News Review

Back to News Review

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

Week Ending: July 14^th , 2007

Alan Franciscus
Editor-in-Chief

To download pdf version click here

This Issue:

July 9th, 2007

Woman tries unusual drug for hepatitis
http://www.theolympian.com
keri brenner
the olympian

Mary Findley might be one of the few people in the country to cure herself of hepatitis C, a virus-caused inflammatory liver condition, using a drug designed to treat Parkinson's disease.

Findley, 56, a Eugene, Ore., natural cleaning products retailer, suspects she contracted the potentially lethal liver disease from a blood transfusion 21 years ago during a hysterectomy. She said that was the only time she had some sort of blood-to-blood contact - the only way to get hepatitis C.

The disease - which Washington officials in May said was one of the top state health concerns - can be contracted by sharing injection drug needles with an infected user. Health practitioners also can contract it from a needle stick during a medical procedure with an infected patient.

Other sources could be sexual contact if there are open sores on both partners, tattoos or from sharing a razor or a toothbrush with an infected person whose gums or skin are bleeding. There is no vaccine, although people at risk are advised to be vaccinated for Hepatitis B.

"Hepatitis C is the most common blood-borne infection in the U.S. and is the leading cause of liver transplants," said Wendy Dillon, hepatitis C coordinator for the state Department of Health. "There are eight times as many hepatitis C cases as there are cases of HIV/AIDS infection in our state."

The standard drug treatment is a cocktail made from two potent antiviral drugs, interferon and ribavirin. A study reported in May indicates that about half of the patients who try the cocktail could be "cured" of the disease - meaning the virus is eradicated.

But Findley said the down sides of interferon are its side effects and expense.

"Interferon is not an option. It's a death threat," she said. "They stick you with this needle which you are going to pay out your nose for. It will destroy your liver, put your life on total hold for a year, possibly kill you, cause many to commit suicide," she said.

Findley says she was cured by amantadine, an inexpensive, less-harsh antiviral drug used for Parkinson's patients.

Findley said she went to several doctors before she found one willing to prescribe the amantadine for her. She had to threaten to go to Mexico to get the drug before her doctor would write the prescription, she said.

Despite its side effects - which include dry mouth, jitters and irritability - amantadine was worth the effort, she said.

"It was not so bad compared to the horrible side effects of interferon," she said.

Findley also adhered to a natural, chemical-free unprocessed foods diet, an exercise regimen to promote liver detoxification, and other protocols such as sweating out toxins in a hot bath.

Thomas Griffith, an Olympia naturopathic physician, said he has never heard of using amantadine for hepatitis C.

"It's very much an off-label use," Griffith said.

However, he agreed with Findley that interferon therapy, while appropriate in some cases, can be "fraught with side effects, is very expensive, can damage the immune system, and is like having a flu all the time."

Griffith said the best therapy for hepatitis C "really depends on how progressive a person's disease is and the lab parameters," he said. "Not everybody who has hepatitis C is a candidate (for interferon)."

Griffith said he consults with a liver disease specialist to determine whether interferon would be the best treatment option - and will have the specialist administer the drug if appropriate.

For his part, Griffith offers herbal and supplement therapies that can complement - but don't interfere with - the prescription drug regimen.

That could include milk thistle, a liver-protective herb, or phosphatidylcholine, a form of unrefined lecithin. Phosphatidylcholine is a main constituent of cell membranes and useful in inflammatory conditions such as hepatitis, Griffth said.

"You should contact your practitioner for dosages," Griffith said. "And be careful of the supplements you buy - some of the ones with raw materials from India or China could have contaminated products in them."

Findley was symptom-free for most of the last two decades until January 2002. That was when she saw a doctor because of a yellowish tint in her eyeballs - a sign of jaundice.

"I was getting tired at that time, and losing memory, but I attributed it to aging," said Findley, who owns and operates Mary Moppins Co.

A blood test, however, showed Findley had 1.2 million copies of the hepatitis C virus in one milileter of blood - a heavy viral load.

Now, five years later, in February of this year, a blood test found no detectable signs of the virus. Findley feels great, she said.

"Had I not done the research, stuck to my guns and insisted on the amantadine, my stomach would be bloated, my kidneys and liver failing, and I would be bed-ridden," she said. "There are times I'm glad I was born in Missouri and as stubborn as their mules."

Keri Brenner covers Thurston County and Tumwater for The Olympian. She is also a licensed acupuncturist in Oregon and holds a master's degree in Oriental medicine and acupuncture from the Oregon College of Oriental Medicine in Portland. Brenner is the author of "Sleep Disorders: An Alternative Guide" and a contributing editor to "Alternative Guide to Women's Health, Vols. I and II." She can be reached at 360-754-5435 or kbrenner@theolympian.com

Resources
Mary Findley's Web site, Mary Moppins: www.goclean.com .

Thomas Griffith, a naturopathic physician: Vital Healthcare, 200 Lilly Road N.E., Ste. B-3, Olympia; 360-455-8281; www.docgriffith.com.

Back to top

US firm sues Cadila in patent row
http://www.business-standard.com
P B Jayakumar / Mumbai

Three Rivers Pharmaceuticals, a US-based speciality drug manufacturer, has sued Zydus Cadila (Cadila Healthcare) and its US subsidiary Zydus Pharmaceuticals (USA) for infringing on the former’s patent on a process for manufacturing an anti-viral drug Ribavirin used in the treatment of Hepatitis C.

Three Rivers Pharma has alleged that Zydus Cadila infringed on its patent on an improved process for manufacturing Ribavirin pellets using wet granulation.

The lawsuit was filed in the district court of Virginia about a month ago to prevent Zydus Cadila from making, selling or importing finished dosage forms of ribavirin in the United States.

Ribasphere, Three Rivers’ Ribavirin drug, was approved by the US Food and Drug Administration in April 2004. Ribavirine is an old-generation molecule used in the treatment of Hepatitis C as a combination therapy with drugs such as Roche’s Pegasys.

Zydus Cadila declined to comment on the development. It also declined to reveal the abbreviated new drug applications (ANDA) with a Para IV certification filed in the US.

According to the US rules, ANDAs with Para IV certifications are a challenge on an innovator’s drug patent. The challenge has to be notified to the innovator company, which in turn has to sue the challenger within 45 days of the notice.

“We expected Zydus to respect our intellectual property without the need for litigation. But they refused to provide us with any meaningful assurance that it had not used and would not use our patented process,” Donald Kerrish, president and CEO of Three Rivers, stated on the company’s website.

Zydus Cadila has around 27 approvals since the commencement of filing process with the US Food and Drug Administration (FDA) in 2003-04, and has filed over 60 ANDAs and 51 drug master files (DMFs). However, most of its ANDAs were for patent non-infringing processes.

