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Week Ending: September 29th , 2007
Alan Franciscus
Editor-in-Chief
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This Issue:
September 22nd, 2007
Kaua‘i sees spike in hepatitis C cases
http://kauaiworld.com/
by Nathan Eagle - THE GARDEN ISLAND
With a surge of hepatitis C cases recently diagnosed on the Garden Island, Malama Pono Kaua‘i AIDS Project Executive Director D.Q. Jackson helped host an educational luncheon Friday afternoon at Wilcox Memorial Hospital in Lihu‘e.
More than 50 local residents packed the conference room to hear Dr. Jimmy Yoon, Kaua‘i Medical Clinic’s infectious disease specialist, and Joseph Leahy, a Tibotec Pharmaceutical community liaison, share information about the viral liver disease and answer questions.
More than 450 cases of hepatitis C have been diagnosed on Kaua‘i and an estimated 600 to 1,000 more people are infected but unaware, Jackson said.
“We had no idea” there were so many cases, he added, noting a number of residents are co-infected with HIV, a deadly immune system disease.
Hepatitis C is spread through contact with infected blood, contaminated needles, razors and tattoo or body-piercing tools, but it is not easily spread through sex, according to a Hepatitis Foundation International fact sheet.
“Alcoholism is one of the biggest problems causing hepatitis C,” Leahy said, noting how inflammation of the liver can lead to the disease causing cirrhosis and cancer.
“There’s a lot of need in the community to talk more about hepatitis C,” he added.
In the U.S., 4 million people live with hepatitis C and 30,000 new cases are diagnosed annually. More than 150 million worldwide have been diagnosed, according to Leahy.
This is compared to 1.4 million people in the U.S. with HIV and 40 million worldwide, he added.
Although effective treatment exists, the longer a person lives with the “silent killer,” the greater the risk of death or need for a transplant.
Hepatitis C earned its nickname because only one in five people with acute infection show symptoms, which include fever, fatigue, poor appetite, stomach pain, nausea and jaundice, Leahy said.
“These are things people excuse for a common cold,” he added.
Yoon and Leahy volunteered to stay after the scheduled one-hour time slot to field additional questions from residents.
“It’s not all doom and gloom. It’s not a death sentence,” Yoon said, adding that 80 percent of people with the disease die from something else.
But most patients are asymptomatic, he reiterated, stressing the need for residents to get tested so treatment can be as effective as possible.
Malama Pono, 4357 Rice St. Suite 101, Lihu‘e, offers confidential and free HIV and hepatitis C testing, counseling, outreach and treatment information.
For more information, call 246-9577 or visit www.malama-pono.org .
• Nathan Eagle, staff writer, can be reached at 245-3681 (ext. 224) or neagle@kauaipubco.com.
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Mansfield workshop will deal with hepatitis C and treatment (Sep 29)
http://www.mansfieldnewsjournal.com
By LISA MILLER
News Journal
MANSFIELD -- If you have hepatitis C, you also have options.
That's the message the Mansfield/Ontario/Richland County Health Department is trying to deliver to people with the liver disease, their families and friends and health professionals.
The agency will host a teleconference Sept. 29 at the health department to offer information and answer questions.
The free event is being sponsored by the American Liver Foundation, The Ohio State University Medical Center, Roche and Transcript Pharmacy.
People may also access information about side effects, management, psychosocial issues, alternative medicine and nutritional concerns, from home.
Tina Nichols, the department's HIV and AIDS health educator, said health officials have made strides in identifying people with hepatitis C, but now they are trying to further educate them about the illness.
While funding is unavailable to help the uninsured, the cost of treatment can be similar to that of chemotherapy, Nichols said.
"There are manageable things that you can do," she said. Options include over-the-counter medication, alcohol avoidance and proper nutrition.
Department epidemiologist Mary Derr said hepatitis C is the "most reportable disease," other than sexually transmitted diseases, in the county.
She said so far this year there have been 60 reports in the county of people exposed to the disease, with further testing showing another 35 to be chronic cases.
Calling it a "silent killer," with no vaccine available, Derr said many people don't realize they have the disease until they are screened for something else.
Exposure to the bloodborne pathogen that can result in liver cancer and the need for a transplant could have happened decades ago.
Pregnant women can also pass it to their unborn babies.
A continental breakfast will be served at the event.
lkmiller@nncogannett.com 419-521-7240
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Apath gets federal grant for West Nile treatment, Hepatitis C tool
http://www.stltoday.com
By Rachel Melcer
ST. LOUIS POST-DISPATCH
Apath LLC, a drug-discovery startup based in Creve Coeur, said Friday that it received $2.2 million in federal grants to develop a treatment for West Nile virus and a hepatitis C research tool.
The bulk of the money is in a three-year, $2.1 million biodefense grant from the National Institutes of Health that should fund
Apath through preclinical trials of a drug aimed at West Nile virus — but which also could prove effective against related diseases such as dengue and yellow fevers, said President and Chief Scientific Officer Paul Olivo.
Commercial partners may be interested in funding further development if the drug works against the other diseases, he said. But a treatment solely for West Nile virus, which occurs in sporadic outbreaks, would not provide a sufficient market.
If West Nile proves to be the only good target for the drug, "we will do the work as long as the government will support it," Olivo said.
The project is being carried out in collaboration with Dr. Michael Diamond, a researcher at Washington University.
Apath also received a second NIH grant: a six-month, $100,713 award that provides the company with a more immediate path to profits. It will be used to improve a research tool for discovering treatments to hepatitis C — a tool that Apath already licenses to big pharmaceutical companies.
"We're improving it to make it a better system for industry to use," Olivo said. If that occurs, Apath expects licensing revenue to grow.
The company also will be eligible for a follow-on NIH grant of $750,000 over two years.
Apath, with about 20 employees, receives between $300,000 and $400,000 a year in licensing revenue, Olivo said. The company is in the Nidus Center for Scientific Enterprise biotech business incubator.
rmelcer@post-dispatch.com | 314-340-8394
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The other big C
http://living.scotsman.com
AS TOLD TO RUTH WALKER
IN 2004, Petra Wright, 52, from Bo'ness, was diagnosed with hepatitis C, the same disease Anita Roddick revealed she was suffering from last February. The virus is still surrounded by stigma, despite the fact that it can be contracted during a blood transfusion, as happened to Roddick.
JUST after I had moved to a new job at Standard Life, I started having terrible problems with concentration and aches and pains in my arms - I was generally not feeling myself. My liver function tests came back normal, but when we did the test for hepatitis C, it was positive.
The first thing I thought was: "Oh my God, I'm going to die tomorrow." There was so little information out there about it. I finally found the Hepatitis C Trust website and that woke me up to exactly what it was.
This will be the first time I've actually said this, but the trust has helped me come to terms with a lot of things - I know that my hepatitis was probably caused by stupid drug use in my early life. We're talking 30 years ago and, really, that person is not the person I am today.
I had a very stressful family time in 2000 and never seemed to recover properly. To me, it feels as if the stress possibly allowed the virus to replicate more and bring things to a head.
Letting the family know was hugely traumatic; telling my son was particularly difficult. And then I did it in ever-increasing circles. So I started with my son and my husband, then told my brothers and sisters, and finally my work colleagues, although I wasn't exactly straight with them about the situation until my retirement dinner.
I was very surprised by the reactions. Some people have dropped off my radar since then. But I think of it this way: did I really want anyone who stopped contacting me to be my friend anyway? However, a lot of my good friends offered support.
The last part of my coming out was doing a trek to Nepal for the trust last October. I realised I would have to make more people aware, and went to the local press, which was a bit frightening. But the community here just rallied round me. It was so nice to be buoyed by that support: people sounding their car horns at me in the street when I was doing my training, and a few actually came up to me and told me they also had hepatitis C, or somebody in their family did. It was very revealing.
Doing the actual trek was fantastic. I am so glad I did it and couldn't believe I managed to complete it. It was more difficult than I'd imagined, but that made it all the sweeter at the end.
I have depression and fatigue. I've got the arthritis that goes along with it as well. It's like a gradual breaking down of your quality of life. Sticking to a diary is difficult. The more important something is, the more likely I am to forget about it. Sometimes I'll remember the stupidest thing, but then at other times I'll struggle. I've got to the stage now where I look to my husband to finish my sentences for me.
Taking early retirement from work two years ago was a big thing because there was no way I was in a position to afford to do something like that. But I had to try to avoid stress at all costs - and marketing just wasn't the environment for that.
