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U.S. Moves Toward Making Anthrax Vaccine Available

By NICHOLAS WADE

"Government health officials have taken the first step toward opening a second line of defense against anthrax in the form of a vaccine. Though the only well-known source of vaccine is a small stockpile owned by the Department of Defense, a large amount of new vaccine has been manufactured by BioPort, the sole maker. It is unavailable because the Food and Drug Administration has not yet approved BioPort's new plant or completed testing its vaccine lots, a company spokeswoman said. But the agency can permit treatments on an experimental basis. Last week, the Centers for Disease Control and Prevention applied for permission to use anthrax vaccine on these terms...." (for more on Bioport and its anthrax vaccine, see below)

Cipro? We Got Your Stinkin’ Cipro

The Bush administration’s stiff upper lip can’t conceal the perilous state of the public health system.

by Steve Perry

POSTED OCTOBER 24, 2001--

In the past week the government has toiled ceaselessly to assure a restive public that the bioterror threat is under control, even as our elected representatives were lighting out for the territories at the first sign of anthrax spores on Capitol Hill. LibertyBut never fear. Americans at large face minimal risk, the feds are hot on the trail of the terrorists and there will be antibiotics enough for all. It’s true the public health risk—so far—is low unless you happen to be a Congressional aide, or secretary to a network news luminary. Or, of course, a postal worker like those unfortunate souls in Trenton and D.C. who were still being told they didn’t need testing while the House and Senate sounded retreat. Two of them are dead now, and at least two more are likely to follow; some wire accounts refer obliquely to an additional eight or nine post office staffers whose illnesses are deemed “suspicious.” Again, though, have no fear. The New York Times reports the White House has made discreet inquiries about purchasing equipment to irradiate the mail and kill any spores inside—inside the mail bound for federal government offices, that is.

Meantime investigators are phoning around to see if, and where, any anthrax has gone missing from labs lately. This portion of the official PR campaign is ludicrous. It seeks to comfort the public by implying that there’s something exceptional, and therefore likely to be traceable, about the process of getting one’s hands on a sample of anthrax. Until very recently, at least, the opposite has been closer to the truth. Anthrax cultures are kept in countless labs in the U.S. and elsewhere. According to Michael Osterholm’s book, Living Terrors: What America Needs to Know to Survive the Coming Bioterrorist Catastrophe, they could be ordered from any of 50-plus commercial vendors around the world as recently as 1998. But to say as much would only promulgate more panic; this is not an option.

Consequently there’s a great deal of serious-sounding hoohah about “weapons-grade” and “non-weapons-grade” spores, much of it from officials still struggling to get straight whether anthrax is a virus or a bacterium. To pretend there is any means of tracing a particular strain to a single lab, or a country where it was acquired, is only blowing smoke. There has been conjecture that the strain now circulating may have come from an Ames, Iowa, veterinary lab originally, but suppose that’s so—there’s no telling when it was lifted or whether it then fell into the hands of terrorists from Kabul, Kuala Lumpur, or Des Moines. Unless police agencies get lucky in locating the perpetrator or perpetrators by other means (an acquaintance, perhaps, a nosy neighbor) they’ll probably never know the pedigree of the spores. Which doesn’t mean they won’t concoct one. Remember always that Iraq a) is known to possess anthrax and b) was on the Pentagon’s short list of preferred targets even before the first powdered letter arrived.

But these sleights of hand concerning the investigation are a small thing compared to the whoppers being passed off about public health. To date we’ve seen no sign of any wide-scale public release of spores through open air or the ventilation systems of large buildings, but it remains entirely in the realm of possibility. It’s no trick growing the bacteria in quantity; the tougher part is milling it to a size that can cause infection in the lungs, and whoever is behind the attacks has already proven they can do that.

