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Study Questions Value of Biotech Drug

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From Reuters

An expensive drug used to dissolve blood clots in heart attack victims is no more effective than a competing drug that costs one-tenth as much, a large Italian study of TPA and streptokinase released Thursday in Florence shows.

The long-awaited study, involving 19,000 patients, is the largest study ever to directly compare the drugs in heart attack victims.

It shows that there was no significant difference between the two drugs’ effectiveness among patients treated with TPA or the much less expensive streptokinase.

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TPA is sold under the brand name Activase by South San Francisco-based Genentech. Streptokinase, sold under the brand name Streptase, is distributed by West German drug giant Hoechst AG.

Genentech’s Activase, a genetically engineered drug, sells for $2,200 a dose while stretokinase sells for $200.

Genentech has long contended that its drug is superior to streptokinase, and says the high price is justified because of the costs of developing the drug.

TPA is Genentech’s major product. Last year it sold nearly $200 million worth of the product.

Genentech’s stock dropped $1.125 a share to $26.125 on the New York Stock Exchange on Thursday.

In a statement, the steering committee for the study concluded, “On the basis of the present trial’s findings, the choice of thrombolytic (clot dissolving) treatment cannot be based on clinical grounds alone but must take full account of public health economy considerations.”

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It also said the higher rate at which TPA dissolved clots did not “appear to correspond” to a better outcome for heart attack patients.

Genentech said the results of the study did not use a treatment regimen that is favored in the United States, which makes the results of little use to American doctors.

“It appears that this trial offers limited new information to the understanding of thrombolytic therapy,” said G. Kirk Raab, president and chief executive of Genentech.

“Although we don’t know how this study will ultimately impact our sales, we are confident that physicians will consider their personal experience in treatment over 170,000 patients with TPA in the past two years,” Raab said in a statement.

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