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Employees with Hepatitis C Don't Consult Doctors Unless Advised SourceURL:http://asia.news.yahoo.com

Monday November 15, 10:21 AM (Kyodo) _ Eighty-six percent of office workers who tested positive for the hepatitis C virus in health checks do not consult doctors unless they are advised by their employers to do so, according to a survey in Aichi Prefecture.

"Employers should make sure to advise employees tested positive to consult doctors to protect their health," said Yoshitaka Fukuzawa, assistant professor of Aichi Medical University.

The university jointly conducted the survey with a medical examination center operated by the JA Aichi Koseiren medical group. The study covered the results of physicals conducted last year on 12,000 employees and their family members.

Of the 118 people who tested positive, only 16 people, or 13.6 percent, consulted doctors, the survey found.

By comparison, 54.5 percent of people who tested positive for hepatitis C during health checks conducted by one local authority in Aichi later went to see their doctors, the researchers said.

These infected people were more likely to seek medical advice because the municipality sent pamphlets advising to them to see doctors, while the employees just received test results, they said.

In many of cases, no symptoms develop during the early phase of infection, but the researchers said infected people should begin treatment early since 40 percent to 50 percent will go on to develop liver cancer by age 70 if they are not treated, according to studies.

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Virionics Taps Top Research to Bring Products to Market SourceURL:http://www.bizjournals.com
Jeanne Winograd
Contributing Writer

Virionics Corp.'s strategy is to find proven biopharmaceutical technologies, which it will license and take into clinical trials and, ultimately, to the public.

Organized in 2003, the early-stage company is working with researchers at such well-known places as the National Institutes of Health, Emory University and the U.S. Department of Defense.

Currently, the company's focus is on applications for treating hepatitis C. It is developing proprietary recombinant virus-like particle, or VLP, immunotherapies and vaccines.

"A VLP is an empty protein sphere that mimics a live virus but is completely safe, acting as a platform for the next generation of vaccines and immunotherapies," said Virionics Chief Executive Robert E. Kennedy, who has a background in finance and private equity.

Seeing whether the product works and getting Food & Drug Administration approval are hurdles Kennedy faces with Virionics chief scientist and President Joseph Sinkul, who works from Maryland.

"There shouldn't be any problem in lining people up to see if the product works. We believe by using an empty virus protein shell that we've got a very safe product with minor side effects, such as minor skin irritation from the injection," Kennedy said.

The World Health Organization estimates 4 million people are chronically infected with hepatitis C, half of whom don't know they have it. In the United States, the disease is a major cause of liver failure and often re-infects the livers of transplant patients.

Current hepatitis C medications are only 20 to 30 percent effective and are a costly course of medicine, Kennedy said. He estimates Virionics' products will cost probably an eighth of currently available medications such as Interferon, Alpha-interferon and Ribavirin.

Within five years, he hopes Virionics' vaccines will be on the market for bio-defense applications.

The hepatitis C technology has the potential to help people who suffer from other deadly diseases such as ebola, human immunodeficiency, melanoma and human papilloma, the latter a virus leading to cervical cancer.

To get there, the company needs funds for Phase I clinical trials, Kennedy said.

"We're looking for a minimum of $2 million from a combination of angels."

Virionics Corp
City: Scottsdale and Germantown, Md.
CEO: Robert Kennedy.
Phone: 480-767-6004.
Web: www.virionics.com

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Health Group Pushes Mandatory Hepa B Immunization for Babies SourceURL:http://www.sunstar.com.ph/
Manila

A GROUP of health experts has agreed to ask Congress to make compulsory the immunization of infants against Hepatitis B 12 hours after being born.

"If we are able to get the help of others to our cause, we can protect people against Hepatitis B because Hepatitis B has a significant role in the development of liver cancer and liver cirrhosis," said Dr. Lulu Bravo, executive director of the Philippine Foundation for Vaccination.

Bravo said most Hepatitis B carriers are not aware of their condition because the symptoms do not immediately shows.

"The chances of pregnant women passing on the virus to their offspring is as high as 20 to 30 percent," Bravo said.

The health groups that signed the draft resolution containing the appeal to Congress include the Community Pediatric Association of the Philippines, Integrated Midwives Association of the Philippines, Pediatric Infectious Disease Society of the Philippines, the Philippine College of Physicians, Philippine Nurses Association, Philippine Obstetrical and Gynecological Society Inc. and the Philippine Society for Microbiology and Infectious Diseases.

Dr. Myrna Cabotaje, director of the Department of Health (DOH) National Center for Disease Prevention and Control, said the immunization is expected to give birth to a generation of Filipinos who are liberated from Hepatitis B.

"It is more practical in a sense that you prevent the infection early on in life. If you complete the three doses needed, it will offer immediate protection to the child," she added.

The proposed law will supercede Republic Act (RA) 7846 or the Hepatitis Vaccination Law, which mandates that pregnant women who are positive for Hepatitis B be vaccinated to prevent them from infecting their babies.