If one or more such mass releases were to occur, the public health system is in no way prepared to respond. Osterholm’s book paints a revolting picture. The government has no plan for meeting bioterror, he writes, just a Babel of conflicting jurisdictions and priorities; and the health care system itself is strained to the breaking point by the unbridled gouging of managed care consortiums and their suppliers of equipment and medicine. For years health care syndicates have been taking sumptuous profits and reinvesting token sums in the capacity of the system. Relatively minor flu outbreaks already cause crises in major urban hospitals, and the numbers of people involved are minuscule compared to what we might see in a concerted bio-war attack.

The deeper fissures in the public health system are not yet widely evident to those Americans who enjoy private health insurance; right now everyone’s looking at drug supplies. And in the aftermath of September 11 there has been no spectacle here at home quite as galling as watching the pharmaceutical companies cast both eyes to the bottom line and dig in their heels, and seeing governments capitulate. When the Canadian health service ordered large quantities of a generic Cipro clone as a precautionary measure, the German patent-holder, Bayer AG, howled to the heavens and threatened litigation. Canada backed down. (Cipro, by the way, is not the only drug likely to be viable for treating anthrax exposure, nor Bayer the only recalcitrant patent owner; it belongs to a family of relatively new antibiotics known as fluoroquinolones.) South of the border the reaction has been even more timorous. Pursuant to 28 USC 1498, the American government has the legal authority to declare patents on essential goods null and void in a national crisis, despite Health and Human Services Secretary Tommy Thompson’s plaintive cries to the contrary last week. On Monday, finally, George W. Bush issued an executive order asserting that prerogative—with a twist.

After last month’s airline aid package, Bush feinted at drawing a line in the sand: Read my lips; no new bailouts. But his executive order struck a very different chord. In the event that the U.S. might maybe someday need to, you know, violate drug patents, then Thompson’s HHS would be empowered to pick up the tab for any legal and financial risks that fell to the manufacturers of generic substitutes. National emergency or no, in other words, the United States will subsidize pharmaceutical companies who see their almighty patents trod upon. On the bright side, however, Bayer AG has agreed to stop the profiteering it has practiced since the anthrax scare first surfaced. In reaching its settlement with Canada, the company announced it would scale back its soaring wholesale prices for Cipro to pre-September 11 levels. reprinted from Cursor

Steve Perry lives in Minneapolis, where he was the editor of City Pages from 1989 to 1997.


Shortages of Cipro — whether caused by a genuine anthrax emergency or by panic buying — may convince Bush administration health officials that they want the generic version, ciprofloxacin, more than Bush administration trade officials want Bayer's patent protected.American budget officials could also decide to buy cheaper generic drugs. Alternatively, American consumers might become outraged to learn that while Cipro has cost nearly $350 a month in the United States, a generic drug from reputable suppliers costs only $10 a month in India. Senator Charles E. Schumer, Democrat of New York, proposed today that the government buy generic versions for its emergency stockpile, noting that such a step would reduce dependence on a single supplier and could significantly reduce the costs of getting the amount of ciprofloxacin needed. --NYT, 10/17/01

Cipro Price Fixing Litigation

"Gilman and Pastor, LLP, is prosecuting a nationwide class action, In re Ciprofloxacin Hydrochloride Antitrust Litigation, on behalf of all persons or entities in the United States who purchased and/or paid for Cipro at any time since January 8, 1997. Cipro is a brand-name for the prescription drug ciprofloxacin hydrochloride, an antibiotic approved to treat various sinus, respiratory, urinary and skin infections.

"We allege that beginning on January 8, 1997, Bayer AG entered into unlawful and anti-competitive agreements with Barr Laboratories, Inc. and Hoescht Marion Roussel, Inc. under which, in exchange for over $50 million per year, Barr and Hoescht Marion Roussel agreed not to manufacture or market a generic version of Cipro. These agreements allowed Bayer to maintain a monopoly over the ciprofloxacin market as well as to fix and maintain supra-competitive process for Cipro. As a result of the unlawful agreements, Plaintiffs and the Class have been deprived of the ability to purchase generic ciprofloxacin at a competitive price."

