PHARMACY

FDA approves Nexavar for treatment of liver cancer

BY Drew Buono

WAYNE, N.J., and EMERYVILLE, Calif. Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have received approval from the Food and Drug Administration for the supplemental drug application for Nexavar, for the treatment of inoperable liver cancer, according to the CNN Money Web site.

Nexavar is now the first approved systemic therapy for liver cancer. The drug was approved in 2005 for the treatment of advanced kidney cancer. The drug has now been approved for unresectable hepatocellular carcinoma, which is the most common type of liver cancer, responsible for about 90 percent of the liver tumors in adults, according to the National Library of Medicine.

“The approval of Nexavar in liver cancer marks the second time in two years that this novel kinase inhibitor has been granted FDA approval on a priority review basis, making it rapidly available to patients who previously had limited treatment options,” said Arthur Higgins, chairman of the executive committee of Bayer HealthCare. “This milestone will likely establish Nexavar as the standard systemic therapy for the treatment of liver cancer, and is a turning point in improving treatment outcomes in patients facing the devastating impact of this disease.”

Liver cancer is the sixth most common type of cancer in the world, affecting about 19,000 people in the U.S. each year, according to the World Health Organization and the California Cancer Clinic.

Nexavar comes in 200 mg tablets and the usual dose is two tablets taken twice a day on an empty stomach.

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Millenium takes a long-term view on expansion

BY Allison Cerra

BOSTON Biotechnology company Millennium Pharmaceuticals said that it has taken a less intense approach to bidding for experimental drugs, Reuters reported.

Millennium, which makes cancer drug Velcade, said Thursday that although its shareholders keep it on a longer leash, it will not destroy its focus on the value of the company, rather than trying to expand when it is impossible or unnecessary. “One of our strategies is to look outside to accelerate growth,” said Deborah Dunsire, Millennium’s chief executive, at the Reuters Health Summit in New York. “But our larger shareholders want us to stay religiously focused on being able to return value after we’ve paid for the assets.”

Last year’s bidding war with fellow biotechnology company Genzyme Corp. caused Millennium to intently concentrate on other things, including its pipeline of experimental products and its partnerships.

Meanwhile, Dunsire said the company has talked to several potential partners about MLN1202, its experimental antibody designed to reduce a protein that evidence suggests is related to coronary artery disease. While there no solid proof that elevated C-reactive protein directly contributes to an increased risk of heart disease, Dunsire said, the Food and Drug Administration would not approve the drug just because it reduces the protein.

Other companies involved in developing drugs for cardiovascular disease, however, could find it a very valuable tool and potentially a product in its own right. “We have taken this forward to determine whether it is an interesting avenue to explore,” Dunsire told Reuters.

For now, the company is expanding sales of Velcade, which is being tested in multiple combinations to determine its function when pooled with other drugs, Dunsire said. “We’re very optimistic we’ll get good growth in 2008. We’ve never looked at this as a zero-sum game.”

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J&J combats slow sales with creation of three units

BY Drew Buono

NEW BRUNSWICK, N.J. Johnson & Johnson will create three new units to combat its recent lagging sales, according to the Associated Press.

The three new units are: an office of strategy and growth to identify new opportunities; a surgical care group to focus on technology and services to improve patient care; and a comprehensive care group which will treat chronic and pervasive conditions. The office of strategy and growth is one of they key areas, as the company reported a decline in profit recently.

Nicholas Valeriani, the worldwide chairman for medical devices and diagnostics will lead the strategy and growth office. Sherilyn McCoy, the chairwoman for Ethicon, a medical device company, will be the worldwide chairwoman of surgical care and will become a member of the executive committee. Donald Casey, group chairman for the diabetes franchise, will become worldwide chairman of the comprehensive care unit and will join the executive committee.

“We have the know-how across our pharmaceutical, biologics, devices, diagnostics and consumer businesses to bring completely new solutions to market,” chief executive William Weldon said in a statement.

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