Emergent BioSolutions Inc. (NYSE:EBS) announced that it has received a contract from the Department of Health and Human Services (HHS) for over $24.3 million to fund the further development of Emergent’s anthrax monoclonal antibody AVP-21D9. This contract will be jointly administered through the Office of the Biomedical Advanced Research and Development Authority (BARDA), and the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH). The four year contract provides funding for scale-up of the manufacturing process, for non-clinical studies, and for a Phase I clinical trial. Emergent anticipates that it will receive approximately $20 million over the first two contract years in support of the scale-up of the manufacturing process and the completion of a Phase I clinical trial. Emergent expects to focus on completing certain non-clinical studies during the final two years of the contract.

“We are very pleased to have secured this important contract with HHS. The AVP-21D9 antibody is a fully human antibody that has demonstrated very high affinity to the anthrax toxin in animal studies and shows great promise as an effective post-exposure anthrax therapeutic. We believe this funding from HHS underscores the U.S. government’s commitment to a multi-prong approach in responding to the threat of bioterrorism in our country. We are certainly encouraged that we were able to secure this contract so soon following our acquisition of AVP-21D9 earlier this year,” said Stephen Lockhart, senior vice president, product development of Emergent BioSolutions.

The continued development of this anthrax monoclonal antibody candidate further solidifies Emergent’s franchise of anthrax countermeasures, which now includes:

BioThrax® - the only FDA-approved vaccine to prevent anthrax. More than two million men and women of the United States military have received the vaccine, and HHS has procured more than 28 million doses of BioThrax for the SNS;

rPA - a recombinant anthrax vaccine candidate, which is composed of a purified protein with an aluminum adjuvant and is designed to induce antibodies that neutralize anthrax toxins;

AV7909 - an anthrax vaccine candidate composed of BioThrax® and the immunostimulatory oligodeoxynucleotide compound CPG 7909 (VaxImmune®), licensed from Pfizer Inc;

AIG - a polyclonal anthrax immunoglobulin product candidate being developed as an intravenous post-exposure treatment for patients who present with symptoms of anthrax disease, AIG is derived from human plasma from individuals who have been vaccinated with BioThrax.

This project has been funded in whole or in part with Federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272200800040C and from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Grant No. U01AI070493-01.

About the AVP-21D9 anthrax monoclonal antibody candidate

AVP-21D9 is a fully human anthrax monoclonal antibody that appears to be a highly active therapeutic for anthrax based on laboratory and animal studies conducted to date. This could be due to its putative mechanism of action compared to other monoclonal candidates under development - binding to protective antigen and inhibiting heptamer (pore) formation, rather than inhibiting binding of toxin to its receptor. Based on non-clinical studies in mice, rats, and rabbits, AVP-21D9 provides a high level of protection even in animals with clinical symptoms of anthrax. These studies indicate that AVP-21D9 has the potential to be a life-saving medical countermeasure and to fill an important unmet need. AVP-21D9 was acquired from Avanir Pharmaceuticals (Nasdaq:AVNR) in March 2008, which advanced the technology through proof-of-concept studies and clinical-scale manufacturing funded by a NIAID grant.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a leading biopharmaceutical company dedicated to one simple mission-to protect life. Emergent develops, manufactures and commercializes immune related biologics, vaccines and biotherapeutics that assist the body’s immune system to prevent or treat infectious and other life threatening diseases. Emergent’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s clinical pipeline includes programs targeting anthrax, botulism, typhoid, tuberculosis and hepatitis B. http://www.emergentbiosolutions.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our expected revenue growth and net earnings for 2008, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the timing of, and the potential for successful outcomes resulting from future product development efforts and our ability to obtain additional funding from the U.S. government for them, and other factors identified in the company’s current report on Form 10-Q for the quarter ended June 30, 2008 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Emergent BioSolutions Inc.

Human arteries play distinct roles in the immune system depending on their anatomical location, researchers at Emory University School of Medicine have discovered.

Their findings explain why vascular diseases affect different parts of the arterial network and could help doctors fine-tune the treatment of such diseases as atherosclerosis and vasculitis. Atherosclerosis causes heart attacks and strokes because it occurs preferentially in arteries supplying the heart and the brain.

The results were published online this week by the journal Circulation.

Arteries can play an active role in sensing foreign invasion and bodily injury, because cells embedded in the arterial walls called dendritic cells act like smoke-sensing fire alarms for the immune system, says senior author Cornelia Weyand, MD. PhD, co-director of the Kathleen B. and Mason I. Lowance Center for Human Immunology at Emory University.

“All of our major arteries have this alarm system,” she says. “To our surprise, we found that the arteries of the neck, the arms, the abdomen and the legs are triggered by different infectious organisms. Thus, each artery functions in a specialized way.”