Each Hepatitis B vaccine costs P13 per dose while vaccines for polio, measles, diphtheria and other diseases that are covered by the DOH's expanded immunization program cost much lower.

Cabotaje admitted that over the last four years, only around 40 percent of newborn infants were being immunized against the liver disease, which is way below the 80 to 100 percent global target.

The National Government allocates annually P11 million only for the purchase of Hepatitis B vaccines but P101 million more is needed to ensure full coverage. Marie S. Neri)

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November 16th, 2004


Corrections Chief Pushes Bills SourceURL:http://www.casperstartribune.net
By BRODIE FARQUHAR

Star-Tribune correspondent LANDER--Inmates with HIV, hepatitis, tuberculosis or other contagious and life-threatening viruses sometimes throw or project their body fluids at prison guards, the state Department of Corrections director says.

In an attempt to reduce that hazard, Bob Lampert is asking the Legislature's Joint Judiciary Interim Committee to sponsor a bill that would define projecting diseased body fluids or waste at correctional officers as aggravated assault and battery.

Lampert's proposed bill is intended to deter such attacks by elevating the offense from misdemeanor to felony status.

"Other states have done this, and they've seen these sort of attacks decline," Lampert said.

In 1998, Congress heard graphic testimony from correctional guard John Parcell, who was speaking on a bill mandating that federal prisoners be tested for AIDS. Parcell said officers can be exposed to dangerous diseases when rushing to the aid of inmates cut and bleeding from assaults by their fellow prisoners.

What's worse, Parcell testified, is when inmates create "hideous mixtures of potentially disease-laced blood, urine, feces, spit and semen intentionally thrown on correctional officers in deliberate attempts to infect them. Inmates call this horrendous practice ‘gasing’ or ‘being served.

"Such behavior is not isolated," Parcell said. "In fact, it's becoming more and more commonplace. It's a way to gain stature within a prison population. It's a badge of honor to ‘serve’ a correctional officer such a deadly mix."

Lampert said two Wyoming corrections officers were similarly assaulted last year, by inmates who spat on them.

"It is very traumatic to the staff," Lampert said. Guards have to be tested to determine whether they've contracted a disease through such exposure. The stress on guards and their families is considerable, he added.

The Connecticut Supreme Court ruled in May that the virus that causes AIDS is a job hazard for prison guards, clearing the way for them to receive workers' compensation for the deadly disease. According to a report carried by the Associated Press, the court held that the state must consider a workers' compensation claim by the family of an unidentified correction officer who was diagnosed with HIV in 1992 and died a year later.

In his presentation to the Wyoming legislators, Lampert estimated that enhanced penalties for assault by contamination would result in up to 20 inmates serving an additional 10 years in prison.

In a telephone interview, Lampert said county prosecutors are reluctant to file charges against inmates, because spitting on or throwing body fluids at a corrections officer is now a misdemeanor.

Lampert suggested additional legislation last week n primarily to increase the professionalism of the corrections staff.

Lampert wants to establish minimal training standards through the Wyoming Peace Officers Standards and Training Commission, to establish a separate certification track for correctional officers.

"This will professionalize our state corrections work force, enhance current hiring requirements and provide a systemic career development program for our state corrections officers," Lampert said.

All new hires would be required to obtain such certification, while current employees would be afforded the opportunity to become certified, he added.

"My hope is that through attrition, all our staff will be certified in the future," Lampert said.

Community colleges could also play a continuing education role, he added.

Lampert also wants to see legislation that would make corrections employees eligible for law enforcement retirement benefits, eliminate inequities in inmate pay schedules and shift responsibility for victim notification away from the Department of Corrections to the Board of Parole.

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Hepatitis B Cases in Kids Fall 89 Percent SourceURL:http://www.floridatoday.com
ASSOCIATED PRESS

Cases of hepatitis B among children and teenagers have dropped by almost 90 percent in the past decade, thanks to a vaccination program against the virus, the government said this month.

A total of 13,829 youngsters had hepatitis B in the United States between 1990 and 2002, the period of the study. The rate for that group dropped from 3.03 cases per 100,000 people in 1990 to 0.34 per 100,000 in 2002, the Centers for Disease Control and Prevention said.

A government recommendation that all infants get hepatitis B vaccinations was put in place in 1991. The program was expanded in 1995 to 11- and 12-year-olds and in 1999 to all children.

The hepatitis B attacks the liver. It can cause scarring of the liver, liver cancer, liver failure and death. The virus can be transmitted by casual contact with blood or other body fluids, as well as through sex or shared needles or from mother to baby during birth.

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Countywide Task Force Focuses on Diagnosing, Treating Hepatitis C
SourceURL:http://www.chicoer.com
Chico, California
By STEVE BROWN - Staff Writer

The only good thing about diseases is that some aren't as life-threatening as others. Hepatitis C is a case in point. Jeannie Maes, a public health nurse and coordinator of a countywide Hepatitis C Task Force, begins her discussion of the disease by being as upbeat about it as she can: It's hard to get and most people who get it don't develop symptoms. Effective treatments are available for those who do develop symptoms.

