FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers

The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Even with appropriate antibiotics and intensive care, between 10 percent and 15 percent of people who develop meningococcal disease die from the infection. Another 10 percent to 20 percent suffer complications such as brain damage or loss of limb or hearing.

Although the rates of meningococcal disease are low in the United States, infants and toddlers are more susceptible to getting this serious illness. Meningococcal disease is particularly dangerous because it progresses rapidly and can cause death within hours. Early symptoms are often difficult to distinguish from influenza and other common illnesses.

“The highest rate of meningococcal disease occurs in children under one year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease,” said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which over 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability. Occurrence of fever was comparable to other vaccines routinely recommended for young children.

Menactra is given as a two-dose series beginning at 9-months, three months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

Menactra was originally approved on Jan. 14, 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years. Menactra is manufactured by Sanofi Pasteur Inc. of Swiftwater, Pa.

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Expansion of HIV/AIDS Vaccine Program Announced by GeoVax Labs, Inc.

/PRNewswire/ -- GeoVax Labs, Inc. (OTCQB/OTCBB: GOVX), announced today that it is expanding its preventative HIV/AIDS vaccine development effort in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) and the HIV Vaccine Trials Network (HVTN). Specifically, the HVTN plans to clinically test a novel vaccine product developed by GeoVax scientists that expresses human granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with inactivated HIV proteins. The novel vaccine consists of a recombinant DNA vaccine co-expressing human GM-CSF and non-infectious HIV virus-like-particles. The DNA vaccine is used to prime immune responses that are subsequently boosted by vaccination with a recombinant modified vaccinia Ankara (MVA) vectored vaccine. The MVA expresses the HIV virus-like-particles, but does not express GM-CSF. The regimen builds on the GeoVax DNA/MVA vaccine that is currently in Phase 2a clinical testing through the HVTN.

GM-CSF is a cytokine (growth stimulating protein) that serves to expand and mature cells that initiate immune responses and has undergone extensive testing in humans for cancer vaccines. The GM-CSF-adjuvanted vaccine was added to GeoVax's portfolio because of the outstanding ability of the simian prototype vaccine to induce immune responses that prevented simian immunodeficiency virus (SIV) infection. In nonhuman primates, the GM-CSF enhanced vaccine achieved protection against SIV in 70% of the animals. Protection was measured against 12 weekly rectal challenges using a dose of SIV which is estimated to be 30 to 300 times higher than the typical exposure dose of HIV in mucosal transmission in humans.

"For years, the HIV vaccine field has been working with vaccines that elicited immune responses that primarily controlled immunodeficiency virus challenges in infected animals, but did not actually prevent infections. The ultimate goal is to prevent infections. The co-expression of GM-CSF with the SIV proteins is a vaccine design that appears to be a large step towards reaching this goal," said Dr. Harriet Robinson, Chief Scientific Officer at GeoVax. "In our trials in nonhuman primates, GM-CSF enhanced the quality of the SIV-specific antibody response. Antibody is present in blood and tissues and has the potential of blocking SIV before it infects cells. The GM-CSF-adjuvanted vaccine induced the production of antibodies characterized with increased tightness of antibody binding. The tightness of antibody binding, known as avidity, can be expressed as an index. Animals with indices above 40 were protected from infection, whereas animals with lower indices were infected with the number of challenges to infection correlating with their index."

"We are very pleased that the HVTN will be conducting trial HVTN 094 of our GM-CSF adjuvanted vaccine product, which we expect will begin late this year," said Dr. Robert McNally, CEO of GeoVax. "The HVTN, funded by the NIAID, is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. We are looking forward to working with an excellent team of HVTN trial investigators."

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FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age

The Food and Drug Administration (FDA) today approved the use of Zostavax, a live attenuated virus vaccine, for the prevention of shingles in individuals 50 to 59 years of age. Zostavax is already approved for use in individuals 60 years of age and older.

In the United States shingles affects approximately 200,000 healthy people between the ages of 50 and 59, per year. It is a disease caused by the varicella-zoster virus, which is a virus in the herpes family and the same virus that causes chickenpox. After an attack of chickenpox, the virus lies dormant in certain nerves in the body. For reasons that are not fully understood, the virus can reappear in the form of shingles, more commonly in people with weakened immune systems and with aging.

"The likelihood of shingles increases with age. The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease" said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

Shingles is characterized by a rash of blisters, which generally develop in a band on one side of the body and can cause severe pain that may last for weeks, and in some people, for months or years after the episode.

Approval was based on a multicenter study conducted in the United States and four other countries in approximately 22,000 people who were 50-59 years of age. Half received Zostavax and half received a placebo. Study participants were then monitored for at least one year to see if they developed shingles. Compared with placebo, Zostavax reduced the risk of developing shingles by approximately 70 percent.

The most common side effects observed in the study were redness, pain and swelling at the site of injection, and headache.

Zostavax was originally approved on May 26, 2006, for the prevention of shingles in individuals 60 years of age and older.

Zostavax is manufactured by Merck & Co. Inc., of Whitehouse Station, New Jersey.

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FDA: Gardasil approved to prevent anal cancer

The U.S. Food and Drug Administration today (December 22) approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females. It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.

Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN. Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well.

Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination. For all of the indications for use approved by the FDA, Gardasil's full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Individuals recommended for anal cancer screening by their health care provider should not discontinue screening after receiving Gardasil.

As of May 31, 2010, more than 65 million doses of Gardasil had been distributed worldwide, since its approval in 2006 according to the manufacturer, Merck and Co. Inc, of Whitehouse Station, N.J. The most commonly reported adverse events include fainting, pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries. This can be prevented by keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.

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New Low-Cost Method to Deliver Vaccine Shows Promise

/PRNewswire/ -- Researchers have developed a promising new approach to vaccination for rotavirus, a common cause of severe diarrheal disease that is responsible for approximately 500,000 deaths among children in the developing world every year. In a study published in the November issue of Clinical and Vaccine Immunology, a vaccine delivered as nasal drops effectively induced an immune response in mice and protected them from rotavirus infection. The new vaccine delivery system has also been tested successfully and found to be heat stable with tetanus and is currently being tested with diphtheria and pertussis.

