Department of Health and Human Services

Feds ok Iomai Phase II adjuvant patch study

Wed, 16 Apr 2008 06:59:54 -0400

Health and Human Services is giving Iomai the green light to do a mid-stage dose ranging study of its adjuvant patch for bird flu vaccine. HHS provided a $128 million contract backing Iomai's effort last year, and was rewarded with dramatic Phase I/II data on its ability to boost the effectiveness of bird flu vaccine.

The U.S. government, like other governments around the world, has been stockpiling vaccine to fight a potential pandemic. Iomai's patch worked well enough to provide protection to many people after a single dose, rather than the two usually required. That would allow physicians to stretch available vaccines over a much larger population on a much quicker basis.

"The Iomai immunostimulant patch has the potential to change how we react to an influenza pandemic, and we will move ahead quickly with the development of this technology," said Iomai CEO Stanley C. Erck. "Based on the data from this new Phase II study, Iomai and HHS will evaluate whether to proceed next with a pivotal Phase III trial."

- here's the press release

ALSO: South Korea has mobilized troops to help fight the spread of H5N1 in poultry. Report

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SPOTLIGHT: GAO questions antidotes for pandemic

Thu, 24 Jan 2008 06:59:53 -0500

The GAO says that a pandemic vaccine can offer little help during the crucial initial stages of an outbreak. The Department of Health and Human Services has estimated that it would take 20 to 23 weeks to develop and manufacture a vaccine targeted at a specific strain. And increasing access to antivirals--the second key strategy for dealing with a pandemic--would demand construction of new facilities and fresh sources of production material. FierceVaccines

ALSO NOTED: AstraZeneca completes cancer study enrollment; Smallpox vaccine success triggers milestone; and much more...

Fri, 30 Nov 2007 06:59:50 -0500

> Here's a good estimate of how much it costs when a drug goes into free-fall: $440 million. That's how much Johnson & Johnson is writing off on Natrecor, a heart failure treatment that went into a downward spiral when medical researchers suggested that it might boost the risk of kidney problems and death. Report

> AstraZeneca says that it has completed patient enrollment in a study of Zactima (vandetanib), an oral anti-cancer drug. It's the first of four planned studies of the drug, and data from the trial is expected in 2008. Release

> Bavarian Nordic has successfully completed a Phase II trial of its next-generation smallpox vaccine candidate Imvamune. The trial completion has triggered a $25 million milestone payment from the Department of Health and Human Services. Release

> Cell Therapeutics has entered into agreements to sell approximately $6.5 million of its 7 percent convertible preferred stock and warrants in a registered offering to several institutional investors. Release

> According to TheScientist.com, a former University of Washington researcher who was discovered to have faked data in a number of instances, is now working at Schering Plough. Post

> An FDA advisory panel gave its backing to Abbott's new Xience stent, albeit an endorsement tinged with caution. The committee said Xience should be cleared for sale on one condition--that Abbott conduct post-marketing research on the product. Report

> Herceptin has become a lightning rod for debate over cancer treatment in England. Radiotherapists--including the specialty's chief at the National Health Service--are saying that cancer treatment is weighted too heavily toward expensive drugs and not enough toward more cost-effective radiation treatments. Report

And Finally... Wondering what Jean-Pierre Garnier will do with his free time when he steps down as GSK's head honcho in May? Wonder no more. Report

Sanofi launches trial of revolutionary flu vaccine

Wed, 07 Nov 2007 06:59:56 -0500

Sanofi-Aventis has launched a mid-stage study of a new seasonal flu vaccine that hopes to advance a completely new method to make vaccines. The vaccine is made from cell cultures as opposed to the traditional egg-based approach. This experimental vaccine uses a cell line--PER.C6--licensed from Crucell. Sanofi-Aventis' closely-watched development program is expected to short circuit the slow, crude manufacturing process now in place and help revolutionize the whole vaccine business.

"This project is part of a contract awarded in 2005 by the U.S. Department of Health and Human Services (HHS) aimed at accelerating the development of a new cell culture-based influenza vaccine," Sanofi-Aventis said in a statement.

- take a look at the release from Sanofi
- read the report from In-PharmaTechnologist.com

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Sanofi vaccine effective against new bird flu strains. Report
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Report: FDA lax in clinical trial oversight

Fri, 28 Sep 2007 06:59:58 -0400

A new report has found that the FDA does little to protect the safety of patients who participate in clinical trials. Daniel R. Levinson, inspector general of the Department of Health and Human Services, has released a report slamming the FDA's oversight of the trials. The FDA has 350,000 testing sites but only 200 inspectors, some of whom work part time. The inspectors managed to visit less that 1 percent of testing sites. When problems were found at the sites, they were often overlooked by top FDA officials and the FDA rarely followed up with those that were cited for problems. One expert interviewed by the New York Times noted that animal testing has more stringent oversight than human testing in the U.S.

The OIG concluded that the FDA does not have a mechanism to identify all clinical trials and Institutional Review Boards. It also lacks a comprehensive database for tracking its inspections of clinical trials. "Data limitations hinder the FDA's ability to ensure that participants are protected from unreasonable risks," said Levinson. Janet Woodcock, director of the Center for Drug Evaluation and Research, acknowledged there problems with the inspection process and that the FDA is working to address them.