Then she gets to the crux of her message: About 5 percent of those who get Hepatitis C will need a liver transplant if they don't get treatment. "I don't want to downplay how severe this illness can be."

Hepatitis C is a liver disease caused by a virus. The liver is one of the body's workhorses. It seldom complains when it is mistreated. "It's a silent organ that performs hundreds of tasks," Maes said. "It keeps functioning until it becomes severely damaged." Even when the liver becomes inflamed, it doesn't necessarily signal its distress. The liver then becomes scarred, and it shrinks and hardens. It may not cause any symptoms until it gets to this point.

One of the reasons the task force was formed is to draw attention to this illness. Dr. Mark Lundberg, the county's public health officer and task force chairman, said it's second on the list of frequently reported communicable diseases in the county, with almost 300 cases in 2003. It is estimated that 4 percent of people in the United States may be infected with Hepatitis C. That means as many as 8,000 people in Butte County could have it.

Hepatitis C is a blood-borne virus. Intravenous drug users who share needles have the greatest risk of becoming infected. It is sometimes transmitted sexually and can be passed from an infected mother to her fetus. Maes said it is no longer spread through blood transfusions. Since 1992, the blood supply has been screened for Hepatitis C.

Tests are available to determine if people have been infected and to detect liver damage. "Hepatitis C needs to be treated like any chronic illness," Maes said. "Even if treatment isn't needed, it needs to be checked every year or two."

Lundberg said the Task Force wants to encourage county residents who think they have been infected with Hepatitis C to be tested. It then wants to ensure that those who are diagnosed receive the information and counseling they need, from professionals and support groups.

He said protocols for dealing with Hepatitis C have become routine enough that primary care physicians can treat it. Until recently, physicians have referred patients to specialists, "but with the number of cases increasing in the county the load needs to be shared."

Maes said people with Hepatitis C should get Hepatitis A and Hepatitis B vaccines. Those diseases can also damage the liver. They should also adopt health practices that will give their livers a break. This includes stopping drinking and smoking, exercising and eating nutritious food. "Taking these steps can reverse liver damage," Maes said.

Hepatitis C support groups are offered. Lundberg said peer counseling is as important for patients as professional care.

The Task Force has 26 members representing 13 agencies and individuals. It meets once a month. Those wishing more information about it can call Maes at 538-7276.

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Himalaya to Launch New Drug for Hep B in Mid-2005
SourceURL:http://www.pharmabiz.com
Our Bureau, Bangalore

The Himalaya Drug Company, the herbal healthcare, is getting ready to launch the new product for Hepatitis B next year. The company is currently doing clinical trials at 12 centres in the country and the product will be launched in the first half of 2005.

The company is also actively researching in the areas of critical diseases like cancer and AIDS apart from tropical diseases like malaria, where it is working towards introducing a new range of drugs expected to be launched from its pharmaceutical division next year. "However, it will take a while for us to complete the studies for which we are vigorously conducting studies for drugs in malaria, cancer, and AIDS," stated Dr. SK Mitra, executive director, research and technical services, The Himalaya Drug Company who was non-committal about the timeframe for completing research and getting the final products ready.

With the clearance by the Karnataka mega projects committee for its 200 acre of land at Bidadi in Ramanagaram taluk on the Bangalore Mysore Road, Himalaya Drug Company has slated a major investment of Rs 165crore for a manufacturing unit and a research and development centre for ayurvedic formulations.

The proposed production plant will be a state-of-the-art, international grade modern facility that deploys superior cutting-edge technology with prior approvals from International Regulatory bodies. The company is gearing up for construction in early 2005 on the 200 acres of land, stated Ravi Prasad, president& CEO, The Himalaya Drug Company.

In first phase of the new project, only production plant will be commissioned. The research facility will be slotted for the second phase of the project. The company's research and development wing is the foundation for all drug development. It is currently operating full-fledged at Makali, on the Tumkur Road in the outskirts of Banglalore which is its headquarters.

"Although the company does not have a fixed funding allocated towards research and development programmes, it strictly abides by its Research and Development policy which states that no investment is too much when it comes to scientifically creating safe drugs and therapies," stated Dr. Mitra. The company has around 70 scientists in the research and development wing.

The company is expected to touch a turnover of Rs 400 crore on March 2005. The exports that are on the upward trend forms 15 per cent of the revenues.

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Organetix, Inc. Receives a Financing Commitment for up to $5 Million; Company Commences Phytochemistry on A4+L
SourceURL:http://home.businesswire.com

NEW YORK--(BUSINESS WIRE)--Nov. 16, 2004--Organetix Inc. http://www.organetixinc.com; (OTCBB: OGTX) announced today that it is now formalizing discussions with certain investment bankers and has received a term sheet for financing up to $5,000,000 from a NASD member broker-dealer. The funding is based on the recent positive test results on the Company's A4+L liver product. The study was designed to determine the effectiveness of A4+L on the quality of life of Hepatitis C patients. The test was designed by independent doctors in the USA and Peru and was conducted in Peru.