The team from the Cummings School of Veterinary Medicine at Tufts University and Tufts University School of Medicine collaborated with researchers from Boston and Tulane Universities to test the effectiveness of immunization with harmless bacteria that were engineered to display rotavirus protein.

"The new vaccine, in conjunction with an agent that enhances immunity, induced sufficient antibody formation against rotavirus to protect mice against infection when the mice were exposed to rotavirus three weeks after their third immunization," explained John E. Herrmann, Ph.D., research professor in the infectious diseases division of the department of biomedical sciences at the Cummings School of Veterinary Medicine at Tufts University and the senior author of the published study.

"We created the rotavirus vaccine using a harmless bacterium called Bacillus subtilis (B. subtilis), which we can modify to display on its surface or in its cytoplasm proteins from infectious bacteria and viruses. When people are exposed to these proteins, they develop antibodies against them and therefore become immune to the bacteria and viruses," said the study's first author Sangun Lee, Ph.D., DVM, research associate at the Cummings School. "The B. subtilis bacteria are so harmless that they are part of the normal diet in several Asian countries."

"The vaccine with the Bacillus bacteria is very inexpensive to produce in large quantities and, unlike most traditional vaccines, requires no special purification steps before use. As a result, the cost of vaccine production is unusually low," explained Saul Tzipori, BVSc (DVM), DSc, Ph.D., Agnes Varis University Chair in Science and Society, distinguished professor of microbiology and infectious diseases, and director of the infectious diseases division of the department of biomedical sciences at the Cummings School. These findings are consistent with the team's previous studies in which they demonstrated that B. subtilis bacteria displaying a fragment of tetanus toxin protein completely protect mice from tetanus. Tetanus vaccines have been stored for more than a year at 113(o)F without any loss of potency, a property that may be common to all B. subtilis vaccines.

Vaccines currently available have to be stored in refrigerators or freezers until the moment they are administered. This cold chain is difficult and costly to maintain. In many parts of the world, there is insufficient refrigeration or electricity to keep vaccines cold. The lack of refrigeration combined with the lack of trained personnel, especially in rural areas in developing countries, make it impossible for many children and adults to be vaccinated against standard infections, such as tetanus, rotavirus, diphtheria, pertussis (whooping cough) and other diseases.

"In addition to being heat-stable and low-cost, the B. subtilis vaccines are given in the form of nasal drops or spray. A needle-free approach to vaccination is particularly advantageous in developing countries where clean needles and syringes and trained personnel are not always available," said team leader Abraham L. (Linc) Sonenshein, Ph.D., professor and acting chair of molecular biology and microbiology at TUSM and member of the genetics and microbiology program faculties at the Sackler School of Graduate Biomedical Sciences at Tufts.

"This vaccine project is still in the developmental stage," he continued. "The next major step for these vaccines is to show that they are safe and work well in humans, and then to extend the rotavirus and tetanus vaccine technology to include diphtheria, pertussis and other infectious diseases. Those diseases cause tens of thousands of deaths, particularly in newborns and in South-East Asia. We are actively looking for partners in the U.S. and around the world to help us pursue our goal of reaching the point where many childhood and adult vaccines can be manufactured in a way that avoids the need for injection or refrigeration. Jerry Keusch of Boston University School of Public Health and I started this project 15 years ago, and it has taken a long time to reach the stage where we now have effective needle-free vaccines. The technology has now advanced enough that we can expect to be successful with many other vaccines in a short time frame."

Additional authors include Boris R. Belitsky, Ph.D., assistant research professor in the department of molecular biology and microbiology at TUSM; James P. Brinker, M.P.H, in the department of biomedical sciences at the Cummings School; Kathryn O. Kerstein, MS, senior research associate in the department of molecular biology and microbiology at TUSM; David W. Brown, Ph.D., DVM, clinical assistant professor in the infectious diseases division of the department of biomedical sciences at the Cummings School; Gerald T. Keusch, MD, professor in the department of international health at Boston University School of Public Health, professor of medicine at Boston University School of Medicine and U.S. chairman of the Indo-U.S. Vaccine Action Program at the National Institutes of Health; and John D. Clements, Ph.D., professor and chair of the department of microbiology and immunology at Tulane University Health Sciences Center.

This study was supported by a grant from the Grand Challenges in Global Health program of the Bill and Melinda Gates Foundation, and this grant was administered by the Foundation for the National Institutes of Health. Patent applications related to the discoveries reported in these studies have been filed by Tufts University.

Lee S, Belitsky BR, Brinker JP, Kerstein KO, Brown DW, Clements JD, Keusch GT, Tzipori S, Sonenshein AL, Herrmann JE. Clinical and Vaccine Immunology.. 2010 (November); 17 (11): 1647-1655. "Development of a Bacillus subtilis-based rotavirus vaccine." DOI: 10.1128/CVI/00135-10.

Lee S, Belitsky BR, Brown DW, Brinker JP, Kerstein KO, Herrmann JE, Keusch GT, Sonenshein AL, Tzipori S. Vaccine. 2010 (September 24); 28 (41), 6658-6665. "Efficacy, heat stability and safety of intranasally administered Bacillus subtilis spore or vegetative cell vaccines expressing tetanus toxin fragment C." DOI:10.1016/j.vaccine.2010.08.016.

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NIH Awards $10 Million to Develop Microneedle Vaccine Patch

The National Institutes of Health (NIH) has awarded $10 million to the Georgia Institute of Technology, Emory University and PATH, a Seattle-based nonprofit organization, to advance a technology for the painless, self-administration of flu vaccine using patches containing tiny microneedles that dissolve into the skin.

The five-year grant will be used to address key technical issues and advance the microneedle patch through a Phase I clinical trial. The grant will also be used to compare the effectiveness of traditional intramuscular injection of flu vaccine against administration of vaccine into the skin using microneedle patches. In animals, vaccination with dissolving microneedles has been shown to provide immunization better than vaccination with hypodermic needles.

"We believe that this technology will increase the number of people being vaccinated, especially among the most susceptible populations of children and the elderly," said Mark Prausnitz, a professor in the Georgia Tech School of Chemical and Biomolecular Engineering, and the project's principal investigator. "If we can make it easier for people to be vaccinated and improve the effectiveness of the vaccine, we could significantly reduce the number of deaths caused every year by influenza."