Three Rivers Pharmaceuticals is a privately held company based in Cranberry Township, Pennsylvania, and focuses on specialised therapies.

Back to top

Selenium supplements linked to diabetes in U.S. study
www.reuters.com

People who take selenium supplements in the hope of preventing diabetes may actually worsen their odds, U.S. researchers said on Monday.

An unusually well-controlled trial showed that people who took selenium pills raised their risk of diabetes by more than half, compared to similar people taking placebos.

The trial is one of a few surprising studies that have found vitamin and mineral supplements can sometimes do more harm than good.

"I would not advise patients to take selenium supplements greater than those in multiple vitamins," said Dr. Saverio Stranges of Warwick Medical School in Britain, who led the study.

Stranges, formerly of the State University of New York at Buffalo, and colleagues were studying another idea -- whether selenium supplements could prevent skin cancer.

But there was research suggesting the mineral might help prevent diabetes.

The Stranges team looked at 1,202 people taking selenium for the skin cancer trial who did not have diabetes at the beginning of the study.

50 PERCENT GREATER RISK

Half took a 200 microgram selenium supplement and half received a placebo pill for an average of 7.7 years.

Reporting in the Annals of Internal Medicine, the researchers said 58 of 600 people taking selenium and 39 of 602 taking placebos developed type-2 diabetes over the 7.7 years.

That is an increase in relative risk of about 50 percent.

About 60 percent of Americans take multivitamin pills, many of which contain between 33 and 200 micrograms of selenium, in addition to the selenium taken in from food and the air.

The higher a person's normal blood level of selenium, the worse the risk of diabetes, the researchers said.

"The U.S. public needs to know that most people in this country receive adequate selenium from their diet," Dr. Joachim Bleys, Dr. Ana Navas-Acien and Dr. Eliseo Guallar, all of Johns Hopkins University in Baltimore, wrote in a commentary.

"By taking selenium supplements on top of an adequate dietary intake, people may increase their risk for diabetes."

The original cancer trial found that those who took selenium had a somewhat lower risk of dying from cancer, although the supplements did not lower the risk of getting skin cancer in the first place.

Another surprising study found that smokers who took beta-carotene supplements raise their risk of cancer.

Back to top

Thyroid Disorders Common with Hepatitis C
http://www.onlinenews.com.pk

ISLAMABAD: People chronically infected with hepatitis C virus (HCV) have a significantly increased rate of thyroid abnormalities, according to a new report.

This association "implies that these patients should be screened for thyroid function on a periodic basis," says lead author Dr. Alessandro Antonelli from the University of Pisa School of Medicine, Italy. "A substantial proportion -- 13 percent in our series -- have hypothyroidism, and thus might benefit from treatment."

Thyroid involvement in HCV-infected patients has been reported previously, the authors explain in The American Journal of Medicine, but little is known about the prevalence and nature of thyroid disorders in such patients. Antonelli and colleagues looked into this in a study of 630 patients with chronic hepatitis due to HCV infection. Significantly more HCV-infected patients than uninfected subjects or hepatitis B virus-infected patients were positive for anti-thyroid autoantibodies, the authors report.

Also, low thyroid function (hypothyroidism) was significantly more common among HCV-infected patients (13 percent) than among the comparison groups (3-5 percent).

"We are planning a population based epidemiological study to assess the association between thyroid disorders and HCV infection," Antonelli added. A possible association of HCV infection with thyroid cancer and diabetes is also under investigation.

Back to top

July 10th, 2007

Doctor convicted of deliberately infecting patients with Hepatitis C
http://www.haaretz.com/
By Mijal Grinberg, Haaretz Correspondent

The Be'er Sheva District Court on Tuesday convicted Dr. Sergei Puntos of 25 counts of causing grievous bodily harm, intentionally spreading a disease, and possession and use of narcotics.

Puntos, who worked as an anesthesiologist at Be'er Sheva's Soroka Hospital, was accused of infecting 31 of his patients with hepatitis C by injecting them with sedatives using a syringe that he had used to inject himself with narcotics.

Puntos was acquitted of aggravated assault.

"I rule that the prosecution adequately proved that the defendant committed all of the crimes of which he was accused, in addition to the 25 counts of causing grievous bodily harm," wrote the judge.

In addition, Puntos was convicted of stealing from an employee, fraud and negligence.

Following his first indictment, Puntos was released to full house arrest on condition that he refrains from contacting his former patients and other Soroka employees.

According to a later indictment, following his release, Dr. Puntos contacted a fellow Soroka doctor who was to be summoned as a key witness in the case and threatened him, telling him that "You will see what it means to testify against me. "

Back to top

Mich. task force created to cope with hepatitis C
http://www.statenews.com
By COLLEEN MAXWELL
The State News

The list of celebrity victims includes Pamela Anderson, Naomi Judd, Mickey Mantle, James Earl Ray and Steven Tyler.

But hepatitis C, a deadly virus which affects more than 4 million Americans, now will be tackled by a new Michigan task force.

The Hepatitis C Advisory Task Force will advise the governor and Legislature on policies for reducing the risk of hepatitis C, said T.J. Bucholz, a spokesperson for the Michigan Department of Community Health.

Hepatitis C is a blood-born, infectious virus caused by the hepatitis C virus. The virus, which has no cure, can lead to cirrhosis, liver failure or cancer.

This summer, Peter Gulick, an associate professor of medicine in the College of Osteopathic Medicine, was appointed to the task force by Gov. Jennifer Granholm.

Along with 10 other appointees, part of Gulick's job will be to increase awareness in Michigan.

Each appointee represents a different group in the state, from religious organizations to the legal community, to the education community, Bucholz said.

"They will provide an annual report to the governor and Legislature on major risk factors," he said.

Karen Hunter, a spokeswoman for the Center for Disease Control and Prevention, or CDC, said those who are at especially high risk are people who have injected illegal drugs or those who have received blood donations or solid organ transplants before July 1992.

"Even health care workers can be at risk after an exposure to a needle stick," Hunter said.

It's the leading cause of liver cancer, Gulick said.

"A lot of people don't know that," he said. "In the next couple of years, it's going to get worse if we don't start recognizing it, especially with baby boomers."

Eighty percent of people with hepatitis C have no symptoms, according to the CDC. If symptoms do occur, they can include joint pain, fatigue and stomach pain, according to the American Liver Foundation.

In order to diagnose the disease, a blood test is done to test for antibodies in order to see if the person has been exposed to the disease before, Gulick said.

If the person tests positive, they are then tested for the active virus in the blood stream.

Blood banks perform the test before a person donates, he said.

"If a person wants to get tested and not have to pay, they can do it that way," he said.

The task force most likely will focus on finding ways to better diagnose and treat the virus, and educate different groups about the virus - especially those in the prison system, Gulick said.

"There are a lot of people with hepatitis C in prisons," he said.