***

The Anthrax Vaccine Scandal

Why did the Pentagon allow BioPort Corp. to remain the sole U.S. supplier of a crucial weapon against bioterror despite years of failure to deliver the vaccine?

By Laura Rozen, Salon

Oct. 13, 2001 | WASHINGTON -- "With each new confirmed anthrax infection raising fears of a wider bioterror attack in the U.S., pressure is mounting on the Defense Department and the Food and Drug Administration (FDA) to give the green light to Michigan-based BioPort Corporation, the nation's lone anthrax-vaccine manufacturer, to ship new lots of the vaccine to the Pentagon.

Anthrax vaccine shipments from BioPort have been suspended by the FDA since 1998 because of questions about the facility's quality control, forcing the Pentagon to dramatically reduce its program to vaccinate all 2.4 million U.S. soldiers and reservists against anthrax. Now the lack of the vaccine threatens to become a scandal, as the U.S. is sending thousands of soldiers overseas, calling up reserves, and as the public is clamoring for access to protection from the deadly bacterium. After three years of getting bailed out by the Defense Department, BioPort could be poised to make a fortune -- as its CEO Fuad El-Hibri did working with the British seller of anthrax vaccine, Porton International, during the Gulf War a decade ago. But only if the FDA approves the company's renovated plant, as expected, sometime in the next week. The decision could open the door for BioPort to market the drug to a worried public, as new anthrax scares are reported daily.

"The story of the troubled U.S. anthrax-vaccine program is a tangled saga of science, politics, private-sector deal-making and national security. There have been persistent questions about the vaccine's safety and effectiveness. Critics say Defense Department studies have never proven the vaccine works against the more dangerous inhaled form of anthrax, only against cutaneous, or skin anthrax. Some military personnel have complained of mysterious illnesses after taking the vaccine, and at least 400 have been disciplined for refusing the mandatory inoculation. But the Pentagon insists the vaccine is both effective and safe. Even now, some researchers say the vaccine is seriously outdated, as BioPort gears up to ship more. Then there are questions about BioPort's role as the nation's only anthrax vaccine maker. How did Fuad El-Hibri, 43, a German-born entrepreneur and former director of British vaccine-maker Porton Products, come to have so much control over the West's supply of anthrax vaccine? Why didn't the Pentagon turn to a larger, more established drug-maker for the crucial anti-biowarfare weapon? And how could it let BioPort remain the sole maker of the vaccine after it failed repeatedly to gain FDA approval for its renovated facility?

"Why did the Pentagon allow BioPort Corp. to remain the sole U.S. supplier of a crucial weapon against bioterror despite years of failure to deliver the vaccine?...

Anthrax Vaccine: Barbara Walters Looks For Answers, But Gets A Run-Around

This evening on ABC's 20/20, Barbara Walters interviewed Robert Kramer, President of Bioport, about its production of anthrax vaccine. Here's what we learned. Bioport, a private company, is the only producer of anthrax vaccine, and its sole client is the Department of Defense. Although Bioport signed the contract some years ago in order to protect the U.S. military from anthrax bioweapons, only a relatively small number of its soldiers have been given the vaccine, for two reasons. First, the single facility in Michigan that produces the vaccine has been closed down since 1999 for failing to pass various FDA checks of its product and its facility, 18 violations in all. Secondly, a significant number of members of the military, both officers and enlistees, have refused to take the vaccine due to its side effects. Some refusals have resulted in court martial proceedings. Wolters noted that some have said the anthrax vaccine was the cause of what has been called the "Gulf War Syndrome." Kramer indicate that there was no evidence for that.

Although Kramer told Walters that there is a stockpile of previously created vaccine, enough to cover military needs, the Department of Defense has stopped giving the vaccine to its military until Bioport gets FDA approval. Kramer claims that the vaccine has now been determined safe by the FDA, but its facilities were in violation. Congressman Tim Hutchinson was asked to comment upon Bioport, and he noted that it was a bad idea for the Department of Defense to contract with a single producer with a single facility to produce all of the anthrax vaccine used to protect our armed forces in case of anthrax attack. Hutchinson noted that the Defense Department has spent [$42] millions on Bioport, including its facilities.

