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Week Ending: April 28th , 2007
Alan Franciscus
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This Issue:
April 22nd, 2007
New Protein Controls Growth of Hepatitis C Virus
http://www.sciencedaily.com
Science Daily — Researchers reveal a new protein that prevents the hepatitis C virus from replicating, which could help devise new drugs against hepatitis C.
Hepatitis C is a blood-borne, infectious disease that can cause liver inflammation, fibrotic scarring of the liver -- or cirrhosis -- and liver cancer. The virus spreads within its host by replicating its RNA and using it to build proteins that form new viruses and by inhibiting various antiviral proteins inside host cells. By understanding both mechanisms, scientists hope to prevent the virus from replicating, thus stopping the infection.
Stanley M. Lemon and colleagues discovered a new protein involved in stopping the virus from replicating. Called p21-activated kinase 1, the protein is known to play a role in several cellular signaling pathways, but it has not been shown previously to be involved in regulating the replication of hepatitis C virus.
Article: "p21-activated Kinase 1 Is Activated through the Mammalian Target of Rapamycin/p70 S6 Kinase Pathway and Regulates the Replication of Hepatitis C Virus in Human Hepatoma Cells" by Hisashi Ishida, Kui Li, MinKyung Yi, and Stanley M. Lemon
Note: This story has been adapted from a news release issued by American Society for Biochemistry and Molecular Biology.
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April 23rd, 2007
Vertex Vibrates Hepatitis Drug Sector
http://www.thestreet.com
By Adam Feuerstein
Senior Writer
Vertex Pharmaceuticals (VRTX) hogged most of the attention at last week's European liver disease meeting in Barcelona, but the fortunes of other companies also were affected.
Roche, for example, now finds itself in an interesting position. Vertex is using Roche's version of long-acting interferon alpha, called Pegasys, in all the clinical trials for Vertex's telaprevir hepatitis C drug. That's good for Roche, because if telaprevir is ultimately approved and becomes part of the hepatitis C standard of care, doctors might start using a lot more Pegasys, too.
In this scenario, the loser would be Schering-Plough (SGP) , which markets its own long-acting interferon under the brand name Peg-Intron.
But Roche's advantage could be fleeting, because newer forms of interferon alpha are working their way through clinical trials. Most notably, Human Genome Sciences (HGSI) is developing a longer-acting interferon, dubbed albuferon, which can be injected once every two weeks. (Both Pegasys and Peg-Intron required weekly injections.)
Follow-up data from a phase II study presented at the meeting showed that albuferon is just as effective as Pegasys. Patient measures of quality of life were higher for albuferon than for Pegasys.
One note of concern was higher patient dropouts with albuferon, but this is partially explained by the fact that the phase II study didn't allow doctors to make dosing adjustments to account for toxicity or tolerability.
The buzz on albuferon at the Barcelona meeting was positive, according to a couple of fund managers who were there and spent a lot of time quizzing doctors. What the doctors like about albuferon is the less frequent dosing, which is better for patients.
If telaprevir and albuferon are both approved, there won't likely be any specific clinical data combining the two drugs. But doctors didn't seem concerned by this, saying they'd freely replace Pegasys or Peg-Intron with albuferon in any telaprevir-containing treatment regimen, my fund manager sources said. (Neither of them currently has a position in Human Genome Sciences.)
Human Genome Sciences and partner Novartis (NVS) are enrolling patients in a pivotal phase III albuferon trial right now. This trial will take a while to run, but if every-two-week dosage of albuferon turns out OK and is approved, it might easily take a big chunk of the $2-billion-to-$3-billion-plus interferon market for hepatitis C.
Roche is a major player in hepatitis C, however, so it's not sitting back and letting other companies mold future treatment for the disease.
That's why the Swiss drugmaker inked a big-time partnership with InterMune (ITMN) last year to tie up ITMN-191, which, like telaprevir, is a protease inhibitor against hepatitis C but might be more potent and require less frequent dosing.
I say "might" because so far, the only data we've seen from ITMN-191 have been from the test tube. There were no new data on the drug presented in Barcelona. The first viral reduction data using ITMN-191 in hepatitis C patients should be ready later this year. This report is highly anticipated because it will be used to stack ITMN-191 against Vertex's telaprevir.
Of course, other drug companies are working hard on new hepatitis C drugs. Schering-Plough has a protease inhibitor in clinical trails, but the data made public so far haven't lived up to expectations.