Many prisoners with hepatitis C go unmonitored, and end up with liver disease. By then, it is too late to help them, he said.

"It's not being appropriately treated," he said. "Were going to sit down and go through it on different levels to try and see how we can go through with giving it its proper awareness in the state."

Bucholz said hepatitis C is a continuing health issue and the task force's goal will be to reduce the number of people infected with it.

"It's an incredibly debilitating disease," he said.

Back to top

Hepatitis C study seeks isle volunteers
http://starbulletin.com/
By Helen Altonn
haltonn@starbulletin.com

Researchers will test a new drug that stays in one's body longer

Isle residents with hepatitis C have an opportunity to participate in a clinical research trial for a drug to be taken every two weeks instead of weekly.

Dr. Alan Tice, infectious disease specialist, said 15 patients have signed up, and he is seeking more. Interested people are asked to call him as soon as possible at 373-3488 because the trial has been opened internationally, he said.

Only 200 slots are left out of 1,500 planned for the study, he said. Patients must meet certain criteria for the trial, done under U.S. Food and Drug Administration oversight. The tests and drugs are worth about $50,000 a year, Tice said.

The study will investigate a new form of interferon, which must be taken with ribavirin pills. It might have the same side effects as other forms of interferon, such as anemia and depression, so patients will be closely followed, Tice said.

The new formula stays in the body longer, but the patient must be treated for a year, he said.

A part-time University of Hawaii faculty member with his own practice, Tice is most interested in hepatitis and Staphylococcus aureus as two significant health problems in Hawaii. He represented the Infectious Disease Society of America at a recent American Medical Association meeting.

"Hepatitis is something that has been ignored in many respects," he said, "because hepatitis C often affects primarily people who used drugs in the past, people who don't have money, who often have adjustment problems and limited medical resources."

A number of people became infected with the virus through transfusions before 1992, he said.

"It's a sneaky agent," Tice said, explaining hepatitis C causes cirrhosis, liver scar tissue or liver cancer at a rate of 1 percent or 2 percent a year.

People do not realize for decades that they have the chronic blood-borne infection because in the first years they are not sick, he said.

Many people who used drugs in the '60s and '70s thought they would be safe, Tice said. "Now we have the highest rate of liver cancer per capita in the country. The tip of the iceberg is coming to the surface, and they're coming down with these things they didn't know they had for 20 to 30 years."

About 22,000 isle residents are infected with hepatitis C, according to the Hepatitis Prevention, Education, Treatment and Support Network of Hawaii.

"The majority of people with hepatitis C probably don't realize they have it," he said.

"It's a difficult thing to get people to admit they used drugs. ... A lot of people don't want to know."

Back to top

South Asian music resource tackles hepatitis C awareness
http://www.healthcarerepublic.com

A music CD is being launched to raise awareness of hepatitis C within the South Asian community and tackle the stigma related to the virus so as to encourage those at risk to seek help and support.

With emerging evidence showing that people from a South Asian background may have a higher prevalence of hepatitis C infection than the general population in this country, the CD aims to improve understanding of how the virus is transmitted, diagnosed, treated and prevented.

‘My Story’ has been created by the Department of Health’s FaCe It campaign and features advice from healthcare professionals and an interview conducted by TV health presenter Yasmin Qureshi with Shabana Begum, a Pakistani woman who recounts her experience of hepatitis C. The CD also features music from popular Asian artists.

Dr Shahid Khan, Consultant Physician within the Department of Hepatology and Gastroenterology at St Mary's Hospital and Hammersmith Hospital in London believes it is vital to raise awareness within the South Asian community:

"As medical professionals, we should be on the lookout for people who may have unknowingly been exposed to the risk of hepatitis C. This community is one area to focus on. Many people may have visited back street barbers where razors are shared, or undergone medical care abroad, or may have shared ear and nose piercing equipment, which could be contaminated with infected blood. This CD is a great tool to communicate with the South Asian community and enables us to meet the stigma attached to the virus head on."

‘My Story’ has been recorded in both English and Urdu and will be distributed through Asian businesses, organisations and melas during the summer as part of a pilot project. The CD will be supported by information leaflets, which are available in a range of languages.

Dr Kiran Patel, Chairman of Trustees for the South Asian Health Foundation, believes this is a positive step in the right direction:

"I hope 'My Story' will encourage more Asian people to consider whether they may have been at risk of contracting hepatitis C and to get themselves tested. By highlighting Shabana's experience, a real sense of reality is added, and hopefully this will motivate and inspire others within the community to come forward."

It is estimated that around 200,000 people in England have hepatitis C and of this number, the majority are probably unaware of their condition since many experience no symptoms for a number of years. If undetected, hepatitis C can develop into cirrhosis or even liver cancer, and in a small proportion of cases, can be fatal.

Launched in December 2004, the Department of Health’s hepatitis C awareness campaign ‘FaCe It’ aims to raise awareness of the virus and its prevention, diagnosis and treatment, while tackling the stigma, which is often attached to it. Further information on hepatitis C is available on the campaign website, which can be found at www.hepc.nhs.uk

The public can also call the Hepatitis C Information Line on 0800 451 451 (textphone 0800 0850859) from 7am-11pm, 7 days a week for confidential information and advice.

Back to top

UCLA/VA develops tool to gauge quality of life of hepatitis B patients
http://www.eurekalert.org

“Am I going to die" I have no future.” “I feel depressed at times, fearful I may not see my children marry or be a grandparent.” Such heart-rending statements from patients with chronic hepatitis B reveal the social and mental impact of this disease, which affects 350 million worldwide.

In a new study, UCLA researchers measured the effect of hepatitis B on patients’ quality of life — beyond just the physical symptoms of the disease — and created a new tool to better assess patients’ overall well-being, which may help clinicians guide treatment. The study appears in the July issue of the journal Hepatology.

“Our results revealed that to effectively treat hepatitis B patients, clinicians need to consider the social and psychological impact of the disease, as well as biological functioning,” said Dr. Brennan M.R. Spiegel, principal investigator and assistant professor of medicine at the David Geffen School of Medicine at UCLA and the Veterans Affairs Greater Los Angeles Healthcare System.

Hepatitis B is caused by a viral infection that can damage the liver and lead to chronic disease. It is contracted most often through contact with infected blood or bodily fluids.

According to Spiegel, little research had been done previously on quality-of-life issues for the majority of hepatitis B patients — those who do not have advanced liver disease or, even rarer, end-stage complications.

In developing the first-of-its-kind assessment tool for patients, researchers reviewed existing literature, conducted a focus group with health experts and interviewed hepatitis patients. They then took the information and developed a patient questionnaire that clinicians could use to measure patients’ quality of life.