- see the OIG's release on the FDA
- read this article for more

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IOM slams FDA, calls for major reforms. Report

Press Release: HHS Unveils Two New Efforts to Advance Pandemic Flue Preparedness

Maureen Martino — Fri, 02 Feb 2007 11:43:27 -0500

HHS Unveils Two New Efforts to Advance Pandemic Flue Preparedness

Planning guidance to assist community decision-makers; PSAs to raise public awareness

The Department of Health and Human Services (HHS) and its Centers for Disease Control and Prevention (CDC), in cooperation with departments and agencies across the Federal Government, today announced two new efforts designed to improve state, local and community preparedness for an influenza pandemic, which can occur when a new strain of flu appears for which people have no immunity, and disease spreads rapidly around the world.

CDC released new guidance on community planning strategies that state and local community decision-makers, as well as individuals, need to consider based on the severity of an influenza pandemic. These strategies are important because the best protection against pandemic influenza -- a vaccine -- is not likely to be available at the outset of a pandemic. Community strategies that delay or reduce the impact of a pandemic (also called non-pharmaceutical interventions) may help reduce the spread of disease until a vaccine that is well-matched to the virus is available.

The CDC guidance released today was developed in collaboration with other federal agencies and public health and private partners. The federal government has undertaken many efforts in the last few years to encourage and strengthen the nation’s pandemic influenza preparedness, and this guidance builds upon previously released planning documents and guidelines.

“The threat of a pandemic continues to be real. We need to continue helping state and local decision-makers determine some of the specific actions they could take during the course of a pandemic to reduce illness and save lives,” said HHS Secretary Mike Leavitt. “An important consideration for action is the severity of a pandemic once it emerges. The new CDC guidelines are a step forward in that direction.”

The new guidelines focus primarily on community-level measures that could be used during an influenza pandemic in an effort to reduce the spread of infection. In order to help authorities determine the most appropriate actions to take, the guidelines incorporate a new pandemic influenza planning tool for use by states, communities, businesses, schools and others. The tool, a Pandemic Severity Index (PSI), takes into account the fact that the amount of harm caused by pandemics can vary greatly, with that variability having an impact on recommended public health, school and business actions.

The PSI, which is modeled after the approach used to characterize hurricanes, has five different categories of pandemics, with a category 1 representing moderate severity and a category 5 representing the most severe. The severity of pandemic is primarily determined by its death rate, or the percentage of infected people who die. A category 1 pandemic is as harmful as a severe seasonal influenza season, while a pandemic with the same intensity of the 1918 flu pandemic, or worse, would be classified as category 5.

“It’s important that we try in advance to imagine and evaluate some of the steps that could be taken to slow the spread of pandemic influenza in communities,” said Dr. Julie Gerberding, CDC director. “That requires a great deal of forethought, vision, and collaboration. I’m proud of CDC’s efforts to guide the efforts of many federal and state partners to develop the severity index -- and to then link severity with potential actions. We recognize that much work remains, but this new approach should help communities, schools, businesses, and others strengthen their pandemic influenza plans.”

Based on the projected severity of the pandemic, government and health officials may recommend different actions communities can take in order to try to limit the spread of disease. These actions, which are designed primarily to reduce contact between people, may include:

1. Asking ill persons to remain at home or not go to work until they are no longer contagious (seven to 10 days). Ill persons will be treated with antiviral medication if drugs are available and effective against the pandemic strain.
2. Asking household members of ill persons to stay at home for seven days
3. Dismissing students from schools and closing child care programs for up to three months for the most severe pandemics, and reducing contact among kids and teens in the community
4. Recommending social distancing of adults in the community and at work, which may include closing large public gatherings, changing workplace environments and shifting work schedules without disrupting essential services.

These measures will be most effective if they are implemented early and uniformly across communities during a pandemic, objectives that can only be met through advance planning. The guidance illustrates the interventions that are likely to be recommended at each category of severity.

While these actions could significantly reduce the number of persons who become ill during a flu pandemic, they each carry potentially adverse consequences that community planners should anticipate and address in their planning efforts. The guidance describes many of these consequences, and provides planners with initial recommendations on strategies to address them. These recommendations may be revised in the coming months based on feedback that the government will seek from a variety of specific communities, including the private sector, education community, faith and community-based organizations and the public health community.

Planning guides for businesses and other employers, child care programs, elementary and secondary schools, colleges and universities, faith-based and community organizations, and individuals and families are included in the appendix of the guidance.

This guidance was developed through a collaborative process that included public health officials, mathematical modelers, researchers, and stakeholders from government, academia, private industry, education and civic and faith-based organizations. It will be refined as needed based on further knowledge gained from research, exercises and practical experience.

Also today, as part of the continuing effort to raise awareness and educate the public about pandemic influenza and the need to prepare in advance, HHS unveiled a number of new radio and television public service announcements (PSAs). The PSAs encourage people to learn more about pandemic influenza and to know more about their state and local community’s efforts to prepare for a potential pandemic.

“We need to keep up our efforts to educate the public before a pandemic emerges, and these PSAs will help people ‘know what do to about pandemic flu,’” Secretary Leavitt said.