Drug treatment did clear the virus but unfortunately it came back when I stopped. Now there is no other treatment for me at the moment - I'm waiting for the scientists to come up with one. My consultant told me that, even though the treatment hadn't worked, the time I was on it had given my liver a rest, and whereas before he may have said I was going to progress to cirrhosis within five to ten years, now he would be happy to say ten to 15. So it bought me time.
I've got a lot of anger. I've had to change a lot of things. I don't drink alcohol, but I have even had to make simple changes, such as switching from ibuprofen to paracetamol. Wee things can make such a big difference.
I was in floods of tears when I heard Anita Roddick had died [from a brain haemorrhage]. It meant so much to me when she came out on TV. It felt as if the disease had moved into the realms of normality, and some of the stigma had gone away.
There is still so much to learn about the virus. And in the Forth Valley we have no support group whatsoever. I'm trying to get that under way because it's very important. One lady from Livingston, who had been diagnosed some years earlier, called me and said she'd never spoken to anybody else who had it. She'd been busy keeping it a secret and there was I, loud and proud. That meant a lot to me, that she wanted to phone and speak to me.
HEPATITIS C
Hepatitis C is a blood-borne virus that affects the liver gradually over 20-30 years and can lead to liver scarring (fibrosis), cirrhosis and, ultimately, liver cancer or liver failure and death.
It was discovered in the 1980s but only properly identified in 1989. A screening process was developed in 1991 that made it possible to detect it in blood samples.
Symptoms
Symptoms include fatigue, pain in the liver area, digestive problems, concentration difficulties ('brain fog') and flu-like symptoms such as headaches, shivering and aching joints. The presence or absence of symptoms is no indication of how much damage the virus is doing to the liver, which is why hepatitis C is also called 'the silent killer'.
How common is it?
Estimates vary but the Department of Health believes 0.4% of the UK population has chronic infection, equivalent to 240,000 people. In the UK only 50,000 have been diagnosed with chronic hepatitis C, meaning that up to eight out of ten have no idea they are infected.
How is it transmitted?
By blood-to-blood contact: via blood transfusions (before a test became available in 1991 to screen donated blood); by sharing equipment for injecting drugs or snorting cocaine; by medical or dental treatments in countries where sterilisation is inadequate; by sharing razors or toothbrushes that come into contact with broken skin (in both people); by tattooing or piercing, if done with unsterile equipment; or from mother to baby at birth. Hepatitis C is not transmitted through normal social contact, such as touching, hugging or kissing.
Treatment
The combination therapy of pegylated interferon-alpha and ribavirin is effective in clearing the virus in around 50% of people. Unfortunately, it is not suitable for everyone and can cause severe side-effects.
To find out more or to get support, call the Hepatitis C Trust helpline (0845 223 4424), Monday-Friday, 12-6pm (Thursdays till 7pm), or log on to www.hepctrust.org.uk
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September 24th, 2007
European Union's CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
http://www.examiner.com
KENILWORTH, N.J., Sept. 24 - Schering-Plough Corporation (NYSE: SGP) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of combination therapy with PEGINTRON(TM) (peginterferon alfa-2b, 1.5 mcg/kg once weekly) and REBETOL(R) (ribavirin, 800 - 1,400 mg daily) for retreating adult patients with chronic hepatitis C whose previous treatment with interferon alpha (pegylated or non- pegylated) and ribavirin combination therapy or interferon alpha monotherapy did not result in a sustained response. Upon European Commission approval, PEGINTRON and REBETOL will be the only available hepatitis C therapy in the European Union (EU) indicated for retreatment of prior treatment failures.
"A large and growing number of patients whose previous hepatitis C therapy did not result in a sustained response are in need of viable treatment options today," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "Upon EU approval of this new indication, PEG-INTRON combination therapy will help address this serious unmet medical need."
The CHMP recommendation serves as the basis for a European Commission approval of this expanded indication for PEGINTRON and REBETOL combination therapy, which is currently approved in the European Union (EU) for treating chronic hepatitis C in naive (previously untreated) adult patients, including naive patients with clinically stable HIV coinfection. Upon approval, this new retreatment indication will result in Marketing Authorization with unified labeling that will be valid in the current EU 27 member states as well as in Iceland and Norway.
The CHMP positive opinion is based on results from an ongoing non-comparative clinical study (EPIC3)(1) in which 1,336 patients with moderate to severe fibrosis or cirrhosis who failed previous treatment with combination alpha interferon/ribavirin therapy were retreated with PEGINTRON combination therapy.
In this study, virological response at week 12 of treatment was shown to be an important predictor for achieving a sustained virological response (SVR), with 57 percent (282/499) of patients who had undetectable virus (HCV-RNA) at week 12 going on to achieve SVR with a 48-week course of therapy. Within this subgroup, the SVR rates were 59 percent and 47 percent for patients who failed prior therapy with non-pegylated or pegylated interferon, respectively. Approximately 37 percent of patients in the study overall had undetectable virus at week 12. Importantly, patients who achieved a significant reduction in virus (greater than 2 log decreased) but did not have undetectable virus at week 12, had little chance of achieving SVR (6 percent). Overall, 23 percent of patients in the study achieved SVR. SVR is defined as undetectable HCV-RNA at 24 weeks post-treatment.
"The ability with PEGINTRON to help predict efficacy of retreatment early in the course of therapy would assist physicians in managing this hard-to- treat patient population," said Thierry Poynard, M.D., professor of medicine, University of Paris VI, Hopital Pitie-Salpetriere, Paris, and a lead investigator of the clinical trial. "Patients with undetectable virus at week 12 have an even chance of success regardless of whether they failed previous therapy with pegylated or non-pegylated interferon and are motivated to continue treatment, and those patients who fail to achieve an early response can have their therapy stopped with confidence."
In the study, failure to prior therapy was defined as relapse or non- response to one or more courses of interferon alpha plus ribavirin combination therapy (HCV-RNA positive at the end of a minimum of 12 weeks of treatment). Patients who were HCV-RNA negative at treatment week 12 continued treatment for a total of 48 weeks and were followed for 24 weeks post-treatment.
Based on results from this clinical study, the recommended duration of dosing with PEGINTRON combination therapy for retreating patients who failed previous therapy and who have undetectable virus at week 12 is 48 weeks, regardless of HCV genotype.
PEGINTRON in the European Union
PEGINTRON and REBETOL combination therapy for chronic hepatitis C was approved in the EU in March 2001. The recommended dose in the EU for combination therapy is PEGINTRON 1.5 mcg/kg once weekly plus REBETOL 800-1,400 mg daily, adjusted to body weight. The recommended duration of treatment is 24 weeks for naive patients with HCV genotype 1 and low viral load, or HCV genotype 2 or 3. The recommended duration of treatment is 48 weeks for naive patients with HCV genotype 1 and high viral load, HCV genotype 4 or HIV coinfection regardless of HCV genotype. PEGINTRON had previously received centralized marketing authorization in the EU and is marketed as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C.
Chronic hepatitis C is estimated to affect more than 10 million people in major world markets, including 5 million in Europe. It is a leading cause of chronic liver disease and one of the most common reasons for liver transplant in Europe.
PEGINTRON in the United States
In the United States, PEGINTRON is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age. PEGINTRON is not indicated in the United States for retreatment of patients who failed previous interferon therapy.
Important Safety Information Regarding U.S. Labeling for PEGINTRON and REBETOL
Alpha interferons, including PEGINTRON and INTRON(R) A, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping PEGINTRON and/or INTRON A therapy.
Use with Ribavirin: Ribavirin may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with REBETOL therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen
Contraindications
PEGINTRON is contraindicated in patients with hypersensitivity to PEGINTRON or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic CHC patients before or during treatment. INTRON A (Interferon alfa- 2b, recombinant) for Injection is contraindicated in patients with hypersensitivity to INTRON A or any component of the product, autoimmune hepatitis, and decompensated liver disease. PEGINTRON or INTRON A in combination with REBETOL therapy is additionally contraindicated in patients with hypersensitivity to ribavirin or any other component of the product, women who are pregnant, men whose female partners are pregnant, patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL/min.
Avoid Pregnancy
REBETOL therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients during therapy and 6 months post-treatment. Patients should use at least two effective forms of contraception and have monthly pregnancy tests during therapy and for 6 months after completion of therapy. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.
Incidence of Adverse Events
There are no new adverse events specific to PEGINTRON as compared to INTRON A; however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEGINTRON were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEGINTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEGINTRON.
Psychiatric adverse events, which include insomnia, were common (57%) with PEGINTRON but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEGINTRON.
The following serious or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.