Kramer said that if the upcoming FDA review of its facilities gains approval, he could begin production of new vaccine for the military in six months. He estimates that he could begin the production of anthrax vaccine for the civilian population in two years. When asked if there was any vaccine stockpiled for civilian use, Kramer refused to answer due to "national security." Last week Sec. of Health Tommy Thompson said the U.S. was prepared for any bioterrorist attack, but he didn't offer any specifics about anthrax vaccine. When Barbara Walters called the FDA for further information about anthrax vaccine for civilians and other such questions, she was told to contact the Department of Defense. That department told her to contact the Department of Health. That department told her to contact the FDA.

Although Bioport President Kramer is not known by the general public, one member of the four-person board of directors is, Adm. William Crowe, Jr., former Chairman of the Joint Chiefs of Staff and former chairman of the President's Foreign Intelligence Advisory Board. Crowe has a 13% interest in Bioport and would logically be the contact man for the Department of Defense which, as noted above, designated Bioport as the sole producer of anthrax vaccine for its needs, gave Bioport millions to gear up, and stood behind the company under heavy fire from members of the military and Congress because of the quality of its product. The Chairman and CEO of the company is Fuad El-Hibri, who was not an American citizen when Crowe agreed to represent Bioport, and specializes in the acquisition of biomedical and telecommunications companies. Earlier in his career he was the mergers and acquisitions manager at Citigroup NY and their operations and credit manager in Saudi Arabia. According to ABC's Howard Rosenberg, "Bioport’s predecessor, Michigan Biologic Products Institute, was under fire from the U.S. Food and Drug Administration for sloppy record-keeping after an inspection report raised questions about the anthrax vaccine’s potency and sterility. The FDA even threatened to revoke the facility’s license. Just a few months later, Bioport emerged as a leading bidder to take over the troubled company and purchased MBPI for $25 million after the Pentagon promised to ante up $15 million to renovate the plant. Bioport Corp. was created solely to take over the assets of MBPI by Adm. Crowe, his partners in a company called Intervac L.L.C. and a group of former managers of the Michigan-based institute. It is Intervac that has the most interesting history. According to Crowe’s associate and spokesman, Jay Coupe, Crowe owns 22.5 percent of Intervac shares, though he hasn’t “invested a penny” in the venture." (more). --Jerry Politex, 10/10/01

Note. For background on the above, go here


Why Anthrax Vaccine Is Scarce. Report Questions Bioport's Version Of Reality

By Kristen Philipkoski, Wired Magazine
2:00 a.m. Oct. 10, 2001 PDT

"The vaccine against anthrax is in the hands of a single company that is running out of money, hasn't gained FDA approval for the vaccine or its manufacturing facilities and hasn't produced a single dose of the vaccine since it took over production in 1998. The entire United States is relying on BioPort, of Lansing, Michigan, to produce the anthrax vaccine, for which demand has spiked since Sept. 11. The company has supplied the military with only half a million doses out of 14 million promised, leaving even front-line military personnel unprotected in the event of a bio-terrorism attack. The company, which would not return phone calls, has a spotty past, and possibly not much of a future if Congress passes the Defense Authorization bill, which includes an amendment that would bring the production of the anthrax vaccine under government control.

"'We've had 10 years of experience with the private sector trying to produce it with little to show for it,' said D.J. O'Brien, a spokesman from the office of Senator Tim Hutchinson (R-Arkansas). The amendment would give BioPort until April 2002 to clean up its act, after which it recommends that the military stop paying BioPort and find an alternative source for the vaccine. The amendment allocates $3.8 million for the planning and design of a new facility owned by the government. O'Brien said Hutchinson thinks a new facility would cost about $380 million.

