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HCV ADVOCATE WEEKLY NEWS REVIEW: A Review of HCV, HBV and HIV/HCV Coinfection Related News and Highlights

Week Ending: June 26^th, 2004

Alan Franciscus
Editor-in-Chief

To download pdf version click here

In This Issue:

•Chiron Relaxes Patent Licenses
•Chronic hepatitis C virus (HCV) infection, an estimated $3 billion market
•Company relaxes licensing practices over hepatitis C patents
•GlaxoSmithKline Releases Multi-Language Hepatitis B Educational Materials
•Beaver Dam man lives with disease, uncertainty
•41 million Chinese believed to have hepatitis C virus: report

June 22nd, 2004

Chiron Relaxes Patent Licenses
L.A Times
Denise Gellene, Times Staff Writer

The biotech firm acts amid criticism that its upfront fees stifle work on drugs for hepatitis C.

Chiron Corp. today plans to announce a change in the licensing policy on its patents covering the genetic makeup of the hepatitis C virus, a move that could lead to the development of new drugs to fight the disease.

Scientists at the Emeryville company were the first to identify the virus in 1987, and Chiron has more than 100 patents on the virus' genome — the molecular code the virus uses to reproduce itself. The company has been accused of controlling its patents too tightly, stifling research that could lead to new treatments.

Chiron has consistently maintained that its defense of its patents, which expire in 2015 in the United States, has been appropriate and fair.

But Chief Executive Howard Pien said Chiron would no longer demand that licensors pay upfront fees and make annual payments to obtain rights to the hepatitis C patents. Pien said the company had heard complaints that the fees were too steep for small companies.

About 4 million Americans and 170 million people worldwide are infected with the hepatitis C virus, which can lead to severe liver damage.

The disease is typically treated with a combination of interferon and ribavirin, but at best only half of patients respond to those drugs.

Pien said he did not want Chiron to be viewed as a company that blocked drug development — particularly in Washington, where the cost of medical innovation has become part of the broader discussion about pharmaceutical pricing.

Along with other drug firms, Chiron is lobbying to block laws that would permit the importing of low-cost drugs from Canada, saying such legislation would hurt profits and damage the industry's ability to develop new products.

"Our ability to make a meaningful contribution in policy debates is in part influenced by whether we are perceived as a good corporate citizen," Pien said.

Chiron's first contract under its new patent policy is with Prosetta Corp., a San Francisco biotech firm with seven employees. Pien wouldn't discuss the contract in detail but said Prosetta should
save "millions of dollars" in the early years of the contract.

But the deal could pay off later for Chiron if Prosetta develops a marketable drug. The contract includes a higher royalty on sales than called for under previous agreements. The new terms show "we want to commercialize the technology and get it into the hands of anyone who seeks it," Pien said.

Michael Farmer, chief operating officer of Prosetta, said the company had been leery about negotiating with Chiron because it could not afford the company's "seven-figure fees."

"We concluded that if we had to pay those kinds of sums we were not going to go after hepatitis C," Farmer said.

Chiron, which is working on a vaccine and drug for hepatitis C, has licensed its patents to 15 other companies. The licenses are an important source of revenue for Chiron, which had revenue of $1.8 billion last year. In 2003, Chiron received $312.2 million in royalties, mostly from licenses on hepatitis C, HIV and a drug used to treat multiple sclerosis.

But the company's defense of its patents came under scrutiny last year in a report by the National Academy of Sciences on intellectual property rights.

The report said there had been complaints that lawsuits filed by Chiron to protect its patents "are deterring others from developing" drugs to fight hepatitis C. And it noted that the firms being sued had refused to sign licensing agreements that included "significant up-front payments" and royalties.

Gilead Sciences Inc. of Foster City, Calif., dropped work on a hepatitis C drug in 1999 after it was sued by Chiron. Last year, Gilead agreed to license Chiron's patents so it could continue to work on drugs for the disease.

June 23rd, 2004

Chronic hepatitis C virus (HCV) infection, an estimated $3 billion market
SourceURL:http://medical.press-world.com

Research and Markets announces the addition of this new report entitled "Competitive Outlook on HCV: What to Know& Expect in R&D and Business Development" to its offerings.

The competitive business environment for the pharmaceutical market of chronic hepatitis C virus (HCV) infection is fierce and changing. The entry of Hoffmann-La Roche into this $3 billion market, previously dominated by Schering-Plough, has certainly paved the way and will make life easier for other HCV drug developing companies. Competition is healthy, and market dominance by one big pharma provides far fewer business opportunities compared to two companies fighting to be the world leader.