Based on the results reported by the doctors, who tested and examined the patients, the Company has decided that there was significant success in the areas of depression, health-related quality of life burden, clinical symptoms, and within blood results relating to the prothrombin activity and the serum cholinesterase.

A recent ten (10) patient study reported a significant increase in the prothrombin activity and the serum cholinesterase, which suggests increased protein synthesis by the liver and a decrease in the degradation of the liver. Clinical research suggests it is regenerating liver tissue thus allowing the liver to begin functioning again despite years of damage from the virus.

As quoted by Dr. Joseph Nystrom, Chief of Staff Elect at the East Pasco Medical Center, located in the Tampa Bay Metropolitan area: "In summary, the Nutraceutical Product A4+L has enormous potential as therapy for emotional and physical suffering of the burgeoning number of Hepatitis C sufferers. A larger placebo controlled long-term study is warranted. Further study of A4+L may reveal it to be useful in other disease processes as well."

Upon the successful completion of funding, the Company intends to use the proceeds to fund additional research, clinical studies, patents, acquisition of intellectual property and working capital. The funding is subject to certain conditions including the execution of a definitive Placement Agent Agreement.

The Company has already commenced the phytochemistry and the technology processes relating to the A4+L product.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any securities.

About Organetix, Inc.
Organetix, Inc. (www.organetixinc.com) is a biotechnology company that is in the process of treating patients with a unique nutraceutical that appears to relieve symptoms of Hepatitis C. Organetix has the exclusive worldwide rights for this nutraceutical product. Hepatitis C is a life-threatening, blood-borne, liver disease that is caused by a virus. It is estimated that millions of individuals worldwide are infected with Hepatitis C making it one of the greatest public health threats faced in recent years.

Statements contained in this press release, which are not historical facts, are forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based largely on the Company's expectations and are subject to a number of risks and uncertainties beyond the Company's control, including but not limited to economic, competitive and other factors affecting the Company's operations, management team effectiveness, expansion strategies, available financing, market prices and recovery costs, government regulations involving the Company, facts and events not known at the time of this release, and other factors discussed in the Company's filings with the Securities and Exchange Commission.

These statements are not guarantees of future performance and readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update publicly any forward-looking statements.

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Prevalence and Incidence of HIV, Hepatitis B Virus, and Hepatitis C Virus Infections Among Males in Rhode Island Prisons
American Journal of Public Health

The authors evaluated prevalence and intraprison incidence of HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) infections among male prison inmates in Rhode Island. They observed intake prevalence for 4,269 sentenced inmates at the Rhode Island Adult Correctional Institute between 1998-2000 and incidence among 446 continuously incarcerated inmates who had been in prison for 12 months or more.

The researchers found that HIV, HBV and HCV prevalences were 1.8 percent, 20.2 percent and 23.1 percent respectively, and that infections were significantly associated with injection drug use.

Incidence per 100 person-years was 0 for HIV, 2.7 for HBV and 0.4 for HCV.

"Our data and that of other studies suggest that activities to prevent transmission of hepatitis in a correctional setting are important for both inmates and correctional staff," the authors noted. "Although our data suggest that concerns about prisons serving as an amplifying reservoir for HIV and HCV might be overstated, these data are indicative of significant ongoing HBV transmission."

"Offering hepatitis B vaccination in prisons must be a public health priority," the researchers concluded, "given the impact of infected individuals on the incarcerated population and, beyond the prison walls, on the transmission of HIV, HBV, and HCV in the communities to which inmates return."

SOURCE: American Journal of Public Health (07.04); Vol. 94; No. 7: P. 1218-1223::Grace E. Macalino, PhD; David Vlahov, PhD; Stephanie Sanford-Colby, MPH; Sarju Patel, MSc; Keith Sabin, PhD; Christopher Salas, BS; Josiah D. Rich, MD, MPH

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November 17th, 2004

Quebec City Patients Recalled for HIV, Hepatitis Tests
SourceURL:http://www.cbc.ca

QUEBEC CITY - A Quebec City hospital has asked 567 patients who underwent eardrum surgery to return to get tested for diseases such as HIV and hepatitis.

Officials at the Centre hospitalier universitaire de Québec say contaminated tissue was used in eardrum surgeries between 1984 and 2002. The tissue was supplied by the British Columbia Ear Bank.

FROM FEB. 20, 2003: Ear transplant patients told to get tested for HIV, hepatitis

The hospital's testing call comes more than 20 months after tissue from the Ear Bank was recalled. B.C. health officials discovered the facility did not have records of screening procedures used to prevent transmission of HIV, or hepatitis B or C.

A Health Canada investigation later revealed the agency had poor quality control over sterilization procedures and did not keep good records of blood samples taken from donors.