The PSAs and the community planning guidance, titled Interim Pre-pandemic Planning
Guidance: Community Strategy for Pandemic Influenza Mitigation in the United States - Early Targeted Layered use of Non-Pharmaceutical Interventions, are available at www.pandemicflu.gov.

Press Release: Iomai Awarded Government Contract

Maureen Martino — Wed, 17 Jan 2007 12:40:18 -0500

Iomai Awarded Government Contract, Totaling $128 Million, to Develop Dose-Sparing Patch for Use in an Influenza Pandemic

GAITHERSBURG, Md., Jan. 17 -- Iomai Corporation today announced it will receive a contract from the Department of Health and Human Services (DHHS) to fund the company's development of a dose-sparing patch for use with a pandemic influenza vaccine. If the product is developed through licensure, the total cost reimbursed by DHHS, plus the fixed fee, is estimated to be $128 million. DHHS has allotted approximately $14.5 million to cover performance under this contract through March 31, 2008.

Iomai is developing a skin patch that, when used in conjunction with an injectable influenza vaccine, is designed to stimulate an immune response to even small doses of vaccine. This would allow public health officials to extend vaccine supply in the event of an influenza pandemic.

"We believe our novel immune-boosting patch for use with injectable vaccines for pandemic influenza could play a critical role in addressing the growing concern about vaccine supply in the event of a pandemic," said Stanley C. Erck, President and Chief Executive Officer of Iomai. "Unfortunately, history suggests that influenza pandemics are inevitable, and given current concerns about the avian H5N1 strain, we are looking to accelerate the development of this product to help alleviate those supply concerns."

During the course of the contract, the company will be reimbursed for research, development and capital costs associated with the preclinical and clinical testing of the immunostimulant patch. Under the contract, Iomai will develop a plan to bring the product to market and move forward to assess the safety and immunogenicity of the patch. The initial funding will be used to show safety and immunogenicity in humans.

Stretching the Vaccine Supply

Dose-sparing strategies for pandemic influenza could be a significant component of the response to an influenza pandemic. Recent research indicates that even at peak capacity, vaccine production may only be sufficient to vaccinate less than 10 percent of the U.S. population. These concerns prompted DHHS, earlier this year, to call for proposals on ways to "stretch the domestic influenza vaccine supply in the event of an influenza pandemic." Preclinical work suggests that the Iomai patch could cut the vaccine dose needed to provide protection by as much as 10- to 100-fold, helping to address those supply concerns.

The Iomai approach uses a potent adjuvant, applied to the skin through a patch that is affixed over the site of the injected vaccine. Once the patch is applied, the adjuvant passes into the skin, targeting cells called Langerhans cells. Those specialized skin cells carry the adjuvant into the lymph nodes, where it works to boost an individual's immune response to the vaccine. This proprietary approach, known as transcutaneous immunization (TCI), has been shown in a clinical study to boost immune responses to traditional influenza vaccines in a group of elderly volunteers.

Ideal for Stockpiling

The patch is designed to be used in conjunction with any pandemic influenza vaccine. It is also designed to be stored and shipped at room temperature, making the product ideal for stockpiling and rapid distribution. The patch is easily applied, requires no equipment to use and is disposable.

In addition to accelerating the pace of research and clinical testing, Iomai will also develop for DHHS a detailed production plan explaining how the company would produce 150 million immunostimulant patches in a six-month period. Though Iomai will soon begin that planning process as laid out by DHHS, the contract announced today does not cover commercial production of the patches; additional funding would be required to produce the patches at the scale needed for stockpiling.

Conference Call Details

Iomai will hold a conference call today to discuss this announcement. To access the live conference call at 1 p.m. Eastern Time via phone, please dial 866-700-6979 from the United States and Canada or 617-213-8836 internationally. The conference ID is 12510795. Please dial in approximately ten minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through Jan. 24 and may be accessed by dialing 888-286-8010 from the United States and Canada or 617-801-6888 internationally. The replay passcode is 93025186.

To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the Company's website at http://www.iomai.com . Please connect to the web site at least 15 minutes prior to the call to allow for any software download that may be necessary. The webcast is also being distributed through the Thomson StreetEvents Network. Individual investors can listen to the call at www.earnings.com , Thomson's individual investor portal, powered by StreetEvents. Institutional investors can access the call via Thomson StreetEvents (www.streetevents.com ), a password-protected event management site.

About Iomai Corporation

Iomai Corporation discovers and develops vaccines and immune system stimulants, delivered via a novel, needle-free technology called transcutaneous immunization (TCI). TCI taps into the unique benefits of a major group of antigen-presenting cells found in the outer layers of the skin (Langerhans cells) to generate an enhanced immune response. Iomai is leveraging TCI to enhance the efficacy of existing vaccines, develop new vaccines that are viable only through transcutaneous administration and expand the global vaccine market. Iomai currently has four product candidates in development: three targeting influenza and pandemic flu and one to prevent E. coli-related travelers' diarrhea. For more information on Iomai, please visit www.iomai.com .