“We were shocked to find that for many hepatitis B patients without advanced liver disease, the psychosocial impact of the disease affected their lives more than the physical symptoms,” said Spiegel, who is also director of the UCLA/VA Center for Outcomes Research and Education. “No one had ever documented this before.”

The questionnaire measures quality of life on several levels, including psychological well-being, anxiety, vitality, disease stigma, vulnerability and transmissibility.

“We hope that this quick questionnaire can become a ‘vital sign’ taken in the doctor’s office to help see how the patient is doing,” added Spiegel.

Spiegel notes that the questionnaire could also be used in clinical trials to help measure outcomes and also to equip patients with knowledge to help them better select between competing disease management strategies.

###
The study was funded by the pharmaceutical company Novartis. Spiegel is a consultant for Novartis and has received research support form the company.

Other study authors from the David Geffen School of Medicine at UCLA include Roger Bolus, Ph.D., Dr. Eric Esrailian and Jennifer Talley, also of the UCLA/VA Center for Outcomes Research and Education; Dr. Steven Han, also of the VA Greater Los Angeles Healthcare System; Dr. Myron Tong; and Dr. Francisco Durazo.

Other authors include Dr. Tram Tran, Cedars-Sinai Medical Center; Jason Smith, Pharm.D., VA Greater Los Angeles Healthcare System; Dr. Hetal A. Karsan, Atlanta Gastroenterology Associates and Emory University School of Medicine; Dr. Bruce Bacon, Center for Liver Diseases at Inova Faifax Hospital in Virginia; Dr. Paul Martin, Emory University School of Medicine; Dr. Zobair Younossi, Center for Liver Diseases at Inova Fairfax Hospital; Siew Hwa-Ong, Novartis Pharma AG in Basel, Switzerland; and Dr. Fasiha Kanwal, St. Louis University.

Back to top

Biotron Releases Hepatitis B Antiviral Program and Phase I Trial Update
http://au.biz.yahoo.com

Original Announcement: Hepatitis B Antiviral Program and Phase I Trial Update

Biotron advised that its compounds have shown potent activity against the Hepatitis B virus (HBV). The company's lead anti-HIV drug, BIT225, is currently in a Phase I clinical trial in human. The trial is designed to determine the safety and drug blood levels of BIT225 in healthy volunteers after a single dose after fasting or with food and is well advanced and is meeting all of the company's expectations.

Back to top

Peregrine Pharmaceuticals Initiates Bavituximab Clinical Trial in HCV Patients Co-Infected With HIV
http://www.finanznachrichten.de

TUSTIN, Calif., July 10 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, (Nachrichten) Inc. , a clinical stage biopharmaceutical company developing monoclonal antibodies for the treatment of cancer and hepatitis C virus (HCV) infection, today announced initiation of patient enrolment in a study of bavituximab in patients co-infected with HCV and the human immunodeficiency virus (HIV). The multi-center trial will be initially conducted at Saint Michael's Medical Center in Newark, NJ under the direction of Dr. Stephen Smith, director of the Peter Ho Memorial Clinic, the largest HIV/AIDS treatment facility in the state.

"This is an important study for the bavituximab HCV clinical program that is designed to evaluate an extended treatment schedule in an important HCV patient population," said Steven W. King, president and CEO of Peregrine. "We believe that bavituximab's unique targeting mechanism has the potential to act on both HCV and HIV virus infections, and we look forward to working with Dr. Smith and his colleagues to assess the potential of bavituximab in this high need co-infected population."

The co-infection trial is an open-label, dose escalation safety study designed to assess the safety and pharmacokinetics of bavituximab in approximately 24 patients chronically infected with HCV and HIV. Patient cohorts will receive ascending dose levels of bavituximab weekly for up to 8 weeks. HCV and HIV viral titers and other biomarkers will be evaluated, although they are not formal study endpoints.

In the United States alone, an estimated 300,000 individuals are co-infected with HIV and HCV, representing up to 30% of all HIV-infected patients. Co-infected patients have been shown to have a lower response to current interferon/ribavirin HCV regimens and the adverse effects of these regimens can be especially problematic for some HIV patients.

Bavituximab is a monoclonal antibody in a new class of anti-phosphotidylserine (PS) immunotherapeutics that targets and binds to cellular components that are normally not present on the outside of cells, but which become exposed on certain virally infected cells and on the surface of enveloped viruses, including both HCV and HIV. Bavituximab helps stimulate the body's immune defenses to destroy both the virus particles and the infected cells. Since bavituximab's PS target comes from the host and not the virus, bavituximab is expected to be less susceptible to the development of anti-viral resistance than many other therapies. Bavituximab has successfully completed Phase la and lb clinical trials as monotherapy in patients with chronic HCV infection, which showed that the drug appears safe and well-tolerated and demonstrated encouraging signs of anti-viral activity.

About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection in the U.S. and India with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com/), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com/.

Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that the results from the co-infected HCV/HIV clinical trial will not be consistent with the results from the Company's prior HCV clinical trials and the risk that bavituximab will not be as effective as the current standard of care for co-infected patients. It is important to note that the Company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the Company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2006 and the quarterly report on Form 10-Q for the quarter ended January 31, 2007. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

Contacts:
GendeLLindheim BioCom Partners
Investors Media info@peregrineinc.com
Barbara Lindheim (800) 987-8256 (212) 918-4650

Back to top

July 11th, 2007

Longer Hepatitis C Treatment Best
http://www.webmd.com/
By Salynn Boyles

Cure Rates Are Higher With Longer Treatment of 6 Months

WebMD Medical NewsReviewed by Louise Chang, MDJuly 11, 2007 -- Shortening treatment to less than six months does not appear to be a good strategy for patients with the most curable types of hepatitis C virus infection, new research suggests.

Patients with hepatitis C genotypes 2 and 3 who were treated for four months had lower cure rates and higher relapse rates than those treated for six months.

The study, which appears in tomorrow’s New England Journal of Medicine, shows that longer treatment benefits even those with highly treatable hepatitis C, researcher Mitchell L. Shiffman, MD, tells WebMD.

“I tell patients if they can tolerate treatment and can stay on it for 24 weeks, they have a better chance of achieving the best possible outcome, which is a cure,” he says.

Hepatitis C Treatment Strategies
Long-term infection with hepatitis C virus (HCV) is a leading cause of cirrhosis, liver cancer, and liver transplants in the United States. As many as 4 million Americans are infected, but most don’t know it, experts say.

About 70% of infected Americans carry the genotype 1 form of hepatitis C, which tends to be less responsive to treatment than genotypes 2 and 3.

With aggressive treatment, nearly 80% of people with genotypes 2 or 3 achieve complete and sustained viral eradication, or cures, compared with about 40% to 45% of people carrying genotype 1 virus.

These days, most patients are treated with a long-acting version of the injected drug interferon along with the antiviral drug ribavirin.