Tests conducted since 2003 have shown about 40 of the tissue donors to the Bank had hepatitis B and syphilis.

Although the Quebec hospital had been given notice of the potential danger more than a year ago, staff had to pore over more than 5,000 files to locate the 567 patients, said Carl Taillon, director of services at the hospital. The letters were sent out to patients.

Starting in 1985, the B.C. Ear Bank distributed more than 6,000 bone and tissue samples for transplant into patients with hearing loss, sending them to 87 hospitals in the U.S. and Canada. The facility was closed in 2002.

Hepatitis B, Hepatitis C and HIV can also be transmitted through ear tissue. However, Health Canada says the risks of contamination are low. Taillon says the chances someone has been contaminated with HIV are only one in a million

Written by CBC News Online staff

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Nucleonics Licenses Apath Technology for Use in Hepatitis C Therapeutic SourceURL:http://www.pharmalive.com

HORSHAM, Pa. & ST. LOUIS--(BUSINESS WIRE)--Nov 17, 2004 - Nucleonics, Inc. and Apath, L.L.C. today announced that Nucleonics has received a non-exclusive license to Apath technology related to the 3' non-translated region of the Hepatitis C viral genome, which Nucleonics is using as a target in its development of an expressed RNAi therapeutic against Hepatitis C. Financial details of the license agreement were not disclosed.

"Nucleonics has continued to build its intellectual property portfolio to support our product development efforts in the areas of Hepatitis B and C," said Robert J. Towarnicki, president and chief executive officer of Nucleonics, Inc. "We have designed a therapeutic candidate against Hepatitis C that targets this region of the Hepatitis C viral genome, and this license to Apath's gene discoveries in this area gives us the freedom to move forward in its development."

"We are very pleased to grant this license to Nucleonics," said Charles M. Rice, Ph.D., Apath founder and managing director. "This license agreement further validates the importance of Apath's genetic discoveries in the area of Hepatitis C and other medically important human viral pathogens."

About Apath, L.L.C.
Apath, L.L.C. is a privately held pharmaceutical discovery company, with a focus on the development of broad-spectrum therapeutics for RNA viral diseases. Apath was founded in St. Louis, Missouri in 1997 by Charles M. Rice, Ph.D., currently professor of Molecular Biology at The Rockefeller University, and formerly with the Washington University School of Medicine.

About Nucleonics, Inc.
Nucleonics, founded in January 2001, is an emerging biotechnology company focused on the development of novel RNA interference-based therapeutics for viral and other diseases. Privately owned Nucleonics is headquartered in Horsham, Pennsylvania.

Contact Nucleonics, Inc.
Robert Towarnicki, 267-518-0101 rtowarnicki@nucleonicsinc.com or Apath, L.L.C. L. Janet Milton, 314-812-8160 Milton@apath.com or Kureczka/Martin Associates (Media) Joan Kureczka, 415-821-2413 Jkureczka@comcast.net

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Hepatitis Spreading with 5.8 Percent Prevalence Rate
SourceURL:http://www.dailytimes.com.pk
By Shahzad Raza

ISLAMABAD: Hepatitis B is spreading in the country with a prevalence rate of 5.8 percent, according to Extended Programme of Immunisation (EPI) estimates.

The job of EPI, part of the National Institute of Health (NIH), is to administer the hepatitis vaccine to over 80 percent of the total child population.

Hepatitis B is a deadly liver disease that has the same modes of transmission as AIDS. NIH sources told Daily Times that millions of Pakistanis were infected with Hepatitis B, but no public health agency had accurate information about the number of cases. If the 5.8 percent prevalence rate figure is used, there may be around 8 million Hepatitis B patients in the country.

There are five types of hepatitis: A, B, C, D and E. Of these, types A and E are caused through oral infection, contaminated water and unhygienic food. Types B, C and D are caused by the use of un-sterilised syringes, sexual relations, blood transfusions and from mother to child transmission.

Hepatitis B and C are global health problems. Worldwide, 350 million people are infected with Hepatitis B. Medical experts believe that Hepatitis B is spreading so quickly because of a lack of awareness and limited preventive measures.

Medical experts say symptoms of Hepatitis B include abdominal pain, fever, fatigue, lack of appetite, nausea, jaundice and dark urine. There is no cure for Hepatitis B, although bed rest and dietary changes can alleviate some of the symptoms.

Hepatitis C is often called the “silent epidemic.” The virus can live in the body for decades, often with no symptoms, while attacking the liver. Long-term consequences of Hepatitis C can include liver disease, liver cancer, and death. There is also no cure for Hepatitis C and no vaccine.

Sources said the NIH has been facing problems and high rates of Hepatitis B in rural areas of the country where parents are not cooperative about immunising young children. EPI has prepared a plan to control the disease in the next 10 to 15 years. However, success depends on proper prevention, immunisation and public awareness.

