Events at Cetus cast doubt on firm's future - C&EN Global Enterprise

Cetus, one of the premier California biotechnology drug companies, is being shaken to its foundation. Just over two weeks after a Food ... Email a Col...
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doses of chlorine, but never to mustard or nerve agents. In addition to personal agent detectors, "each unit has a remote field detector, which is an early-warning device," Allingham explains. In the presence of agent, the detector gives off a loud, irritating sound. West Germany is also lending U.S. forces 10 Fox vehicles, mobile gas chromatography-mass spectrometry units. These reconnaissance, or earlywarning, vehicles are the same type being used in the truck convoys now carrying U.S. chemical weapons across West Germany en route to Johnston Atoll in the Pacific for eventual destruction. Lois Ember

Petrochemical prices jump in Europe, U.S. In the wake of the Persian Gulf crisis, the soaring cost of naphtha, the primary chemical feedstock in Western Europe, has started working through the product chain. As executives of BP Chemicals pointed out at a press briefing at its London headquarters last week, if crude oil is $25 per barrel, the naphtha equivalent is $260 per metric ton—11.79 cents per lb. That's the price cracker operators in West Europe were seeing in mid-August. But within a week, the naphtha price was up to $300 per metric ton. In mid-July, it was $157. The West European petrochemicals industry produces 70% of its ethylene from naphtha, using some 5 million metric tons of naphtha equivalent monthly. At $260 per metric ton, BP estimates, feedstocks have cost the industry an extra $515 million per month since Aug. 1. European polyethylene producers, for example, have generally been raising prices 10%. According to Bryan Sanderson, BP Chemicals chief executive officer, the price must go up 20% just to cover the naphtha price increase. Even then, however, the price would be less than that of last year. BP has now announced an average 10% increase for September. Douglas Campbell, chief executive for the petrochemicals division,

warns that "there will be fewer term-contracts for naphtha in the industry. The question is how fast can those costs be passed through. There is not much extra inventory—those prices will show up very quickly." BP is not alone in starting to raise prices. Last week, European Vinyls Corp., the Brussels-based polyvinyl chloride maker, said the price of PVC would rise about 10% at the beginning of September. In the U.S., B. F. Goodrich has announced a 2 cent-a-lb, across-theboard increase for its PVC resin and compound prices, effective Sept. 1. The company also will eliminate a 1-cent temporary voluntary allowance on Sept. 1, which applied only to PVC resin customers. Goodrich attributes the 2 cent-per-lb increase directly to increased crude oil prices caused by the Middle East crisis. "We are now paying significantly higher costs for raw materials, transportation, and plant energy, and we simply cannot absorb these costs," says W. F. Patient, president of Goodrich's Geon Vinyls Division. Other producers, including ICI in the U.K., DSM in the Netherlands, and Neste Chemicals in Finland, also are raising prices about 10% on polyolefins. The situation, they say, is on a month-to-month basis; September may see further price hikes. Patricia Layman

Events at Cetus cast doubt on firm's future Cetus, one of the premier California biotechnology drug companies, is being shaken to its foundation. Just over two weeks after a Food & Drug Administration advisory committee failed to recommend approval of the company's first proprietary drug product, the much hyped but yet unproven interleukin-2, the firm was hit with a major aftershock—the resignation of Robert A. Fildes as president and chief executive officer. Speculation has spread in the financial community on the 19-year-old firm's ability to survive. According to Cetus, Fildes' resignation was precipitated by "differing views regarding the company's priorities." Ronald E. Cape, a

Fildes: bearing brunt of blame founder and chairman of Cetus, will return—only temporarily, some observers expect—to the position of CEO, which he held until 1986. Hollings C. Renton will remain chief operating officer while taking over as president. Earlier this month, Fildes, responding to the FDA committee's decision, told C&EN that delays in first-time approval for biotechnology drugs are "nothing unique." But he added, "It's disappointing and frustrating, but it's something the company will overcome." However, Fildes is bearing the brunt of the blame for Cetus' lack of success. "Ultimately, it was the CEO's responsibility to be sure that the regulatory approval package as submitted to FDA was well organized, complete, and persuasive," says David Webber, a biotechnology analyst with Alex. Brown & Sons in New York City. "It was the single most important thing in the history of the company, and it was crucial that it work." In addition, as CEO, explains Webber, Fildes was responsible for the strategic decisions that built up operating expenses in anticipation of this approval. "Here's a company that's losing $60 million per year and it's the second oldest biotech company, yet it doesn't have a biotech [drug] product on the [U.S.] market." The price per share of the August 27, 1990 C&EN 5

