BUSSINESS INFORMATION

The FDA has approved a new indication for blood clot drug Fragmin to treat symptomatic venous thromboembolism in patients with cancer, according to the drug's developers Pfizer and Eisai.
Symptomatic venous thromboembolism (VTE) is the formation of a blood clot that can travel from a leg vein to the lung, with potentially fatal results. Fragmin is the first low-molecular- weight heparin approved in the US for the extended treatment of recurrent VTE in patients with cancer
The approval is based on data from a study which showed that, during a six-month period, nearly twice as many patients treated with standard anti-coagulant treatment warfarin experienced at least one episode of DVT or PE, the two conditions described as VTE, compared to those treated with a once-daily administration of Fragmin. Mortality rates were similar between the study groups at the end of the study, while safety rates were higher for the Fragmin group.

Eisai licensed exclusive US rights to promote Fragmin from Pfizer in 2005, and has assumed responsibility for product distribution

Spectrum Pharmaceuticals has reported additional information from its satraplatin phase III trial confirming that the drug provides both pain relief and improvement of progression-free survival for prostate cancer patients.
The SPARC trial is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer who have failed prior chemotherapy.

"If approved, satraplatin will be the only drug for hormone refractory prostate cancer patients in the second-line setting, and we believe that the convenience of oral dosing and favorable tolerability will also offer an improvement in quality of life," said Luigi Lenaz, chief scientific officer of Spectrum Pharmaceuticals.

The study showed that pain response rates for patients treated with satraplatin were statistically significantly superior compared to the pain response rates for those patients in the comparator arm. Pain response rates were 24.2% for the satraplatin plus prednisone arm compared with 13.8% for the prednisone arm

Cases of hepatitis in the US have declined sharply in the last 10 years, mainly due to vaccination programs, according to the US Centers for Disease Control and Prevention.
Since 1995, new cases of reported acute hepatitis A have declined by 88%, while the number of hepatitis B and C cases have also dropped, the Centers for Disease Control and Prevention (CDC) said. The main factor behind the declines in new cases of hepatitis A and B was the availability of vaccines, while declines in reported new cases of hepatitis C were likely to be due to reductions in high-risk behaviors among injection drug users, according to the agency.
More than 4.5 million Americans are living with chronic hepatitis B and hepatitis C and are at serious risk for liver cirrhosis and cancer.
However, hepatitis non-profit group The Hepatitis C Caring Ambassadors Program urged people not to become complacent. Tina St John, medical director of the Caring Ambassadors Program, said: "The vast majority of people infected with the hepatitis C virus become chronically infected and many sustain serious, even life-threatening liver damage before the infection is diagnosed.
"It is critically important that people recognize chronic hepatitis C is an ongoing, substantial problem for millions of Americans."
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