NEW YORK (Reuters) - Shares of biotechnology companies resumed their steep slide on Tuesday, with Protein Design Labs Inc. (PDLI.O) leading the Nasdaq percentage losers after news that one of the drug developer's European patents had been revoked.
Shares of Protein Design Labs slid 38 percent on the Nasdaq, or 51-15/16, to 82-3/16, by Tuesday afternoon, extending a 26 percent decline by the stock the previous session.
Late Monday, the California drug developer said broad claims on its European patent for humanized monoclonal antibodies had been revoked. It said it planned to press an appeal of the decision over the next several years, during which time the patent decision would be suspended.
The announcement, which came after regular U.S. stock trading, was the latest piece of unfavorable news for a sector that has suffered a sharp setback over the past two weeks. On Tuesday, the Nasdaq biotech index slipped 30.96, or 2.85 percent, at 1056.53, bringing its losses to about 35 percent since March 6. Before then, the index had risen more than 80 percent since the beginning of the year.
The selling pressure spread to a broad range of biotech stocks even though analysts saw no far-reaching negative precedent involved in the European patent ruling and said the outlook for Protein Design Labs remained strong.
"We think this is one of the great all-time buying opportunities, and the event that happened yesterday is completely nonmaterial," said Matthew Geller, senior biotechnology analyst with CIBC World Markets. "The decision has no impact on products sold or manufactured in the United States. So there's a very questionable dubious impact five or six years from now."
[a4a: No impact because of the lack of consumer awareness in the US.]
William Tanner, a biotechnology analyst with SG Cowen, said he was still bullish on Protein Design Labs. "We'd upgrade the stock here if we didn't have a 'strong buy' rating on it."
Some analysts, however, thought the Protein Design downturn was unlikely to hurt the sector because the companies use different technologies to make antibodies.
An antibody is a naturally-occurring immune system protein that selectively seeks out and destroys pathogens or other proteins that are deemed "foreign" invaders. They can be harvested and manipulated in the laboratory by so-called recombinant methods for future use as drugs.
Protein Design specializes in making "humanized" antibodies, that have mostly human components, but also traces of mouse antibodies. Abgenix Inc. (ABGX.O) and Medarex Inc. (MEDX.O) by contrast, grow "fully human" antibodies in mice whose immune systems have been genetically changed to produce antibodies with purely human characteristics and no mouse components.
Antibodies of all types are the rage among drug makers because they are an effective and relatively easy to produce means of treating and preventing disease.
[a4a: A vital part of the human immune system, up for sale. "Humanized" antibodies?]
Among other biotech stocks, Myriad Genetics Inc. (MYGN.O) was down 44 percent, or 53, at 67; Medarex slid 23 percent, or 15-13/16, to 51; and Antigenics Inc. (AGEN.O) was down 24 percent, or 7-1/4, at 22-1/2.
"Everybody was of the consensus that (biotechs) were a little overextended," Tanner said. "The first few months of this year the Nasdaq biotech index went ballistic."
Biotech stocks tumbled last week, falling as much as 14 percent, after President Clinton and British Prime Minister Tony Blair said scientists worldwide should have free access to research on the mapping of human genes.
[a4a: Here's an example of good news causing market problems -- free access to the human genome makes the market tumble; had Clinton and Blair said "the human genome should be sold to the highest bidder" the market would have surged.]
Tanner said stocks were now returning to a more realistic value. "It's not hype so much," he said. "It's not a house of cards, there's substance (to the sector)."
[a4a: Now we see the biotech spin machine in motion.... Everything's fine. Don't worry, be happy. I'm tempted to unearth old news material on DDT, and I bet they said the same thing. Don't worry, be happy, little consumer. You are getting sleeeeepy, Amerika.... so very sleeeeeepy...]
WASHINGTON (Reuters) - Biofoods sold in grocery stores are safe, but U.S. agencies that regulate genetically altered plants must work harder to protect health and the environment, the National Academy of Sciences said on Wednesday.
In a long-awaited study that is expected to influence the U.S. policy debate over whether biofoods need more stringent regulation, the Academy emphasized no evidence existed to suggest that biofoods were unsafe. But it also called for long-term monitoring to detect any effects on health or the environment.
The 260-page report was immediately criticized as biased by two Congressmen and some environmental and consumer groups, who contend that members of the science panel had financial links to the biotech industry. The food industry hailed the study as confirming its view that potato chips, puddings, salad dressings and other foods made with altered crops are safe.