"The BioPort contract is being carefully re-examined by the Department of Defense in light of the Sept. 11 attacks, a spokesman said. "The Department is close to finishing the review, and will make the best decision to protect its service members against the threat of biological weapons," said James Turner, a spokesman for the Department of Defense. Many believe it's time to dissolve BioPort's military contract, in light of its performance since it took over production of the anthrax vaccine in 1998. "As a general principle, this is something that really belongs in the private sector," said Stephen Block, a professor of biological sciences and applied physics at Stanford University. "But in this particular instance, and especially in light of recent events, it may be better done within the military."

"BioPort bought out the state-owned Michigan Biologic Products Institute in 1998, and the Department of Defense became its only customer. The takeover itself is considered suspicious by some. "The company acquired the Michigan Biologic Products Institute for the express purpose of taking over and acquiring a lucrative military contract," said a bio-warfare expert who asked not to be named and accused company officials of "war profiteering." BioPort's most visible board member is Admiral William J. Crowe, former chairman of the Joint Chiefs of Staff. The FDA repeatedly flunked BioPort in inspections in 1999 and 2000 because of contamination and suspicious changes made to expiration dates. The agency has barred the company from releasing any of the vaccine as a result. A third FDA inspection has not yet been scheduled. If it passes, the company has told reporters it hopes to begin producing more anthrax vaccine this year.

"The problems don't end with the FDA inspections. BioPort has also been questioned about where it has spent advance payments made by the military. The military gave BioPort an $18 million advance in 1999. Still, the company told the Pentagon in early 2000 it faced a possible cash shortfall of up to $18 million. The Department of Defense paid the company an additional $24 million in June 2000 to stay afloat. An audit by the Pentagon's inspector general in April 2000 reported that BioPort had spent more than $2 million inappropriately, according to Defense Week. About $1 million went to renovate a plasma production operation, a commercial venture unrelated to the anthrax program. Another $1.1 million was spent on office remodeling, furniture, parking lot and road paving. Furniture for the company's CEO, Fuad El-Hibri, cost $23,000, the audit said. The report also said the company was incurring "excessive travel costs, excessive severance pay and unsubstantiated consulting costs." The investigation found that $1.28 million had been set aside for senior management bonuses in 2000, or "109 percent greater than the managers' base salary," which inspectors deemed "unreasonable in light of its current financial condition."

"The anthrax vaccine was the subject of controversy even before it was in such high demand. Approximately 400 soldiers faced reprimands rather than take the vaccine because of side effects that some said were severe. The FDA has found the vaccine to be effective, but approved it only for anthrax absorbed through the skin. In the event of a bio-warfare attack, anthrax would most likely be released into the air and inhaled, which causes a different version of the disease for which the vaccine has not been tested. The FDA could be in violation of federal law for allowing military personnel to take it.

"BioPort apparently lost one of its own employees to the vaccine in July 2000: Richard Dunn, who monitored test animals for BioPort and its state-owned predecessor. He had received 11 doses of the anthrax vaccine. A county medical examiner said Dunn experienced an inflammatory response to the vaccine that contributed to his death. BioPort hired its own pathologist and put out a press release saying, "His autopsy report does not reveal that the anthrax vaccine led to the death of BioPort Corp. employee Richard Dunn." Rather, the pathologist said his death was caused by "ventricular arrhythmia" that may or may not have been caused by the vaccine. A man in Florida died of the first case of anthrax in 25 years on Friday. A second case has been confirmed, and still another was reported by the New York Post on Tuesday. All three people worked in a Boca Raton building housing several supermarket tabloids, including The National Enquirer. Officials said "human intervention" is likely, but terrorism has not been confirmed. The 300 people who work in the building and anyone who spent more than an hour inside since Aug. 1 were advised to be examined for exposure.

"About 1,200 people so far have called BioPort asking how they can get vaccinated. The company responds with a recording that says no vaccine is commercially available because any that will be produced is reserved for the military. National Guard sentries began guarding the company's facilities last week. Some experts say anthrax is the most likely agent to be used by terrorists because it's tasteless, odorless and difficult to detect in the air or water. "It's the easiest to work with," said Mark Wheelis, a professor of microbiology and a bioweapons historian at the University of California at Davis. "It's not particularly hazardous to grow and it has a long shelf life." The problem is, Wheelis said, it has to be broken into extremely small airborne particles. Also, for a person to become infected he must inhale 10,000 spores of anthrax bacteria. "The first cases would appear within three days, but there could be new cases appearing for a month," Wheelis said. "Sometimes spores are inhaled and can sit (dormant) for three weeks."

