Washington Editor

WASHINGTON - European drugmakers are pulling ahead of U.S. companies in pharmaceutical innovation, according to a new report in the Washington public policy journal Health Affairs, which challenged earlier claims to the contrary.

But the U.S. has remained slightly ahead of Europe in biotech product innovation, the analysis showed.

The European trade association last year reported that U.S. research investments grew 5.2 times from 1990 to 2007 compared with 3.3 times in Europe, a view that reinforced a 2006 study, which had concluded that the U.S. had overtaken Europe in new molecular entity (NME) discoveries over the two decades from 1982 to 2003.

Those widely held notions about U.S. dominance in drug research productivity, in addition to claims that U.S.-produced drugs are superior, are "motivating companies to develop and market drugs that add little value, instead of rewarding true added value," argued author Donald Light, a professor of psychiatry at the University of Medicine and Dentistry of New Jersey and a visiting professor at Stanford University.

"This is not good for the long-term vitality of the industry or for those paying too much for too little," he asserted.

While the U.S. share of approved new drugs increased from 1993 to 2003 compared with the previous decade, that rise was due to manufacturers pumping more money into American research laboratories, Light contended in a reanalysis of data from the 2006 study, also published in Health Affairs.

Research productivity and total funding often are confounded, he wrote. If U.S. research teams received 33 percent of the budget, they should discover about 33 percent of all NMEs, Light insisted.

But, he said, the U.S. discovered far fewer new medicines than its proportional share of funding: 0.76 from 1982 to 1992 and 0.75 from 1993 to 2003. Europe's ratio of NMEs to investment, however, went from 0.99 in the first period to 1.17 in the second, Light said.

He noted that Japan's proportionate ratio was the highest: 1.49 in the first period and 1.36 in the second.

In global NMEs, European research productivity was about the same as the U.S. in the first period. However, European research productivity increased by 30 percent during the second period, while it declined by 26 percent in the U.S.

In first-in-class drugs, European relative innovativeness moved from well behind the U.S. in the first period to well ahead in the second, Light said.

But, he said, the U.S. remained ahead of Europe in biotech product innovation, despite a decline in productivity in this nation and an increase in Europe in the second period.

Gains by Europe and declines by the U.S. put both about even in the second period in research productivity for orphan drug products, the analysis showed.

Light said that based on his analysis, earlier assertions that the U.S. overtook Europe in innovative performance of first-in-class, biotech and orphan products were unsubstantiated.

"Congressional leaders and others concerned about high prices of new patented drugs will be heartened by this analysis, because lower European prices seem to be no deterrent to strong research productivity," Light contended.

Light also asserted in his report that "the real innovation crisis" for patients and society is not the recent decline in new drugs but the small percentage over many years of NMEs that provide clinical advantages over existing medications.

He blamed that outcome on the effectiveness of drugs being defined as ones that are better than placebo and using "soft surrogate" endpoints rather than "hard" endpoints in clinical trials.

"If we want new drugs to be clinically superior to existing ones, we need to reward companies for developing them and not for developing drugs that are merely superior to placebo," Light insisted.

President's Advisers Push for Early H1N1 Vaccine

The president's science and technology advisers Monday said the government should make a portion of the H1N1 flu vaccine available by next month rather than October and accelerate an FDA decision about approving intravenous antivirals.

A report from the President's Council of Advisors on Science and Technology (PCAST), an independent group of industry and academic scientists assembled by the White House science office, concluded that the 2009 H1N1 swine-origin influenza A virus is unlikely to be as deadly as the 1918-19 flu, but poses a serious health threat to the nation because of the new strain's ability to infect more Americans, which could overwhelm the U.S. health system.

The PCAST estimated that there could be up to 90,000 deaths this fall, concentrated among children and young adults.

"There is an urgent need to expand the available range of antiviral drugs that can be used for prophylaxis or treatment of influenza," the panel said, noting that there are only two antivirals that are effective against the H1N1 swine flu: Roche AG's Tamiflu (oseltamivir) and GlaxoSmithKline plc's Relenza (zanamivir).

The panel noted that those options may soon narrow, given that most seasonal influenza already has developed resistance to Tamiflu and a handful of cases of resistance to the drug have been reported among 2009 H1N1 isolates.

There currently are no antiviral drugs approved for intravenous use to treat seriously ill patients. However, the panel noted that I.V. formulations of Tamiflu and Relenza are being tested, along with BioCryst Pharmaceuticals Inc.'s experimental intravenous drug peramivir, which was shown to be as good as Tamiflu against seasonal flu in Phase III testing. (See BioWorld Today, July 20, 2009.)

The PCAST panel urged the FDA to consider granting the drugs an accelerated approval or an Emergency Use Authorization.

That recommendation sent BioCryst's shares (NASDAQ:BCRX) up 25 percent Monday, to close at $12.60. Shares dipped slightly Tuesday, closing at $12.44, a loss of 16 cents.