The race is on and due to the limitations of current treatment for chronic hepatitis C virus infection, a lot of R&D activities are spent on novel therapeutic strategies targeting events specific to viral replication. A number of newer therapies, including protease and helicase inhibitors, ribozymes, antisense therapies, and therapeutic vaccines, are in preclinical or clinical development and may significantly enhance existing therapeutic options for the future.

This report takes a fresh look on both the current world status of R&D and business development in HCV. Research and analysis is built on more than 150 companies from over 18 different countries and include more than 160 pipline drugs in development for HCV.

An up to date outline of the HCV competitive landscape is given, involving 66 selected collaborations divided into 7 major clusters of companies, whereof six are interconnected and one cluster stands alone. Find out key data on each cluster, such as Type of Collaboration (9 classes), R&D Focus, Number of Drugs in Development, Competitive Edge etc.

This HCV R&D analysis thoroughly discusses drug and vaccine development world wide. The analysis covers more than 108 pipeline drugs, ranging from pre-clinical to phase III. Key points in the analysis are to deduce trends in HCV drug development, evaluate all major drug targets and outline country by country efforts in HCV. The analysis also addresses the issue of what demands are raised on new HCV drugs and how the industry gradually will move over from interferon to small molecular drugs and combination therapies. Special emphasis is put on linking analysis with concrete R&D projects through high value tables, in order to facilitate further research.

This report has been written for people in business development, competitive intelligence, and for R&D project responsibles in HCV. This report is also suitable for CEOs, especially in smaller sized companies.

For a complete index of this report click on http://www.researchandmarkets.com
/reports/218916

About Research and Markets Ltd.
Research and Markets Ltd. are Europe's largest resource for market research. R&M distribute thousands of major research publications from the world's leading publishers, consultants and market analysts. R&M provide you with the latest forecasts on international and regional markets, key industries, the top companies, new products and the latest market trends.

For additional information on ResearchandMarkets.com, their range of reports or their value-added services, visit their web site at http://www.researchandmarkets.com or press@researchandmarkets.com

company: Research and Markets
contact person: Laura Wood
e-mail: laura.wood@researchandmarkets.com
site: http://www.researchandmarkets.com

Company relaxes licensing practices over hepatitis C patents
SourceURL:http://www.kansascity.com
BY MIKE MCGRAW
Knight Ridder Newspapers

KANSAS CITY, Mo. - (KRT) - A California company that has been accused of delaying research into hepatitis C now will make it easier for other companies to develop drugs to fight the virus.

Chiron Corp., which discovered the virus in 1987, announced this week that it will relax its strict licensing practices over use of its hepatitis C patents.

The Kansas City Star reported earlier this year that numerous small firms had abandoned or avoided hepatitis C research because of Chiron's high licensing fees.

The federal agency that collaborated with Chiron on the discovery also was reviewing an agreement in which it had assigned the company exclusive rights to the virus, the newspaper reported.

"Some in the scientific community have recently raised concerns about the impact the agreement may be having on public health," the Centers for Disease Control and Prevention told The Star in a written statement earlier this year.

CDC spokesman Tom Skinner said Thursday he did not know whether the agency's ongoing review had anything to do with Chiron's policy changes. But, Skinner said, "What has developed here is a really positive step in the right direction for those working to combat this disease."

The California biotech firm announced the new licensing terms in a news release Tuesday.

In granting a research license to Prosetta, a small California company, Chiron said it had dropped its requirement of up-front payment and annual fees to use its technology. Royalties would still be due for any successful products that are developed.

Tom Higgins, Prosetta's president and CEO, said Thursday that the company would have dropped its hepatitis C research if Chiron had not relaxed its licensing policies.

"We only very recently approached Chiron about a license, and we happened to intersect at a very propitious time," Higgins said. "Chiron was very responsive."

Prosetta will use the license from Chiron to research new treatments for the virus, for which there is currently no vaccine. Treatments can have serious side effects and help only about half the patients who try them. The virus has infected 4 million or more Americans and an estimated 170 million people worldwide.

Chiron officials did not return phone calls Thursday.

But in an interview published this week in the Los Angeles Times, Chiron Chief Executive Howard Pien said the policy change had come about because he did not want Chiron to be viewed as blocking drug development.

