ANOTHER LEFTOVER SCANDAL FROM CLINTON (BACKGROUND OF ANTHRAX VACCINE MANUFACTURER BIOPORT) [Free Republic]

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The controversy over the mandatory anthrax vaccination program in the military has been extensively covered in the press. Some say it poses an unacceptable health risk to the troops for little or no benefit. The program has met stiff resistance, with over 400 soldiers leaving in protest and other resisters being court-martialed. There has been a new development, with charges in federal court that the entire program is illegal.

But except for an ABC News story by Howard L. Rosenberg, we have not seen a serious examination of the financial and special interests that have kept the program going. Rosenberg has examined the involvement of Admiral William Crowe in the company making the anthrax vaccine.

Crowe was an early supporter of President Clinton and was appointed by him as Ambassador to England.

The company is Bioport. Rosenberg described Crowe, former chairman of the Joint Chiefs of Staff, as the company’s most visible corporate director. Bioport is the only licensed U.S. manufacturer of anthrax vaccine and landed an exclusive $29 million contract with the U.S. Department of Defense to "manufacture, test, bottle and store the anthrax vaccine." Eventually, Bioport could make $60 million from the deal. But former Central Intelligence Agency military analyst Patrick Eddington told ABC News that this could just be the beginning.

"The Pentagon has a $322 million, 10-year program to develop at least three, and perhaps as many as a dozen additional biological warfare vaccines," Eddington told ABC News. "These have never really been tested, and most importantly, no one has provided data to validate the threat."

Admiral Crowe provides a cover of respectability to a company that has some rather curious foreign connections. Bioport was created by Crowe and his partners out of another company called Intervac. Crowe owns 22.5 percent of Intervac shares, although it’s been reported that he hasn’t "invested a penny" in the venture. Rosenberg’s investigation also determined that 30 percent of Intervac shares are owned by Nancy El-Hibri, a mother and homemaker in suburban Maryland and the rest of the company is in the hands of "I&F Holdings," a company directed by Nancy El-Hibri’s father-in-law, Ibrahim El-Hibri, a Venezuelan citizen, and her husband, Fuad El-Hibri, a German citizen of Lebanese descent. Rosenberg said that Fuad El-Hibri appears to be the real day-to-day director of Intervac and is listed by Dun & Bradstreet as the "chief executive" of Bioport.

All of these foreign connections are curious and interesting because Rosenberg noted that experts in defense policy said it’s very unusual to have a foreign-dominated company as the sole manufacturer of a vaccine considered vital to national security. It also seems suspicious that a "friend of Bill" considered extremely close to President Clinton in 1992, and who endorsed Clinton for president, should get involved in a company making millions from the anthrax vaccine program. Some critics view this as a pay-off for political support. They are waiting for the new Bush Administration to complete a review of the whole affair.

Still forcing military personnel to take the vaccine. Still saying they are running short, but no reliable information. This has been a scam from the start...the vaccine was optional during President Bush's tenure but slick willie made it mandatory as a way of a pay off to his friend, Admiral Crowe.

I wonder if anyone on this site can find out anything about the firms mentioned in this article, Intervac and I&F Holdings.

BTW, just a clarification....only those military personnel slated to serve in the Persian Gulf are required to take the vaccine.

...But except for an ABC News story by Howard L. Rosenberg, we have not seen a serious examination of the financial and special interests that have kept the program going. Rosenberg has examined the involvement of Admiral William Crowe in the company making the anthrax vaccine. Crowe was an early supporter of President Clinton and was appointed by him as Ambassador to England. The company is Bioport. Rosenberg described Crowe, former chairman of the Joint Chiefs of Staff, as the company’s most visible corporate director. Bioport is the only licensed U.S. manufacturer of anthrax vaccine and landed an exclusive $29 million contract with the U.S. Department of Defense to "manufacture, test, bottle and store the anthrax vaccine." Eventually, Bioport could make $60 million from the deal.

The reason Bioport has an exclusive contract is that they took over the operations of the State of Michigan Bio-Products lab, the only place where the vaccine has been sucessfully produced. The government tried to make it themselves on a small scale in one of their research labs and failed.