The national programme was launched with support from the Global Alliance for Vaccines and Immunisation, which is financially supported by the Bill and Melinda Gates Foundation. The aim of the programme is to immunise every newborn child.

Sources said that by the end of 2005, Pakistan would get more than 81 million doses of vaccine from the global alliance to immunise more than 21 million children.

Three doses of the hepatitis vaccine are administered to every child at the age of six weeks, 10 weeks and 14 weeks, along with the three polio vaccinations.

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November 18th, 2004


Eisai In-licenses Anti-Hepatitis B Agent Clevudine from Bukwang Pharm (South Korea) SourceURL:http://uk.biz.yahoo.com
JCN Newswire

Tokyo, Japan Eisai Co., Ltd. (TSE: 4523) announced today that the Company has in-licensed an anti-hepatitis B agent (generic name: clevudine) from Bukwang Pharm (Headquarters, Seoul, South Korea, President: Sung-Koo Lee).

Under the agreement, Eisai will obtain the exclusive right to develop, manufacture and market clevudine in ten Asian countries excluding South Korea. Eisai will develop the compound in those Asian countries, principally in China, aiming at filing of new drug applications for approval.

Clevudine is an antiviral agent for treatment of hepatitis caused by the hepatitis B virus based on DNA polymerase inhibition. In South Korea, Bukwang is currently conducting Phase III clinical trials. For the treatment of hepatitis B, antiviral agent, interferon, or liver protective agent are used. When plasma virus concentration is high, antiviral agent or interferon are used to control the level of virus. In this case, treatment may take a long time. Clevudine is expected to be a new option for hepatitis B treatment by its powerful antiviral effect.

Hepatitis B is a serious disease with numerous patients particularly in China. Eisai will work to develop this new Hepatitis B, especially in China, to contribute to improving the health care of patients in Asia.

Reference data
About Eisai Co., Ltd
Year Founded : 1941
Headquarter : Tokyo, Japan
Paid-in Capital : 44,985 Million (March 31, 2004)
Sales : 500,164 Million in FY2003
Employee : 7,700 (World Wide, March 31, 2004)
Business : Pharmaceuticals

About Bukwang Pharm
Year Founded : 1960
Headquarter : Seoul, South Korea
Paid-in Capital : 11,206 million won (March 31, 2004)
Sales : 96,834 million won in FY2003
Employee : 612 (March 31, 2004)
Business : Pharmaceuticals

About clevudine
Mode of Action : Antiviral action by HBV DNA polymerase inhibition
Characteristics : Expect powerful and continuous antiviral effect High safety profile
Development Phase : Phase III ongoing in South Korea by Bukwang Pharm
Filing for approval expected in December 2004

Hepatitis B patients in China
HBV carrier: About 120 Million (about 10% of total population)
Chronic hepatitis B patients: About 12 Million
About Eisai Co., Ltd.
Eisai Co., Ltd. (TSE: 4523)(OTC: ESALY) is a research-based human health care company that discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. The Company reported sales of nearly $4.5 billion in fiscal 2003/4, with approximately 15 percent of sales spent for research and development.Eisai Co., Ltd.

Contact:
Eisai Co., Ltd.
Corporate Communications Department
Phone +81-3-3817-5120 (Tokyo)

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Needle Exchange Recommended for Irish Prisoners
SourceURL: Ireland Online

There is fresh evidence of the benefits of prison needle exchange programmes in the battle to protect prisoners from disease.

The schemes, which operate in more than 50 prisons in six countries, reveal the controlled usage of sterile syringes in prisons could reduce the spread of HIV and Hepatitis C.

Rick Lines of the Irish Penal Reform Trust is calling on the Government to introduce a pilot programme here based on this new research.

He said: “What we need to do is look at international best practice, to learn from how other countries have adapted successfully to meet the challenges presented to public health by the use of injected drugs in prison, and try to bring Ireland’s prison health policy into line with international best practice in this regard.”

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Protest in Parliament Chamber
SourceURL:http://icstirlingshire.icnetwork.co.uk

A lone protester disrupted First Minister's Question Time in the Scottish Parliament.

The protest was the latest staged at Holyrood on behalf of haemophiliacs who contracted hepatitis C and HIV from infected NHS blood products in the 1970s and 1980s.

The man went to the front of the public gallery overlooking the chamber and shouted out his demand for a public inquiry into how hundreds were contaminated. He was quickly led away by a security guard and female police officer. A similar protest was staged in September.

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November 19th, 2004


Going After a Silent Killer
SourceURL:http://www.wokr13.tv/

Liz Bonis (11/19/04) -- A trial is currently underway by the National Institutes o Health that could someday offer a new treatment for Hepatitis C, a disease many people may have and not even know it. The new treatment may offer patients an alternative when nothing else works.

This past year when little things like walking the dog became an effort Rita McQuearry knew something was terribly wrong.

"I was very, very tired, sometimes I would have to come home and take a three-hour nap, which was very unlike myself," she said.