Pien told the Times that it was particularly important now, because pharmaceutical pricing has become such a big issue in Washington. The Times story noted that Chiron and other drug firms were lobbying to block laws that would permit the importation of low-cost drugs from Canada.

"Our ability to make a meaningful contribution in policy debates is in part influenced by whether we are perceived as a good corporate citizen," Pien said.

Pien also said that Chiron had heard complaints that its fees were too steep for small companies.

The Star's story in February noted that a 2003 study by the National Academy of Sciences said that Chiron was one of several companies with a reputation for aggressively enforcing patents in a way that may limit access to them.

The study said Chiron's licensing terms at the time "included significant up-front payments" and royalties on the final product.

But earlier this year Chiron told The Star that it had done nothing to delay research, which it said would violate its own rules, and that complaints from small firms were groundless.

All told, company officials said at the time, "Chiron's discovery of the virus and the resulting millions of lives saved, as well as the billions of dollars in health-care and other societal costs avoided, is a paradigm for how the public benefits from the incentives provided by the patent system."

Working with the CDC in the 1980s, Chiron identified the virus and patented a clone, which led to the first reliable blood testing and early treatments.

But in February The Star inquiry showed that control of the patent was the subject of a bitter dispute.

The government, which feared Chiron would limit access to the patent through strict licensing agreements or high prices, wanted some control over it. Chiron refused.

Under a 1992 agreement, Chiron paid $2.2 million over five years to the CDC and a CDC scientist who had worked on the breakthrough.

The Kansas City Star.

New Video and Brochures Designed as Educational Tools for Healthcare Providers and Consumers

RESEARCH TRIANGLE PARK, N.C., June 24 /PRNewswire/ -- GlaxoSmithKline (GSK) announced today the release of new educational materials that address the causes, symptoms and risks associated with chronic hepatitis B. The video, Hepatitis B: Facing the Challenge, is now available to healthcare professionals and consumers at http://www.hepatitisbhelp.com, GSK's hepatitis B Web site. The video is available in English as well as Cantonese, Korean, Mandarin, Spanish and Vietnamese. In addition to the video, a 12-page, full-color, hepatitis B disease awareness brochure is available for download on the Web site in the same languages.

In the United States, one in 10 people of Asian and Pacific Islander descent is infected with chronic hepatitis B. If left untreated, chronic hepatitis B can result in complications including cirrhosis of the liver, liver failure and liver cancer. In fact, one in four chronically infected individuals in the United States will die from liver failure or liver cancer.

Infants born to infected mothers are among those at greatest risk for contracting hepatitis B. Unlike adults, 90% of infants and 50% of young children infected with hepatitis B will develop a chronic infection if they are not treated. For this reason, GSK will strive to provide the materials to community outreach programs in ethnic communities. GSK also will offer the materials to medical associations, healthcare organizations, schools and health fairs.

The video and brochures can be downloaded by visiting http://www.hepatitisbhelp.com.

Facts About Hepatitis B
The virus is transmitted through direct contact with blood and other bodily fluids. The hepatitis B virus (HBV) targets the liver and can eventually lead to cirrhosis of the liver, liver failure and liver cancer.

While uncommon in the general U.S. population (only 0.3% of the general population has chronic HBV and liver cancer does not rank among the 10 most common cancers), the statistics for the Asian and Pacific Islander community are vastly different. One in 10 Asian and Pacific Islander Americans in the U.S. are infected with hepatitis B, one in four of whom, if left untreated and unmonitored, will die from complications from cirrhosis, liver failure and liver cancer, according to the Centers for Disease Control and Prevention (CDC) and Asian Am Pac Isl J Health, 2001;9:141-152.

About GSK
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. Visit GlaxoSmithKline at http://www.gsk.com or http://www.hepatitisbhelp.com.

SOURCE GlaxoSmithKline

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June 25th, 2004

Beaver Dam Wisconsin man lives with disease, uncertainty
TOM GIESE - Associate Editor
Daily Citizen
http://www.citizenol.com

When Wayne Bennett underwent heart bypass surgery last August, he saw the operation as a step toward regaining the lifestyle he'd led for many years.

Instead of the shortness of breath he'd been experiencing, he was looking forward to bowling, singing, polkaing and smelling the flowers he cherished.

Unfortunately, today he is little more than a shell of his former self, clinging to life in a hospital bed in the Beaver Dam apartment he shares with his wife, MaryLou.

Wayne has been diagnosed with hepatitis C, a disease that is slowly destroying his liver. He has dwindled to 110 pounds because his appetite is gone.