The standard course of treatment for patients with the more treatable types of hepatitis C infection is half that of patients with genotype 1 hepatitis C -- 24 weeks compared with 48 weeks.

In several recent studies, it was reported that shortening treatment to four months and even three months had no impact on cure rates in hepatitis C genotype 2 or 3 patients.

In an effort to test these findings, Shiffman and colleagues from Virginia Commonwealth University compared outcomes among genotype 2 or 3 patients treated for four months and six months.

They report that 31% of patients treated with the shorter course of therapy eventually relapsed, compared with 18% of patients who got the full six months of treatment. Relapse was defined as having detectable levels of virus in the blood at follow-up despite complete viral eradication at the end of treatment.

Overall, 62% of patients treated for four months achieved sustained viral responses, compared with 70% of patients treated for six months.

Among patients who achieved complete viral responses within a month of starting treatment, 79% of those treated for four months achieved complete, sustained responses, compared to 85% of the patients treated for six months.

Individualized Hepatitis C Treatment
Shiffman understands the desire of patients and doctors to shorten treatment. The drugs used to treat hepatitis C are very expensive and they can cause severe fatigue, fever, depression, and other hard-to-tolerate side effects.

But he says a better strategy than shortening treatment is lowering drug dosage in patients who have trouble tolerating hepatitis C treatments.

He adds that rapid response to treatment has become as important as viral genotype for predicting response to treatment.

Patients who show no signs of hepatitis C infection within a month of beginning treatment have a 90% cure rate, regardless of genotype, he says.

“We are learning that the optimal way to treat hepatitis C is to monitor the virus during treatment, no matter what the genotype, and adjust treatment duration based on response.”

T. Jake Liang, MD, of the National Institutes of Health, says this individualized approach to hepatitis C treatment will become more common as more is learned about the virus.

Liang is chief of the liver disease branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

“As our technology improves we will be more able to identify patients who will benefit from a shorter course of treatment,” he tells WebMD. “For now, though, genotype 2 and 3 patients who can tolerate the treatment should remain on it for a full six months.”

SOURCES:

Shiffman, M.L. New England Journal of Medicine, July 12, 2007; vol 357: pp 124-134. Mitchell L. Shiffman, MD, professor, Virginia Commonwealth University; chief of hepatology, Virginia Commonwealth University Medical Center, Richmond, VA.
T. Jake Liang, MD, chief of the liver diseases branch, NIDDK, Bethesda, Md. Journal of the American Medical Association, July 9, 2003.

Hepatitis C infection presents many patients with a troubling Catch-22 situation.

Chronic infection with the hepatitis C virus (HCV) is the leading reason patients receive liver transplants today. Unfortunately, infection of the new liver by residual HCV in the blood is inevitable, and the immune system suppression crucial to prevent transplant rejection can worsen HCV-mediated disease in transplant patients.

Now, a study from the University of Wisconsin-Madison School of Medicine and Public Health offers new promise for a double-duty treatment that may provide both immune suppression and anti-HCV activity in a single drug.

A common immunosuppressive drug, called cyclosporine A, has hinted of such antiviral activity - at least in a lab dish - but past clinical studies have not shown conclusive evidence that it effectively fights HCV in patients.

"The thought was that maybe cyclosporine was doing something good because it has this antiviral activity, but in fact the clinical data doesn't really support that very well," says Robert Striker, UW-Madison professor of medicine and medical microbiology and immunology, who led the new study.

In spite of past unconvincing clinical studies, the circumstantial evidence is strong enough to have kept many scientists intrigued. For example, another immunosuppressant, tacrolimus, has largely replaced cyclosporine for transplant patients in recent years - a time period also marked by a trend toward poorer post-transplant recovery of HCV-infected patients.

The Wisconsin study, which was published online June 28 in the journal Hepatology, provides new support for anti-HCV effects of cyclosporine - plus a possible reason why previous studies may have missed it.

By monitoring the evolution of cyclosporine resistance, the group discovered that HCV forms with slight genetic differences - varying at only a handful of their 9,000 genetic bases and in just two proteins - have dramatically different sensitivities to cyclosporine.

HCV is highly genetically variable, Striker says - in fact it is the most variable virus known, meaning that many different versions exist with slightly different genetic sequences.

The new finding suggests that patients with cyclosporine-sensitive HCV variants may show antiviral benefit from cyclosporine treatment, while those with resistant variants would not.

"One of the more exciting aspects of this study is that it fits some data already [known] that in fact there is an effect from cyclosporine but that it is a genotype- or strain-specific effect," says Striker.

Naturally occurring genetic variations may have masked the effects of cyclosporine against HCV in previous clinical trials, he says. "This study reveals a complexity of the issue that was previously not studied very rigorously."

Though the results from the current analysis are too preliminary to determine whether individual patients should switch drug regimens, he suggests that more rigorous investigations are needed that will take into account viral variability and differential drug sensitivities.

The high degree of HCV variability means there will probably never be a one-size-fits-all treatment, but rather that many factors will likely play important roles in deciding the best course of action for an individual patient, including which viral strain is involved and which drugs are used.

"We don't know how important these factors are in patient care right now, but they are impacting decisions that are made right now," Striker says.

Understanding how cyclosporine acts against HCV should help doctors choose complementary drug combinations to reduce the development of drug resistance, Striker says, while the specific proteins identified - important in viral replication - offer a novel target for antiviral drugs.

"Slightly altered versions of cyclosporine that may be better as antivirals are in clinical trials now," he says. "This paper strengthens the rationale to give these compounds a chance."

Funding for this work was provided by the UW-Madison School of Medicine and Public Health from "The Wisconsin Partnership Fund for a Healthy Future" and by the National Institutes of Health and American Cancer Society.

Back to top

Hepatitis sufferer learns lesson through treatment
http://www.sentinelnews.com
By Brent Schanding/Sentinel-News Staff

Don Israel, 59, is an avid fisherman.

But the Shelby man's story about surviving a dangerous liver disease -- despite discomfort, disillusion and distress -- is no exaggerated fish tale.

Israel's story starts in the jungles of Vietnam, more than 30 years ago, where he was shot and wounded as a solider in the war. There, he required a life-saving blood transfusion that was likely tainted with the hepatotropic virus, or more commonly, Hepatitis C. The disease can spot a body's liver, before causing cirrhosis, cancer and ultimately death.

The virus apparently lived undetected in Israel's bloodstream for decades, until a routine physical revealed a higher-than-normal liver enzyme count. It sent red flags to doctors who advised Israel to take immediate action.

Despite at least one professional recommendation against treatment for hepatitis, Israel committed four years of his life to the daily management of his disease.

He injected shots of Interferon, a drug with psychotropic side effects, into his stomach and legs in a process similar to chemotherapy cancer treatments.