But former Central Intelligence Agency military analyst Patrick Eddington told ABC News that this could just be the beginning. "The Pentagon has a $322 million, 10-year program to develop at least three, and perhaps as many as a dozen additional biological warfare vaccines," Eddington told ABC News. "These have never really been tested, and most importantly, no one has provided data to validate the threat."

The lack of the actual process of reporting facts seems to be lost on Irvine, Kincaid, Rosenberg, and Eddington. I thought Reed Irvine had a good reputation. What Eddington is talking about is the Joint Vaccine Acquisition Program (JVAP), which went out for bid in about 1996. JVAP had at least three serious bidders, including a group that included the Michigan lab before they were Bioport, as well as Battelle, the large research firm based next to Ohio State University. A group other than Michigan/Battelle won the contract, which included production of an advanced anthrax vaccine. The winning bidder did make an initial inquiry about using the Michigan (now Bioport) Lab for the "new" vaccine, but that work was to be later in the program. Also, only a small portion of the "$322 Million" had been authorized and the bulk of JVAP may never happen. I am unsure how much more of the JVAP program was authorized in the last year or so, if any.

It is widely known that Crowe did not put up money, but was used for his knowledge of the US Military. But Crowe once having been the Head of the Joint Chiefs and an early supporter of Clinton has NOTHING to do with BioPort being the sucessful bidder to take over the Michigan facility.That was a result of a sale of assets by the State of Michigan, which was (and is) under the administration of a Republican governor, John Engler, and a Republican State Senate and Dem State house (almost equal with Repubs then) that wanted to remove from tha budget a operations that was losing $12-15 million a year and needed $20 million or more in renovations to comply with the FDA's very strict newer rules. The highly political battle about selling the labs, inflamed by a Dem Gadfly nutcase local House member, scared off any regular Bio-products firm from the bidding. These vaccines are almost a boutique industry, and the Billion $ companies didn't want to put up with the political hell for something that would net them less than $75 million over 10 years. The upside potential is private sales to foreign governments at a hefty "world" price instead of the profit restricted DOD price that reflects that the US government refitted the labs (in buildings over 60 years old) with federal money.

The only serious other bidder at the end of the State of Michigan process was an Italian firm

It also seems suspicious that a "friend of Bill" considered extremely close to President Clinton in 1992, and who endorsed Clinton for president, should get involved in a company making millions from the anthrax vaccine program. Some critics view this as a pay-off for political support. They are waiting for the new Bush Administration to complete a review of the whole affair.

Again - this is just so much garbage. Legitimate questions can be asked about the Anthrax program, including the financing. But Irvine hasn't asked any.

Not for commercial use. Solely to be used for the educational purposes of research and open discussion.

PREPARED TESTIMONY OF MR. FUAD EL-HIBRI PRESIDENT AND CHIEF EXECUTIVE OFFICER, BIOPORT CORPORATION BEFORE THE HOUSE COMMITTEE ON GOVERNMENT REFORM SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS, AND INTERNATIONAL RELATIONS JUNE 30, 1999, WEDNESDAY

Mr. Chairman and distinguished members of the Subcommittee, my name is Fuad EIHibri and I am the President and Chief Executive Officer of BioPort Corporation, a biopharmaceutical company headquartered in Lansing, Michigan.

Intervac LLC is owned by Admiral Crowe, my wife Nancy and me, and I and F Holdings N.V., a Netherlands Antilles investment company owned by my father Ibrahim El-Hibri.
I have been asked to discuss, from BioPort's point of view, the acquisition strategy and procurement activities related to the Department of Defense's (DoD's) purchase of anthrax vaccine. Joining me is Dr. Bob Myers, our Chief Operating Officer, who has previously testified before this Subcommittee and who can provide added detail regarding the historical and technical aspects of the relationship.

As the Subcommittee is aware, BioPort has been operational for about nine months. BioPort was formed to purchase the Michigan Biologic Products Institute (MBPI) from the State of Michigan and to operate the facility as a private sector facility. For thirty years, MBPI had been the sole provider of Anthrax Vaccine Adsorbed (AVA) to the DoD. For a number of years prior to our purchase of MBPI, the State of Michigan had expressed its intention to sell the facility and get out of the AVA business, but had been unable to find a buyer. It is our understanding that the State of Michigan planned to close the facility if it did not find a suitable buyer.