In the PEGINTRON/REBETOL combination trial, the incidence of serious adverse events was 17% in the PEGINTRON/REBETOL groups compared to 14% in the INTRON A/ REBETOL group. The incidence of severe adverse events in the PEGINTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEGINTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34% of those receiving INTRON A/REBETOL.
Additional Safety Information
Relapse of drug addiction/overdose has occurred in patients on PEGINTRON therapy. Aggressive behavior sometimes directed towards others has occurred in patients with and without a previous psychiatric disorder during PEGINTRON and/or INTRON A treatment and follow-up. If patients develop psychiatric problems, including clinical depression, it is recommended that patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PEGINTRON and/or INTRON A be discontinued, and the patient be carefully followed with psychiatric intervention, as appropriate. Cases of encephalopathy have been observed in some patients, usually elderly, treated with higher doses of PEGINTRON and/or INTRON A. Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alpha therapies, including PEGINTRON and INTRON A. Dental and periodontal disorders have been reported in patients receiving PEGINTRON or INTRON A in combination with REBETOL therapy.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential of PEGINTRON and REBETOL. Forward-looking statements relate to expectations or forecasts of future events. Schering- Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering- Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A, "Risk Factors" in the company's second quarter 2007 10-Q.
Reference
(1) EPIC3 (Evaluation of PEGINTRON in Control of Hepatitis C Cirrhosis) is a large multicenter global clinical study evaluating the benefits of PEGINTRON in the fibrotic and cirrhotic patient at approximately 140 sites worldwide.
SOURCE Schering-Plough Corporation
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US FDA Fast Tracks PI-88 for the Treatment of Post Resection Liver Cancer
http://money.cnn.com
BRISBANE, Sept. 24 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited announced today that its investigational anti-cancer drug PI-88 has been awarded Fast Track status by the U.S. Food and Drug Administration (FDA). The fast track designation has been granted to PI- 88 for the prevention of tumor recurrence following curative liver resection in patients with hepatocellular carcinoma (HCC, primary liver cancer).
Under the FDA Modernization Act of 1997, the fast track program is designed to facilitate the development and expedite the regulatory review of new drugs that demonstrate the potential to treat serious or life-threatening diseases where there is an unmet medical need. The Fast Track designation will enable Progen to file a New Drug Application (NDA) on a rolling basis as data becomes available. This permits the FDA to review the different components of the Drug Master File as they are completed in advance of receiving the final submission.
Mr. Justus Homburg, Progen's CEO commented, "This designation will speed the process of bringing this potentially clinically very important drug to patients with liver cancer. The FDA decision to award fast track status to PI- 88 was based on recent Phase 2 clinical data and the high unmet need for treatments for patients with resectable primary liver cancer. The key Phase 2 study showed that PI-88 has the potential to improve the time a patient remains disease free following surgery. As we enter the final stages of clinical development and commence a multinational Phase 3 trial, we look forward to collaborating closely with the FDA to expedite the development and approval of PI-88."
Conservatively, over half a million new cases of HCC are diagnosed worldwide each year, making it the fifth most common cancer and the third major cause of deaths due to cancer worldwide. The most common causes of HCC are related to chronic infection with hepatitis B and C (HBV, HCV). Due to late disease diagnosis, currently only about 25% of patients are eligible for surgery and half of those patients will have their disease recur within 12-15 months. No products have been approved by the FDA to prolong the time a patient remains disease free following surgery.
The fast track designation is fully aligned with Progen's Phase 3 trial design. The double blinded, placebo-controlled Phase 3 trial will be powered for the primary endpoint of disease-free survival determining if PI-88 can prevent early recurrence following curative hepatic surgery. The trial will begin later this year and targets 600 patients with liver cancer post resection, in more than a dozen countries.
About Progen:
Progen Pharmaceuticals Limited is an Australian-based globally focused biotechnology company committed to the discovery, development and commercialization of small molecule therapeutics primarily for the treatment of cancer.
About PI-88:
PI-88 is one of a new class of multi-targeted cytostatic cancer therapeutics. It is a novel anti-cancer compound with a first-in-class mechanism as a heparan sulfate mimetic. Its anti-tumor activity is based on inhibition of two biological processes - angiogenesis (the growth of new blood vessels) and metastasis (the spread of cancer to other sites) - critical to the growth and progression of cancer. In a Phase 2 trial in post-resection liver cancer, PI-88 demonstrated a 25% improvement in the primary endpoint of disease-free rate at 48 weeks and 78% improvement in secondary endpoint of disease-free survival. These results, combined with positive feedback from the FDA, provide Progen with confidence in the potential of PI-88 for this indication and we are therefore aggressively pursuing its development towards registration and commercialization.
Progen Information:
Justus Homburg
Progen Pharmaceuticals Limited
T: +61 7 3842 3333
E: justush@progen-pharma.com
Noreen Dillane
Progen Pharmaceuticals Limited
T: +61 7 3842 3333
E: noreend@progen-pharma.com
Media and Investor Relations Australia:
Rebecca Piercy
Buchan Consulting
T: +61 2 9237 2800 / +61 422 916 422
E: rpiercy@bcg.com.au
Rebecca Wilson
Buchan Consulting
T: +61 417 382 391
E: rwilson@bcg.com.au
Media Relations USA:
Robert D. Stanislaro
Financial Dynamics
T:212-850-5657
E: robert.stanislaro@fd.com
Investor Relations USA:
Evan Smith
Financial Dynamics
T: 212-850-5606
E: evan.smith@fd.com
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Organ size may be linked with cancer
http://www.sciencedaily.com
BALTIMORE, Sept. 24 (UPI) -- U.S. scientists have discovered a chemical chain reaction that controls animals' organ size might also control cancer.
"This chain reaction, a domino-like chain of events we call the Hippo pathway, adds a single chemical group on a protein nicknamed Yap," said Johns Hopkins University Associate Professor Duojia Pan.
"The good news is that maybe all organ growth can be reduced to this one chemical event on the Yap protein," said Pan. "But the better news is that we potentially have a new target for cancer therapy."
Pan and colleagues previously discovered in fruit flies that too much Yap supercharges growth-inducing genes and causes organs to overgrow. In the new study designed to see if the same effect occurred in mammals, the research team genetically altered mice to make high levels of Yap protein but only in liver cells.
Those animals' livers grew to be five times the size of a normal mouse liver and often were dotted with large tumors. "We were totally amazed," said Pan. "We think it might be the extra Yap in these cells contributing to their cancerous growth."
The study is detailed in the journal Cell.
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Largest Gift in Duke University School of Medicine History to Fund Landmark Study
http://www.dukenews.duke.edu
Researchers will apply the latest biotechnology to conduct broad, epidemiological studies linking genetic data to disease risk and outcomes.
Durham, NC -- Duke University will receive $35 million from billionaire real estate developer David H. Murdock to support a massive biomedical research project at the North Carolina Research Campus (NCRC) in Kannapolis, N.C., university president Richard H. Brodhead, Ph.D., and Chancellor for Health Affairs Victor J. Dzau, M.D., announced Monday.
"For the first time, we will be able to generate a global database of human health and disease that will provide us the opportunity to clearly transform medicine," Dzau said. "We are honored and tremendously pleased with this gift from Mr. Murdock and share his commitment to advancing the treatment of disease in patients here and around the world."
"We are most grateful for this gift, and David Murdock's vision, because it will bring together scientists from Duke and other North Carolina institutions to address a pressing social need," Brodhead said. "The 'M.U.R.D.O.C.K. study' has the potential to revolutionize health care by finding ways to match treatment to a patient's genetic profile. This research could lead to improved medicine around the world, but I am especially pleased that we will first be able to share our advances with citizens of North Carolina."
The Kannapolis-based M.U.R.D.O.C.K. study (Measurement to Understand the Reclassification of Disease of Cabarrus and Kannapolis) will combine the talents of physicians and scientists at Duke, the University of North Carolina and the North Carolina Community College System. They will apply the latest biotechnology to conduct broad, epidemiological studies linking genetic data to disease risk and outcomes.
Study backers say it is the 311,000-square-foot David H. Murdock Core Laboratory at NCRC – which houses world-class, state-of-the art equipment – that makes conducting this study possible.
Murdock says the gift is heartfelt. "In this life, we have only a few opportunities to make a lasting difference in the world. I am proud to join with the great researchers at Duke University to seize this opportunity and transform the world's approach to the prevention and treatment of disease. Ever since losing my wife to cancer at a young age, human health has been my driving passion. With my gift to Duke and the work that will be done at the North Carolina Research Campus, this passion becomes the point of departure for a scientific adventure that will save countless lives. And for that, I am grateful."
