WASHINGTON _ A top-level panel created to spur AIDS drugdevelopment is mulling over what new incentives could be offered toindustry to jump-start the field.
An informal survey conducted by the National Task Force on AIDSDrug Development (NTFADD) revealed that most companiescurrently working on protease inhibitors _ considered the hottestprospects for the next generation of AIDS drugs _ plan to abandontheir AIDS efforts if current candidates flop in the clinic.
NTFADD members from industry said interest in AIDS drugs hasbeen dampened by shrinking profits and research and developmentbudgets and repeated failures. "Drug development in AIDS is underpressure," explained Stephen Carter, senior vice president ofworldwide clinical research and development at Bristol-MyersSquibb. "The pharmaceutical industry is fundamentally changed in1995 and investment in AIDS is not what it was five years ago."
Kirk Raab, president and CEO of Genentech Inc. and a NTFADDmember, said his company has spent about $175 million researchingand testing various AIDS vaccines and therapeutics. "That moneyrepresents about 8 percent of our R&D budget since the start of thecompany," he said. To date, none of the drugs have panned out.
"At some point, a responsible leader of a company must decidewhether or not to continue to focus on this area," Raab said. "And ifindustry walks away from AIDS research, there's no guarantee thatthe government will step in and commercialize products."
Raab told NTFADD members that creating strong investmentincentives for industry is critical. One idea he offered: double theresearch and development tax credit for money spent on AIDSresearch. Philip Lee, Assistant Secretary of Health at the Departmentof Health and Human Services (HHS) and chairman of NTFADD,proposed that a public forum be held on the issue this Spring.
NTFADD member Mindy Thompson Fullilove, from ColumbiaUniversity's HIV Center, said that while industry incentives areimportant, the real obstacle to developing AIDS drugs are the"awesome, knotty scientific problems" at the core of the research.
PhRMA's 1995 R&D Spending Will Break Records
According the Pharmaceutical Research and Manufacturers ofAmerica's (PhRMA) annual report, U.S. drug companies will spenda record $14.9 billion on research and development in 1995,breaking the 1994 record of $13.8 billion. However, the rate ofincrease in research and development investment is slowing, from arecent high of 10.2 percent in 1992 to a projected 7.9 percent in1995. PhRMA member companies expect to invest 19.9 percent ofU.S. sales and exports in research and development, up from 19.2percent in 1994.
PhRMA member companies project 1995 worldwide sales ofroughly $87 billion ($56.6 billion in the U.S. and $30.5 billionabroad), an increase of 47 percent from PhRMA's 1990 figures.
PhRMA released its annual report at a press briefing last week _ thedata is based on a survey of the more than 100 pharmaceuticalcompanies that are members of the trade association (including 40biotechnology companies). The trade group also released its annualfigures on FDA approvals and the implementation of the PrescriptionDrug User Fee Act of 1992, which sets new goals for reducing theagency's regulatory review times.
According to PhRMA, FDA review times are down but the agencyhasn't been doing a stellar job with biotechnology drug approvals.(See BioWorld Today, Jan. 19, 1995, p. 1.) ICOS Corp. chairmanand CEO George Rathmann told reporters at the briefing that FDApolicies governing the early stages of experimental drug testing _specifically, Phase I and II clinical trials _ are hurting thebiotechnology industry.
Rathmann said that, due to the FDA's excessively cautious approach,many companies are moving their research abroad. He cited aninformal survey by PhRMA's Regulatory and Scientific AffairsDivision that showed nine out of nine research directors at PhRMAcompanies said they now do most, if not all, of their Phase I testingin Europe.
"While meeting Europe's high scientific standards, they see noreason to bear the unreasonable U.S. regulatory burden that appliesto early clinical research," said Rathmann. He claimed that whileEuropean regulators require about 40 pages of data for Phase Itesting, the FDA requires about 2,000 pages of information. n
-- Lisa Piercey Washington Editor
(c) 1997 American Health Consultants. All rights reserved.