Fearful of a consumer backlash similar to what happened in Europe, the agribusiness industry this week launched a $50 million public relations campaign to persuade Americans that gene-spliced crops have benefits that have been overlooked.
[a4a: You get a sense of the money to be made in this "industry" that they'll throw out $50 million just to lull Americans into slumber.]
Several U.S. green and consumer groups, however, have pressed the federal government to require more testing and hold the altered crops to the same strict standards of food additives or pharmaceuticals.
``Public acceptance of these foods ultimately depends on the credibility of the testing and regulatory process,'' said Perry Adkisson, chancellor emeritus at Texas A & M University and the head of the National Academy of Sciences panel.
[a4a: Or it can depend on the ignorance of the American consumer -- that seems to be the path the biotechs are pursuing. Ignorance is bliss, or so we're told.]
``The federal agencies responsible for regulating transgenic plants have generally done a good job,'' he said. ``Given the current level of public concern and following our review of the data, it is the committee's belief that the agencies must bolster the mechanisms they use to protect human health and the environment.''
As the report was unveiled, two dozen demonstrators wearing white lab coats marched outside the academy's headquarters to protest industry ties of some of the study's authors.
The protesters complained that one of the original members of the panel resigned a few weeks after the study began to take a job with the Biotechnology Industry Organization, a trade group. Four of the scientists on the panel received research funds from the industry, and a lawyer on the committee represents biotech companies.
[a4a: The above is significant. This same panel is tied with the biotech industry. Can you say "conflict of interest", boys and girls? Don't worry...be...happy....]
Top executives of the National Academy of Sciences, which is often called upon by cabinet members or Congress to sort out thorny scientific issues, insisted the report was fair.
``We stand behind the committee we appointed,'' said E.W. Colglazier, chairman of the academy. ``We feel they have done a very credible and independent job.''
[a4a: Well, gee, I'm convinced. Aren't you? This reporter seemed to be.]
Food and agribusiness groups said they welcomed the findings, which used science to examine the biofoods issue.
``The findings by the NAS solidify the fact that sound science and common sense should continue to guide the U.S. regulatory approach to biotechnology,'' said Stacey Zawel, a vice president of the Grocery Manufacturers of America.
[a4a: "sound science and common sense" -- this means "anything which will allow biotech firms to make boucou money off of consumer ignorance". Anything against that core value is either "junk science" or "extremism" to these clowns.]
The report also backed up industry's claim that altered crops can reduce use of pesticides, said Val Giddings, a vice president of Biotechnology Industry Organization.
Long-term monitoring of the environmental impact of the transgenic crops was also needed to spot any problems that may not have been predicted in company tests, the report said.
The scientists took no position on the controversial laboratory study issued last summer by Cornell researchers indicating that monarch butterflies were hurt by pollen from Bt corn, a variety engineered to resist a destructive bug.
The issue needs more research, including ``rigorous'' field evaluations and testing to see if the same results occur in actual farm fields, the panel said.
Likewise more study is needed about the potential risks of transgenic plants, it said.
``The committee did not identify anything that we would call a mistake,'' said Stanley Abramson, a Washington attorney on the panel. ``Our recommendations are designed to help the EPA and its sister agencies do a better job.'' Last year, American farmers grew more than 70 million acres of transgenic crops such as Bt corn and Roundup Ready soybeans, a variety treated to resist a widely used weedkiller. That level will drop slightly this year for the first time since 1995, according to the USDA.
[a4a: In this case, "doing a better job" means -- "toeing the company line to the letter". Anything else is unacceptable. Those agencies, to do the best job, should just rubber-stamp anything heading their way. That's what these people want.]
The academy's investigation grew out of a battle over the EPA's attempt to regulate plants engineered to protect against destructive bugs. The agency should finalize its rules, first proposed in 1994, that are aimed at preventing plants from crossbreeding and creating super-weeds, the report said.
WASHINGTON (Reuters) - The Clinton administration sought on Wednesday to reassure American consumers that genetically modified foods are safe, saying it will require developers to meet with regulators who will publish research and safety data on the Internet.
[a4a: Lip service.]
The initiative was immediately criticized by some environmental and consumer groups for failing to follow the lead of the European Union, Japan and other nations that require labels on biofoods. The measure also does not require specific safety tests or monitoring the long-term impact on human health and wildlife.