The shots are expensive. A month supply is $1,500, and Israel said he was fortunate that insurance covered most of those costs.

But that's where Israel's good fortune stopped.

"The treatment about kills you," he said. "It's very debilitating."

Within an hour after his injections, Israel reported feelings of nausea, weakness and disorientation. It also made him irritable.

"The shots got me so I couldn't do anything," he said. "I couldn't stand up."

So Israel slept his days away -- rotating between his bed and the couch-- sometimes not even getting up to brush his teeth.

The man, who easily tops 6 feet tall, dropped nearly 90 pounds in a short time, and photos taken during his treatment showed Israel as a gaunt reflection of his former self.

"All I did for the last few years was lay on my back," Israel said.

He did, however, make infrequent trips to the grocery store with his wife, Cindy, although he was confined to a wheel chair. He also only vaguely recalls his son's wedding.

"It was nice from what I can remember," he said. "But my thought process suffered. My memory was gone."

Slowly, the treatments showed signs of effectiveness. Physical therapy helped Israel regain his strength, and he largely credits his therapists for "bringing him back."

He also credits God and the patience of his wife, whom he described as a saint.

Today, Israel said his hepatitis is nearly undetectable. He stays fit by running, swimming and riding a stationary bike. He's regained much of his muscle mass, and even felt well enough to go fishing earlier this spring.

He's expecting his first grandchild in December and hopes to return to his job as a heavy construction superintendent in the fall.

And even his wife, Cindy, is getting her dues. Israel is serving as a "house husband," washing dishes and doing laundry, while his wife works.

"She stood by me and we're closer now than ever."

While Israel reports it's unlikely he'd ever choose to go through treatment again, he said his illness has taught him to take nothing in life for granted.

"I don't think anyone can understand it unless you go through it yourself," Israel said.

Back to top

Technique predicts hep C treatment success
http://www.physorg.com

By identifying genes that respond to interferon -- a drug commonly used to treat hepatitis C viral infections and certain types of cancers -- researchers have devised a novel way of predicting patient response to treatment.

Scientists from Indiana University Bloomington, the University of Haifa (Israel) Insititue of Evolution, St. Louis University and the University of Pittsburgh used a blind, statistical approach to identify 36 genes that are not only actively expressed in the presence of interferon, but also are turned on in patients whose virus counts are dramatically diminished. The researchers describe the technique and report the results of the first test in last week's Public Library of Science (PLoS): ONE.

"This method gives us the opportunity of identifying genes that are import in the response to any drug," said IUB biologist Milton Taylor, who led the study. "This method is not necessarily confined to hepatitis C. In this case we were just using interferon and hepatitis C to see if the method works."

A growing consensus among medical scientists holds that one reason why patients respond differently -- sometimes very differently -- to a given treatment is due to the patients' unique genetic identities. But how are scientists to know which genes -- out of the 50,000 that make up the human genome -- are actually involved in mitigating, say, the flu, herpes or Hodgkin's Lymphoma?

It is not enough to simply look at what genes are turned on in the midst of an infection, or even to look at which genes are most active in patients who are faring well with a prescribed treatment, Taylor says. So he and University of Haifa mathematician Leonid Brodsky decided to delineate the most important genes by combining viral counts in the blood with gene expression across time for each individual patient.

The scientists examined expression patterns of 22,000 genes in 69 patients at six different time points during treatment. Their analysis turned up 36 candidate genes that are closely associated with virus removal in patients. A quarter of these 36 have no known function. Lending credibility to their methodology, however, a sweep of the literature shows that nearly all 36 genes have previously been identified as playing a role -- known or unknown -- in the human response to interferon treatment. Using other methods, Taylor says, a researcher would have to examine perhaps 1,000 genes altered by the treatment and from these decide by other means which were most important.

Citation: "A Novel Unsupervised Method to Identify Genes Important in the Anti-viral Response: Application to Interferon/Ribavirin in Hepatitis C Patients" PLoS: ONE, 07/04/2007

Source: IndianaUniversity

Back to top

Former minister raises fear of HIV blood cover-up
http://www.guardian.co.uk/
Sarah Hall
The Guardian

· Lord Owen claims officials knew of hepatitis risk
· 1,700 dead and many terminally ill after blunder

New concerns are raised today that government officials attempted to cover up evidence that they could have stopped thousands of people becoming infected with HIV from contaminated blood supplies. Lord Owen, who was a Labour health minister in the 1970s, says he has unearthed the first concrete proof that officials knew more than 30 years ago that there was an increased risk of contracting hepatitis from imported blood products.

More than 1,700 people went on to die and many are terminally ill after contracting hepatitis C and then HIV from infected blood during treatment for haemophilia in the 1970s and 80s. Lord Owen, who as health minister pledged that Britain would no longer import blood products, has found a document from the Department of Health which shows officials knew in February 1976 that imported blood products were "more costly" to the NHS and came with a "higher hepatitis risk" - something that has been consistently denied.

The discovery comes ahead of Lord Owen's appearance today at the independent public inquiry into the contaminated blood scandal, chaired by the former solicitor-general Lord Archer of Sandwell. Lord Owen is expected to query why several volumes of documents relating to the issue were destroyed at a time when a similar HIV-tainted blood scandal was erupting in France. "This may be a coincidence - but it may also be a reason why the documents were destroyed. The inquiry will find out if there is any deliberate cover-up or simply maladministration."

As health minister from 1974 to 1976 the then David Owen was concerned about the hepatitis risk when he pledged Britain should stop importing blood products in January 1975. For more than 20 years he has repeatedly been told by officials that there was no known risk. Describing the document as a gem, Lord Owen said: "We now at last have actual evidence from the department that corroborates ... that we knew [the imported product] was more likely to be contaminated. What is important is that here they are in February 1976 - and they more or less concede every argument: it is cheaper to go for self-sufficiency and there is higher hepatitis risk [from imported products]."

Since 1988 Lord Owen, who went on to become foreign secretary before later leading the SDP, has battled to see evidence backing up what he was told by doctors and officials at the Department of Health and Social Security (DHSS) during his time as health minister. The DHSS pulped his official papers 10 years after he left the department, without telling him - an action he describes as "inexplicable".

But in May the Department of Health released 68 documents following pressure from the inquiry into the scandal. The three-paragraph minute, dated February 20 1976, was among those documents.

Roddy Morrison, chair of the Haemophilia Society, described the discovery of the new memo as "very significant. It begs the question of why this information was not shared more widely with the haemophilia community so that they could make an informed choice on whether to be treated," he said.

Lord Owen said that he was "quite convinced" hundreds of patients with haemophilia would not have contracted HIV if self-sufficiency had been introduced.

A total of 4,670 people with haemophilia were infected with hepatitis C between the late 1970s and mid-1980s, and 1,200 of those were also infected with HIV.