Some matters discussed in this press release constitute "forward-looking statements" that involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Such forward-looking statements include statements about the anticipated reimbursement from DHHS for the costs associated with testing the immunostimulant patch; the potential future funding authorized by DHHS; the possibility of developing the dose-sparing patch through pre-clinical and clinical testing stages, into licensure and finally into market production; the possible shortage of influenza vaccine in the event of an influenza pandemic; the ability of the immunostimulant patch to reduce the necessary vaccine dosages by magnitudes of 10 to 100; the ability to store the patch safely at room temperature; and Iomai's ability to develop 150 million immunostimulant patches in six months. Applicable risks and uncertainties include, among others, that Iomai may not meet its contractual milestones in order to fully perform under the contract and thereby receive complete reimbursement from DHHS; that Congress will not authorize sufficient funds for DHHS to fully fund this contract; that DHHS will not authorize all tasks under the contract; that Iomai may not be able to enroll sufficient numbers of patients in its pre-clinical and clinical trials; that the timing and effectiveness of the pre-clinical and clinical trials are dependent on sufficient coordination and cooperation with third parties; that Iomai may be unable to obtain the regulatory approvals necessary to conduct required clinical trials; that pre-clinical and clinical trials fail to indicate that the immunostimulant patch reduces the necessary vaccine dosage by as much as anticipated; and the other risks identified under the heading "Risk Factors" in Iomai's Quarterly report on Form 10-Q for the three months ended September 30, 2006 and its Annual Report on Form 10-K for the year ended December 31, 2005 and filed with the Securities and Exchange Commission. Iomai cautions investors and others not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read the Company's filings for a discussion of these and other risks and uncertainties which are filed with the Securities and Exchange Commission and available at www.sec.gov. All statements in this press release only speak as of its date, and Iomai undertakes no obligation to update or revise the statements.

Press Release: GSK Awarded $63 Million HHS Contract for Pandemic Vaccine Research and Development

Maureen Martino — Wed, 17 Jan 2007 12:38:17 -0500

GlaxoSmithKline Awarded $63 Million HHS Contract for Pandemic Vaccine Research and Development

Company Begins Government and Retail Shipments of its Antiviral Relenza(R)
PHILADELPHIA, Jan. 17 -- GlaxoSmithKline, one of the world's largest vaccine manufacturers, has been awarded a contract from the U.S. Department of Health and Human Services (HHS) for the development of pre-pandemic and pandemic flu vaccines. With a value of at least $63.3 million, the contract supports GSK's ongoing pandemic vaccine research in using the company's innovative adjuvant technology in combination with antigens to induce a strong immune response.
Under the terms of the contract, GSK will engage in research and development leading towards licensure of antigen-sparing pre-pandemic and pandemic vaccines with adjuvant that will help the U.S. Government extend the limited North American supply of pandemic flu vaccines to protect larger populations in the event of a flu pandemic. The 5-year contract also gives the U.S. Government the option to fund an additional $44 million of future clinical development programs related to antigen-sparing pandemic vaccines.
"A limited global supply capacity of flu antigen makes it critical that we use innovative adjuvant system technology to produce a new generation of flu pandemic vaccines," said David Stout, President of Pharmaceuticals at GlaxoSmithKline. "GSK's research in adjuvant technology over the past two decades uniquely positions our company to develop adjuvants designed to boost immune response and give broader protection while using smaller amounts of antigen. This award leverages our adjuvant expertise, and supports GSK's short and long-term vision of helping governments around the world in their pandemic preparedness efforts."
In a separate action related to pandemic preparedness GSK also announced that the company has begun shipping up to 15.5 million treatment courses of its antiviral Relenza® (zanamivir for inhalation). The Relenza shipments are part of GSK's agreement with the Federal Government announced last year to provide the U.S. Government and the states with Relenza for building their flu pandemic stockpiles. GSK also has started to ship Relenza to retail pharmacies to fulfill patient prescriptions for seasonal flu treatment and prevention.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies, and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.
About GSK Biologicals
GSK Biologicals, based in Rixensart, Belgium, is the vaccine division of GlaxoSmithKline. As one of the world's leading vaccine manufacturers, GSK Biologicals employs more than 1,500 scientists devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems.
GSK's 2005-2007 Milestones in Pandemic Preparedness
January 2007: GSK begins supplying its antiviral Relenza® zanamivir for inhalation), to the U.S. Government and begins working with private-sector businesses and other organizations to provide Relenza as part of their business continuity planning.

December 2006: GSK received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use CHMP) for its candidate alum-adjuvanted pandemic vaccine. GSK plans to submit a file to the European regulatory authorities in the coming weeks for the licensing of both a pandemic and a pre-pandemic vaccine with our proprietary adjuvant system technology.

November 2006: GSK received a $40 million initial order for bulk H5N1 antigen from HHS.

2006: GSK signs contracts with several countries for pre-pandemic vaccines.

September 2006: GSK reached an agreement with the Simcere Pharmaceutical Group of Nanjing, China, granting the right to manufacture and sell the antiviral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnam and all Least Developed Countries.

July 2006: Clinical studies announced by GSK showed promising preliminary results on the potential immunogenicity of a vaccine for pandemic flu using a GSK novel proprietary adjuvant system.