"The vaccine business is not attractive to biotech and pharmaceutical entrepreneurs. It's unpredictable and rarely profitable, which is why only four biotech businesses are based on developing vaccines. Seldom do big pharmaceuticals take on vaccines. he government needs to find a way to give companies incentives to contract with a federal facility, but a mechanism for that is still not clear. "The problem is right now there's no market, and hopefully there never will be a market for these sorts of pharmaceuticals," said Frank Cilluffo, senior policy analyst and deputy director of the Center for Strategic and International Studies in Washington."


Anthrax Vaccine Maker Criticized

By THOMAS D. WILLIAMS
The Hartford Courant
October 31, 2000

"BioPort Corp., the manufacturer of the controversial anthrax vaccine, has once again been sharply criticized by federal inspectors over its manufacturing process. Last week, the U.S. Food and Drug Administration cited BioPort for 18 violations of manufacturing procedures after about 2½ weeks of inspections of its Lansing, Mich., plant. An FDA report on the inspections was not available to the public Monday, but BioPort acknowledged criticism from the FDA inspectors. The FDA cited BioPort for lack of consistency in its manufacturing processes, and for problems with assurances of sterility in vaccines, drug products other than anthrax and its overall procedure for packaging and filling vaccines, said Kelly Rossman-McKinney, a BioPort spokeswoman. Although the anthrax vaccine was one of the products involved in the packaging and filling operation, said Rossman-McKinney, it had been already closed down in July. The FDA cited that operation anyway in an attempt to remedy BioPort's procedures. But Rossman-McKinney said the problems cited by the FDA are not crucial to continued operations, do not involve its efforts to produce its own new batches of the vaccine, and will be corrected. This marks at least the fourth time federal inspectors have raised serious questions about operations at BioPort or the previous manufacturer of the vaccine.

"The vaccine, aimed at eventually protecting 2.4 million service members from airborne anthrax spores used as a warfare and terrorist weapon, has been under heavy attack for more than a year from a number of members of Congress, who have demanded the inoculation program be shut down. Those members of Congress, including U.S. Rep. Christopher Shays, R-4th District, claim the vaccine has not been proven either safe or effective. The Pentagon has made the vaccine mandatory and threatened reluctant military personnel with courts martial or hefty fines if they refuse to take it. But when supplies of the vaccine ran low this year, the Pentagon limited the shots to those going overseas to areas of high conflict risk. Last December, the Pentagon announced that the second phase of its vaccination program had been postponed for six months to a year because of BioPort's failure to pass inspections to produce its own vaccine supply. The company has been exclusively using old supplies of the vaccine since it purchased the operation from the state of Michigan's health department two years ago. The vaccine's former manufacturer had been threatened with a shutdown of its operations during FDA inspections in 1996 and 1997. More than 1,500 service people have complained about side effects, of varying severity, that they blame on the vaccine. Hundreds of service people have refused to be inoculated and have been disciplined or discharged."

Note. For background on the above, go here


AVANT LICENSING DEAL EXPECTED

Better vaccine against anthrax sought in pact

By Jeffrey Krasner, Globe Staff, 10/10/2001

"Avant Immunotherapeutics Inc. of Needham [Mass] is expected to announce today that it is licensing its vaccine technology to a Department of Defense contractor working to improve anthrax vaccine, people close to the company said. The deal is a multiyear licensing arrangement under which DynPort Vaccine Company LLC will have access to Avant's advanced vaccine patents. The arrangement comes as officials widened their investigation of two anthrax cases in Florida. Officials said they suspect foul play was responsible for the infection of two workers of American Media Inc., a publisher of tabloid newspapers. The Palm Beach County Health Department tested more than 700 employees for evidence they had been exposed to the anthrax bacteria. Results could take days, even though the labs at the Centers for Disease Control in Atlanta are running around the clock.