Backers say the M.U.R.D.O.C. K. study will ultimately mean better health and longer lives for millions of people. They liken it to the historic Framingham study, founded in Framingham, Mass., in 1948, that followed generations of residents and produced much of our current knowledge about heart disease.
"Our project is no less ambitious," said Robert Califf, M.D., M.U.R.D.O.C.K.'s lead investigator and director of the Duke Translational Medicine Institute. "Like the Framingham study, M.U.R.D.O.C.K. will also seek detailed information about thousands of participants and their families over time. By measuring genes, proteins and metabolites, we aspire to be able to give advice to individuals about how to stay healthy and optimally treat illness when it occurs. Combining this information across entire counties using electronic health records, we believe we can provide much better prevention programs for the diseases that are causing death and disability in our society and beyond."
"This is a Framingham Study for the molecular age," Califf said.
M.U.R.D.O.C.K. researchers will focus on high-impact diseases, including cancer, heart disease, high blood pressure, obesity, diabetes, hepatitis, osteoarthritis and mental illness.
"With all of the data we expect to generate, we will essentially be able to rewrite the textbook of medicine," Califf said.
Califf said data in their new "medical textbook" will reveal molecular signatures that characterize disease and provide doctors with cost-effective, real-world tools to inform healthcare decision-making. "But perhaps the most important part of the project will be the linkage of all of this information to clinical data, images and traditional risk factor measures that will help us treat patients according to their specific biological profile," Califf said. "There won't be any more 'one size fits all' in patient care. This is what translational medicine is all about."
Duke has some of the most extensive clinical databases and biospecimen repositories in the world. With the M.U.R.D.O.C.K. support, investigators will begin their work with samples from those sources. Simultaneously, they will begin laying the groundwork for enrolling study volunteers from in and around Kannapolis and surrounding Cabarrus County. Patients enrolled in the study can expect to donate blood samples and other clinical data. Investigators will follow them over time to see how they fare and how they respond to specific treatments.
The information generated will be combined with a major health project planned for Durham County and a project under development involving Duke's new Graduate Medical School in Singapore.
"Local physicians are a critical component of the plan," said John McHutchison, M.D., co-leader of M.U.R.D.O.C.K. and associate director of the Duke Clinical Research Institute. Duke and Cabarrus County physicians already have strong relationships dating back to 1973, when they began a partnership to increase subspecialty training in the area.
"Now, we will be calling on their expertise again," McHutchison said. "Through their routine care of area patients, they will be the closest clinical contacts for any patients enrolled in the study and the first to pinpoint any changes in patients' health."
McHutchison will lead a major M.U.R.D.O.C.K. initiative focusing on the genetic underpinnings of Hepatitis C infection. "I can't speak for all of our scientists, but personally I know that for me this is the day I've been waiting for. I bet I have at least tens of thousands of specimens from our liver patients collected over the last 20 years waiting to be analyzed. We can't wait to get started."
Dzau, in noting that improving global health is one of the key missions of the university, said, "Thanks to Mr. Murdock, our collective research will enable unprecedented understanding of human disease, and how genetics, geography and environment contribute to health and wellness. Mr. Murdock's gift is truly a gift to us all."
David H. Murdock is the owner and chairman of Dole Food Company Inc. and Castle & Cooke Inc., one of the largest real estate development companies in the world. He is an outspoken advocate of improving global health through disease prevention, better nutrition and innovation in crop science.
For more information, contact: Michelle Gailiun | (919) 660-1306 | michelle.gailiun@duke.edu
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Watch for More Volatility at Vertex
http://www.thestreet.com
By Adam Feuerstein
Senior Writer
BOSTON -- Another nugget of positive clinical data came out last week from Vertex Pharmaceuticals (VRTX) and its experimental hepatitis C drug, but it has been a bit overshadowed by some downward volatility in the company's stock.
At a meeting of infectious-disease researchers in Chicago, investigators reported that some patients who prematurely discontinued treatment with Vertex's drug telaprevir were still able to clear the hepatitis C virus completely from their system.
"This speaks to the potency of telaprevir," says Cowen biotech analyst Rachel McMinn, who covers Vertex. "These patients received a short course of therapy with telaprevir [less than the 12 weeks they were supposed to receive] , but they still were able to achieve a sustained virologic response." McMinn has an outperform rating on Vertex, and Cowen doesn't do banking for the company.
While bullish on Vertex and telaprevir, McMinn was also responsible (albeit inadvertently) for raising some worries about the drug that caused the stock to take a midweek swoon.
In a short note to clients last Wednesday, McMinn lowered her prediction for the percentage of patients in the ongoing telaprevir U.S. phase II study who would achieve a sustained virologic response, or SVR. (In layman's terms, these patients are cured of hepatitis C.)
McMinn lowered her projected SVR range to 59% to 61% from her previous estimate of 61% to 65%. The actual data on telaprevir and its SVR rate will be made public in early November at a liver disease meeting being held in Boston.
Vertex shares were trading around $40 Wednesday when McMinn's note hit trading desks. The stock quickly fell about 7% to an intraday low of $37.33. The stock has only partially recovered, closing Friday at $38.24.
In a postnote interview late last week, McMinn said that she adjusted her estimate based on the data presented at this week's infectious disease meeting, but that she didn't intend to send a negative signal.
"Our earlier projections [for a telaprevir cure rate] were a little too high, but there was nothing negative fundamentally to take away from the data presented," she said.
To put these numbers in perspective, a hepatitis C cure rate of 59% to 61% for telaprevir would represent a significant improvement over the current standard of care, which only succeeds in eliminating the hepatitis C virus from about 40% of U.S. patients.
Telaprevir is a pill designed to attack hepatitis C by inhibiting the protease enzyme, one of the key enzymes the virus uses to copy itself. This "direct antiviral" approach differs from current hepatitis C drugs, which boost the immune system's ability to tamp down and eliminate the virus.
The current standard of care for hepatitis C patients is a weekly injection of long-acting alpha interferon combined with daily oral doses of a generic drug, ribavirin. A normal treatment course for Type 1 hepatitis C (the most prevalent form) takes 48 weeks to complete, and many patients find the side effects, such as flulike symptoms, anemia and depression, difficult to tolerate.
Telaprevir is being combined with interferon and ribavirin to create a more potent and less time-consuming hepatitis C treatment regimen. Three large phase II studies are underway, investigating various treatment schedules. The most promising combination so far treats hepatitis C patients for 12 weeks with the triple combination (telaprevir, interferon and ribavirin), followed by 12 weeks of interferon and ribavirin on their own.
That's 24 weeks of total treatment -- half the current standard of care.
At the infectious disease meeting held last week, investigators from the U.S.-based phase II telaprevir study, known as Prove 1, reported new details on a group of 27 patients enrolled in two arms of the study. These patients didn't receive the full 12 weeks of telaprevir for various reasons.
However, investigators were able to follow up on 19 of these 27 patients to determine whether even a shortened course of telaprevir would be effective enough to result in a cure. Of these 19 patients, 7 of them, or 37%, achieved an SVR, or cure. The other 12 patients relapsed.
It was entirely possible to assume that these hepatitis C patients who weren't able to complete their treatment would have relapsed or otherwise not have been able clear the virus from their system. Instead, at least some of them were cured, which suggests that telaprevir is a very potent drug, McMinn says.
Although data collected and presented on telaprevir have been promising so far, it's the results not yet made public that will inform the ultimate verdict on the drug. The most important telaprevir data to date will be presented Nov. 2-6 at the annual meeting of the American Association for the Study of Liver Disease.
Vertex shares have been on a monster run since late June, when shares had dipped to around $26. This week's volatility may be a precursor of more to come, as some investors choose to take profits instead of risking gains before new data are released in November.
Adam Feuerstein writes regularly for RealMoney.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
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September 25th, 2007
Hepatitis How-To’s
http://adblog.msnbc.msn.com
In general, offers that begin with a “Have you ever wondered?” or “Have you ever wanted to?” make us immediately go “no” and move on.
But we were more than a little intrigued with an ad we stumbled over on the Web asking, “Trying to catch hepatitis C? Not sure where to start?” Not particularly. Wait -- what?
The animated spot features a little doodle of a guy, who evidently is named Dennis. An onscreen narrator asks the question (at the time Dennis -- obviously highly-motivated -- is licking the jagged rim of a tin can) and offers some ... er ... helpful information on ways he could have already caught it. These include, but are not limited to, sharing a razor, getting a tattoo and spending a holiday doing drugs and listening to techno music. (We pause at this point to remind all our readers that if you or someone you care about listens to techno, get help immediately
The message, of course is, that seemingly mundane things you’ve done may put you at risk for the disease. And since there aren’t any symptoms, get tested. In the end Dennis does, and a buzzer turns red for his test results. He looks happy, then dejected. We couldn’t figure out whether that meant he was happy he was positive, unhappy he was negative, happy he was positive until he considered the ramifications … or … well, we’re just sure we don’t want hepatitis. In addition to the severe medical implications, it could possibly lead to this.