Some vascular diseases attack arteries only in the abdomen or in the neck and upper extremities, and this selectivity has puzzled doctors for years, Weyand says.

To probe the differences among arteries, Weyand and her co-workers examined the activity of genes that encode Toll-like receptors in blood vessels from human donors.

Toll-like receptors are a cornerstone of the “innate” immune system, which can be activated by common features of infection-causing invaders. The capture of bacterial or viral fragments through Toll-like receptors alerts the immune system early during an infectious attack. Toll-like receptors can respond to whip-like antennas on bacteria called flagellae, parts of bacterial cell walls, or DNA and RNA that leaks from viruses or bacteria.

Each type of artery had a different set of Toll-like receptor genes turned on, the authors found. In contrast to arteries, veins could not be stimulated through Toll-like receptors.

For example, cells in the iliac arteries, located in the vicinity of the gut, respond avidly to flagellae but cells from the subclavian arteries, which transport blood to the upper body, do not.

A possible explanation is that dendritic cells from iliac arteries are better able to sense flagellae because of the abundant bacterial flora that inhabits the gut, Weyand says.

Weyand hypothesizes that the dendritic cells in arteries are mainly performing a protective, calming function. Arteries are in constant contact with blood borne infectious agents, with potentially dangerous consequences of damaging the vessel wall.

“It’s when that protective function breaks down that we see inflammation and various vascular diseases,” she says.

She says her team is now investigating how the dendritic cells in arteries move and change as they receive various signals.

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The first author of the paper is research specialist Olga Pryshchep, with contributions from postdoctoral fellow Wei Ma-Krupa, PhD, Joerg Goronzy, MD, PhD, co-director of the Lowance Center, and Brian Younge, MD, of the Mayo Clinic.

The research team used samples from 37 deceased donors with an average age of 64. Only arterial samples without atherosclerotic lesions were used.

The research was funded by the National Institutes of Health, the Dana Foundation and the McIntyre Family Discovery Fund.

Reference: Vessel-specific Toll-like receptor profiles in human medium and large arteries Circulation, Sep 2008; doi:10.1161/CIRCULATIONAHA.108.789172

Source: Holly Korschun
Emory University

Richard Cox, operating department practitioner, has been struck off the HPC Register for failing to disclose his conviction to the HPC and his employer, Sandwell and West Birmingham NHS Trust.

A panel of the HPC Conduct and Competence Committee heard when the lead practitioner for main theatres and surgical day unit theatres at the Trust had notified the police about missing drugs from the operating theatre, a list of all staff working on the relevant shifts was provided to the police. As a result of the police investigation the trust was informed that Richard Cox had a conviction.

The panel were also presented with a copy of the HPC registration/readmission form signed by Richard Cox and found that he failed to disclose his conviction.

Panel Chair, Martin Ryder commented:

“The Panel concluded that the registrant’s conviction for matters of dishonesty and deception fell well below the standards of honesty and integrity expected of a registered health professional. It was a matter of serious concern that the registrant had secured registration as an operating department practitioner on the basis of dishonesty and deception”

The panel decided the most appropriate action was to strike Richard Cox from the Register.

Richard Cox was not present at the hearing.

1. The Health Professions Council is an independent, UK-wide health regulator set up by the Health Professions Order (2001).? The HPC keeps a register for thirteen different health professions and only? registers people who meet the standards it sets for their training, professional skills, behaviour and health. The HPC will take action against health professionals who do not meet these standards or who use a protected title illegally.

2. Full details of this hearing will be posted online here.

3. Information about the HPC’s fitness to practise proceedings can be found on the HPC website here.

4. HPC currently regulate the following thirteen professions. Each of these professions has one or more ‘protected titles’. Anyone who uses one of these titles must register with the HPC. To see the full list of protected titles please see here.

-???? Arts therapists
-???? Biomedical scientists
-???? Chiropodists / podiatrists
-???? Clinical scientists
-???? Dietitians
-???? Occupational therapists
-???? Operating department practitioners
-???? Orthoptists
-???? Paramedics
-???? Physiotherapists
-???? Prosthetists / orthotists
-???? Radiographers
-???? Speech and language therapists

Source - Ebony Gayle
Health Professions Council

Sexual activities other than intercourse carry some risk of sexually transmitted infections, according to a report from the American College of Obstetricians and Gynecologists published recently in the journal Obstetrics and Gynecology, Reuters reports. An ACOG committee said that although many people engage in “noncoital” sexual activities — such as oral sex, mutual masturbation and anal sex — in an attempt to prevent pregnancy and reduce the risk of STIs, these sex acts come with some degree of STI risk, and it is important for people to protect themselves.