May 2006: GSK received an award of $274 million to develop cell-culture technology to speed the development of new cell-culture-based seasonal and pandemic influenza vaccines scale-up cell-culture manufacturing capability at GSK's Marietta, PA site.

2005: GSK made three important acquisitions in North America: a vaccine manufacturing site in Marietta for cell-culture-based flu vaccines and secondary operations; Corixa Corporation, for its work in developing innovative adjuvants designed to stimulate immunity; and ID Biomedical, which offered a significant increase in flu vaccine manufacturing capacity to help address both seasonal and pandemic influenza threats.

Press Release: BMS Announces Agreement In Principle to Settle Federal Investigation

Maureen Martino — Wed, 20 Dec 2006 13:41:47 -0500

Bristol-Myers Squibb Announces Agreement In Principle to Settle Federal Investigation Into Pricing, Sales And Marketing Practices

Company Lowers GAAP 2006 Earnings Guidance and Reaffirms non-GAAP 2006 Earnings Guidance

NEW YORK, December 21, 2006 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company ("the Company"), the United States Department of Justice, and the Office of the United States Attorney for the District of Massachusetts have reached an agreement in principle, subject to approval by the U.S. Department of Justice (DOJ), to settle several investigations involving the Company's drug pricing, and sales and marketing activities. The investigations began several years ago.

The agreement in principle provides for a civil resolution and an expected payment of $499 million. There would be no criminal charges against the Company. The agreement in principle also provides for the Company to enter into a corporate integrity agreement with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS). The settlement is contingent upon the parties' agreement to the terms of a final settlement agreement, including on the terms of the corporate integrity agreement, and approval by the DOJ. There can be no assurance that the settlement will be finalized.

As a result of the agreement in principle, the Company has increased its reserves related to these investigations by $353 million, bringing the aggregate reserves for these matters to $499 million. The increased reserve will be recorded in the fourth quarter of 2006. The aggregate reserves reflect the Company's estimate of the expected probable loss with respect to these matters, assuming the settlement is finalized. If the settlement is not finalized, the amount reserved may not reflect eventual losses.

In addition, the Company will record an estimated pre-tax charge of $220 million for the previously disclosed debt restructuring completed in the fourth quarter. This charge is unrelated to the agreement in principle.

The two charges discussed above were not reflected in the Company's previously issued 2006 earnings guidance. Accordingly, the Company is lowering its 2006 full-year earnings guidance for fully diluted earnings per share from continuing operations on a GAAP basis to between $0.72 and $0.77, from $0.97 and $1.02 as previously provided at the end of the third quarter of 2006. The Company's revised GAAP guidance is based on the assumption that none of the expected payment under the settlement agreement will be tax deductible. The Company's previous accrual of $146 million in connection with the matter also was recorded on the assumption that there would not be any tax benefit associated with the charge. The Company expects that a portion but not all of the expected $499 million settlement payment will be tax deductible, although the amount of the tax benefit cannot be reasonably estimated at this time.

The Company reaffirms its 2006 full-year earnings guidance of between $1.02 and $1.07 on a non-GAAP basis, with the expectation that its full-year non-GAAP earnings will be in the upper end of that range. The Company's non- GAAP earnings guidance excludes "specified items" as discussed under "Use of Non-GAAP Financial Information," below. Details reconciling adjusted non-GAAP amounts with the amounts reflecting specified items are also provided below. The non-GAAP guidance provided above does not include other specified items, which may occur during the remainder of the year, such as milestone payments in connection with previously announced external development, copromotion or alliance charges and payments for in-process research and development, gains or losses from asset disposals, charges related to new transactions, charges and recoveries relating to significant legal proceedings, and restructuring activities.

For additional discussion of the investigations referenced above, see "Item 1. Financial Statements Note 18. Legal Proceedings and Contingencies," in the company's Form 10-Q Quarterly Report for the period ending September 30, 2006.

Bristol-Myers Squibb is a global pharmaceutical and related health care products Company whose mission is to extend and enhance human life.

Use of Non-GAAP Financial Information

This press release contains non-GAAP earnings per share information adjusted to exclude certain costs, expenses, gains and losses and other specified items. Among the items in GAAP earnings but excluded for purposes of determining adjusted earnings are: gains or losses from sale of businesses and product lines; from sale or write-down of equity investments and from discontinuations of operations; restructuring items that meet the requirements of SFAS 112 for severance and SFAS 146 for other exit costs; accelerated depreciation charges under SFAS 144 related to restructuring items described above; asset impairments; charges and recoveries relating to significant legal proceedings; upfront and milestone payments for in-licensing of products that have not achieved regulatory approval that are immediately expensed; copromotion or alliance charges and payments for in-process research and development which under GAAP are immediately expensed rather than amortized over the life of the agreement; income from upfront and milestone payments that is immediately recognized for out-licensing of products, including deferred income recognized upon termination; costs of early debt retirement; and significant tax events, including the repatriation of special dividends pursuant to the AJCA. This information is intended to enhance an investor's overall understanding of the company's past financial performance and prospects for the future. For example, non-GAAP earnings per share information is an indication of the company's baseline performance before items that are considered by the Company to be not reflective of the company's operational results. In addition, this information is among the primary indicators the Company uses as a basis for evaluating company performance, allocating resources, setting incentive compensation targets, and planning and forecasting of future periods. This information is not intended to be considered in isolation or as a substitute for diluted earnings per share prepared in accordance with GAAP.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the prospective settlement of a litigation matter. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the settlement will be finalized and receive required approval from the U.S. Department of Justice. If the settlement is not finalized, there is no guarantee that claims would not be made against the company, and that there would not be a material financial impact. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2005, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Press Release: HHS Cancels VaxGen's Anthrax Vaccine Contract