Vaccine-delivery patches contain hundreds of micron-scale needles so small that they penetrate only the outer layers of skin. Their small size would allow vaccines to be administered without pain -- and could allow people to apply the patches themselves without visiting medical facilities.

While the ability to immunize large numbers of people without using trained medical personnel is a key advantage for the microneedle patch, the researchers have learned that administering the vaccine through the skin creates a different kind of immune response -- one that may protect vaccine recipients better.

"We have seen evidence that the vaccine works even better when administered to the skin because of the plethora of antigen presenting cells which reside there," said Ioanna Skountzou, co-principal investigator for the project and an assistant professor in Emory University's Department of Microbiology and Immunology. "This study will allow us to determine how we can optimize the vaccine to take advantage of those cells that are important in generating the body's immune response."

Among the issues to be addressed in the five-year study are:

• Developing an administration system that will be simple to use, intuitive and reliable. "Our goal is to make these patches suitable for self-administration, so that anybody could take a patch out of an envelope, put it on, and have it work with high reliability," Prausnitz said.

• Studying the long-term stability of vaccine used in the patches, and optimizing technology for incorporating it into the dissolving microneedles. "We need to put the vaccine into a dry form in this patch," said Prausnitz. "That will require different processing than is normally done with vaccines. We expect that this dry vaccine will provide enough stability that the patches can be stored without refrigeration."

• Evaluating the economic, regulatory, social and medical implications of a self-administered vaccine. PATH, an international nonprofit organization, will assist with this work, and will help strategically address any issues. "We will be assessing the barriers that may exist to introduction of a self-administered flu vaccine so we can anticipate those issues and develop possible solutions," said Darin Zehrung, leader of the vaccine delivery technologies group at PATH.

The funding will come from the Quantum program of the National Institute of Biomedical Imaging and Bioengineering (NBIB), which is part of the NIH. The initiative is designed to bring new medical technologies into clinical use.

While the funding focuses specifically on influenza vaccination, the lessons learned may advance other microneedle applications -- including vaccination efforts in developing countries where skilled medical personnel are limited and concerns about re-use of hypodermic needles are significant.

Additional design and development of the microneedle patch will largely be done at Georgia Tech, with vaccine development, immunological studies and the Phase I trial carried out at Emory University. The trial, to be conducted by the Hope Clinic of the Emory Vaccine Center, is expected to take place during the final year of the grant, setting the stage for Phase II and Phase III clinical trials that would be required to obtain FDA approval.

Ultimately, the goal will be to produce an influenza vaccine delivery patch that could be made widely available. Prausnitz expects that will be done by an established company with the ability to manufacture and market the devices.

Microneedle drug and vaccine delivery systems have been under development at Georgia Tech and elsewhere since the 1990s. The technology got a significant boost in July of 2010 with publication of a study in Nature Medicine that showed mice vaccinated with dissolving microneedles were protected against influenza at least as well as mice immunized through traditional hypodermic needle injections.

The patches used in that study contained needles just 650 microns long, assembled into arrays of 100 needles. Pressed into the skin, the needles quickly dissolved into bodily fluids thanks to their hydrophilic polymer material, carrying the vaccine with them and leaving only a water-soluble backing. In contrast, use of hypodermic needles leaves the problem of "sharps" disposal.

Prausnitz hopes that the $10 million in NIH funding will help accelerate development of the microneedle patches to make them available for general use within five to ten years.

"This research will focus on optimizing the microneedle-based delivery of vaccines into the skin and understanding how this method affects immune responses both at the mucosal surfaces of the body and through the systemic response inside the body," added Skountzou. "Combined with the convenience of self-administration, painless application and absence of sharps waste, this novel immunization route could make the microneedle patch a powerful new weapon against infectious diseases."

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FDA Grants Orphan Drug Status for Personalized Cancer Vaccine, BiovaxID®, Targeting Mantle Cell Lymphoma

(BUSINESS WIRE)--Biovest International, Inc. (OTCQB: “BVTI”) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest’s personalized cancer vaccine, for a second lymphoma indication: mantle cell lymphoma. Mantle cell lymphoma is an aggressive and lethal B-cell blood cancer for which there is no current consensus standard-of-care. Mantle cell lymphoma is the newest disease for which Biovest has announced its intent to pursue regulatory approval for and Orphan Drug Designation represents a significant development step in the Company’s regulatory strategy. The FDA previously granted Orphan Drug Designation for BiovaxID for the treatment of indolent follicular non-Hodgkin’s lymphoma. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage, patient-specific cancer vaccines vying to be among the first to reach market.

With FDA Orphan Drug Status granted for this second indication, Biovest gains seven-years of market exclusivity for BiovaxID upon approval for the treatment of mantle cell lymphoma and/or indolent follicular lymphoma, thereby offering competitive protection from similar drugs of the same class. Orphan Drug Status also provides Biovest with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduces the requisite filing fees for marketing applications.

According to Biovest’s Vice President, Product Development & Regulatory Affairs, Dr. Carlos F. Santos, “Orphan Drug Designation is an important step in our regulatory strategy. With promising clinical trials now complete in both follicular lymphoma and mantle cell lymphoma, we are preparing to seek regulatory approvals for BiovaxID in two separate indications. In addition to our ongoing regulatory efforts with regard to follicular lymphoma, we look forward to formally presenting our mantle cell Phase II clinical trial results to the FDA, and potentially the EMEA, later this year, as we explore potential expedited market registration pathways to offer this therapeutic vaccine regimen as a new treatment option for mantle cell patients.”

In the BiovaxID mantle cell lymphoma Phase II study, tumor-specific immune responses were observed in 87% of the patients vaccinated with BiovaxID following rituximab-containing chemotherapy (EPOCH-R). Consistent with all other BiovaxID studies, the vaccine was very well tolerated and safe.

Biovest’s President, Samuel S. Duffey added, “As we prepare to exit reorganization as a fully restructured public company, we remain firmly committed to our goal to bring needed new therapies to patients suffering with lymphoma. I am pleased that we received Orphan Designation for mantle cell lymphoma, and I am excited about our opportunity to potentially advance the role of personalized cancer vaccines for the treatment of lymphoma.”