Richard Guido and colleagues wrote in the report that “[n]oncoital sexual activity is not necessarily ’safe sex.’” Guido added, “Most people, including adolescents, are unlikely to use condoms during oral sex, which places them at risk for acquiring” an STI. He added, “This unlikelihood is partly because of a greater perceived safety compared with intercourse.”

According to Reuters, the viruses that cause genital herpes, genital warts and hepatitis can be transmitted through oral sex. The bacteria that causes chlamydia, gonorrhea and syphilis also can be transmitted to oral sex. In terms of HIV/AIDS transmission, ACOG said that receptive anal sex carries the highest risk, followed by receptive vaginal sex. There also have been HIV/AIDS cases linked to oral sex, according to the report.

In the report, the panel advises physicians to ask both adult and teenage patients about all of their sexual activities and to counsel them on how to reduce the risk of STIs. Guido said that although this “is a sensitive issue to address for both patients and physicians, it’s important to discuss frankly and without judgment so that we can help our patients fully protect themselves” against STIs. The panel also recommends “correct and consistent” condom use for all types of sexual activity, but particularly for vaginal and anal sex. Other ways to curb STI transmission include staying in a mutually monogamous relationship and getting tested for STIs before starting a new relationship, the panel said (Reuters, 9/2).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2008 The Advisory Board Company. All rights reserved.

More than three-quarters of workers questioned in a national survey view paid sick days as a basic right of employment that should be guaranteed by the government, according to a survey recently conducted by the National Opinion Research Center at the University of Chicago and funded by the Public Welfare Foundation, Working Mother reports. In addition, the survey found that one out of six workers reported that they or a family member had been fired, threatened with being fired, suspended or punished for taking time off because of personal illness or to care for a sick child or relative.

Having paid sick days was considered “very important” by 77% of respondents, and 86% of those polled said employers should be required by law to provide them. Respondents also ranked paid sick days as being as important as receiving minimum wage, overtime pay, and family and medical leave. They also considered it more important than maximum hour limits and the right to join a union. According to the survey, 68% of workers without paid sick days go to work with the flu or some other contagious illness, compared with 53% of workers who receive paid sick days. Respondents said concern about sick employees spreading diseases at work is the most convincing argument for paid sick days legislation.

Strong support for paid sick days crosses all political and demographic lines and includes approval of pro-rated paid sick leave for part-time workers, according to the survey. It also found that people are considerably more likely to vote for a candidate who supports paid sick days for all workers. About 46% of respondents said they are more likely to vote for a candidate who supports paid sick days and 10% said they would be less likely to do so. Tom Smith, a senior fellow at NORC, said, “Supporting paid sick days is a plus for political candidates,” adding, “Both before and after hearing arguments for and against paid sick days, voters indicate they are more likely to vote for a candidate who backed this requirement.”

According to Working Mother, 40% of private sector workers and 75% of low-wage workers lack paid sick days. San Francisco and Washington, D.C., are the only jurisdictions that mandate paid sick days; however, a dozen states considered such legislation this year, and the issue will be on the ballot in Milwaukee and Ohio in November. Working Mother also reports that debate on the issue is expected to be taken up in more states next year, as well as by Congress when it considers the Healthy Families Act, which would provide seven paid sick days annually to workers in businesses with 15 or more employees.

Deborah Leff, president of the Public Welfare Foundation, said, “The lack of paid sick days has real consequences for Americans forced to choose between losing a day’s pay or going to work sick,” adding, “It’s difficult for employees to be productive when they are not well. They also expose co-workers and customers to illness. Providing paid sick day — which this survey shows is favored by the vast majority of Americans — is a simple matter of good employer practice and good public health” (Working Mother, 9/3).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2008 The Advisory Board Company. All rights reserved.

More than 100 researchers from many countries will share ideas on manufacturing techniques for newly developed miniature devices for a variety of industry sectors at the third International Conference On MicroManufacturing, Sept. 9-11 at Carnegie Mellon University.

Many fields, including medical, aerospace, military/defense, optics, automotive, consumer products, and communications, have been increasingly demanding miniature devices and components with complex micro-scale features made from a wide selection of materials. Some current applications of miniature parts - with dimensions ranging from a few micrometers to tens of millimeters - include miniature motors and turbines, micro-satellites, implantable medical devices, minimally invasive surgery equipment, micro robots, and miniature molds and dies. It is expected that miniature parts will be increasingly demanded in the future.

The 3rd International Conference on MicroManufacturing (ICOMM’08) focuses on the processes, equipment, and systems for fabricating miniature parts with micro-scale features. The conference will be held at Carnegie Mellon University in Pittsburgh, Pennsylvania, USA.