Maureen Martino — Wed, 20 Dec 2006 12:52:40 -0500

HHS Cancels VaxGen's Anthrax Vaccine Contract

BRISBANE, Calif., Dec. 19 -- VaxGen, Inc. announced today that the Department of Health and Human Services (HHS) has terminated for default the company's contract to provide 75 million doses of a modern anthrax vaccine for civilian biodefense. HHS based the decision on its determination that VaxGen "failed to successfully cure the condition endangering performance and failed to" meet a milestone imposed by HHS that required VaxGen to initiate a clinical trial of the vaccine candidate by December 18, 2006.

Press Release: FDA Maintains Clinical Hold on VaxGen's Anthrax Vaccine Trial

Maureen Martino — Tue, 19 Dec 2006 11:21:28 -0500

FDA Maintains Clinical Hold on VaxGen's Anthrax Vaccine Trial

BRISBANE, California – December 18, 2006 – VaxGen, Inc. announced today that the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) has informed the company that it is maintaining its clinical hold on the company's second Phase II trial for its investigational anthrax vaccine. The hold is due to CBER's continued concerns about the vaccine candidate's stability.

The Department of Health and Human Services (HHS), under its contract with VaxGen to purchase 75 million doses of its recombinant anthrax vaccine, rPA102, had imposed a deadline of today, December 18, for the company to initiate its next clinical trial for the vaccine candidate. The Office of Public Health Emergency Preparedness (OPHEP), the office within HHS that administers the contract, has yet to inform VaxGen what direction it intends to take with respect to the contract.

At a recent meeting with CBER, which was also attended by OPHEP representatives, VaxGen presented its expanded number of methods for measuring the vaccine's potency and stability, and its progress toward further enhancing the stability of the vaccine's formulation. Based on that exchange, VaxGen believes that CBER wishes to engage the company in additional, more detailed technical discussions about the analytical methods and formulation development. However, the clinical hold will remain in place until sufficient vaccine stability has been demonstrated to resume clinical testing.

About VaxGen
VaxGen, Inc. is a biopharmaceutical company engaged in the development, manufacture and commercialization of biologic products for the prevention and treatment of human infectious diseases, including anthrax and smallpox. VaxGen has been awarded an $877.5 million contract by HHS to provide 75 million doses of a modern anthrax vaccine for civilian biodefense. Based in Brisbane, Calif., VaxGen operates a wholly owned manufacturing facility in California and owns a minority interest in Celltrion, Inc., a company in the Republic of Korea established to provide contract manufacturing to the global pharmaceutical industry. For more information, please visit the company's web site at www.vaxgen.com.

Note: This press release contains "forward-looking statements" within the meaning of the federal securities laws. These forward-looking statements include, without limitation, statements regarding VaxGen's ability to address FDA/CBER's concerns over vaccine stability, to resolve the clinical hold imposed by FDA/CBER and to perform under its contract with HHS. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Item 8.01 of the company's Current Report on Form 8-K filed by VaxGen on February 16, 2006 under the heading "Risk Factors" for a more detailed description of such risks. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. VaxGen undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

Contacts:
Lance Ignon
Vice President, Corporate Affairs
(650) 624-1016

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HHS awards H5N1 contracts

Mon, 20 Nov 2006 19:01:38 -0500

The Department of Health and Human Services has awarded a total of $199.45 million to three vaccine makers in order to stockpile 5.3 million additional doses of H5N1 vaccine. The bulk of the money--$117.9 million--has been awarded to Sanofi Pasteur for 3.7 million doses of the drug. Novartis has received $40.95 million for 800,000 doses and GSK also garnered $40.6 million for 800,000 doses. "These newest vaccine purchases supplement the existing stockpile of 5.9 million doses of H5N1 vaccine and build on the department's plans to buy enough vaccine for 20 million people," HHS stated in a press release. At two 90-microgram doses per person, HHS says these purchases provide enough courses to vaccinate nearly 2.7 million people. Initial studies of these vaccines show that they may protect against the bird flu, but the HHS noted that further testing is underway to fully determine their effect.

- see the HHS press release

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Press Release: GSK to supply and store H5N1 vaccine products for US flu pandemic stockpiling

Maureen Martino — Mon, 20 Nov 2006 15:26:31 -0500

GSK to supply and store H5N1 vaccine products for US flu pandemic stockpiling

GlaxoSmithKline awarded HHS contract

Philadelphia, PA, November 20, 2006–– GlaxoSmithKline (NYSE:GSK), one of the world’s largest vaccine manufacturers, today announced it has been awarded a contract to supply pre-pandemic vaccines to the US strategic national stockpile. The company has received an initial $40 million order under the contract from the U.S. Department of Health and Human Services (HHS) for bulk H5N1 antigen - the substance in the vaccines that will help produce an immune response.