About Biovest International, Inc.

Biovest International, Inc. is an emerging leader in the field of active personalized immunotherapies targeting life-threatening cancers of the blood system. Developed in collaboration with the National Cancer Institute, BiovaxID® is a patient-specific, cancer vaccine, demonstrating statistically significant Phase III clinical benefit by prolonging disease-free survival in vaccinated patients suffering from indolent follicular non-Hodgkin’s lymphoma, confirming a previous positive Phase II study. BiovaxID has been granted “Fast-Track” status and Orphan Drug Designation for the treatment of follicular lymphoma by the FDA and Orphan Drug Designation by the European EMEA. A BiovaxID Phase II clinical trial treating patients suffering with mantle cell lymphoma, an incurable and aggressive type of non-Hodgkin’s lymphoma, also demonstrated promising results with the FDA granting Orphan Drug Designation for this second targeted indication.

Biovest is also developing and marketing a proprietary line of automated hollow fiber bioreactor systems, including the innovative AutovaxID™ which is a production platform for the scalable manufacture of difficult-to-produce biologics including personalized medicines, monoclonal antibodies, cell culture vaccines and therapeutics targeting highly infectious agents. Since 1981, Biovest has been offering its clients a wide range of instrumentation and cell culture contract manufacturing services. Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the OTCQB™ Market with the stock-ticker symbol “BVTI”, and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC: “ABPIQ”).

For further information, please visit: http://www.biovest.com

Forward-Looking Statements:

Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to statements about BiovaxID®, AutovaxID™, events occurring after dates hereof, and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.

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Vaccine-Delivery Patch with Dissolving Microneedles Boosts Protection

A new vaccine-delivery patch based on hundreds of microscopic needles that dissolve into the skin could allow persons without medical training to painlessly administer vaccines -- while providing improved immunization against diseases such as influenza.

Patches containing micron-scale needles that carry vaccine with them as they dissolve into the skin could simplify immunization programs by eliminating the use of hypodermic needles -- and their "sharps" disposal and re-use concerns. Applied easily to the skin, the microneedle patches could allow self-administration of vaccine during pandemics and simplify large-scale immunization programs in developing nations.

Details of the dissolving microneedle patches and immunization benefits observed in experimental mice were reported July 18th in the advance online publication of the journal Nature Medicine. Conducted by researchers from Emory University and the Georgia Institute of Technology, the study is believed to be the first to evaluate the immunization benefits of dissolving microneedles. The research was supported by the National Institutes of Health (NIH).

"In this study, we have shown that a dissolving microneedle patch can vaccinate against influenza at least as well, and probably better than, a traditional hypodermic needle," said Mark Prausnitz, a professor in the Georgia Tech School of Chemical and Biomolecular Engineering.

Just 650 microns in length and assembled into an array of 100 needles for the mouse study, the dissolving microneedles penetrate the outer layers of skin. Beyond their other advantages, the dissolving microneedles appear to provide improved immunity to influenza when compared to vaccination with hypodermic needles.

"The skin is a particularly attractive site for immunization because it contains an abundance of the types of cells that are important in generating immune responses to vaccines," said Richard Compans, professor of microbiology and immunology at Emory University School of Medicine.

In the study, one group of mice received the influenza vaccine using traditional hypodermic needles injecting into muscle; another group received the vaccine through dissolving microneedles applied to the skin, while a control group had microneedle patches containing no vaccine applied to their skin. When infected with influenza virus 30 days later, both groups that had received the vaccine remained healthy while mice in the control group contracted the disease and died.

Three months after vaccination, the researchers also exposed a different group of immunized mice to flu virus and found that animals vaccinated with microneedles appeared to have a better "recall" response to the virus and thus were able to clear the virus from their lungs more effectively than those that received vaccine with hypodermic needles.

"Another advantage of these microneedles is that the vaccine is present as a dry formulation, which will enhance its stability during distribution and storage," said Ioanna Skountzou, an Emory University assistant professor.

Pressed into the skin, the microneedles quickly dissolve in bodily fluids, leaving only the water-soluble backing. The backing can be discarded because it no longer contains any sharps.

"We envision people getting the patch in the mail or at a pharmacy and then self administering it at home," said Sean Sullivan, the study’s lead author from Georgia Tech. "Because the microneedles on the patch dissolve away into the skin, there would be no dangerous sharp needles left over."

The microneedle arrays were made from a polymer material, poly-vinyl pyrrolidone, that has been shown to be safe for use in the body. Freeze-dried vaccine was mixed with the vinyl-pyrrolidone monomer before being placed into microneedle molds and polymerized at room temperature using ultraviolet light.

In many parts of the world, poor medical infrastructure leads to the re-use of hypodermic needles, contributing to the spread of diseases such as HIV and hepatitis B. Dissolving microneedle patches would eliminate re-use while allowing vaccination to be done by personnel with minimal training.

Though the study examined only the administration of flu vaccine with the dissolving microneedles, the technique should be useful for other immunizations. If mass-produced, the microneedle patches are expected to cost about the same as conventional needle-and-syringe techniques, and may lower the overall cost of immunization programs by reducing personnel costs and waste disposal requirements, Prausnitz said.

Before dissolving microneedles can be made widely available, however, clinical studies will have to be done to assure safety and effectiveness. Other vaccine formulation techniques may also be studied, and researchers will want to better understand why vaccine delivery with dissolving microneedles has been shown to provide better protection.

Beyond those already mentioned, the study involved Jeong-Woo Lee, Vladimir Zarnitsyn, Seong-O Choi and Niren Murthy from Georgia Tech, and Dimitrios Koutsonanos and Maria del Pilar Martin from Emory University.

"The dissolving microneedle patch could open up many new doors for immunization programs by eliminating the need for trained personnel to carry out the vaccination," Prausnitz said. "This approach could make a significant impact because it could enable self-administration as well as simplify vaccination programs in schools and assisted living facilities."

