FDA nixes fast track for cancer vaccine
Thu, 31 May 2007 12:12:35 GMT
By JANE WARDELL, AP Business Writer
LONDON - GlaxoSmithKline PLC revealed Thursday that the U.S.
Food and Drug Administration has declined to grant a priority review to its experimental cancer vaccine Cervarix, adding to pressure on the drug maker after controversy surrounding its diabetes drug Avandia.
The FDA ruling means that Cervarix will have to go through a standard 10-month review, instead of a fast-track process that would have accelerated the approval and marketing of the vaccine in the key U.S. market.
Glaxo now expects to get the drug, which targets cervical cancer and is expected to become a multibillion-dollar product, to market in the United States sometime in 2008.
The company applied for U.S. marketing approval in March, hoping to receive a "priority review," which the FDA grants to medicines that represent a significant improvement compared with existing therapies.
Glaxo expects to launch the vaccine in Europe and several other markets in the second half of 2007. It was approved by health regulators in Australia earlier this month.
The decision on Cervarix comes as the company defends its diabetes drug Avandia after a study published in the
New England Journal of Medicine last week said that people taking the drug are at greater risk of heart attacks.
The findings hit Avandia sales hard, with a report from market intelligence group Impact RX showing that the drug's share of the market for newly prescribed oral anti-diabetics fell to around zero from around 10 percent in the two days after the article was published.
The Avandia family of drugs, which includes combination treatments Avandamet and Avandaryl, last year posted sales of 1.6 billion pounds, making it GlaxoSmithKline's second best-selling drug after asthma treatment Advair.
In a letter to The Lancet medical journal published Wednesday, Ronald Krall, GlaxoSmithKline's medical director, said that data from long-term, large-scale trials of Avandia had indicated that the risk of heart attack associated with the drug was similar to two other commonly used generic diabetes medicines, metformin and sulfonylurea.
Krall attacked the methodology in The New England Journal of Medicine study and referred to two medical trials that had been published previously, known as ADOPT and DREAM, and findings from another as-yet unpublished study of more than 30,000 diabetic patients.
He said that those studies showed the incidence of hospitalizations for heart attack for patients on Avandia was the same as for other diabetes treatments.
Shares in Glaxo were marginally higher on Thursday, up just 0.08 percent at 1,329 pence on a broadly higher London Stock Exchange after losing around 13 percent since the New England Journal of Medicine report was published.
Starbucks switches to 2 percent milk
Thu, 31 May 2007 18:52:10 GMT
SEATTLE - Starbucks Corp. said Thursday it will replace whole milk with 2 percent for espresso drinks in all of its U.S. and Canadian stores by the end of the year.
Drinks in North America will soon be made by default with the lower-fat milk, but customers can still request their cappuccino with whole milk, the company said.
Starbucks said it made the switch based on increased requests from consumers for low-fat milk in stores, as well as increasing purchases of lower fat milk in U.S. consumers' homes.
The coffeeshop company tested the 2 percent espresso drinks in Jacksonville, Fla.; Orange County, Calif.; the state of Oregon; and London, Ontario, in Canada and said the results were "overwhelmingly positive."
A 16-ounce "grande" latte made with reduced fat milk has 190 calories, compared with 260 calories in one made with whole milk.
The company is also considering the switch to lower-fat milk in locations outside of North America.
Shares of Starbucks gained cents to $28.80 in afternoon trading.
Swiss ask Novartis to withdraw drug
Thu, 31 May 2007 15:18:15 GMT
ZURICH, Switzerland - The Swiss pharmaceuticals regulator said Thursday it ordered the withdrawal of Novartis AG's Zelmac for irritable bowel syndrome, saying the risks of the treatment are greater than the benefit.
Swissmedic, the regulatory agency, said a new analysis of the data from clinical studies revealed an increased risk of cardiovascular issues, such as angina and heart attack, with the medicine when compared to a placebo.
Novartis agreed in March to stop selling Zelnorm in the United States, the name under which it was sold there, at the request of the
Food and Drug Administration after it was linked to a higher chance of heart attack, stroke and worsening chest pain that can become a heart attack.
Novartis reacted to the Swissmedic decision with "surprise and disappointment," according to a statement.
The company said it would comply with the request, but is still convinced that Zelmac offers important benefits to patients. Novartis said Swissmedic had rejected a compromise to partially allow the restricted and controlled sale of the medicine.
Zelmac, or Tegaserod, has been licensed in Switzerland since the end of October 2001 for the treatment of irritable bowel syndrome, including stomach pain and constipation, in women.
Novartis shares slipped 0.2 percent to 68.70 Swiss francs in Switzerland.
Cancer expected to skyrocket in Asia
Thu, 31 May 2007 05:43:38 GMT
By MARGIE MASON, AP Medical Writer
SINGAPORE - Asia is bracing for a dramatic surge in cancer rates over the next decade as people in the developing world live longer and adopt bad Western habits that greatly increase the risk of the disease.
Smoking, drinking and eating unhealthy foods — all linked to various cancers — will combine with larger populations and fewer deaths from infectious diseases to drive Asian cancer rates up 60 percent by 2020, some experts predict.
But unlike in wealthy countries where the world's top medical care is found, there will likely be no prevention or treatment for many living in poor countries.
"What happened in the Western world in the '60s or '70s will happen here in the next 10 to 20 years as life expectancy gets longer and we get better control on more common causes of deaths," said Dr. Jatin P. Shah, a professor of surgery at Memorial Sloan-Kettering Cancer Center in New York, who attended a cancer conference last month in Singapore.
"The habit of alcohol consumption, smoking and dietary changes will increase the risk of Western world cancers to the Eastern world," Shah said.
An estimated 40 percent of cancers worldwide can be prevented by exercise, eating healthy foods and not using tobacco, according to the
http://www.uicc.org/