The cartoon (and a game on the site featuring Dennis that we were too lame to finish) calls attention to the more serious matter of World Hepatitis Awareness Day. It’s Oct. 1. What, not on your Outlook calendar? Ours neither, we just checked. It obviously targets a non-U.S. audience, since understanding that silliness can drive home a serious message isn’t really the strong suit of a country where Jim Carrey is so overwhelmingly popular. (Yes, we know he’s actually Canadian.).
There is good information on the site. It’s worth a quick spin, if not more.
See the ad here.
World Hepatitis Awareness Day site is here.
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Inhaled Nitric Oxide Has Benefits in Liver Transplantation
http://www.medscape.com
By Megan Rauscher
NEW YORK (Reuters Health) Sept 17 - Inhaled nitric oxide (NO) administered during orthotopic liver transplantation inhibits hepatic ischemia-reperfusion injury, resulting in improved liver function, preliminary results of a small study indicate.
"The key observations in this study were that inhaled nitric oxide had effects beyond the lung in humans and specifically protective effects in the context of liver transplantation," Dr. Rakesh P. Patel of the University of Alabama at Birmingham noted in comments to Reuters Health.
As Dr. Patel and colleagues explain in the September issue of the Journal of Clinical Investigation, "Ischemia/reperfusion injury in transplanted livers contributes to organ dysfunction and failure and is characterized in part by loss of NO bioavailability."
In a prospective, blinded, placebo-controlled study, 20 adults undergoing orthotopic liver transplantation were randomized to inhaled NO at 80 ppm or inhaled placebo during the operative period only.
Evaluation of serum transaminases and coagulation times showed that inhaled NO "improved the rate at which liver function was restored after transplantation," the authors report.
"This effect, our data suggested, was related to prevention of liver cell death," Dr. Patel noted.
"The study also provided data suggesting that inhaled nitric oxide may protect extrapulmonary organs from ischemia-reperfusion injury by increasing levels of the anion, nitrite," the researcher said.
"Importantly," the team notes, "use of inhaled NO at 80 ppm for the duration of surgery was well tolerated" with no undesirable change in cardiopulmonary performance or subsequent complications.
Inhaled NO, relative to placebo, also significantly decreased time spent in the hospital by about 10%, the investigators found.
While larger clinical trials are needed, they conclude, the current study "supports the clinical use of inhaled NO as an extrapulmonary therapeutic to improve organ function following transplantation."
J Clin Invest 2007;117:2583-2591.
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September 26th, 2007
Second-Line Isn't Second Best
http://www.fool.com
By Brian Orelli
A drug company's decision to get approved as a first-line treatment for a disease (versus a second-line one) is usually tricky. The first-line market is obviously larger, but usually has more competition. Adding further complexity to the decision, patients who've failed first-line treatments are usually harder to treat.
On the other hand, Schering-Plough's (NYSE: SGP) move in the European hepatitis C market was really quite easy. It's PEGINTRON and REBETOL combination therapy is already approved as a front-line treatment, and there aren't any drugs approved in Europe to treat cases that have failed other therapies. A market with no competition -- at least on the marketing level -- should work wonders for sales.
The company moved one step closer to its goal on Monday, when the Committee for Medicinal Products for Human Use (CHMP) recommended approval of the combination therapy PEGINTRON and REBETOL for retreating patients. The European Medicines Agency (EMEA) will get the final say on whether the drug is approved for marketing.
PEGINTRON is approved for treating hepatitis C in the U.S., both by itself and in combination with REBETOL as a front-line treatment. Its main competition both in the U.S. and Europe comes from Roche's Pegasys. The second-line treatment approval should set Schering apart -- at least in Europe. There's no word on whether the company will try to get a second-line designation in the U.S.
Schering-Plough needs all the additional sales from second-line treatments it can get. Up-and-coming stars including Vertex Pharmaceuticals' (Nasdaq: VRTX) telaprevir, with its stellar phase 2 data, and Pharmasset's (Nasdaq: VRUS) R7128 -- which will be tested in combination with Roche's Pegasys -- might be able to take front-line treatment market share if they're approved.
Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.
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Partying Pam Courts Disaster
http://www.nypost.com
September 26, 2007 -- FRIENDS of Pamela Anderson are worried about the bombshell's increasingly wild behavior. "She parties almost every night," our source said. "She drinks, she does stuff . . . and she's got hepatitis C. Her liver is shot but she keeps living this crazy lifestyle. We don't think she understands how serious this is. She has two kids and may not be around to see them grow up at this rate." The increasingly haggard pin-up has gotten even wilder now that she's hanging with Paris Hilton's sex-tape partner, Rick Salomon. "They went wild over the VMA weekend," the spy added. "I just watched them party with my jaw open." Anderson's two boys with Tommy Lee, Dylan and Brandon, are mostly taken care of by her brother or mother while she stars in Hans Klok's magic show in Las Vegas. Meanwhile, she's telling pals alternately that she is either engaged or already married to Salomon, whom she's only known about six weeks. A rep for Anderson said she'd get back to us.
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Health Officials Advise Tests for Tattoos by Garner Man
http://www.kcrg.com
By Becky Ogann
GARNER (AP) - Hancock County health officials are advising people who got a tattoo from a Garner man to be tested for blood-borne diseases, such as HIV and Hepatitis B and C.
Lance Alvarez is accused illegally tattooing out of his home. Police say he frequently used nonsterilized instruments.
Alvarez is charged with providing a tattoo to a minor and unauthorized practice of tattooing.
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Telehealth services let University of New Mexico physicians help patients from afar
http://abqtrib.com
By Stephanie Garcia Krenrich
Telehealth innovations
Doctors at University of New Mexico Hospital say new technology helps specialists treat patients in rural New Mexico. Here are some innovations in telecommunications:
• Store-and-forward technology allows doctors to take a picture from a digital camera and store it on a computer, then forward it to a specialist for interpretation.
• Behavioral specialists can talk to doctors and patients in clinics through video. Doctors are also working on getting schools connected with telehealth, a form of telecommunications that allows doctors and patients to communicate with specialists in different locations.
• Project ECHO, a national award-winning program at UNM, provides patients with expert advice on complex diseases, such as hepatitis C, through telecommunications.
Sanjeev Arora treats patients for hepatitis C in parts of rural New Mexico without ever having to leave his office in Albuquerque.
The patients don't have to travel from their hometowns, either.
Using "telehealth" - a form of telecommunications that allows family doctors and patients to interact with specialists - doctors can deliver services hundreds of miles away via the Internet.
And doctors around the world are looking to New Mexico as a model for their own countries.
"Rural doctors face a lack of specialized resources and a lack of adequate specialists. They are alone, and they get professionally isolated . . ." said Arora, executive vice chairman of the Department of Medicine at the University of New Mexico.
UNM Hospital is one of many in Albuquerque using telehealth to change all that by providing patients and physicians with expert advice from specialists in other parts of New Mexico.
The process of using technology to connect physicians and patients has been around for 12 years at UNM Hospital and has grown significantly because of changes in communication networks and affordability, doctors say.
Dale Alverson, professor, physician and medical director at the Center for Telehealth at UNM, said the technology only reached a couple hundred patients in New Mexico in 1995. By 2006, it was available to more than 7,000.
UNM Hospital connects more than 50 communities with such services and has more than 100 sites throughout New Mexico where people can receive expert advice.
Arora helps people through Project ECHO, an award-winning program that provides consultation on complex diseases such as hepatitis C through telecommunications.
Leslie Hayes, a family doctor at El Centro Family Center in Española, said telehealth helps her treat patients with complicated conditions by consulting with specialists far away.
She said if she didn't have these tools, her patients would have to travel elsewhere.
"Most of them (patients) don't have insurance or transportation that will get them to Santa Fe or Albuquerque," she said. Unable to travel, she said, "most of them would live with the disease."
By providing patients with care in rural areas, Alverson said, telehealth has helped reduce the number of people visiting UNM Hospital to get expert advice.
"One-fourth of the patients that are sent to the University of New Mexico for hospitalization in intensive care units are unnecessary," he said.
He said technology helps keep people in their hometowns, which "frees up a lot of beds" at UNM Hospital.
Behavioral issues are affected as well.