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Abzyme Research Foundation Announces Promising HIV Vaccine Candidate

/PRNewswire/ -- The Abzyme Research Foundation announces today that Dr. Sudhir Paul, a scientist at University of Texas Houston Medical School, has identified an important immunological deficiency in HIV-infected patients and has created a promising HIV vaccine candidate that rectifies the deficiency. The discoveries were presented on July 19th and 20th, 2010 at the XVII International AIDS Society Conference in Vienna, Austria.

The HIV vaccine candidate has been tested in mice and rabbits. It was effective in inducing the production of protective antibodies that stopped the HIV from infecting human blood cells in laboratory tests.

Dr. Paul and his colleagues discovered that HIV patients do not produce sufficient protective antibodies of a type called IgG that are capable of attacking the vulnerable CD4 binding site on the HIV. The virus binds to human host cells through this site to cause infection. The CD4 binding site is a small part of gp120, a protein found on the surface of HIV. Studies of mice injected with gp120 confirmed an insufficient IgG response to the CD4 binding site. Previous vaccine tests by other researchers used the gp120 protein itself without success in protecting against infection.

"Using an electron-seeking form of gp120, we triggered the production of the crucial IgG antibodies to the CD4 binding site in animals," said Dr. Paul. "We believe this method is the key to developing an HIV vaccine."

Dr. Paul's team has found that chemical stimulation of the immune system by electron-seeking (electrophilic) proteins is the central step for rectifying the defective antibody response to the CD4 binding site. Since the structure of the CD4 binding site is very similar in all HIV strains throughout the world, a globally effective HIV vaccine may be possible.

Lead E-VAC Candidate

The researchers have developed a synthetic electrophilic vaccine candidate, or E-VAC, which works by focusing the antibody response at the CD4 binding site. The E-VAC is a synthetic portion of gp120 that successfully mimics the shape of the CD4 binding site expressed by the HIV virus. Administration of E-VAC to animals induces antibodies with enzymatic activity, or abzymes. Unlike traditional antibodies that neutralize the target on a 1:1 basis, abzymes are significantly more efficacious because each abzyme molecule can neutralize thousands of target molecules.

E-VAC administered to mice and rabbits induced the production of blood-borne IgG antibodies that blocked the infection of human cells by genetically divergent HIV-1 strains from across the world.

"We are backing the research of Dr. Paul's team because his approach using abzymes shows enormous progress in creating an HIV vaccine," said Alan Kleiman, chairman of the board for the Abzyme Research Foundation. "Our foundation aims to drive discovery and innovation in the field of HIV research in hopes of one day eliminating the HIV/AIDS pandemic."

The lead E-VAC was developed from recent proof-of-concept studies that validated targeting of the CD4 binding site and chemical stimulation of the immune system as published recently by Dr. Paul's team in the journals AIDS and The Journal of Biological Chemistry. The work is being conducted at the University of Texas Houston Medical School and California Department of Public Health with support from the National Institutes of Health.

In addition to Dr. Paul, key contributors are Drs. Stephanie Planque, Yasuhiro Nishiyama and Carl Hanson. Dr. Planque is presenting the results at the Vienna AIDS Conference. Dr. Planque's paper was selected by International AIDS Society for the IAS/ANRS Young Scientist Award to be presented at the Conference.

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First Smallpox Vaccine for Special Populations Delivered Under Project BioShield

Delivery to the Strategic National Stockpile of the first 1 million doses of the nation's first smallpox vaccine for certain immune-compromised populations is now complete, the result of a Project
BioShield contract.

Under this contract the Danish company Bavarian Nordic is manufacturing and delivering 20 million doses of its next generation smallpox vaccine known as modified vaccinia Ankara (MVA) or Imvamune. Delivery of the first million doses began in May and deliveries will continue through
2013. The contract is administered by the Biomedical Advanced Research and Development Authority, BARDA, a part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

In an emergency, such as the virus being obtained from a secure lab and used in an act of terrorism, the vaccine may be authorized for use to protect people who have weakened immune systems, specifically HIV persons who have not progressed to AIDS. Addressing the needs of such special populations is mandated under the Pandemic and All-Hazards Preparedness Act (PAHPA).

The Strategic National Stockpile (SNS), operated by the Centers for Disease Control and Prevention (CDC), has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency, such as a terrorist attack or flu outbreak, severe enough to cause local supplies to run out. Once federal and local authorities agreed that the SNS supplies were needed medicines could be delivered to any state in the U.S. within 12 hours. Each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible.

Project BioShield gives BARDA the contracting authority to develop and procure medical countermeasures against chemical, biological, nuclear and radiological threat agents. In 2007, Bavarian Nordic was awarded a $505 million contract to develop and deliver the MVA smallpox vaccine to the SNS. This contract was the first to use advance and milestone payments under Project BioShield as modified by PAHPA.

"This product began with a basic research and development program initiated by the National Institute of Allergy and Infectious Disease at the National Institutes of Health in 2003, and progressed to the point that Project BioShield could be used for further development and procurement," said BARDA Director Dr. Robin Robinson. "It represents a concerted, coordinated effort among federal agencies and with the private sector throughout the R&D process. It's a model for us going forward."

As a next step, BARDA is supporting Bavarian Nordic's work to improve the product further by developing a freeze-dried version of Imvamune. The freeze-dried formulation may have an improved shelf-life, reduced storage costs, and simplified transportation logistics compared to the
current vaccine formulation.

U.S. government agencies including BARDA, CDC, the National Institutes of Health, the Food and Drug Administration, and the Department of Defense have collaborated to develop requirements and policies, provide guidance, and work with manufacturers to develop and procure smallpox
medications and vaccines - known as medical countermeasures - for the SNS.

BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides a comprehensive integrated portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing
infrastructure building of the necessary vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health medical emergencies including chemical, biological, radiological, and nuclear threats, and pandemic influenza, and emerging infectious diseases. For additional information, visit www.hhs.gov/aspr.

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ARCA Launches First Therapeutic Trial with GeoVax Vaccine

PRNewswire-- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced today The AIDS Research Consortium of Atlanta (ARCA) has received approval to begin enrollment of the first therapeutic trial ever conducted using a promising HIV vaccine candidate from GeoVax, Inc. Although the GeoVax vaccines are currently being studied for HIV prevention, this is the first study using the same products for treatment of persons who already have HIV infection. ARCA is the only site for this trial.

