work with the FDA to ensure that the most up-to-date and accurate safety
information" is included in the drug's label.
(Reporting by Lisa
Richwine and Lewis Krauskopf; Editing by Gerald E. McCormick, Gary Hill)