Back to top

July 12th, 2007

Abbott Announces Approval of First Fully-Automated Blood Screening Test for Hepatitis C Antibodies
http://money.cnn.com/

New Test Completes the ABBOTT PRISM(R) Hepatitis Panel

ABBOTT PARK, Ill., July 12 /PRNewswire-FirstCall/ -- Abbott announced today it received approval from the U.S. Food and Drug Administration for its ABBOTT PRISM(R) HCV test. This test can be used by laboratory technicians to screen individual donations of blood and plasma for antibodies to hepatitis C (HCV).

Used in more than 30 countries, the PRISM system was approved for use in the United States with its first three hepatitis B tests: a core hepatitis B test (PRISM(R) HBcore), introduced in October 2005; and two hepatitis B surface antigen tests (PRISM(R) HBsAg and HBsAg Confirmatory), introduced in July 2006. Additional retrovirus screening tests are currently under FDA review.

"With the ABBOTT PRISM system, we continue to support the infectious disease testing needs of the laboratory while helping them realize greater efficiencies and enhanced operator safety throughout the blood and plasma screening process," said William E. Brown III, Ph.D., vice president, diagnostic assays and systems development, Abbott. "The introduction of the PRISM HCV test reinforces Abbott's role as a leader in ensuring the safety of the world's blood supply."

In 1985, Abbott developed the first HIV blood-screening test approved in the United States. Abbott's hepatitis tests are used thousands of times every day around the globe for blood screening and diagnostic testing.

According to the American Association of Blood Banks (AABB), eight million volunteers donate about 15 million units of whole blood each year. Each donated unit of blood is tested for infectious diseases including hepatitis, HIV and other retroviruses.

Important Product Usage and Safety Information
The ABBOTT PRISM(R) HCV test [Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5)] can be used by laboratory technicians to screen individual donations of blood and plasma for antibodies to hepatitis C (HCV). This assay has not been validated for use with pooled specimens. The assay is not intended for use on cord blood specimens or for the laboratory diagnosis of HCV infection. This product contains human sourced and/or potentially infectious components.

About ABBOTT PRISM
The PRISM instrument consolidates testing into a single system automating many of the manual testing procedures and steps currently used to screen blood. Safety features built into the system help track and monitor each sample throughout the testing process providing documentation and quality control for testing facilities. The PRISM system can run 160 samples per hour, making it possible to test more than 1,200 samples per eight-hour shift.

About Abbott Diagnostics
Abbott Diagnostics is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics. With more than 69,000 institutional customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnostics from an art to a science through the company's commitment to improving patient care and lowering overall costs. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements.

About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

Back to top

Black AIDS Group Expands Focus to Cervical Cancer, Hepatitis C
http://www.kaisernetwork.org

The Balm in Gilead, an 18-year-old, national not-for-profit that promotes HIV/AIDS awareness among black religious communities, will expand its focus to address cervical cancer and hepatitis C, Pernessa Seele, founder and CEO of the organization, said on Tuesday, Religion News Service/USA Today reports.

"We know that HIV is not the only issue that we must address as a people," Seele said. The group will collaborate with local congregations, urging them to become active in public policy, while promoting good health as a "unique part of our spiritual life," Leslie Watson-Malachi, the organization's national policy director, said.

The Balm in Gilead also will establish the African-American Faith-based Health Policy Institute, which will be located in its Washington, D.C., office. The institute will provide education and advocacy training for black religious communities on HIV/AIDS, cervical cancer and other health disparities. The group will target young girls and black women in particular.

"We want to train people in the faith community to become more involved in holding their elected officials accountable," the Rev. Susan Newman, director of the organization's Washington, D.C., office, said, adding, "We need to do more than just pray. ... Prayer is the first action step. The next one is to talk about what's wrong and then make sure our elected officials are held accountable and do something about that" (Religion News Service/USA Today, 7/12).

Back to top

Pharmasset and Roche Initiate Studies to Advance R7128 for HCV
http://money.cnn.com

- Triggers a $7.5 Million Milestone Payment to Pharmasset -

PRINCETON, N.J., July 12 /PRNewswire-FirstCall/ -- Pharmasset, Inc. announces the start of long-term chronic toxicology studies in two animal species as part of their collaboration with Roche for the development of R7128 for the treatment of hepatitis C virus (HCV). R7128 is currently being evaluated in a Phase 1 clinical trial. The primary objective of the chronic toxicology studies is to assess the safety of R7128 when given for six months. Roche triggered a $7.5 million milestone payment to Pharmasset by initiating these studies.

"As we progress the ongoing 14-day multiple ascending dose study of R7128, we are encouraged that Roche has initiated the long-term chronic toxicology studies in support of the potential advancement of R7128 into Phase 2 clinical trials," stated Schaefer Price, Pharmasset's President & CEO. "This achievement is a clear indication that our cooperative partnership with Roche is focused on the common goal of accelerating the development of R7128 in order to bring new treatment options to patients with hepatitis C."

About R7128
R7128 is a polymerase inhibitor being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.

R7128 Phase 1 Study Overview
The Phase I clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This Phase 1 study is comprised of two parts:

Part 1 is a single ascending dose study conducted in 38 healthy volunteers. The primary objective of Part 1 is to assess the safety, tolerability and pharmacokinetics of R7128 following single ascending doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on the pharmacokinetics of R7128.

Preliminary data from the single ascending dose portion of the study indicate:

All doses of R7128 studied were generally well-tolerated.
All patients completed the study with no gastrointestinal adverse events or serious adverse events reported during the study.
No hematological or laboratory abnormalities of clinical significance were noted.

Part 2 is a multiple ascending dose study being conducted in up to 40 patients chronically infected with HCV genotype 1 who have previously failed interferon therapy. The primary objective of Part 2 is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily or twice-daily dosing for 14 days. The secondary objective is to assess antiviral efficacy by measuring the decrease in HCV RNA.

About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).

Pharmasset is currently developing three product candidates: Clevudine for the treatment of chronic HBV infection, which is expected to enter US, European and South American Phase 3 registration clinical trials and is already approved for HBV in Korea and marketed by Bukwang Pharmaceuticals under the brand name Levovir; R7128, an oral treatment for HCV, in a Phase 1 clinical trial through a strategic collaboration with Roche; and Racivir for the treatment of HIV in combination with other approved HIV drugs, which has completed a Phase 2 clinical trial.

Contact
Alan Roemer, Vice President
Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125

Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements" that involve risks and uncertainties, including without limitation the risk that we will not receive the $7.5 million milestone payment, the risk that our collaboration with Roche will not continue or will not be successful, the risk that the clinical trial or the toxicology studies of R7128 will not be successful or that R7128 will not be successfully developed and commercialized. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2007 filed with the Securities and Exchange Commission entitled "Risk Factors" and discussions of potential risks and uncertainties in our subsequent filings with the Securities and Exchange Commission.