"ARCA is pleased to be conducting this important clinical trial," said Dr. Melanie Thompson, Principal Investigator for ARCA. "New approaches to HIV treatment are critically needed, and an effective therapeutic vaccine would be an important tool in our ongoing efforts to treat people with HIV infection. A vaccine that enhanced the body's ability to control HIV and delayed or decreased the dependence on anti-HIV drugs would be a major breakthrough for HIV treatment."

To be eligible for the study, persons should have had a negative HIV test followed by a positive test up to 6 months later, and they should have started drugs to fight HIV within 6 months of being diagnosed. The study will last up to 77 weeks. All patients will be followed closely for safety and for the ability of the vaccine to elicit protective immune responses in vaccinated participants. Patients will be compensated for their participation in the study. Only 10 to 12 persons will be selected to participate. Persons who believe they may qualify for the study should contact ARCA at vaccine@arcatlanta.org or 404-876-2317. ARCA is also interested in identifying possible candidates who fit the enrollment criteria but have not yet started anti-HIV drugs.

ARCA worked together with GeoVax to design the protocol for the Phase 1 clinical trial. The trial is based on the achievement of excellent post-vaccine viral control in animal studies conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University.

About the AIDS Research Consortium of Atlanta

ARCA is a registered 501(c)(3) not-for-profit clinical research, testing, outreach and educational organization founded in 1988. ARCA works through a network of more than 50 physicians and 5 public health clinics to conduct clinical drug and vaccine trials and prevention research studies. 2 ARCA also provides patient and care-provider educational programs, free STD testing for men, and free, anonymous HIV testing when funds are available. More than 6000 Atlantans have learned their HIV status through ARCA's HIV testing program. ARCA has become one of the most respected and successful HIV/AIDS research facilities in the country over the past two decades by enrolling more than 2,000 metro Atlanta residents in more than 300 clinical drug trials that provide the latest investigational HIV/AIDS medications at no cost to them. ARCA has contributed key scientific information leading to the FDA approval of more than 27 individual and combination drugs now available for people with HIV/AIDS worldwide. ARCA was one of only three centers in the US that participated in a Centers for Disease Control and Prevention (CDC) study to test the safety of tenofovir, an existing HIV medicine, as a possible tool to prevent HIV infections. Over a 14 year period, ARCA enrolled more than 10.000 Atlantans with HIV infection in a CDC study to better understand HIV and AIDS. In all, more than 20,000 Atlantans have participated in ARCA studies and services. For more information, visit www.arcatlanta.org.

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FDA Revises Recommendations for Rotavirus Vaccines

The U.S. Food and Drug Administration today revised its recommendations for rotavirus vaccines for the prevention of the disease in infants and has determined that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

The agency reached its decision based on a careful evaluation of information from laboratory results from the manufacturers and the FDA’s own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, including members of the FDA’s Vaccines and Related Biological Products Advisory Committee that convened on May 7, 2010 to discuss these vaccines.

The FDA also considered the following in its decision:

* Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of vaccine recipients.
* The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans.
* The benefits of the vaccines are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. These benefits outweigh the risk, which is theoretical.

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Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk

FDA is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.

The agency recently became aware that an independent U.S. academic research team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1) in Rotarix, which is manufactured by GlaxoSmithKline. PCV1 is not known to cause illness in humans or other animals. In addition, Rotarix has been studied extensively, before and after approval, and found to have an excellent safety record.

Follow-up tests by GlaxoSmithKline and FDA scientists confirmed the academic team’s findings and confirmed that viral components have been present since the early stages of the vaccine’s development, including during clinical studies. Preliminary testing by both the academic researchers and FDA scientists of another licensed vaccine against rotavirus infection, RotaTeq, has not detected components of PCV1.

"We are making clinicians aware of information recently received by FDA about the Rotarix vaccine,” said Dr. Margaret A. Hamburg, Commissioner for Food and Drugs. “There is no evidence at this time that there is a safety concern. FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation. We will keep the public and the clinical community updated on our findings.”

Rotarix and RotaTeq are given by mouth to young infants to prevent rotavirus disease, which can cause severe diarrhea and dehydration and is estimated to be responsible for the deaths of more than 500,000 infants around the world each year, primarily in low- and middle-income countries. Before the introduction of a rotavirus vaccine, rotavirus resulted in more than 50,000 hospitalizations and several dozen deaths in the United States each year. FDA licensed RotaTeq in 2006 and Rotarix in 2008. Most children vaccinated in the United States received RotaTeq.

“In many countries, rotavirus causes so much severe illness and death that the known benefits of continued use of Rotarix far outweigh any theoretical risk of harm from the vaccine,” said Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention. “We anticipate that many countries will decide to continue vaccinating with Rotarix while more information becomes known.”

FDA will continue to gather more information about the PCV1 components in Rotarix, including whether intact virus, as opposed to DNA fragments, is present. The agency is assessing current vaccine testing methods. In four to six weeks, FDA will convene an expert advisory committee and make additional recommendations on the use of rotavirus vaccines.

FDA will provide updates to patients, providers, and the general public as more information becomes available. The agency will also continue to communicate with the World Health Organization and counterpart regulatory agencies in other countries.

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FDA Approves Pneumococcal Disease Vaccine with Broader Protection

The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

Prevnar 13 is approved for the prevention of invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumoniae. It also is approved for the prevention of otitis media caused by the seven serotypes shared with Prevnar. The bacterium can cause infections of the blood, middle ear, and the covering of the brain and spinal cord, as well as pneumonia.

“Although the rates of invasive pneumococcal disease have declined dramatically, there are still children in the United States who are suffering with this serious illness,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “The availability of Prevnar 13 will help prevent pneumococcal disease caused by the six additional serotypes.”

The seven Streptococcus pneumoniae serotypes against which Prevnar is directed accounted for about 80 percent of IPD in young children in North America at the time that the vaccine was licensed. With the use of Prevnar, by 2007 the overall rate of IPD caused by these seven serotypes in children less than 5 years old was reduced by 99 percent. However, at that time, it was also shown that of the remaining invasive pneumococcal disease in this age group, 62 percent are caused by the six additional serotypes that will be included in Prevnar 13.