Under the terms of the contract, GSK will manufacture and store bulk H5N1 antigen using its recently acquired production facilities in North America. Terms of the contract also state that GSK may be directed by HHS to formulate this bulk antigen at some point in the future. Additionally, HHS also has the option to purchase pre-pandemic vaccines together with one of GSK’s proprietary adjuvant systems, which could mean that less antigen would be needed per dose to achieve a protective immune response. Funding for this contract is provided through the HHS Office of Public Health Emergency Preparedness and the Office of Public Health Emergency Medical Countermeasures.

“We applaud the US government’s proactive steps in protecting American citizens against this potential public health threat,” said David Stout, President, Pharmaceutical Operations, GlaxoSmithKline. “We are committed to helping governments and public health officials around the world effectively respond to the global threat of a flu pandemic and we are pleased to be working with the US government in its preparedness efforts.”

GSK remains in active discussions with other governments to supply their public health programs and has been steadily increasing its support to flu pandemic preparedness efforts globally, leveraging the company’s vaccine and anti-viral expertise.

About GlaxoSmithKline

GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and health care companies, and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: www.gsk.com.

About GSK Biologicals

GSK Biologicals, based in Rixensart, Belgium, is the vaccine division of GlaxoSmithKline. As one of the world’s leading vaccine manufacturers, GSK Biologicals employs more than 1,500 scientists devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems.

Editor’s note

In 2005, GSK made three important acquisitions in North America: a vaccine manufacturing site in Marietta, Pennsylvania, for cell-culture-based flu vaccines and secondary operations; Corixa Corporation, for its work in developing innovative adjuvants designed to stimulate immunity; and ID Biomedical, which offered a significant increase in flu vaccine manufacturing capacity to help address both seasonal and pandemic influenza threats.

GSK was the first company to submit a “mock-up” dossier for an egg-based pandemic vaccine with traditional alum adjuvant to European regulators.

In May 2006, GSK announced, along with HHS, that it had received an award of $274 million to develop cell-culture technology to speed the development of new cell culture-based seasonal and pandemic influenza vaccines, and to scale-up cell culture manufacturing capability at GSK’s Mariettasite.

Clinical studies announced by GSK in July of this year showed promising preliminary results on the potential immunogenicity of a vaccine for pandemic flu using a GSK novel proprietary adjuvant system.

GSK has supplied its anti-viral, Relenza ® (zanamivir for inhalation), to the U.S. government and is now working with private-sector businesses and other organizations to provide Relenza ® as part of their business continuity planning.

A new agreement with the Simcere Pharmaceutical Group of Nanjing, China, granting Simcere the right to manufacture and sell the anti-viral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnamand all Least Developed Countries.

The US is one of several countries to sign a contract with GSK for a pre-pandemic vaccine.

BioShield revamp adds $1B in research funds

Tue, 14 Nov 2006 19:01:37 -0500

In an effort to salvage the deeply troubled $5.6 billion Project BioShield program, Congress is scrambling to pass new legislation that would inject a fresh $1 billion into the project while establishing a central authority inside HHS to oversee the development of new vaccines. BioShield's single largest venture is its billion-dollar effort to develop a new anthrax vaccine at VaxGen. That project has been repeatedly held up and is now stymied by the FDA's refusal to allow human trials to get underway. HHS has also threatened to terminate the contract. Other projects, meanwhile, have been held up as developers struggle to push through programs the government can't pay for until they near approval. The government had thought its commitment to stockpile vaccines against a bioterror attack would gain the interest of large companies with deep enough pockets to fund research. But that formula has been a bust, as the big developers steered away from what looked like long odds on gaining short profits. The new money lawmakers are considering for Project BioShield would fund research, essentially acting as a billion-dollar venture capital outfit.

- check out the article on BioShield from The Washington Post

Related Articles:
Project BioShield fails to deliver. Report
New bioterror bill could provide fresh funds. Report
VaxGen's vaccine program in doubt. Report

FEATURE: A Step in the Right Direction?

Thu, 17 Aug 2006 20:01:32 -0400

A Step in the Right Direction?

By Mike Scott

On November 14, 2002, Mark McClellan was appointed Commissioner of the U.S. Food and Drug Administration and held the position for 14 months. Lester Crawford was confirmed to replace Dr. McClellan on July 18, 2005, and held the office for just 2 months. Indeed, since David Kessler stepped down in February 1997 there has been a confirmed Commissioner of the FDA for less than 4 of the following 9 and a half years. This is not a track record to cheer about. And the stature of the FDA has suffered badly as a consequence.

No one who works in the U.S. biotechnology or pharmaceutical industries can be in much doubt today about the range of challenges facing any individual who holds the office of Commissioner. Not only did Dr. Kessler set a new standard for activism as a holder of this office, but the increasing attempts to influence the decisions of the FDA through political, legal, social, commercial, and other channels has made this position one of the most visible and perhaps unenviable public positions in modern US government. Indeed, the Commissioner commonly has greater name recognition than his or her superiors in the Department of Health and Human Services.