Back to top

Investors hope Vertex drug will match hype
http://www.boston.com

Investors in Vertex Pharmaceuticals Inc. have had a rough ride over the past seven months and there is no indication that the road will get smoother any time soon.

The Cambridge biotechnology company's stock has plunged nearly 40 percent since December amid fears that its experimental hepatitis C drug VX-950, or telaprevir, will not live up to its hype.

What was once talked about as a wonder drug that promised to cure most patients with the liver-destroying disease is taking longer to develop than expected and may not work as well as many had hoped.

"The drug is still safe and effective and promising, but perhaps not as safe and effective and promising as people thought six months ago," said Phil Nadeau, an analyst at Cowen & Co., who has an "outperform" rating on the stock.

There is more money riding on telaprevir than on almost any biotech drug out there that is at a similar stage of development. And optimism over its potential accounts for most of the company's $3.7 billion market value.

Much of the excitement is due to the size of the market for hepatitis C, which affects roughly 4 million people in the U.S. alone, and data from early clinical trials which suggested that telaprevir might crush the disease.

Those expectations have been ratcheted back as more data have emerged, but the hope is that it will still increase the cure rate and shorten the duration of treatment. Current treatments cure only 45 to 50 percent of patients and must be taken for a year.

Vertex's drug is the most advanced in a new class designed to block the protease enzyme needed for the blood-borne virus to replicate and most analysts believe it will be approved, albeit later than originally expected.

If successful, annual sales could rise as high as $1.5 billion, they say, leading some to argue that Vertex's shares are undervalued.

Mike McCully, an analyst at Recombinant Capital, which consults to the biotech and pharmaceuticals industry, says "there is still tremendous upside for Vertex investors."

Based on current market capitalization-to-revenue multiples in the biotech sector, sales of $1.5 billion would put Vertex on track for a market capitalization of $7.5 billion. At the higher end, it could be much greater, he said.

Similarly, Geoffrey Porges, an analyst at Sanford Bernstein who has an "outperform" rating on the stock, believes telaprevir "is one of the most compelling new drug opportunities in the industry."

But others are more circumspect, saying that much depends on the performance of an emerging crop of rival drugs, including those being developed Schering-Plough Corp. and Intermune Inc.

If either one turned out to have fewer side effects or could be given twice a day instead of three times a day, telaprevir could become obsolete very quickly.

"A lot depends on how the competitive market shapes up," said Jason Kolbert, an analyst at Susquehanna Financial Group, who has a "neutral" rating on the stock. "If a rival drug arrives a year after Vertex's drug, it will have the shortest life-cycle in history."

More data on the drugs are expected at a medical meeting in November.

Ding Ding, an analyst at Maxim Group, believes the competitive risk, combined with uncertainty over whether the drug would prove substantially more effective than current treatments, make Vertex shares too expensive, and she recommends that investors sell.

"We no longer believe the current valuation of Vertex is sustainable," she said.

The pullback in the company's shares also reflects greater investor skepticism towards the company's management, which has championed telaprevir with a passion some have come to distrust.

"I think people discount management quite a bit now and evaluate the drug on its own terms," said Edward Nash, an analyst at Stifel Nicolaus, who believes it will be approved and rates the stock a "buy." "People are willing to pay a premium for hepatitis C drugs because it is such a huge and underserved market."

In the end, however, no single drug added to current therapy is likely to solve the problem, experts say. Combinations of different classes of drugs are likely to be needed to not only suppress the virus but keep it suppressed over time.

"The hepatitis C virus is more capable of breeding resistance than the HIV virus," Kolbert said. "It's Darwinism in its finest mode." (Reuters)

Back to top

July 13th, 2007

Novartis, Idenix Suspend Tests on Hepatitis C Drug (Valopicitabine)
http://www.bloomberg.com
By Elizabeth Lopatto and Angela Zimm

The Novartis Institutes for Biomedical Research July 13 (Bloomberg) -- U.S. regulators ordered Novartis AG and partner Idenix Pharmaceuticals Inc. to stop work on an experimental drug for hepatitis C because of the side effects. The shares of Idenix lost more than a third of their value.

The decision by the U.S. Food and Drug Administration on the drug valopicitabine may cause the companies to abandon the treatment, Jean-Pierre Sommadossi, chief executive officer of Cambridge, Massachusetts-based Idenix, said today.

Novartis, based in Basel, Switzerland, and Idenix are among at least a half-dozen companies racing to produce the first drug in a decade to treat hepatitis C, the main cause of liver cancer. About 3 million Americans are chronically infected with the virus that causes the disease.

“I am not optimistic about further development to valopicitabine in the future,'' Sommadossi said on a conference call. Novartis owns about 56 percent of Idenix's outstanding shares.

The failure was the second this week for a drug Novartis licensed after Antisoma Plc, a U.K. developer of cancer drugs, said July 12 one of its products failed to aid survival in ovarian cancer patients.

Idenix shares dropped $2.22, or 38 percent, to $3.57 at the close of Nasdaq Stock Market composite trading. Shares of Novartis fell 85 centimes, or 1.3 percent, to close at 66 Swiss francs in Zurich.

“The recent data suggested safety issues and very modest antiviral activity,'' said Ding Ding, an analyst with Maxim Group LLC in New York, in a telephone interview today. “The FDA, because of the issues with side effects and the mild potency, thought that in the context of multiple choices, something else would come along that would be more attractive.''

Nausea, Vomiting
Risks included nausea and vomiting, Idenix said. The drug was in the second of three phases of testing generally required for U.S. approval.

“We believed the results from our triple combination trial showed improved efficacy and a good safety profile,'' Idenix spokeswoman Teri Dahlman said today in a telephone interview. “The FDA's assessment was different than ours.''

Companies developing new hepatitis C medicines include Vertex Pharmaceuticals Inc., Roche Holding AG, Pfizer Inc. and Human Genome Sciences Inc. The newest experimental medicines target the hepatitis C virus similar to ways AIDS drugs attack HIV, by blocking proteins the virus uses to reproduce.

Valopicitabine is designed to block the protein polymerase. Roche has an experimental hepatitis C drug that also targets polymerase. Vertex's hepatitis C drug telaprevir blocks the protease enzyme the virus needs to reproduce.

Novartis bought rights to the Idenix drug a year ago for $455 million in milestone payments and $70 million in licensing fees. Both companies jointly market a medicine to treat hepatitis B called Tyzeka, or Sebivo.

“Milestone payments have been very low to date,'' Novartis spokesman John Gilardi said in an interview.

To contact the reporters on this story: Elizabeth Lopatto in New York at elopatto@bloomberg.net; To contact the reporter on this story: Angela Zimm in Boston azimm@bloomberg.net.

Back to top

Back to News Review