Safety was evaluated in 5,084 infants and young children who received Prevnar 13, compared with 2,760 who received Prevnar, the control vaccine. Common adverse reactions reported after administration of Prevnar 13 were pain, redness and swelling at the injection site, irritability, decreased appetite and fever. These reactions were similar to what has been observed with Prevnar, which has a good safety record in the United States.

Vaccine effectiveness was assessed in a randomized U.S. multi-center immunogenicity study. Prevnar 13 post-vaccination antibody response comparisons to Prevnar were evaluated by several immunological measures. An evaluation of all these measures showed that Prevnar 13 induced antibodies that were comparable to those shown to be protective in Prevnar.

Post marketing studies will include continued monitoring for reduction in IPD and otitis media, as well as continued evaluation of safety.

The vaccine is administered in a four-dose schedule given at 2, 4, 6 and 12-15 months of age. The vaccine is available in single-dose, pre-filled syringes.

Prevnar 13 is manufactured by Wyeth Pharmaceuticals Inc. of Collegeville, Pa., a wholly owned subsidiary of Pfizer Inc.

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MERIAL Receives Full License Approval for ONCEPT(TM) Canine Melanoma Vaccine

/PRNewswire/ -- Merial, a world-leading animal health company, has gained full-licensure from the U.S. Department of Agriculture for ONCEPT(TM) Canine Melanoma Vaccine, DNA. ONCEPT is a breakthrough vaccine indicated for aiding in extending survival of dogs with stage II or stage III oral canine melanoma, a common yet deadly form of cancer in dogs.

ONCEPT is the first and only USDA-approved, therapeutic vaccine for the treatment of cancer - in either animals or humans.

Traditionally, dogs with stage II or stage III malignant melanoma survive less than five to six months when treated with surgery alone.(1) Clinical studies of ONCEPT demonstrated significantly longer life spans even in dogs with stage II or stage III of oral melanoma. In fact, median survival time of dogs treated with ONCEPT could not be determined because more than 50 percent of the treated dogs were still living melanoma-free at the conclusion of the study or died of unrelated illness.(2)

Canine oral melanoma is a common type of cancer in dogs and is the most common malignant tumor of the dog's mouth. It can also be seen in the nail and footpad.(3) Canine melanoma may be seen in any breed and is a highly aggressive cancer that frequently spreads throughout the body, including the lymph nodes, liver, lungs and kidneys.(4) To date, the most common treatments for this form of cancer have been radiation and surgery to establish local tumor control. Canine oral melanoma, however, has a high propensity to metastasize to other parts of the body and is often resistant to chemotherapy.(2,3)

"Canine melanoma spreads readily, and, unfortunately, existing treatments have not succeeded in controlling the disease," said Dr. Bob Menardi, a veterinarian and spokesperson for Merial. "ONCEPT is a new adjunct treatment option for dogs that have been diagnosed with this often fatal disease."

The vaccine was developed through a partnership between Merial and Memorial Sloan-Kettering Cancer Center. While Memorial Sloan-Kettering was testing a human melanoma vaccine, they received an inquiry from Dr. Philip Bergman - who at the time was with Animal Medical Center, and currently with Brightheart Veterinary Center - seeking novel treatments for canine melanoma. The discussions resulted in clinical trials of the Memorial Sloan-Kettering melanoma vaccine, and subsequent parallel trials by Dr. Bergman and Memorial Sloan-Kettering refined the dosage and protocol to the current therapeutic regimen for dogs. Dr. Bergman completed the initial clinical work on ONCEPT at Animal Medical Center in New York.

"We're very excited about continuing research into this vaccine to explore the potential implications it has for humans. We hope this will result in improved cancer treatment for all," explained Jedd D. Wolchok, MD, PhD, a medical oncologist who specializes in immunotherapy on the Melanoma and Sarcoma Service at Memorial Sloan-Kettering and also Associate Director of the Ludwig Center for Cancer Immunotherapy.

The USDA issued a conditional U.S. Veterinary Biological Product License for ONCEPT in 2007. During the period of conditional licensure, ONCEPT was available to veterinary oncologists as Merial conducted additional research to further support the safety and efficacy of the vaccine.

The results of that research led to the full licensure of ONCEPT. Merial obtained licensing rights from Memorial Sloan-Kettering and Dr. Philip Bergman, and, using their access to and experience with DNA vaccine technology licensed from Vical Incorporated (NASDAQ:VICL) , completed the industrialization and regulatory requirements for full licensure. The vaccine will be administered via a Canine Transdermal Device, which delivers the vaccine without the use of a needle.(5) The device was developed in conjunction with Bioject, Inc., a Portland-based drug delivery company (OTC Bulletin Board: BJCT).

"The Canine Transdermal Device makes administration of the vaccine easy and quick for oncologists and their patients, leaving one less worry for dog owners dealing with their pet's cancer treatment" said Dr. Richard Stout, executive vice president and chief medical officer of Bioject. "We are proud to work with Merial in bringing this breakthrough product to market."

"The approval of ONCEPT is a milestone in the cancer vaccine field and a significant advancement for our DNA delivery technology platform," said Vijay B. Samant, Vical's President and Chief Executive Officer. "Therapeutic vaccines -- the holy grail of vaccinology -- are delivered after disease onset to impede disease progress for the patient's benefit. We believe this achievement is a major step toward the initial approvals of therapeutic vaccines for humans."

ONCEPT is available for use by specialists practicing veterinary oncology, so pet owners will want to ask their veterinarians about how best to access this treatment option.

Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,700 people and operates in more than 150 countries worldwide. Its 2009 sales were $2.6 billion. Merial is the Animal Health subsidiary of sanofi-aventis. For more information, please see www.merial.com.

Bioject Medical Technologies Inc., based in Portland, Oregon, is an innovative developer and manufacturer of needle-free injection therapy systems (NFITS). NFITS provide an empowering technology and work by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. The Company is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies. For more information about Bioject, visit www.bioject.com.

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. Additional information on Vical is available at www.vical.com.