News of the Week firm's stock has dropped precipitously from a high of about $22, just before the committee decision, to less than $8.00. Cetus is now viewed by some analysts as a possible takeover target, in whole or in part. To deal with losses over the past four years, the company has been cutting costs and will continue to do so, with a reduction of about 100 employees—about 10% of staff. While trying to remain independent and intact, and to expand its pharmaceutical products and polymerase chain reaction (PCR) technology (a major tool for amplifying genetic material), Cetus is now expected to look more toward strategic alliances to develop its businesses and decrease its risks. Still cash rich, the firm has a profitable joint venture for producing generic chemotherapeutic drugs, a European subsidiary that markets its interleukin-2 product, its PCR technology, and other products in development. "It's quite possible Cetus will recover," adds Webber. "But from an investment point of view, one might have to wait a very long time." Ann Thayer

HHS rebuts agent orange coverup charge James O. Mason, assistant secretary for health at the Department of Health & Human Services, calls biased and factually incorrect a report by a House Government Operations subcommittee that charged Administration interference in studies on Vietnam veterans' exposure to the herbicide agent orange (C&EN, Aug. 20, page 7). The House committee report is basically a repetition of all the complaints activist representatives of Vietnam veterans have made for years about government studies related to agent orange. The herbicide was spread widely over Vietnam, and because it was contaminated with about 2 ppm of 2,3,7,8-tetrachlorodibenzo-p-dioxin, it has been accused of causing a large variety of health problems in Vietnam vets. But most studies cannot find any connection between TCDD exposure and these illnesses. 6

August 27, 1990 C&EN

Mason was head of the Centers for Disease Control at the time it was performing a Congressionally mandated investigation trying to link service in Vietnam to TCDD exposure. The study was halted before health effects were examined because no link between service in Southeast Asia and TCDD levels in veterans' tissues could be established. The House report says political interference halted the study. Moreover, the American Legion and the Vietnam Veterans of America filed identical lawsuits against several federal agencies earlier this month in the U.S. District Court in

Washington, D.C, to force completion of the project. "There was no White House or any other interference in these studies," Mason says. He denies any kind of conspiracy by pointing out that more than 100 scientists, many from outside the government, reviewed the CDC work and agreed with its conclusions. Mason cites an Office of Technology Assessment study that totally agrees with CDC and concludes that other methods for determining exposure, such as those suggested by the House report, were worse than the CDC method. David Hanson

Suit challenges new policy on radioactivity Challenging the Nuclear Regulatory Commission's new policy deregulating materials with low-level radioactivity, 29 environmental, consumer, and antinuclear groups plus the state of Maine last week filed suit in the U.S. Court of Appeals in Washington, D.C. Copetitioners include Public Citizen, the Natural Resources Defense Council, and Physicians for Social Responsibility. The suit seeks to overturn NRC's adoption of a policy classifying as "below regulatory concern" (BRC) materials with radioactivity below a certain threshold (C&EN, July 9, page 23). NRC will consider for exemption from regulatory controls activities or materials that expose individuals to an average dose of less than 10 millirem per year. To take into account multiple exposures, it adopted an interim individual threshold of 1 millirem a year for radioactive materials widely distributed in products or equipment. However, the plaintiffs charge, "NRC's BRC rule trades off people's lives in favor of the financial interests of the nuclear industry." The industry has not yet sought implementation out of concern for public reaction, notes Jonathan Becker, an analyst at Public Citizen, the lead plaintiff. But the policy could bring unregulated disposal of nearly 200,000 cu ft of low-level radioactive waste annually, he says, which is about 30% (by volume) and 0.01% (by radioactivity) of nuclear power plant radioactive waste. Such waste

could be burned in incinerators or dumped into municipal landfills and sewers, he points out. The policy also permits recycling radioactive materials into consumer products. The plaintiffs contend there is no safe level of radiation exposure, so no deregulation is justified. Moreover, recent studies suggest the health impact of BRC closes is "worse than previously recognized." Five states have already banned radioactive waste deregulation. And bills to do so have been filed in Congress. Indeed, the new policy "poses one of the greatest health risks to the general public ever perpetrated by a government agency," charges Joan B. Claybrook, president of Public Citizen. The group says the maximum dose exempted under BRC could result in at least 12,412 more U.S. cancer deaths a year. In fact, Public Citizen accuses the five NRC commissioners of violating their statutory responsibility to protect the public's health, and urges Congress to remove them from office. In response, NRC describes the BRC levels as "about 3% of the 300 millirem dose people receive annually from naturally occurring sources such as cosmic radiation and radioactive material in the Earth, including radon." For low doses, the costs of reducing risk "far outweigh any small benefits." NRC's regulatory efforts "should be directed toward more important health and safety issues." Richard Seltzer