After undergoing dozens of tests, Rita was diagnosed with Hepatitis C, a virus that shuts down the liver over time.

Liver Specialist Dr. Guy Neff said, "It's the most common reason right now for liver transplantation, we expect 10- to 15-thousand people to die each year from this disease."

Rita's doctor eventually told her she likely contracted the disease nearly 30 years ago through a blood transfusion given to her during a pregnancy. Like so many others living with this disease, it stayed silent, and never manifested any symptoms.

Rita, however, is one of the lucky ones. She responded to traditional treatment for the disease--a combination therapy of an injectible drug called Interferon and a pill called Ribavirin.

However, those who don't respond may soon have another option. Researchers are now looking for patients to test a new drug that would block the production of proteins required for the Hepatitis C virus to replicate or grow in the body.

In the meantime, Rita McQuearry wants others to speak up about having the disease.

"I don't think the disease is a stigmatism, I think people are afraid to let other people know they have hepatitis C, they are ashamed. It's not to be ashamed of, it's extremely treatable, if people will go to the doctor and take the treatment," she said.

Donated blood is now screened for Hepatitis C, so it's no longer transmitted through transfusions.

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NIH Funds Network to Study Drug-Induced Liver Injury (DILIN)
SourceURL:http://www.nih.gov

The National Institutes of Health (NIH) has launched a network of five clinical centers and a data coordinating center to conduct studies over the next three years of patients who have suffered severe liver injury because of both prescription and "over-the-counter medications," nutritional supplements, alternative medicines and herbals. The DILIN centers are located in North Carolina, Indiana, San Francisco, Michigan, and Connecticut, and will be awarded $2.25 million per year.

One objective of DILIN is to develop standardized definitions and instruments to identify and fully characterize cases of drug-induced liver injury. With a systematic way of classifying drug-induced liver injury, researchers will be able to analyze the epidemiology and clinical issues of liver injury and collect biological samples that can be used to study the causes of liver toxicity using biochemical, serological, and genetic testing. The DILIN is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), one of the institutes of the NIH.

Another objective of DILIN is to establish a registry of patients who have experienced severe drug induced liver injury. "Part of the difficulty in studying drug-induced liver disease is the absence of a sufficient cohort of well-characterized patients in whom to carry out clinical, genetic, immunological and biochemical investigation," says Jose Serrano, M.D., Ph.D, director, NIDDKs' Liver and Biliary Diseases Program and coordinator of the DILIN. "DILIN will help to eliminate this barrier and advance the understanding of drug-induced liver injury forward," he adds.

Drug-induced liver injury occurs in all age groups, but most cases occur within the elderly population because they take more medications than younger persons and also use multiple medications. Furthermore, drug-induced liver injury is the most common reason why drugs are not approved by the Food and Drug Administration (FDA) or are removed from the market after they have been approved.

Most drugs that can cause liver injury are entirely safe for the majority of patients taking them. The reason why some patients are susceptible to liver injury from a drug is rarely known. "It is likely a result of many interrelated factors that involve complex interactions between our genes and the environment," says Jay Hoofnagle, M.D., director, NIDDK Liver Diseases Research Branch. "Liver injury is unpredictable and variable in clinical presentation, making causality very tough to assess," explains Hoofnagle.

At present, DILIN has developed protocols for both retrospective and prospective studies of drug-induced liver disease. The retrospective study will establish a registry of patients who have taken one of four specific drugs since 1994 and developed liver injury later.

The four drugs are isoniazid, phenytoin, valproic acid, and clavulanic acid/amoxicillin. These drugs were chosen because they are widely prescribed and have definite clinical presentation. A minimum of 50 cases of each form of drug-induced liver disease will be collected along with an equal number of patients who have taken the drugs safely (controls). The researchers will obtain clinical and DNA information from each patient.

The prospective study will focus on enrolling patients who recently suffered an adverse liver reaction after taking any drug or herbal medicine. These patients will be followed over time to find out what happens to them as a result of their injury. Patients who have not sustained liver injury, but who have taken any of the drugs in question, will also be enrolled in the prospective study.

"Overall, we believe that the DILIN will bring greater focus and interest to the study of drug-induced liver injury and help to develop better ways to prevent, detect, and treat this growing liver problem," says Paul Watkins, M.D., chair, the DILIN Steering Committee and principal investigator for the center in North Carolina.

The DILIN researchers have also developed diagnostic criteria and measures for grading causality in patients with drug-induced liver disease and will prospectively assess these instruments for sensitivity and specificity. Patient enrollment is ongoing.

The DILIN consists of the following principal investigators and centers:
•Dr. Paul Watkins, University of North Carolina, Chapel Hill, North Carolina
•Dr. Naga Chalasani, University of Indiana, Indianapolis, Indiana
•Dr. Timothy Davern, University of California, San Francisco, California
•Dr. Robert Fontana, University of Michigan, Ann Arbor, Michigan
•Dr. Herbert Bonkovsky, University of Connecticut, Hartford, Connecticut
•Dr. James Rochon, (Data Coordinating Center), Duke University, Raleigh-Durham, North Carolina

For more information, contact Leslie Curtis or Marcia Vital at the NIDDK Information Office (301-496-3583).