There also was buzz at the Barcelona meeting about a new protease inhibitor from German drugmaker Boehringer Ingelheim, and Johnson & Johnson (JNJ) is rumored to have one in its labs too, which is interesting, because the company is also teaming with Vertex on telaprevir.
Then there are the so-called polymerase inhibitor drugs, which, like protease inhibitors, take a direct (though slightly different) antiviral approach to battling the hepatitis C virus. Roche has one, as does Viropharma (VPHM) (which partnered with Wyeth (WYE) ).
The polymerase inhibitor with the most data under its belt so far is Idenix Pharmaceuticals' (IDIX) NM283, but so far, potency has not been spectacular, while toxicity has been a problem.
The future of hepatitis C treatment is paralleling the evolution and path of the HIV drug market. Both diseases are viral in nature, although hepatitis C can be cured, and HIV cannot -- yet. And combination drug therapy is the established standard of care with both diseases, although with hepatitis C we're only just getting to where enough new drugs are being developed to approach the day when different drug combinations and treatment regimens might be used.
One of the important lessons from HIV, however, is that being first to market with a new drug doesn't necessarily anoint you the ultimate winner. Case in point, Gilead Sciences (GILD) , which was a relative latecomer to the HIV treatment party, but today, its drugs dominate the market.
In hepatitis C, Vertex's telaprevir might be first, but the competition is likely to be intense. There is really no way of knowing today what drugs or treatment combinations might take the lead in the future.
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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San Francisco Seeks to Reduce Hepatitis B
http://www.redorbit.com
A San Francisco group is beginning a campaign to screen, vaccinate and treat the city's Asian and Pacific Island population for hepatitis B.
The group, made up of government, private healthcare and community organizations, is targeting the 34 percent of the city's population made up of Asian and Pacific Islanders.
Its message -- B Sure, B Tested, B Free -- will be going out on both Asian and mainstream media. Low-cost or free screenings and vaccinations will be provided at physician offices, health clinics and street fairs.
The hepatitis B virus is a highly infectious disease that is affecting the health of our vibrant Asian and Pacific Islander community, said San Francisco Mayor Gavin Newsom. Fortunately, a vaccine exists that is safe and effective.
San Francisco's Asian and Pacific Island residents bear a disproportionate burden of liver cancer and undetected hepatitis B. Hepatitis B is a disease responsible for 80 percent of all liver cancers among Asian and Pacific Islanders.
Source: United Press International
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Draft Bill on Euthanasia Questioned
http://www.sptimesrussia.com
By Galina Stolyarova
Staff Writer
Sixty-year-old Valentina is gradually dying. She has Hepatitis C. But this St. Petersburg pensioner is not receiving treatment for her condition. Doctors have told her that the available medications would in fact serve to hasten her end.
Valentina shrugs her shoulders?at the news that Russia’s Federation Council has come up with a draft bill that, if passed, would legalize euthanasia in ‘exceptional cases.’ She believes that many doctors in Russia are already leaving some patients to die when they should be providing medication and care that would allow them to live longer. The law would only formalize a situation that already exists in practice.
“At least, there is no more hypocrisy. My doctors have essentially left me to die,” she said. “In theory, Russians should be getting free medical treatment from the state but I have to pay for every single thing, even blood tests to evaluate the quantity of the virus in my blood. Doctors are writing me off as though I had already died.”
For Valentina, euthanasia is not an option. “It is getting more and more difficult for me to look after my two grandchildren,” she said.
“But I immensely value every single extra moment of life that I can afford, even if I got so weak that I could only manage to look at my nearest and dearest.”
The brains behind the draft law – which is being debated by the Federation Council this month – are members of the upper house of parliament’s social affairs committee. The head of the committee, Valentina Petrenko, argues that euthanasia, if introduced, will not be widely applied.
The law, however, does not restrict the use of euthanasia to a specific number of cases per year. It also stops short of setting more detailed limitations on its implementation, other than listing requirements for a patient’s consent, the verdict of a medical consultation and a subsequent review by an expert panel selected by a local municipality.
Euthanasia has been allowed in the Netherlands since 2001. Doctors in Belgium, Switzerland and the U.S. state of Oregon are also permitted to terminate the lives of their patients on their request and under specific conditions.
In France, the U.K. and Australia “passive euthanasia”, where terminally ill patients are granted the right to refuse treatment, is allowed.