Arturo Gonzales, director of Sangre de Cristo, a grief intervention and referral treatment center in Santa Fe, said the center has 20 telehealth connection sites statewide and has served 52,000 New Mexicans through them.
"We've been able to provide psychiatric advice to those sites and to providers of those patients," he said.
Hayes, who also gets guidance on behavioral health from doctors through telehealth, said her connection with specialists has made a big difference.
"It helps with patients I am already seeing that have problems that are beyond my training," she said.
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InterMune Announces Start of Phase 1b Trial of ITMN-191
http://www.finanznachrichten.de/
BRISBANE, Calif., Sept. 26 /PRNewswire-FirstCall/ -- InterMune, (Nachrichten) Inc. announced that the company has begun dosing the first patients in their Phase 1b multiple ascending dose (MAD) clinical trial evaluating ITMN-191 (also called R7227) in patients with chronic hepatitis C. ITMN-191 is a hepatitis C virus (HCV) protease inhibitor in development by InterMune and its partner, Roche. InterMune also reported additional information from its recently completed Phase 1a clinical trial of ITMN-191.
Dan Welch, President and Chief Executive Officer of InterMune, said, "We are pleased to have successfully initiated the very important Phase 1b multiple ascending dose study of ITMN-191." Mr. Welch continued, "This is our first opportunity to evaluate the effects of ITMN-191 on viral kinetics in HCV patients, and to gather additional safety information beyond the recently completed Phase 1a SAD study. We look forward to sharing top-line results from the three treatment-naïve dose cohorts of the Phase 1b study in the first quarter of 2008."
Phase 1b Trial Design
The Phase 1b placebo-controlled study is anticipated to enroll approximately 40 HCV patients. The study will assess the effect of multiple doses of ITMN-191 given as a monotherapy on viral kinetics, viral resistance, pharmacokinetics, safety and tolerability. Patients will be administered ITMN-191 twice per day (BID) or three-times per day (TID) with a meal for a period of 14 days. Three ascending dose cohorts of treatment-naive chronic hepatitis C patients infected with HCV genotype 1 will be enrolled. In addition, a single cohort of treatment-experienced chronic hepatitis C patients infected with HCV genotype 1 will be studied. If the results of the first three dosage cohorts indicate that more information would be desirable to more fully inform the design of a planned study of ITMN-191 in combination with Pegasys(R) and ribavirin, the Phase 1b study will be expanded to include additional cohorts of treatment-naive patients.
Further Details on Phase 1a Study -- Safety and Pharmacokinetic Profile of ITMN-191
The Phase 1a placebo-controlled study of ITMN-191 was completed in May of 2007, enrolling a total of 64 healthy volunteers. Doses in this study ranged from less than 10% to many-fold higher than those that will be evaluated in the three dosage cohorts of the Phase 1b trial. The study results show that:
- ITMN-191 was well tolerated in all doses evaluated in Phase 1a study.
- No Serious Adverse Events (SAEs) were reported and no subject discontinued the study due to an Adverse Event (AE).
- All AEs in subjects receiving ITMN-191 were classified as mild (CTCAE Grade 1).
- The most common AEs reported were gastrointestinal-related and consisted of mild diarrhea and mild abdominal pain. These mild Aes occurred predominantly in the highest dose group, a dose many-fold higher than the doses planned in the Phase 1b study just begun.
- No clinically significant laboratory abnormalities or changes in electro-cardiograms were observed.
- Food has a significant effect on the absorption of ITMN-191, with higher AUC in patients who took ITMN-191 with a meal.
- The pharmacokinetics of ITMN-191 were linear over the range of doses planned in the Phase lb study.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as a possible therapeutic candidate for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1a, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com/.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the SEC on March 30, 2007 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) risks related to timely patient enrollment and retention in clinical trials. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at http://www.intermune.com/.
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Pharmasset Shows Off the Goods
http://www.fool.com
By Brian Lawler
Fresh from its IPO earlier this year, Pharmasset (Nasdaq: VRUS) has given investors a sneak peek at its future goals. In a presentation Monday at the UBS Global Life Sciences conference, the antiviral small-molecule pharmaceutical firm discussed upcoming prospects for fighting hepatitis and HIV.
Pharmasset's lead drug, clevudine, is a once-daily treatment for hepatitis B. This pyrimidine nucleoside analog has already been approved in South Korea, and it's been tested in over 800 patients.
Pharmasset licenses the rights to clevudine from a Korean drugmaker, and the drug hasn't yet been approved in the U.S. or European Union, due to their stricter drug approval guidelines. Pharmasset plans to run the drug through phase 3 testing here in the U.S., comparing it head-to-head with leading treatment Hepsera before filing a marketing application with the FDA and European Medicines Agency
The market opportunity for hepatitis b virus (HBV) compounds is nothing to sneeze at. Indeed, Bristol-Myers Squibb's (NYSE: BMY) HBV compound Baraclude posted sales of $83 million last year, while Hepsera racked up $231 million in 2006 worldwide sales for Gilead Sciences (Nasdaq: GILD).
The blockbuster opportunity for Pharmasset, though, lies in its race to produce a complimentary small-molecule drug for current hepatitis C standards of care. Multiple drugmakers are striving to find similar treatments, including Rule Breakers picks Vertex Pharmaceuticals (Nasdaq: VRTX) and InterMune (Nasdaq: ITMN).
Last week, Pharmasset posted the first efficacy results for its hepatitis C virus (HCV) compound, based on a phase 1 study in 40 patients. The drug, R7128, reduced viral loads by up to a mean of 2.7 log for the HCV genotype 1 sufferers in which it was tested in.
Even better, Pharmasset reported that no patients saw the virus levels in their bodies rebound during the fourteen-day study. That suggests that R7128's efficacy could improve over a longer dosing period.
Based on the strength of the phase 1 data, Pharmasset and partner Roche have already slated another study of R7128, in combination with Roche's Pegasys. Data is expected in the first quarter of next year, and if all goes according to plan, phase 2b testing of R7128 will begin later in 2008.
R7128 is a nucleoside inhibitor, and it's worth pointing out that similar drugs have not been as successful in longer-term testing, even if they showed promising phase 1 data. Pharmasset's HCV program can't expect smooth sailing just yet.
Nonetheless, with multiple antiviral candidates aimed at several disease targets, not to mention its anti-HIV compound in phase 2 testing, Pharmasset looks promising enough to merit a spot on Fools' radar screens.
Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has an A+ disclosure policy.
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Confronting hepatitis C
http://www.thisislocallondon.co.uk/
Former drug-addict: John Porter-Weiss has turned his life around, but the legacy of his past is hepatitis C
It is estimated to affect around 200,000 people in England and the late Anita Roddick had it, yet little is known about hepatitis C. CARON KEMP talks to a sufferer from Tottenham ahead of World Hepatitis Awareness Day on Monday.
"I know when I got it. It was September 1, 1974. It was the only time I shared a needle with a stranger. It was at a festival."
John Porter-Weiss, 52, is extremely frank about his condition. As an unhappy teenager he turned to drugs as a form of escapism and soon got addicted. He began regularly injecting barbiturates - drugs that depress the nervous system and produce effects ranging from sedation to euphoria - and he often shared needles.
But a year down the line, realising his life was going downhill, John decided to get clean and turn his life around. He went on to marry and have two children, now aged 24 and 22, and set up home in Tottenham, working in a variety of trades from sculpting to building.
Then, five years ago, a Panorama programme on Hepatitis C triggered John's son into asking his dad to get tested.
John said: "I've never made any bones about it with my sons that many years ago I was involved in hard drugs because I believe you should never hide these things.
"When my son said to get tested it was based on a lot of things. He thought it could explain a lot of symptoms I was experiencing at the time.
"I was feeling ill and didn't know why. In the Eighties I went down with what I thought was the flu but I didn't recover for nine months.
"I had a pain in my right side just under my ribs and couldn't work out what it was. I thought I pulled a muscle but it went on for months.
"I felt weak and lethargic all the time. I was depressed and confused. It was quite worrying."
Like many people, John did not think he could have the virus because he had been clean of drugs for so many years, but went to the doctor to appease his son.
However, hepatitis C can lie dormant for decades before symptoms start to appear and John was found to be a sufferer.
He said: "A lot of people panic when they find out they've got it. It's the sort of thing that happens to other people."
Despite feeling anxious, John set about educating himself and those around him about the illness and even created an awareness badge that was distributed worldwide.
Hepatitis C can seriously damage the liver and affect its ability to function correctly. It is spread via the blood of an infected person, commonly through sharing needles. It can also be contracted through non-sterile tattoo or piercing equipment, pre-1991 blood transfusions (before blood was screened), unprotected sex and sharing razors or toothbrushes with a carrier.