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is a component of the National Institutes of Health (NIH), U.S. Department of Health and Human Services (DHHS). NIDDK supports a significant amount of the Federal Government's research on endocrine and metabolic diseases such as diabetes and obesity, digestive diseases such as hepatitis and inflammatory bowel disease, kidney and urologic diseases such as kidney failure and prostate enlargement, and blood diseases such as the anemias. The Institute carries out a large variety of research initiatives and programs that will bring new knowledge into proven therapies that benefit the public. Health information and additional information about NIDDK can be found on the NIDDK home page at: http://www.niddk.nih.gov/.

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FDA Issues Regulations Governing Tissue Banks after Years of Delay
Associated Press
Laura Meckler

On Thursday, the Food and Drug Administration issued new safety standards for tissue banks that process donated skin, ligaments and bones for transplant. The regulations, which will take effect in May, aim to prevent infection and disease in an industry that has gone unregulated during a period of explosive growth. So far this year, doctors have performed about 1 million tissue transplants, up from 350,000 in 1990.

The FDA rules are the last of three sets defining federal standards for the industry. In January, FDA required all tissue banks to register with the agency and allow regular inspections. In May, FDA said tissue donors, like blood donors, must be screened for diseases including HIV, hepatitis B and C, syphilis and Creutzfeldt-Jakob disease, the human form of mad cow disease. The new rules prohibit pooling material from multiple donors.

Two Senate Government Affairs Committee hearings have covered the need for regulations, with investigators reporting widespread problems: operators running multiple tests on recovered tissue in hope a second test would find the material healthy when the first did not; mishandling cadavers after removing bone and skin; and tissue banks pooling donors' material despite the medical risk of one person's tissue contaminating another's.

This rule is a major step toward ensuring that tissue contaminated with life-threatening diseases is not transplanted into unsuspecting patients, Sen. Susan Collins (R-Maine), the panel's chairperson, said in a statement.

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November 20th, 2004


Accused Too Ill for Tainted-Blood Trial, Lawyer Says
http://www.theglobeandmail.com
By ANDRÉ PICARD
PUBLIC HEALTH REPORTER

Lawyers for one of the central figures in Canada's tainted-blood scandal are asking the courts to drop all criminal charges against him, arguing that Roger Perrault is so ill that the legal proceedings could kill him.

Julianna Greenspan filed papers in Ontario Superior Court this week asking for a stay of proceedings in the case of Dr. Perrault, the long-time director of the Red Cross Society's blood transfusion service.

He has been charged with three counts of criminal negligence causing bodily harm and seven counts of common nuisance by endangering the public. The charges against Dr. Perrault allege that he (among other individuals and institutions) failed to take adequate measures to prevent individuals infected with HIV-AIDS from donating blood, failed to institute testing of blood in a timely manner, and allowed the distribution of blood products that were tainted.

Ms. Greenspan said her client has had several heart attacks and has undergone open-heart surgery. Dr. Perrault, she said, suffers from heart failure, an irreversible and inoperable condition, and the stress of the trial would have "grave" repercussions on his health.

"If the matter were to proceed against Roger Perrault, there would be a violation of his Charter rights," Ms. Greenspan said. Under the Canadian Charter of Rights and Freedoms, a person facing criminal charges has the right to a "full and fair" hearing and has a constitutional right to make a "full answer and defence" to charges.

A date for the stay-of-proceedings hearing will be set Dec. 3.

The other parties involved in the case have yet to file statements, but one high-profile victim of tainted blood said the dropping of charges will be vigorously opposed.

"Many tainted-blood victims struggle with the debilitating effects of HIV and hepatitis C on a daily basis, and many have died waiting for the truth to come out. In their memory, we need to see justice," said Mike McCarthy, who got hepatitis C from tainted blood products.

He said that while victims "appreciate that Dr. Perrault's health may not be 100 per cent, the courts should be able to make him comfortable while the proceedings continue."

In November of 2002, after a five-year investigation, the Royal Canadian Mounted Police laid 32 charges against four individuals, a pharmaceutical company and the Red Cross in connection with tainted blood. The charges are being heard in Toronto and Hamilton.

The Toronto trial relates specifically to the distribution of a blood product called Factorate, manufactured by Armour Pharmaceutical Co. of Bridgewater, N.J. That trial is slated to begin on Nov. 28, 2005, before a judge and jury.

The Hamilton trial, which relates to alleged criminal failings by the Red Cross and Health Canada officials in the screening and testing of blood, does not yet have a date set.

Ms. Greenspan said that because the trials cannot be held simultaneously, the Hamilton trial cannot begin until 2007 at the earliest. Dr. Perrault is the only defendant involved in both.