He sleeps all day and is awake at night. A steady supply of oxygen helps him breathe. While he senses no pain, morphine is available if he needs it.

All the time, MaryLou looks on, wondering how her husband contracted hepatitis C and what the future will bring. Beyond her husband's health, she is concerned about insurance costs as well as paying for items not covered by insurance.

"We're getting by, but that's about it," she said.

MaryLou lost her job when the Weyco shoe factory closed in December. Since then, she has received unemployment benefits while taking a child care course to qualify for a new job. She has also maintained her insurance coverage, paying the costs on her own.

Meanwhile, Sandi Koehn has stepped in to help. She is organizing a fund-raiser for her uncle Wayne and MaryLou, making arrangements for a brat fry that will take place Wednesday, June 30, at Grace Presbyterian Church. Serving will be from 3 until 7 p.m.

Koehn has been joined in the effort by the Rev. Jack Harrison, pastor of Grace Presbyterian, as well as several parishioners. They hope to collect a substantial sum of money so the Bennetts can rest easier.

An account has also been set up at Dodge Central Credit Union. Contributions can be made to the Bennett Fund.

Meanwhile, when Wayne speaks, it's with a strained voice. He has little strength to move from his bed in front of the television set. Every action, even speaking, requires immense effort.

That's a far cry from the man who loved to dance, sang in a barbershop quartet as well as at church and loyally listened to the Barn Show every weekday night. It's also a long distance from the easy going fellow who loved to attend the races and play euchre.

"It's hard to watch someone, who used to be so active; now he can't do anything," MaryLou said.

Wayne's attitude, on the other hand, has run the gamut. At first, he was angry, then disappointed and finally, resigned to his fate. Recently, he planned his funeral.

Doctors are unable to answer Wayne's and MaryLou's questions. They cannot say how he contracted the disease, but predict he has five to seven months to live.

Typically, hepatitis C is contracted in one of three ways: non-sterile needle use, through a blood transfusion from a donor who had the disease, and by sexual relations with an infected person. MaryLou does not have the disease.

"It's bad enough to know that he has the disease," MaryLou said. "We'd like to have some idea where it came from."

Indeed, a good deal has taken place since Wayne entered St. Mary's Hospital in Madison 10 months ago to undergo surgery. He emerged from the hospital with five heart bypasses, ready to resume the lifestyle that had eluded him in recent years.

Within two months, however, Wayne was at the Beaver Dam Community Hospital. His stomach had filled with blood. Subsequently, a Madison physician diagnosed hepatitis C.

Since January, Wayne has had fluid removed four times from his lower abdomen. Each time, doctors extracted between 15 and 20 pounds of fluid.

Today, medications extend Wayne's life. MaryLou maintains a vigil, content to remember the good times the couple have enjoyed since meeting 37 years ago.

Hospice care has begun, giving the couple comfort during their difficult times. They also plan to hold a mock wedding in July for one of their sons, since Wayne, 66, may not live until the Oct. 16 ceremony.

Tom Giese can be reached by e-mail at tgiese@capitalnewspapers.com.

SourceURL:http://news.xinhuanet.com/
www.chinaview.cn

BEIJING, June 26 (Xinhuanet) -- An estimated 41 million people in China have contracted the hepatitis C virus, which could become a fatal "quiet epidemic," according to Professor Xu Daozheng, a liver disease expert with Ditan Hospital in Beijing.

The Chinese Ministry of Health said in a report, issued in February, the number of hepatitis C patient was growing. A national epidemiological survey covering the 1992-1995 period found 3.2 percent of the country's population, or 38 million people, had hepatitis C virus.

Prof. Xu said his estimate is quite conservative, and suggested the disease should be included in normal medical checks, like hepatitis B, because it has become a serious public health issue in China.

At present, a patient with hepatitis C may look normal and feel just as good as a healthy person, and the disease will not be detected until it is too late, the professor warned.

Unlike other types of hepatitis B, 75 percent of people with hepatitis C show no signs of symptoms in the early stage, said Xu.

About 15 percent of the people with hepatitis C will develop hepatocirrhosis and 5 percent would develop cancer if the disease is detected in a later stage, the expert explained.

There is still no vaccine against hepatitis C in China, and the China Medical Association has called for screening the disease in normal blood tests, especially among high-risk groups.

China has about 20 million people with chronic viral liver diseases out of its 1.3 billion population, and half of the 280,000 patients of liver disease died of liver cancer.

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