John was comparatively lucky because his condition had not deteriorated into severe liver damage, which can lead to liver cancer or liver failure.
He began his medication 18 months ago after rejecting previous calls to begin treatment because of the side effects.
He said: "It makes you feel like you've got flu but the tablets send you a bit weird. They affected my vision so everything was dim, as if the lights had been turned off. I had really bad confusion and bad panic attacks. In the end, doctors took me off the treatment because they thought I was going to commit suicide. When I got the panic attacks I could've done anything. I also lost all my hair, but it's coming back now."
John is now in remission and said the condition has enabled him to learn about himself and others.
For more information on hepatitis C contact your GP or sexual health clinic, or visit www.hepc.nhs.uk.
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September 27th, 2007
New insurance scheme for blood transfusion victims
http://www.eveningecho.ie
A new insurance scheme was launched today for people infected with Hepatitis C or HIV through contaminated blood products.
The new scheme, first announced last year, will allow people to take out life insurance, mortgage protection and travel insurance.
It is understood around 3,300 people have initiated claims against the state over the infection – ultimately the bill is expected to hit €1.1bn.
Minister for Health, Mary Harney said the insurance scheme was an important measure in supporting victims.
“The infection of people with contaminated blood products was catastrophic for them,” the minister said.
“This new scheme is an important measure to provide further support to people diagnosed with Hepatitis C and HIV as a result of contaminated blood products being administered to them within the state.
“Since 1997, it has been clear that the inability of these people to buy life assurance or mortgage protection policies added further problems to the damage they had already suffered.”
The Lindsay Tribunal found about 250 people had been infected with HIV or hepatitis C as a result of contaminated blood products used for the treatment of haemophilia.
Separately, about 1,600 women were infected with the hepatitis C virus as a result of receiving contaminated anti-D blood products.
All these people have either been denied, or faced major difficulties securing insurance on mortgages, life policies or even travel cover.
The Health Service Executive said each policy will cost the average premium an uninfected person of the same age/gender pays. The new scheme will pay additional premiums levied or cover the additional risks that would otherwise prevent a policy being taken out.
Inability to get affordable insurance, or any insurance, has long been recognised as a barrier to normal living and working for those infected.
This scheme is the first of its kind anywhere.
“This scheme will have a very positive impact on the lives of those infected as it will ensure that they can take out life or mortgage insurance in much the same way as anybody else,” said John Dwyer, scheme administrator.
“This in effect means that they and their families will now have greater security and peace of mind into the future.”
The scheme runs for a 12-month open period after which applications for mortgage protection and life assurance will be subject to restrictions.
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HIV-positive patients who aren't tested for HCV have an increased risk of death
http://www.aidsmap.com
Michael Carter
HIV-positive patients who are not screened for infection with hepatitis C virus have an increased risk of death, according to French research published in the September edition of the Journal of Viral Hepatitis. The investigators from Lyon found that only older age and a low CD4 cell count had a greater association with death. However the investigators do not think that suboptimal care was the reason why unscreened patients had a greater risk of death. They suggest that the poor health of unscreened patients at baseline made hepatitis C infection less of a priority for their doctors.
Treatment guidelines recommend that all HIV-positive individuals should be tested soon after diagnosis for infection with hepatitis C virus. The guidelines of the British HIV Association (BHIVA) further recommend that individuals with an ongoing risk of infection with hepatitis C should be regularly screened for the infection.
HIV-positive patients who are coinfected with hepatitis C have a poorer prognosis, but there are limited data regarding the characteristics and survival of patients who have not been screened for the infection.
Investigators from Lyon therefore analysed data for 3,244 patients who received HIV care in the city between 1992 and 2005. The data were collected prospectively and entered onto the French Hospital Database on HIV.
At baseline, information on gender, age, presumed mode of HIV infection, AIDS at the time of HIV diagnosis, and CD4 cell count were collected. The investigators also gathered data on hepatitis C screening, the duration of follow-up, and the use of potent antiretroviral therapy.
A total of 14,631 person years of follow-up were available for the investigators’ analysis. The patients had a mean age of 37 years on enrolment, and mean CD4 cell count at baseline was 354 cells/mm3.
The hepatitis C infection status of 299 patients (9%) was unknown. The investigators found that these unscreened patients were less likely to have acquired HIV through either homosexual or heterosexual sex and to have an unknown mode of HIV infection (p = 0.041), to have a CD4 cell count below 50 cells/mm3 or an unknown baseline CD4 cell count (p = 0.009), to have a shorter mean duration of follow-up (40 months vs. 56 months, p < 0.001), to have a greater number of mean hospital visits per year (13 vs. eight, p < 0.001), to have an AIDS diagnosis at baseline (24% vs. 15%, p < 0.001), and to have taken potent antiretroviral therapy during follow-up (29% vs. 20%, p < 0.001).
Significantly more unscreened patients than screened patients died during follow-up (17% vs. 11%, p < 0.001) and the investigators calculated that unscreened patients had an incidence rate of death of 52 per 1,000 patient years compared to an incidence of 24 per 1,000 patient years for screened patients. This rate of progression to death was statistically significant (p < 0.001) and persisted after the investigators controlled for the use of antiretroviral therapy (p = 0.015).
In multivariate analysis, the investigators found that, after controlling for possible confounding factors, being unscreened for hepatitis C infection remained a significant predictor of death (hazard ratio [HR] 2.48; 95% CI, 1.83 – 3.35, p < 0.001). Only age over 56 years (HR 3.37; 95% CI, 1.90 – 5.97, p < 0.001) and baseline CD4 cell counts below 50 cells/mm3 (HR 13.71; 95% CI, 9.63 – 19.50, p < 0.001) and 199 cells/mm3 (HR 5.62; 95% CI, 3.97 – 7.97, p < 0.001), had a stronger association with death.
“We observed that the progression to death was higher for patients with unknown HCV status vs. the patients with known HCV status after adjusting of potentially confounding factors”, comment the predictors.
Although the investigators initially speculated that suboptimal care might be associated with lack of hepatitis C screening and poorer survival, they emphasise that there is good evidence to believe that this was not the case. They write “the missing data on HCV status do not seem to be associated with poor adherence or access to care because these individuals accessed highly active antiretroviral therapy more often...and the mean number of visits was higher in the group not screened for HCV.”
As unscreened patients often had AIDS or a low CD4 cell count at baseline, the investigators speculate that their advanced HIV disease meant that hepatitis C status was less of “a priority to their medical practitioners.” However, they emphasise that “guidelines clearly recommend that HIV-infected persons be screened for HCV infection with HCV antibody test[s].”
Reference
Benet T et al. Characteristics of survival of HIV-infected patients not screened for hepatitis C virus infection in a hospital based cohort. Journal of Viral Hepatitis 14: 730 – 735, 2007.
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Shahnaz hails her hepatitis C 'miracle'
http://www.bdrecorder.co.uk
A "MIRACLE" mum who battled through two deadly illnesses, is fronting the fight that could save thousands of lives.
Shahnaz Ahmad, of Upney Lane, Barking, is battling to clear the ignorance surrounding blood disease hepatitis C, as part of the world awareness day on Monday.
The illness was discovered by chance when Mrs Ahmad moved to London in 2001. She had moved to Huddersfield from Pakistan seven years earlier for life-saving operations to her bowel and intestine for colitis and was having follow-up treatment.
It's feared a blood transfusion in the early 1990s from her husband Muhammed, who later underwent treatment, might be responsible.
After suffering 72 injections over a six month period for hepatitis C, Mrs Ahmad, 40, was given the all-clear and is urging people to forget their misconceptions.
She said: "Not many people know about hepatitis C. Many think it is just a sexually transmitted disease and do not want to talk about it.
"But the fact of the matter is there are a lot of ways it can be transmitted and people need to be aware. It's a very dangerous illness that can show no symptoms.
"We call it the hidden disease and people must get checked."
The illness is prevalent in south Asian communities and Mrs Ahmad believes this is because of "incompetence".
It can lead to liver cancer and prove fatal.
"In the early 1990s, doctors in Pakistan used needles for pretty much every complaint and it's unclear if they were always sterilised. It could even have been picked up through cut-throat razors at the hairdressers.
"I would urge anyone travelling to south east Asia to be particularly careful."
Mrs Ahmad had to quit treatment after becoming anaemic but six years on, the couple are healthy and their liver scarring has gone.
They believe modern science was helped by a big dollop of divine intervention.
