PHARMACY

Congress likely to address patent reform after winter holiday

BY Drew Buono

WASHINGTON A staff member for Sen. Orrin Hatch, R-Utah, announced last week that the Patent Reform Act would probably go to the Senate floor after Congress returns from the holidays in 2008, the FDA reported.

Matthew Sandgren, counsel to Sen. Hatch, made the announcement at CBI Research’s conference on Effective Patent, Intellectual Property and Trademark Strategies. Although the Senate would like to consider patent reform this year, the legislation will try to pass it before the end of the 110th Congress. Sandgren assured attendees that Hatch has stipulated the bill is for innovators and is aimed at preserving innovation, not hurting the pharmaceutical industry. “This isn’t a generic companies’ bill,” he said.

Before the bill goes to the Senate floor, a few outstanding issues need to be addressed, and lawmakers have been working to negotiate these key provisions, Sandgren said. One issue is post-grant review. The goal of this provision is to establish an administrative procedure for reexamining patents that is cheaper and more efficient than litigation, Sandgren said. The provision allows a party to initiate a review of a patent within a year of its issuance and, under the Senate version, after 12 months with certain restrictions. The House version of the bill eliminated this so-called second window for initiating a review.

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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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