(1) Bergman PJ, Wolchok JD. Of Mice and Men (and Dogs): development of a xenogeneic DNA vaccine program for canine malignant melanoma. Cancer Therapy 2008;6:817-826.

(2) Data on file at Merial. Study 05-171. 2009.

(3) Bergman PJ, et al. Development of a xenogeneic DNA vaccine program for canine malignant melanoma at the Animal Medical Center. Vaccine 2006;24:4582-4585.

(4) Liao JCF, et al. Vaccination with human tyrosinase DNA induces antibody responses in dogs with advanced melanoma. Cancer Immunity 2006;6:8-17.

(5) ONCEPT product label.

ONCEPT(TM) is a trademark of Merial.

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FDA Commissioner Addresses Nation's Health Care Professionals on H1N1 Vaccine Safety

FDA Commissioner Margaret A. Hamburg today sent a letter to America’s health care professionals thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on safety monitoring of the 2009 H1N1 vaccines.

“In November, I wrote to thank you for your efforts during the 2009 H1N1 influenza outbreak and to provide information about the development and FDA approval of the H1N1 vaccines,” Hamburg wrote. “I mentioned our continuing robust efforts to monitor the safety of these vaccines and now would like to reassure you that, to date, the safety assessment is very encouraging.

“As a key part of our missions, the FDA, the Centers for Disease Control and Prevention, other agencies across the Department of Health and Human Services, and other parts of the federal government, including the Department of Defense and the Department of Veterans Affairs, have enhanced and expanded our vaccine safety monitoring systems to detect and quickly investigate any unexpected, rare, or serious adverse events. These additional systems enhance our ability to determine whether any adverse events can be attributed to H1N1 influenza vaccines. A detailed description of vaccine safety efforts is available online at www.flu.gov.

“According to the January 8, 2010 update of FDA and CDC vaccine safety monitoring activities, as of December 30, 2009 the total number of doses of H1N1 vaccines distributed was 99.3 million and the vast majority (94%) of adverse events reported to VAERS were classified as "non-serious" (e.g., soreness at the vaccine injection site). Weekly updates on FDA and CDC vaccine safety monitoring activities are available through the VAERS web site http://vaers.hhs.gov/resources/h1n1update#top.”

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FDA Approves Agriflu Seasonal Influenza Vaccine

The U.S. Food and Drug Administration today approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved using the FDA’s accelerated approval pathway, which helps safe and effective medical products for serious or life-threatening diseases become available sooner. In this case, Novartis demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.

Agriflu is administered as a single injection in the upper arm and is available in single dose, pre-filled syringes that do not contain preservatives.

“The approval of the new seasonal influenza vaccine, Agriflu, is an important step in adding to the production capacity to enhance the supply of vaccine for the United States for future influenza seasons,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Common side effects in clinical studies included pain, swelling and redness at the injection site, headache, muscle aches and malaise. People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

As part of the accelerated approval process, Novartis is required to conduct further studies to verify that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza. The company also manufactures another licensed seasonal influenza vaccine, Fluvirin, for use in the United States. Fluvirinis approved for people ages 4 years and older. Agriflu is not intended to protect against the 2009 H1N1 influenza.

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FDA Approves Additional Vaccine for 2009 H1N1 Influenza Virus

The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.

As with the four previous H1N1 influenza vaccines licensed by the FDA on Sept.15, 2009, ID Biomedical Corporation will manufacture its H1N1 vaccine using the established, licensed egg-based manufacturing process used for producing seasonal flu vaccine.

Potential side effects of this H1N1 vaccine are expected to be similar to those of the seasonal and H1N1 flu vaccines. The most common side effect is soreness at the injection site. Others may include mild fever, body aches and fatigue for a few days after the inoculation.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is collaborating with other government agencies to enhance adverse event safety monitoring during and after the H1N1 2009 vaccination program.

ID Biomedical’s H1N1 monovalent vaccine will be produced in multi-dose vials, in a formulation that contains thimerosal.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

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FDA Expands Use of CSL Limited’s Seasonal and H1N1 Vaccines to Infants and Children

The U.S. Food and Drug Administration has approved the use of the CSL Limited’s seasonal and 2009 H1N1 influenza vaccines to include children ages 6 months and older. These vaccine were previously approved for use in adults, ages 18 years and older

“Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of vaccines available for use in children is an important step in responding to the H1N1 outbreak,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

The company’s 2009 H1N1 vaccine is manufactured and tested using the same well-established licensing processes that have been in place for many years for the company’s seasonal flu vaccine.

The approval was based on a study of the company’s seasonal flu vaccine in children, showing both the vaccine's safety and its ability to induce antibodies expected to protect against influenza. These findings supported approval under FDA's accelerated approval regulations, which help safe and effective medical products for serious or life-threatening diseases to become available sooner to the public.

Common adverse events experienced by children after administration of seasonal and H1N1 vaccines typically include pain, redness and swelling at the injection site as well as, in some cases, irritability, loss of appetite and drowsiness.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

Because CSL’s seasonal and H1N1 monovalent vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products.

The vaccines will be available both in single-dose, preservative-free, pre-filled syringes and in multi-dose vials that contain thimerosal, a mercury derivative, as a preservative.

Both vaccines are manufactured by CSL Ltd. of Australia.

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FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use

The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

The safety and effectiveness of Fluarix for use in children ages 3 years and older is documented by a U.S. study comparing 2,115 children who received Fluarix with 1,210 children who received Fluzone, a different influenza vaccine already licensed by the FDA for use in children ages 6 months and older. Study results showed that children 3 years and older vaccinated with Fluarix and Fluzone produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza.

Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.

"This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems.”

With today’s approval, there are now four companies approved by the FDA to manufacture seasonal influenza vaccine for use in children.

Influenza is far more dangerous than the common cold for children, who often require medical care, especially if they are younger than 5 years. It is best to vaccinate children each fall, but vaccination also can occur in the winter months when influenza season often peaks.

Common adverse events experienced after administration of Fluarix are typical of those for flu shots and include pain, redness, and swelling at the injection site as well as irritability, loss of appetite, and drowsiness.

Because Fluarix contains a small amount of egg protein, it should not be administered to anyone allergic to eggs or egg products.

Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.

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