Mrs Ahmad said: "Maybe it was prayers, I don't know. But the illness disappeared and the liver scarring vanished. To me, that is a miracle.
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Gilead Sciences "peer perform"
http://www.newratings.com
Bear Stearns
NEW YORK, September 27 (newratings.com) - Analyst Mark Schoenebaum of Bear Stearns maintains his "peer perform" rating on Gilead Sciences (GILD.NAS).
In a research note published this morning, the analyst mentions that the company is expected to release data on the GS-9190, its hepatitis C compound, at the upcoming AASLD meeting. The product is likely to achieve an impressive competitive position, provided it produces viral load declines of at minimum 1.5 log, the analyst says. Positive results for this product are likely to eventually result in peak sales of $1 billion, Bear Stearns adds.
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ViroPharma's Good Bad News
http://www.fool.com
By Brian Lawler
ViroPharma's (Nasdaq: VPHM) presentation Tuesday at the UBS Global Life Sciences Conference was particularly interesting, in the wake of last month's disappointing and mixed news on its hepatitis C antiviral compound.
The prospects for ViroPharma's HCV-796 darkened significantly after the company reported troubling clinical results. Patients taking the drug in a phase 2 study had elevated levels of a liver enzyme in their blood, which can be an early warning of potential liver damage -- the very thing hepatitis drugs strive to prevent.
Nonetheless, there's still hope for the compound. Other HCV drugs, including Schering-Plough's (NYSE: SGP) PegIntron, have also caused liver-related issues and still made it to market.
The phase 2 study of HCV-796 turned up liver enzyme issues when the drug was combined with PegIntron, but don't rush to blame the latter compound just yet. In the ViroPharma study, 8% of patients treated with both HCV-796 and PegIntron experienced the higher liver enzyme issues, compared with only 1% taking PegIntron alone.
ViroPharma did mention that some of these cases of higher liver enzyme issues were transient. That leaves open the possibility of using HCV-796 to get patients down to undetectable levels of HCV in the first weeks of therapy -- what's known as a rapid or early virologic response (RVR).
An RVR is a good predictor of future treatment success, and the likelihood of completely curing hepatitis C. After stopping treatment of HCV-796 following several weeks of dosing, and assuming the virus counts in their bodies don't then rebound, patients could always continue on PegIntron for the remainder of their therapy.
With such strong efficacy, it's also possible that HCV-796 could be reserved for patients not responding to current therapies. After 12 weeks of dosing with HCV-796 in the phase 2 study, 23% of patients who had previously failed HCV treatments had undetectable levels of the virus.
Likely for these reasons, ViroPharma and partner Wyeth (NYSE: WYE) will continue to run the trial, although they have discontinued the dosing of HCV-796 as a conservative safety precaution. While the drug's path ahead looks tough, ViroPharma says it can't be counted out yet.
Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has an A+ disclosure policy.
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September 28th, 2007
Report Assails FDA Oversight of Clinical Trials
http://www.therapeuticsdaily.com
New York Times Full Feed
The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.
In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.
The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.
''In many ways, rats and mice get greater protection as research subjects in the United States than do humans,'' said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania.
Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, Mr. Caplan said.
Because no one collects the data systematically, there is no way to tell how safe the nation's clinical research is or ever has been.
The drug agency oversees just the safety of trials by companies seeking approval to sell drugs or devices. Using an entirely different set of rules, the Office for Human Research Protections oversees trials financed by the federal government.
Privately financed noncommercial trials have no federal oversight.
''It's crazy that we have all these different sets of rules,'' said Dr. Ezekiel J. Emanuel, chairman of the bioethics department at the National Institutes of Health. ''It would facilitate things a lot if we had one agency overseeing things.''
Dr. Janet Woodcock, chief medical officer at the drug agency, acknowledged that it needs to put more ''teeth'' in its enforcement. ''We are working to address these problems very aggressively,'' Dr. Woodcock said.
The case of Audine Graybill demonstrates the flaws in the system. According to the F.D.A., in the spring of 2005, she decided to try an experimental drug to treat mania associated with bipolar disorder. The consent form that she signed on May 29 stated that she could change her mind at any point in the study.
She checked into High Pointe Healthcare in Oklahoma City, a psychiatric center owned by a psychiatrist, Dr. David Linden. On June 3, Ms. Graybill changed her mind and asked to leave.
Dr. Linden refused to let her go.
On June 6, she was given the experimental medicine. Ms. Graybill's lawyer, Anthony Sykes, obtained a writ of habeas corpus for her to appear in court and took the writ to the hospital, where the staff refused to honor it and said it would not give it to Dr. Linden, Mr. Sykes said.
Mr. Sykes tracked Dr. Linden to another office and had him served with the writ, Mr. Sykes said. Within hours, Dr. Linden's lawyer called Mr. Sykes and said Ms. Graybill was free to go. Mr. Sykes took her home on June 7.
Ms. Graybill could not be reached.
More than nine months later, an F.D.A. inspector appeared at Dr. Linden's research center and uncovered myriad other problems.
The agency sent its warning letter more than two years after Ms. Graybill's experience.
Last November, the Oklahoma Board of Medical Licensure and Supervision suspended Dr. Linden's license for three months because he had sex with two patients and gave them genital herpes infections, according to board records. Dr. Linden, who also owns a psychiatric center in Las Vegas, did not return repeated telephone messages.
Dr. Linden has conducted clinical trials for most major pharmaceutical companies and continues to do research, according to his Web site.
The F.D.A. disqualified investigators from conducting further clinical trials 26 times from 2000 to 2005 and disqualified their data just twice even though the agency found serious problems at trial sites 348 times in that period, the inspector general found.
While some of the report's findings surprised ethicists, its conclusion that the agency's oversight of clinical trials is disorganized and underfinanced has long been known and is, in many ways, identical to criticisms leveled at other agency functions, including its oversight of imported food, foreign drug manufacturers, animal food and the safety of older medicines.
In each case, the size and complexity of the tasks facing the agency have grown enormously as the number of inspectors for those tasks has generally declined.
An inspector general's report in 2000 criticized the oversight of clinical trials and noted that the inspections mostly focused on whether study information was accurate and not on whether human subjects were protected. That is still true.
In the present report, the inspector general recommended that the agency create a registry of all continuing clinical trials, an idea signed into law by President Bush on Thursday.
The report also recommended that the agency create a complete registry of research ethics boards, create a single comprehensive database to track its research inspections and obtain greater authority to regulate research assistants.
Senator Charles E. Grassley, Republican of Iowa, said the agency ''needs to implement these recommendations to meet its duty.''
Representative Rosa DeLauro, Democrat of Connecticut, said it needed more money and guts.
''They're passive, they're reactive, and they often side with industry over public health,'' Ms. DeLauro said.
The agency's reserve is apparent in some of its warning letters.
On May 24, 2005, an inspector, Barbara Breithaupt, went to the office of Dr. Frank A. Wingrove of Ames, Iowa, and for weeks asked to see records of his study of an experimental topical treatment for periodontal disease. Dr. Wingrove refused. Dr. Wingrove did not return telephone messages seeking comment.
More than two years later, the agency sent Dr. Wingrove a warning letter. The inspector general's report suggests that if Dr. Wingrove promised to reform, the agency was unlikely to show up again to see whether he had followed through.
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Idenix Pharmaceuticals Restructures to Concentrate Efforts on HCV and HIV Programs
http://pharmalive.com
CAMBRIDGE, Mass., September 28, 2007 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. , a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced a strategic restructuring. As part of the restructuring, Idenix has amended the collaboration agreement with Novartis Pharma AG related to Tyzeka(R)/Sebivo(R). Per the amended agreement, Idenix will discontinue all development, manufacturing and commercial activities for Tyzeka/Sebivo. Novartis will continue these activities and have full responsibility for ongoing and future clinical trials and regulatory filings related to Tyzeka/Sebivo. Additionally, Idenix will receive a royalty on worldwide product sales. As a result of these changes, Idenix is reducing its workforce by approximately 100 positions, the majority of which support the development and commercialization of Tyzeka/Sebivo in the United States and Europe. Following this reduction, Idenix will have approximately 200 employees at the company. The company anticipates that this action will reduce its cash burn rate by between 40 percent and 50 percent.
"This has been a challenging time in the evolution of our company and we have re-evaluated our strategic plan and our organizational structure," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "We made a strategic decision to focus all of our resources on our hepatitis C and HIV/AIDS discovery and development programs; as such, we have discontinued the development of valtorcitabine for the treatment of hepatitis B and have changed our agreement for Tyzeka/Sebivo to a royalty stream arrangement. These decisions will enable us to concentrate on what we believe is most critical | 