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Register

Source: Chriss Swaney
Carnegie Mellon University

As the Stand Up To Cancer campaign — being put forth by television’s “Big 3″ networks — is opening the nation’s eyes to the need and the benefit of cancer research dollars, The Cancer Institute of New Jersey (CINJ) is highlighting some of its groundbreaking studies being conducted by internationally recognized clinical investigators. CINJ is New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center and is a Center of Excellence of UMNDJ-Robert Wood Johnson Medical School.

September is National Prostate Cancer Awareness Month as well as Gynecologic Cancer Awareness Month, and CINJ is making experts available to comment on new studies, which may hold new treatment promise in these particular areas.

CINJ experts available for comment include:

Robert DiPaola, M.D., associate director for clinical science; chief, Division of Medical Oncology; executive director of the Dean and Betty Gallo Prostate Cancer Center at CINJ; and professor of medicine, UMNDJ-Robert Wood Johnson Medical School. He currently is the lead investigator at CINJ in the recently opened, Phase III clinical trial “Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favorable Risk Prostate Cancer,” also known as the START trial.

This international study is planning to accrue more than 2,100 participants from the United States, Canada and Europe, including 60 from CINJ. Patients with early stage prostate cancer will either undergo the usual standard of treatment, which is to either have radiation therapy or remove the prostate, while the other group will receive what is known as active surveillance, in which their disease will be monitored closely. Recent studies from investigators at CINJ have shown that there are benefits to active surveillance, since it avoids the risk of treatment side effects. The study is expected to take five years to complete.

Grace Lu-Yao, Ph.D., M.P.H., cancer epidemiologist at CINJ and associate professor of medicine at UMDNJ-Robert Wood Johnson Medical School. She was the lead investigator on a study, which showed conservative management can be a viable option to older men diagnosed with Stage I or Stage II prostate cancer in preserving their quality of life in their later years. Dr. Lu-Yao’s findings further support the START trial, which aims to preserve the quality of life of patients with low-risk prostate cancer. Another study led by Dr. Lu-Yao, published in the Journal of the American Medical Association showed that early use of hormonal therapy for low-risk prostate cancer does not improve disease-specific survival. Many experts regard this study as significant, because hormonal therapy is widely used among men with localized prostate cancer and it has substantial side effects.

Lorna Rodríguez, M.D., Ph.D., chief of gynecologic oncology, CINJ; and associate professor of Obstetrics, Gynecology and Reproductive Sciences, UMDNJ-Robert Wood Johnson Medical School. Dr. Rodriguez is close to concluding a clinical trial which indicates the potential for more targeted treatment of ovarian cancer. The study looks at the effects of a mineral called selenium in combination with the standard treatment for the disease.

Currently used are the drugs carboplatin and paclitaxel, which have shown the ability to shrink ovarian cancer tumors; however, that shrinkage may not last due to the development of drug resistance. Previous data shows that selenium inhibits the development of a tumor’s resistance to carboplatin. The study couples selenium with the two drugs with the goal of preventing or slowing drug resistance.

Darlene G. Gibbon, M.D., clinical director of gynecologic oncology at CINJ; and assistant professor of Obstetrics, Gynecology and Reproductive Sciences at UMDNJ-Robert Wood Johnson Medical School. Dr. Gibbon’s specialty lies in the areas of clinical trial developments; new therapeutics in ovarian, cervical and endometrial cancers; and fertility issues in cancer survivors. She is a sub-investigator on the aforementioned selenium trial.

Additional information about cancer clinical trials and research at CINJ can be found at http://www.cinj.org.

Quick Facts:

One in six men will be diagnosed with prostate cancer. According to the American Cancer Society, it is the most frequently diagnosed cancer in men, other than skin cancer, and the second leading cause of cancer death in men. It is estimated that approximately 183,000 new cases of prostate cancer will occur in the United States this year, with the illness affecting more African-American men than those of Asian or Caucasian descent. In New Jersey, 5,000 new cases of prostate cancer will be diagnosed, while 800 will die from the disease this year.

The various forms of gynecologic cancer — which is the growth and spread of cancer cells in the cervix, ovaries, uterus, fallopian tubes, vagina and vulva — also will have a big impact on our nation. According to the American Cancer Society, 78,000 new cases of gynecologic cancer will be diagnosed nationwide with 28,000 deaths resulting from the disease.

According to the American Cancer Society, ovarian cancer — known as the “silent killer” because of its lack of symptoms — is expected to claim some 15,000 lives nationwide this year, with 480 in New Jersey.

Cancer Institute of New Jersey
New Brunswick, NJ 08901
United States
http://www.cinj.org