[a4a: Bingo. We're not dominated by corporations here, are we? No. Those Japanese and Europeans are just being unreasonable. Absolute obedience to corporate rule is the wave of the future, and Amerika leads the way.]
The Food and Drug Administration said it planned to begin mandatory consultations between seed companies and regulators, replacing a voluntary system in effect for the past eight years. Under current rules, seed companies such as Pharmacia Corp.'s Monsanto and DuPont Co. frequently meet with FDA scientists on a voluntary basis anyway.
[a4a: The people have spoken -- that is, if you consider the biotech corporations to be actual people. I mean, legally they are, and they have much bigger voices than you and me, because they talk with money, but their will has prevailed, at least in Amerika. I added that blinking, btw, just to emphasize the point. No "responsible" journalist (hack) would blink an important part of their news bit.]
The companies have considerable freedom to decide what research information and data to share with the agency. The FDA's mandatory consultations will not affect that.
The agency's current guidelines for companies to conduct pre-market safety and environmental tests are already strict enough, Joe Levitt, director of the FDA's Center for Food Safety and Applied Nutrition, told Reuters. They will be part of the FDA's proposed rule, to be published in the autumn.
But the agency saw no need to require specific safety tests -- a demand of some environmental and consumer groups -- because of rapidly changing science and an array of testing procedures, he added.
"We think the guidance we have provides a high level of rigor," Levitt said. The testing guidance asks seed companies to examine human safety issues, such as allergens and changes in the composition of and nutrition from foods.
[a4a: Better to use the public and nature itself as the guinea pig -- that way, if something does go wrong, the public (through the government) can clean up the mess. If a company had to pay the costs of some creation they made, well, that'd be prohibitive. It's good business to pawn your expenses off onto the public -- that's Amerikan "free enterprise" in practice.]
The new policy is mostly intended to reassure consumers that companies are providing scientific data and tests to back up claims that biofoods are safe.
"We want to send a strong signal that the FDA is looking carefully at these products," Levitt said. "We will add to the transparency of the process by putting our reviews up on the Web when we're done."
Administration officials said that while American consumers may want more information, genetically altered foods are safe and special labels are unnecessary.
[a4a: Talk about transparent -- the motives of these groups are transparent: money money money!]
[a4a: Yeah, and global warming was a myth, too. Okee dokee, Smokey. Don't worry, be happy.]
Mandatory labels were opposed by the U.S. food and agribusiness industries as too costly and potentially frightening to consumers.
[a4a: We're like little children -- far better to be kept clueless about these big scary things, than to be treated as thinking beings. An uninformed consumer is a happy consumer. Maybe they can just put pictures on their products, and do away with labels entirely -- no need for pesky information. Just shut up and eat. Let the buyer beware -- a risky rule of thumb when it comes to food, I would think.]
The FDA requires special labels only when a food's nutritional content is changed or allergens introduced.
Consumer and environmental groups have demanded the FDA impose mandatory labeling to give shoppers more information about what they are buying. Genetically altered soybeans, for example, are a common ingredient in everything from snack foods to puddings and salad dressings.
A growing consumer backlash recently prompted Frito-Lay, Gerber baby foods, McDonald's and other foodmakers to halt or reduce their purchases of gene-spliced ingredients.
Instead, the FDA will help the food industry develop voluntary guidelines for companies that wish to market their foods as free of genetically modified ingredients. Those labels are likely to have to carry language to the effect that conventional foods are no safer than gene-spliced foods.
[a4a: The end result will be no labeling. Corporate lobbying has paid off and ensured that wealthy corporate elites carry the day! Thank God for dollar bill democracy! Now the companies can just sit back and profit from consumer ignorance, the way Amerikan capitalism is supposed to work!]
Under the new initiative, the U.S. Agriculture Department will oversee tests to detect tiny amounts of genetically altered ingredients.
All federal agencies involved in biotech regulations -- the Department of Agriculture, FDA, Environmental Protection Agency and State Department -- are also planning a public education effort to explain what they do to protect consumers.
Food industry groups, who in April launched a $50 million advertising campaign touting the benefits of biofoods, praised the administration's actions.
"The FDA's current voluntary consultation process is actually mandatory already. There are no products on the market that have not gone through this process," said Rhona Applebaum, vice president of the National Food Processors Association.
Green groups said the initiative did not go far enough.
"Consumers want genetically engineered foods to be safety tested and to be labeled. This plan does not require either," said Rebecca Goldburg, a scientist with Environmental Defense.
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