“Euthanasia is meant as a possible solution for those patients who suffer from excruciating pain or live with the severest disabilities and just cannot bear it anymore,” said Valentina Petrenko. “We would like to make it possible for the gravely ill, who are begging their doctors for help, to be relieved of this nightmare of a life they are enduring.”
Valentina, for one, does not believe that good intentions were what drove the parliamentarians to come up with this controversial plan. Rather, she argues, a lack of resources and cynicism are what lie behind it. She cites an old Chinese proverb which says that reforms start when the money has run out.
“It looks to me as if the state cannot cope with masses of sick and feeble people. And so it is cynically hoping to reduce their numbers by offering to help them commit painless suicide, as opposed to granting them a course of therapy to ease the pain, a psychotherapist and plenty of medication to improve the quality of their last days,” Valentina said. “That would certainly be a great bargain for the state.”
Yabloko politician Natalya Yevdokimova, who chaired the Social Issues Commission at the St. Petersburg Legislative Assembly from 1998 to March 2007, supports the introduction of euthanasia, though she has expressed fears that the law, if it is written vaguely and contains loopholes, could lead to an increase in medical corruption.
“I am convinced that people need to feel free to end their sufferings,” she said. “It so happens that at the moment one of my closest friends is fatally ill and this person’s condition is rapidly deteriorating. This patient is in a clear state of mind but absolutely helpless, and is undergoing a rapid physical decline. I think everyone in such a condition should have the right to decide for themselves. It is the only merciful way.”
But the expert goes on to warn that in Russia, where corruption is rife, the trend towards shadowy deals between doctors and relatives of terminally ill patients would be marked.
“In countries where euthanasia is permitted, there is legislation to protect the patient and to make sure that the medical profession has made every effort on behalf of the patient. Only after all that is the door left open for euthanasia,” Yevdokimova added. “It has to be a last resort.”
Critics of the draft law also warn that the introduction of euthanasia would ultimately relieve doctors of responsibility for saving the lives of their patients.
Professor Georgy Novikov, head of the Russian nationwide movement Medicine For the Quality of Life called the plan destructive and said the law would only serve to encourage suicide attempts.
“Only someone who is not receiving adequate medical care can express a strong desire to end his or her life,” he said in an interview with Rosbalt News Agency. “It is a shame that our country is looking to euthanasia, rather than developing palliative medicine, as well as better psychotherapeutic treatment, and improving conditions in hospices.”
St. Petersburg’s chief oncologist Alexei Barchuk also opposes the proposal.
“It is too early for euthanasia to be introduced in Russia,” he said at a news conference in mid-April. “Our medical system is not ready for that. The move, if accepted, would inevitably increase the suicide rate among patients who have lost hope. This death machine would swallow up our weakest and most vulnerable people like a meat-grinder.”
Over 100,000 cancer patients are registered in St. Petersburg, and nearly half of them are fatally ill with their cancer in its final stages, said Dr. Barchuk.
The Russian Orthodox Church has condemned the euthanasia plan, calling the initiative “absolutely amoral from the religious point of view.” The Church also suggested that it should be involved in the debate.
Maria Matskevich, a leading researcher with the Institute of Sociology of the Russian Academy of Sciences, said that the prevalent attitudes towards life and death in Russia do not make for a favorable environment for the introduction of euthanasia, at least for the time being.
“While there is massive support for imposing the death penalty on certain criminals, people who commit or attempt suicide are viewed with much compassion, but they are condemned for it,” she said. “Methods which are considered humane in the West are judged here from the moral — rather than humane — perspective. Death is seen as punishment or retaliation, not as something that people should be legally allowed to seek themselves. At least that’s what most people here think,” Matskevich said.
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April 24th, 2007
Cookbook, golfing to target hepatitis C
Marianne Rzepka, News staff reporter
http://www.mlive.com
Deborah and Theodore Green, president of Greenview Data Inc., are taking aim at hepatitis C with fundraisers to finance research against the disease, which can affect the liver, causing cirrhosis, cancer and death.
Their charity, The Greenview Foundation, will turn over funds from the sale of the 280-page cookbook "Cooking Around the World'' to the University of Michigan for hepatitis C research and education.
The 500 recipes have been collected by Deborah Green and, she said, lean toward Asian cuisine.
The cookbook costs $15 at Nicola's Books, 2513 Jackson Road, or Downtown Home and Garden, 210 S. Ashley St., both in Ann Arbor, or through the Greenview Hepatitis C Fund, 2773 Holyoke Lane, Ann Arbor 48103. You can see sample recipes on the Web at www.hepcfund.org.