"'Bioterrorism is a worldwide concern,' said Michael W. Henry, Avant's vice president of business development. ''We are pleased to be entering into this relationship with DynPort Vaccine. Effective vaccines are an important medical countermeasure against biological warfare to protect US military forces and other at risk around the world. We see this opportunity as an excellent way to leverage our vaccine technology into another research area that we do not plan to pursue ourselves.'' Henry declined to identify any specific diseases for which DynPort would be using Avant's technology. But several doctors close to the company believe Avant's vaccine technology would be useful in developing an improved anthrax vaccine. ''Avant's vaccine technology might be helpful against anthrax,'' said Dr. Mark Davis, professor of microbiology and immunology at the Stanford University School of Medicine in Palo Alto, Calif. Davis is a member of Avant's scientific advisory board, which is made up of prominent physicians and researchers who are compensated for consulting to the company. ''They're going great guns with travelers' vaccines such as cholera and typhoid. Anthrax would just be another bug. They are evolving a strategy that seems to be producing excellent vaccines,'' he said.

"Peter Libby, another member of the scientific board and the chief of cardiothoracic surgery at Brigham and Women's Hospital in Boston, added: ''Avant has a firm commitment to producing vaccines that would be useful to people exposed to unusual pathogens. They might well be applying their platform to that disease.'' Avant's Web site says, ''We have completed early clinical studies with a single dose of oral vaccine against typhoid fever and have conducted preclinical work in vaccines for shigella, genital herpes, and anthrax infections.'' Henry declined to comment on the financial specifics of the forthcoming agreement with DynPort, but said, ''We have an opportunityy to leverage off an existing program at Avant and put it in the hands of someone who'll have responsibility. We get to share in the rewards going forward.'' In the biotechnology industry, such arrangements typically include a licensing fee, lump-sum payments for reaching technology milestones and royalties if a product makes it to market.

"DynPort Vaccine, the firm licensing Avant's technology, is a joint venture of DynCorp and Porton International Ltd. It is a subsidiary of DynCorp, a Reston, Va.,-based government contractor with diversified activities in computer networks, space launches, medical information systems and aviation support and maintenance. For the six months ended June 30, the company had revenues of $917 million. A California defense contractor, TekInsight.com Inc. of Irvine, Calif., is seeking to acquire DynCorp in a stock transaction. A spokeswoman for DynCorp referred inquiries to a spokesman for the Secretary of Defense, who did not respond to phone and e-mail messages yesterday.

"The current vaccine to confer immunity to anthrax requires six shots over many months. In addition to the length of time of the treatment, the vaccine also causes side effects, and may not provide ideal levels of immunity. Moreover, government regulators three years ago shut down the plant where BioPort Corp. of Lansing, Mich., made the vaccine for a variety of deficiencies, according to the Wall Street Journal. Subsequent inspections by the US Food and Drug Administration found continued problems. the lack of an approved vaccine supplier, and what some scientists see as shortcomings of the current treatment, provides a huge opportunity for DynPort Vaccine and Avant.

Note. For background on the above paragraph, go here

"In addition to a suite of vaccines aimed at gastrointestinal diseases frequently contracted by travelers, Avant is developing treatments to help cardiac surgery patients whose immune systems overreact, creating potentially life-threatening destruction of viable tissue. The company has forged development agreements with pharmaceutical giants including Novartis Pharma AG of Switzerland, Aventis, and GlaxoSmithKline. ''Avant is a company that's attacking large areas of unmet need,'' said Mark Monane, a stock analyst with Needham & Co. He predicts the company's revenues will reach $3.5 million this year and $167 million in 2005, when the company could post profits. He rates the stock a ''buy.'' Avant's shares yesterday lost 2 cents to close at $2.95 with 267,500 shares changing hands."


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