If one puts aside personal political views and accepts that the FDA "adheres to [four] fundamental principles that frame its actions and lead to more effective public health results," as stated on its Web site, it should be noted that the current Acting Commissioner, Andrew von Eschenbach, has made a strong start in seeking to fill the shoes of some of his more successful predecessors.

Dr. von Eschenbach has moved quickly to address one of the most difficult situations outstanding at the FDA: Barr Laboratories' application for approval of Plan B as an over-the-counter agent for the prevention of pregnancy. It may be that without such action, his ability to gain Congressional approval for his appointment would have proved impossible. It may be that, as a friend of the Bush family, he was able to persuade the Administration in the White House that such action was a political imperative.

One can think of a lot of such, "It may be's." The facts, however, speak volumes about Dr. von Eschenbach's apparent desire to make it clear that, under his leadership, the FDA will seek to be judged on the scientific validity of its decision-making process, even if a little compromise is necessary along the way.

The signs are now strong that Barr Laboratories will gain an approval to market Plan B as an over-the-counter agent available to any woman of 18 years or older. Women under the age of 18 will continue to require a prescription for this drug. Some may claim that this is still a "political" decision and that the FDA should have approved the availability of this agent for younger women as an OTC agent, as originally recommended by an FDA Advisory Committee. And of course such an approval will be a political decision but it would be a good political decision at a time when this nation is torn by strongly held emotional and religious beliefs not only about when life begins but also about when and how life can end. Plan B should become widely available to adults and younger persons will be required to seek some professional guidance associated with the product's use.

The pharmaceutical and biotechnology industries must take a strong stand alongside Dr Eschenbach in support of this decision. The nation is in desperate need of an individual who can and will bring real leadership to the FDA, and who can be relied on to place a premium on the importance of sound science as the imperative that will guide FDA decision-making for the foreseeable future. Small compromises may be necessary on occasion for all sorts of reasons, but good scientific evidence as the fundamental basis for action is the principle that will best benefit the American public and FDA-regulated industries.

Few of us will agree with every decision that Dr. von Eschenbach makes if he is confirmed as Commissioner, but most of us should agree that a strong Commissioner who takes decisive action is essential.

Mike Scott is a principal and executive vice president of Vox Medica, Inc., a Philadelphia-based group of healthcare communications companies.

Report faults FDA's postmarketing vigilance

Sun, 09 Jul 2006 20:01:39 -0400

A report released by the Department of Health and Human Services found that the FDA doesn't always follow up on the status of marketed drugs. Post-approval studies are used to determine the long-term effects and unanticipated complications from a drug, and almost half of the drugs approved between 1994 and 2004 were required to conduct at least one postmarketing study. But HHS noted that of the 336 annual reports due in 2004, 35 percent were missing or contained no useful data. Additionally, the FDA reviewed only about 30 percent of the reports that were filed. The HHS's report concluded that postmarketing vigilance was not high on the list of the FDA's priorities. In response, FDA acting commissioner Andrew von Eschenbach said, "While we embrace several recommendations for improvement that are outlined in the report, we do not agree that FDA cannot readily identify whether or how timely postmarketing study commitments are progressing."

In the wake of the Vioxx debacle, postmarketing vigilance has taken on a new importance. If the HHS' investigation is accurate, such lapses have serious implications and could leave the door open for another major safety failure.

- read this Forbes report for more

Senator makes dramatic demand in Ketek probe

Wed, 14 Jun 2006 20:01:37 -0400

Senator Chuck Grassley (R-IA) says he suspects the FDA is involved in a cover-up of its activities involving the controversial antibiotic Ketek, citing the agency's refusal to make one of its investigators available for questioning. Grassley showed up at the Department of Health and Human Services to make his demands known and quickly filled in reporters after he left with nothing. HHS says that they aren't involved in a cover-up, claiming that they've already turned over more than 400 boxes of information on Ketek and wouldn't offer up the investigator in the middle of an agency inquiry. One point of contention is the use of data from a clinical trial for Ketek that was riddled with fraud. Safety data from that trial was presented to an FDA committee, which wasn't told about the problems that surrounded the study.

- read the article from The Washington Post on Ketek

Novartis wins $220M flu vaccine contract

Wed, 03 May 2006 20:01:37 -0400

Novartis has won a $220 million contract to supply cell culture-derived flu vaccine to the Department of Health and Human Services. The deal will help support seasonal flu programs as well as preparation efforts for a possible bird flu pandemic and the biopharma giant announced plans to create a new manufacturing site in the country using a biotech process to make vaccines. "We will be investing additional resources in highly skilled researchers to set up one of the first flu cell culture manufacturing sites in the US. This plant will contribute to America's vaccine infrastructure for seasonal flu and support the US government's ability to respond quickly to a potential pandemic, with access to new technologies to ensure sufficient capacity," said Novartis CEO Dr. Daniel Vasella.

- read the release on the contract

PLUS: A new study indicates the ideal dosage of Tamiflu for fighting bird flu. Article

ALSO: Noted virologist Robert Webster says that cultural prohibitions on autopsies in Asian countries are hampering scientific efforts to understand bird flu. Report