We bought MBPI with the firm conviction that we could operate the facility as a viable commercial entity. We knew that privatization of a facility that had been state-owned and operated involved certain vagaries and risks. We were convinced that we could get through the privatization process and establish BioPort as a viable entity and a reliable supplier to DoD within the first year of operation.

However, over the last nine months, we have encountered more difficulties in privatizing the facility than initially anticipated. Despite our best efforts (and the due diligence that we conducted before the purchase), certain unanticipated problems have arisen that would make it difficult for any company to operate on a viable commercial basis with the existing DoD contracts. We are in the process of discussing with DoD changes in our contracts that will enable us to operate the company on a viable basis in the future and continue to produce a safe, pure and effective vaccine.The purpose of my testimony (in addition to answering the questions posed by the Subcommittee in its letter of June 15, 1999) is to discuss the business considerations that have led us to where we are today, and to assure the Subcommittee that, with the changes under discussion, BioPort will be in a position to serve DoD as a reliable supplier of AVA long into the future. Background

BioPort's primary mission is to meet the needs of DoD's Anthrax Vaccine Immunization Program (AVIP). BioPort has only one key customer -- DoD -- and one key product -AVA. We manufacture two other biologic products, rabies vaccine and plasma derivatives, but sales of these products are limited and these products currently have only minimal significance to the viability of the company.

BioPort's core purpose is to protect life by fighting disease. We know that anthrax is a deadly weapon in the arsenal of bio-warfare and bio- terrorism -- that some hostile nations and terrorist groups have access to weaponized anthrax, and that the DoD considers, as we do, BioPort's vaccine, which is licensed by the Food and Drug Administration (FDA), to be pure and safe and an effective protection against an anthrax attack.

We employ more than 200 people who are fully committed to providing the highest quality product as the best possible protection against these dangers. Parenthetically, I would like to point out that more than 100 of our employees have received anthrax vaccine shots -- some for more than 20 years -- and that I am one of those 100 employees. BioPort makes the only FDA-licensed bio- defense vaccine in the country, and we are committed to continue producing the vaccine and doing so with the highest quality.

By way of personal background, I would like to explain the basis for my interest in leading the acquisition of MBPI last fall. For the past ten years, I have been involved in the business aspects of the biotechnology industry - in particular, the field of bio-defense. Previously, I was a director with Porton Products Ltd., a biotech company based in the United Kingdom. At Porton, I was involved in the oversight of operations that encompassed drugs and biologic products. During my association with Porton, which had a marketing agreement with the Centre for Applied Microbiology and Research (CAMR), a United Kingdom government-owned lab, I participated in the marketing and distribution of substantial quantities of two bio-defense vaccines - botulinum Type A and anthrax.

In 1996, I learned that the long-anticipated sale of the Michigan lab, MBPI, was going to move forward. Because of the unique similarities between Porton and the Michigan lab, specifically with respect to biodefense vaccines, I later joined forces with the managers of the lab, including Dr. Myers, who had formed Michigan Biologic Products, Inc., a management-owned company, in an effort to acquire the assets of the lab. I invited Admiral William J. Crowe, Jr. to join the group to bid for the acquisition of MBPI. Admiral Crowe has been a friend of my family for many years. When BioPort was originally conceived, we believed that Admiral Crowe's background would be important in ensuring that we did everything correctly in establishing a company that would best serve DoD's needs. We are honored to have him as a director of BioPort.

We received financial backing from I and F Holdings N.V., a Netherlands Antilles investment company which is owned by my father, Ibrahim EI-Hibri. I and F Holdings had participated previously in Porton Products Ltd. as a passive investor.

The Privatization Effort

Together, Dr. Myers and I took the lead in developing a comprehensive plan to privatize MBPI and to perform MBPI's contracts with the DoD. In May of 1998, we formed BioPort Corporation, which is largely an employee-owned company, registered in Michigan. On September 5, 1998, BioPort purchased certain of the assets and assumed certain of the obligations of MBPI from the State of Michigan. The sales process, which took almost two years, was public, open and competitive.

At the time of the transaction, we were well aware that we were taking over an unprofitable venture with an aging physical plant that had never before been operated in a commercial environment. We knew there would be difficulties in establishing a viable commercial operation after years of management by the State. As it turns out, we have encountered problems - and costs -- in privatizing the entity that are substantially beyond what we had anticipated:

- Identifying and tracking costs.

Under the State, the financial accounting system was organized to support the State's appropriations process and there was no effective system in place for tracking costs. To meet regulatory standards, a company in this business must have substantial quality assurance and quality control systems. State-of- the-art renovations are continually needed which require lengthy FDA review prior to being put into service, and evolving product standards require ever-improving analytical methods. Unfortunately, the State's management practices did not include calculation of these costs. The cost information available was minimal in content and difficult to analyze.

It turns out that there was no direct relationship between MBPI's costs of producing AVA and prices paid by DoD for AYA. It has become clear to us that the prices paid by DoD for AVA are significantly below BioPort's costs for producing AVA and what is necessary to enable BioPort to operate as a viable entity.

- Overcoming delays in renovations.

At the time of the acquisition, MBPI was in the midst of renovating the anthrax production facility with, in retrospect, an unrealistic timetable. Unforeseen delays in completion of the anthrax production facility have delayed production and increased costs. In May of this year, after completion of the anthrax facility renovation, BioPort resumed production of the anthrax vaccine (although the delivery of the product is subject to FDA release), but with a delay in excess of four months.

- Improving regulatory compliance and relationships with FDA and DoD.

MBPI's regulatory problems with the FDA required more resources than previously anticipated. Since privatization, BioPort has neared completion of the implementation of its Strategic Plan for Compliance, an accepted plan by which the FDA monitors our compliance progress. We have expended considerable resources in developing new and improved relationships with the FDA as well as with our key customer, DoD.

- Dealing with the uncertain availability of AVA for commercial sales.

Traditionally, vaccine manufacturers have been able to offer lower prices to the Government by recovering a substantial portion of their costs through commercial sales. Under this approach, prices for commercial sales of vaccines are established at levels that are much higher than the prices paid by the Government. Because of the current unavailability of product, the commercial sales market has not materialized as anticipated. Without a second market, the Government cannot expect the rock-bottom pricing it enjoys with some of the other vaccines it purchases.

- Difficulties associated with production of other products.

BioPort's business plan anticipated additional revenues from the sale of other products: i.e., plasma derivatives and rabies vaccine. BioPort encountered unanticipated start-up problems related to the manufacture of plasma derivatives and rabies vaccine. This has contributed to the negative effects on BioPort's financial condition.

- Changing the culture and organization.

The culture was that of a state bureaucracy - where no effective performance standards assured accountability throughout the organization. Changing that culture has been a difficult and costly endeavor. We have augmented the staff with 56 people who have experience in the commercial industry. We are developing business systems, such as cost accounting, inventory control, management information, and material requirements planning to better manage and control the organization.

We have come to understand that the State of Michigan routinely funded the operations of MBPI beyond what we initially understood (in effect, subsidizing DoD's acquisition of AVA). At the same time, the State failed to address urgent needs for facility improvements, which jeopardized the FDA license. As a commercial entity, BioPort cannot continue to subsidize the DoD. However, we are committed to improving the facilities and working closely with the FDA to ensure compliance with all quality measures. All of this has caused us to incur costs beyond what was originally anticipated with respect to producing AVA. Indeed, our experience confirms why every major pharmaceutical company in this country has avoided getting into the defense vaccine business, why limited interest was found in bidding for the Michigan lab, and why the government has had problems retaining suppliers of certain specialized vaccines. It has long been recognized that a vaccine R&D and manufacturing business must operate in an environment involving high capital costs, limited product market potential, significant regulatory hurdles, liability issues, and other technical complexities. I have been advised that this has been independently documented in reports of the Congressional Office of Technology Assessment in 1979, reaffirmed by the Institute of Medicine, National Academy of Sciences in 1985, and most recently in the 1995 Mercer Report commissioned by the U.S. Department of Health and Human Services.

These factors may explain why most U.S. pharmaceutical manufacturers abandoned the vaccine business during the 1970s. It is no accident that today the U.S. vaccine industry is dominated by only four large companies. The CEOs of smaller biotech companies experience major challenges in securing the necessary financing to sustain the tremendous costs of their clinical development, regulatory and manufacturing operations in making these life-saying vaccines available to the public.

Plan For Future Operations

In the last nine months, BioPort has incurred losses at a rate that cannot be sustained in the future. We have taken key measures to minimize such losses. Our employees receive, on average, salaries below the industry norm; performance based bonuses have been temporarily suspended; expenses are being controlled by the CFO directly; and any expenditures not immediately critical to the continued operation have been put on hold. Notwithstanding these measures, however, the current pricing structure is unrealistic given the total costs of manufacturing AVA.

BioPort is currently in the process of restructuring the production and delivery contract with the DoD. The two main terms we are addressing jointly are the price per dose and the quantity of doses committed. The price per dose needs to be adjusted to a level where BioPort can operate on a viable basis. The production levels that are being discussed allow for a growth in the Government inventory for unexpected surges in demand, while still providing BioPort with enough vaccine to meet any reasonable demand from the civilian private sector.

With the changes that are being discussed, BioPort will be in a position to meet all requirements of the AVIP and to serve DoD as a reliable supplier long into the future. The proposed average price per dose will still compare favorably with prices of many other vaccines purchased by the Government. BioPort believes that a fair and equitable adjustment to the contract can be achieved within the time frame needed.

Conclusion

In conclusion, let me simply state that all of us at BioPort are deeply committed to proriding a safe, pure and effective vaccine that meets DoD's force protection needs.

We are working diligently to transform ourselves from a somewhat neglected state agency to a competitive and respected biologics company. This transition will require time and will not be accomplished without the support of our most important customer.

We welcome the scrutiny of this Subcommittee and assure you that as long as we manufacture anthrax vaccines, they will be safe, pure and effective.

Responses To Subcommittee Questions

Now, I would like to turn to the specific questions raised in your letter of June 15, 1999.

Question #1: Discuss in detail the legal and financial relationship between DoD and the BioPort Corporation, including the status of BioPort's performance under current DoD contracts, and the financial, organizational and operational capacity of BioPort to meet all contract obligations.

When BioPort acquired the assets and liabilities of MBPI, we assumed three existing contracts with the DoD and entered into a fourth contract that had originally been offered to the State of Michigan. All of these contracts relate to aspects of the production of anthrax vaccine -- future production, stockpile maintenance, equipment and storage. Three of these contracts were novated, which means they were transferred from the State directly to BioPort Corporation without amendment. The fourth contract was negotiated with DoD concurrently with the final negotiations with the State on the acquisition of MBPI's assets. Meanwhile, the State's budget was exhausted, people were beginning to leave the lab, and the State had threatened to shut down the lab, potentially leaving the country without any source of FDA-licensed anthrax vaccine. After the acquisition, we discovered that the costs of production had been seriously underestimated by the State for years. Under State ownership, a cost accounting system was non-existent. Therefore, the methods used to allocate costs were not very useful in assisting management in running an efficient and financially sound private enterprise. In the case of AVA, as one State official has told us, the State of Michigan essentially subsidized the DoD procurement of anthrax vaccine for nearly 30 years. The State assured solvency, paid unemployment insurance, workers' compensation and liability insurance, assured payroll, covered emergencies, and maintained the physical plant while the DoD paid artificially low prices.

As an illustration of the kind of problems inherited by BioPort in the pre-existing arrangement between the DoD and the State of Michigan, BioPort is responsible for paying all costs associated with the renovation of the anthrax facility, which is only reimbursed by the DoD sometime later, without consideration for the cost of money. BioPort may not charge handling or administrative fees, and must assume the responsibility of supervising and partly executing timely completion without compensation. This is an artifact of the DoD's arrangements with the State, but does not work well in a commercial setting. The newly renovated anthrax production facility is now up and running and currently performing at a higher level than before, although delivery of AVA is subject to FDA release. However, the renovation and startup of the upgraded anthrax production area took more than four months longer than planned at the time of contract negotiation. BioPort has recently submitted a request for restructuring the contract with the DoD. The price per dose and the quantity of doses committed are inversely correlated when using a cost plus approach to pricing; therefore, in light of a lower projected production level, if all other things were equal, the price per dose would adjust upward. DoD and BioPort are currently reviewing BioPort's financial figures of the last nine months, including an audited financial statement of 1998, and BioPort's projections for years 1999 and 2000. We are jointly determining a fair price and quantity requirement within the guidelines established by the Federal Acquisition Regulations and taking into account that BioPort is primarily a one client, one product manufacturer, with limited private sales.

BioPort will be able to meet the anticipated requirements of the AVIP in the years to come. This production level not only meets the anticipated requirements of the AVIP, but allows for a growth in the Government inventory for unexpected surges in demand, while still providing BioPort with enough vaccine to meet the projected demand of the civilian private sector.

BioPort has spent the last several months strengthening the company's organizational capacity to meet our contractual obligations. We have added several highly qualified individuals with extensive industry experience -- particularly in the regulatory, compliance, financial controls and product development areas. We have established a regulatory affairs division, a financial division, a legal affairs division, a human resources and a corporate services division. We conducted national searches before hiring a Chief Financial Officer, an Executive Vice President for Operations, a Vice President for Regulatory Affairs and a Vice President for Marketing. We have designated an Executive Vice President for Business Development. These steps have greatly strengthened our organizational capacity and financial control. BioPort has the operational capacity to continue producing a safe and effective anthrax vaccine at the revised production level (subject to FDA release) meeting the AVIP requirements. Our ability to operate on a viable commercial basis, however, depends upon arriving at a fair and equitable contract price with the DoD.

Question #2: Describe the corporate structure of BioPort, including the identity of all incorporators, directors, principals and all those with any equity, debt or ownership interest of any kind.

BioPort was incorporated in Michigan on May 12, 1998, pursuant to an agreement between Intervac LLC and Michigan Biologic Products, Inc., for the sole purpose of acquiring the assets of MBPI. As mentioned earlier, the core purpose of the corporation is to protect life by fighting disease. A five-member Board of Directors, which I chair, governs us. BioPort's other board members are Admiral William J. Crowe, Jr.; Myron W. Solter; Dr. Robert C. Myers; and Robert C. van Ravenswaay.

BioPort's stock is split into two classes: 80% of the shares are voting; 20% are nonvoting. The non-voting shares are being awarded to each and every BioPort employee, so every one at BioPort has a stake in the company. Managers and employees today own more than 50 percent of the company, assuming a full vesting of all stock options.

Three companies currently hold voting equity in BioPort: Intervac LLC and Intervac Management LLC, which are both Maryland limited liability companies, and Michigan Biologic Products, Inc., a Michigan corporation. Intervac LLC is the controlling shareholder. Intervac LLC is owned by Admiral Crowe, my wife Nancy and me, and I and F Holdings N.V., a Netherlands Antilles investment company owned by my father Ibrahim El-Hibri. As mentioned earlier, I and F Holdings is an investment company in biotech operations, which previously had invested in the management buy-out of Porton Products Ltd. Admiral Crowe and I are the controlling members of Intervac LLC.

I am the general manager of Intervac LLC, which is a private investment group, and of Intervac Management LLC, which includes a group of four dedicated professionals who work with me and assisted in the acquisition. Dr. Myers is President of Michigan Biologic Products, Inc., shares of which are predominantly held by seven former managers of MBPI who have been active in the daily management of BioPort. A minority of Michigan Biologic Products, Inc. shares are held by four local lawyers, who helped the company with legal matters during the sale process. Our major creditor is the State of Michigan, who agreed, as part of the sale, to hold promissory notes secured by essentially all of BioPort's property. We also have product and royalty obligations to the State of Michigan in addition to the notes. I and F Holdings has advanced additional funds to BioPort to help meet unanticipated but continuing short-term cash deficits. In addition, BioPort has incurred indebtedness in the form of a capital lease from Bank One for the purchase of a blood plasma fractionation centrifuge.

Question #3: Discuss any efforts or plans to identify or construct additional anthrax vaccine production source(s).

Although BioPort currently produces anthrax vaccine at a single site, we are looking at developing additional anthrax vaccine production facilities to assure continued product availability in the event of a natural disaster or terrorist attack. When BioPort entered into the current production contract with the DoD, we agreed to evaluate converting an existing idle production area to the production of anthrax vaccine. Although the preliminary engineering design indicates such a conversion can in fact be done, it would be at substantial cost and would still not provide a geographically separate production site to protect against disaster. BioPort has had preliminary discussions with the DoD to identify other facilities for possible conversion in the U.S. We have also talked to the Canadian government and with the Centre for Applied Microbiology and Research in the United Kingdom about the possibility of establishing a second production site that could serve both the redundancy needs of the DoD and the anticipated market demand.

It is important to emphasize that a second facility will require a significant commitment of time and money. Bacillus anthracis is a spore-forming organism and, under current practice, the vaccine must be manufactured in a dedicated facility. To build a new anthrax vaccine production facility using BioPort's technology at a new site, approved by the FDA, would take approximately five to seven years and cost between $70 - $100 million based on BioPort's analysis. Converting an existing biologies facility, which has basic infrastructure, would save time, but would still take 4-5 years, and cost substantially less, depending on the quality of the existing facility. Therefore, BioPort is in the process of identifying existing U.S. facilities suitable and available for conversion.

We should also recognize that many vaccines - including, but not limited to, anthrax have only one manufacturing source. In addition to anthrax, there are at least 14 significant adult vaccines, which are produced by single source manufacturers. These include cholera, Lyme disease, all the MMR series, yellow fever, Japanese equine encephalitis, and meningitis vaccines. Anthrax vaccine, with a single manufacturer, is not unusual.

Question #4: Describe the nature and value of Government Furnished Equipment used in the manufacture of anthrax vaccine and the nature and value of other facility improvements provided or financed by DoD since 1991, including the current renovation and expansion.

By our accounts, the U.S. Government has furnished, and still owns, equipment and materials used to manufacture anthrax vaccine that originally cost a total of $6.9 million. This equipment, which has been acquired on behalf of the Government since 1991, includes the fermenter trains and formulation tanks used in the manufacture of anthrax vaccine, some filling and packaging equipment, cold room modifications, a formulation room, an animal test facility and a building that warehouses production materials. This listing, which is prepared at the end of each fiscal year, already includes most of the items acquired in the recently completed renovation of the anthrax vaccine production facility.

The Government will shortly reimburse any outstanding costs with respect to the recent renovation, which are not substantial at this point. The current value of the Government Furnished Equipment, however, is substantially less, an estimated $3.4 million, based on a depreciated value. In addition, the Government has furnished a total of $4.4 million in renovation costs other than for equipment.

When it came to facility renovations, Michigan's budgeting and procurement practices routinely added months, if not years, to construction schedules. To meet DoD's scheduling requirements, Michigan accepted Government Furnished Equipment on a piece-meal basis, solving short-term problems at the expense of long-term benefits. Although DoD provided equipment for vaccine production, it contributed very little to the soft costs in installing such equipment in a current Good Manufacturing Practices (OMP) production setting -- validation, periodic re-qualification, and regulatory filings. Under Generally Accepted Accounting Principles, all these costs are included in capital expense. The State previously covered and BioPort now covers all such soft costs not reimbursed by DoD.

Question #5: Discuss the status of BioPort's investigational New Drug Application (IND 6847) pending before the Food and Drug Administration (FDA), anticipated approval schedule and the impact of approval on current and future procurements.

We continue to hold an Investigational New Drug application -- IND 6847 -- to improve administration of the anthrax vaccine. Further work is currently on hold while the parties consider the costs and benefits of proceeding in the context of overall program priorities (such as getting the upgraded facility in operation).

This IND was started by MBPI in tandem with the DoD in 1996. It has two major objectives: to reduce the number of doses in the current anthrax vaccination schedule and to further evaluate an immunological correlate of protection.

The initial work on the IND indicates the second shot of the series -- given at two weeks - may be eliminated, but the FDA has specified substantial additional tests that must be conducted before they will consider such a shot elimination. This would reduce the total inoculation series from six shots to five shots. Further reductions may be possible, but require additional clinical trials and time. There will be no immediate impact on the requirements of the Anthrax Vaccine Immunization Program. The future impact in an estimated two years may be a reduction of the number of shots by one- sixth for initial immunization. However, there are no immediate plans to reevaluate the requirement for annual boosters.

Thank you.

END

Seems this could have a link to a pharmacutical company in Canada (Connaught ) that has a relationship with Bubba and Arkansas prison plasma.

Thanks for the heads up. I'm always amazed at how these important stories just fade away so fast. It takes a lot of fortitude to keep an eye on our government.

Do you know anything about the nature of the vaccine in pill form (Cipro) vs. inoculation? As of June, 2001 FDA had not given approval to manufacture any more Cipro, and at that time, I believe Bioport only had a supply of 25,000 or so. Has the FDA approved the drug since then?

Don't know, sorry. I'd also like to know more about the antitoxin that's being developed at the University of Texas.

Look at the date of the article posting!

The daddy, Ibrahim is on the board of an Islamic charity..."Dar Al Aytam al Islamyah"

Can anyone translate that?

When I try to find "I and F Holdings" the stupid google says we disregard the I!

Help!

He was involved in Proton also!

Not sure if it does any better with "I" but try:

-http://www.profusion.com/--

Does Hybridon in Cambridge have any Anthrax???? The Bin Laden family owns a part of Hybridon, correct?

I found out what the charities name traslates into..."House Of Orphans"!

Is that charity on the list of Bin Laden phoney funders?

Is daddy Ibrahim El-Hibri actually a terrorist supporter?

Does anyone think it bizarre that the only anthrax vaccine maker in America is owned for the most part by Middle Easterns?

Did you all see what Faud did before?

How late in the game he became a citizen?

Ann Archy,I have made my allegation to the FBI.

They know that I believe that Bin Laden co-horts own Hybridon and other vital firms all over the world.

They know that I want Hybridon shut down , and all its assests frozen.

They know that I think Bin Laden has developed a master plan to poison us all!

The FBI has my postings from the Cole attack days, with all the Al-Amoudi and Mafouz matters.

I hope that they track down everythong I have charged, including Bin Ladens massive cyber capability.

Does Hybridon have any anthrax in its goodie box,Ann?

I dont know, but I know that Bin Laden terrorist funder friends have ownership of hundreds of firms all over the world that have the capability to kill us all!

Thank you for trying to get something done to save American lives. I pray the FBI will take you seriously and investigate your allegations and then do the right thing with what they find out.

Thanks for sending me your replies.

Thanks Betty Jo.........and all the Freepers who are constantly on guard.

I know this is an old post but I have to say it is . . .

WHAT Fuad El-Hibri DID NOT SAY!

THE ANTHRAX VACCINE LABYRINTH

Fuad El-Hibri was known to have facilitated shipments of anthrax vaccine from a British company he was affiliated with to Saudi Arabia after the Saudis had been turned down by the Pentagon. It was feared he might also ship vaccine to Iraq. In order to develop vaccines, companies must first posses live antrax bacteria.

Avant Immunotherapeutics Inc. was licensing its vaccine producing technology to a defense contractor that is working to improve anthrax vaccine. The contractor was identified as Dynport Vaccine Company LLC, a subsidiary of Dyncorp, a major defense contractor.

However, a perusal of Dyncorp's website reveals that Dynport is not exactly a subsidiary, it is a joint venture between Dyncorp and Porton Products Ltd.(Porton)in the UK. Porton is the British equivelent of Bioport in several respects. It is the "privatization" of a laboratory owned by the British government. The private buyout was organized by none other than FUAD EL-HIBRI who, as a director of Speywood Holdings Ltd.(the owner of Porton) exercised oversight responsibility over Porton. It was in that capacity that he oversaw shipment of anthrax vaccine to at least Saudi Arabia.

In turn, Speywood Holdings is a subsidiary of I & F Holdings, an investment firm incorporated in Netherland Antilles, a notorious haven for money laundering. In his congressional testimoney, Fuad El-Hibri said I&F Holdings is owned by his father, Ibrihim El-Hibri. He did not say "sole" owner and no further questions were asked.

At this point, we should take note of Fuad El-Hibri's stint at CitiGroup, as the dominant investment banking firm in New York. Fuad, at one time, was in charge of the group's operations and credit arrangements in Saudi Arabia. Although the name bin Lauden was not the household word it is today, it beggars belief not to think that Fuad had extensive dealings with the bin lauden family. Aside from the royal family, the bin Lauden construction empire is one of the dominant forces in Saudi Arabia. CitiBank and CitiGroup handles the bin Lauden investment interests in the U.S. and elsewhere.

The situation today screams for an investigation into who really controls the production of anthrax vaccines, both in the U.S. and Britain, and what is in them.

for more information go to http://educate-yourself.org/vcdanthraxvaclabyrinth16oct1.html