The foundation also is sponsoring a May 12 golf fundraiser that includes a Mercedes Benz for the first hole-in-one. The cost is $100 per player. E-mail Ted Annis at tannis@spamstopshere.com or call 734-996-1300.
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Treatment of HBV or HCV in triple-infected individuals not seen to cause rebound of untreated virus
www.aidsmap.com
Derek Thaczuk
A small retrospective study has found that, in people coinfected with HIV, hepatitis B and hepatitis C, treatment of either viral hepatitis infection does not seem to result in reactivation of the other. The findings were published in the April 15th edition of the Journal of Infectious Diseases.
Between 3 - 5% of people with HIV are also infected with both hepatitis B virus (HBV) and hepatitis C (HCV). A “reciprocal inhibition” is usually seen with dual HBV/HCV infection; i.e., one or the other of the viruses tends to predominate, and active viral replication of both HBV and HCV is rarely seen simultaneously. This has led to concerns that HBV- or HCV-suppressive treatment could lead to reactivation of the other virus.
However, a retrospective Spanish study of triply-infected individuals did not find evidence of such outcomes. The study looked at 21 patients from an HIV clinic in Madrid, all of whom were antibody-positive for HIV, HBV and HCV. The group median age was 39, all were white, 19 were male, 19 were former injection drug users, and median CD4 counts were 427 cells/mm3. None had undergone HIV or HCV treatment before the year 2000. People were considered viremic for HBV if they had detectable HBV DNA, and viremic for HCV if they had detectable HBV RNA.
Of the 21, four also had antibodies to hepatitis D virus (HDV). Hepatitis D is known to suppress other hepatitis viruses, and in fact none of the HDV-positive people were viremic for HBV. Low-level HCV viremia was seen in one (who had a CD4 cell count of 96 cells/mm3).
Of the remaining 17, nine were viremic for HBV only (i.e., had measurable blood plasma HBV DNA), five were viremic for HCV (plasma HCV RNA), two had both, and one had no detectable HBV or HCV in the blood plasma.
Results: HCV-viremic only
All five of the patients with detectable HCV RNA only were treated with pegylated interferon-alpha and weight-dosed ribavirin. Treatment success was mixed – the two with HCV genotype 1 relapsed after treatment, while the three with genotype 3 had sustained HCV virologic response. However, even though none of the five received tenofovir or 3TC during the study period, none became HBV-viremic either during or after HCV treatment (although such rebounds have been reported in other reports). The researchers believe this observation “warrants further study and monitoring for longer periods.”
Results: HBV-viremic only
All nine of the patients with detectable HBV DNA only, plus the three who were HDV-antibody positive but not HCV viremic, received HIV antiretroviral therapy that included tenofovir and/or 3TC (both of which are active against HBV). The level of HBV viremia dropped to undetectable levels in all but one of these patients within one year (half were undetectable by week 24). More rapid decreases were seen with tenofovir than with 3TC.
No rebounds in HCV viremia were seen in any of these dozen patients, even after a year of follow-up. The researchers suggest “that HCV had already been eradicated in these subjects, either spontaneously or as a result of continued HBV interference.”
Results: dual viremia
The two patients who were viremic for both HBV and HCV received HCV treatment as well as antiretrovirals including tenofovir and/or 3TC. After one year, both viruses were undetectable in blood serum; unfortunately, HCV viremia rebounded in both after the completion of twelve months interferon-based therapy.
The researchers conclude “the reciprocal inhibitory interaction between HBV and HCV also occurs in HIV-infected patients, at least in those without severe immunosuppression. A careful virologic assessment is warranted… to ascertain which virus is replicating and which is suppressed, so that that appropriate therapeutic decision can be made.” Regarding the consequences of treating HBV and HCV, “our findings suggest that complete suppression of the dominant virus … is generally not followed by a rebound of the other virus.”
Reference
Soriano V et al. Treatment of chronic hepatitis B or C in HIV-infected patients with dual viral hepatitis. J Inf Dis 195: 1181-1183, 2007.
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Artist Befriends Virus With Chocolate Truffles
http://www.gothamist.com
Caitlin Berrigan is a 25 year-old Brooklyn-based artist who chooses media such as fats, sugars, and proteins to address ideas and subjects that are often invisible to the naked eye. At Location One last month, Berrigan presented her Viral Confections project: ping pong ball-sized chocolate truffles she casts from a silicone mold created especially for the task. The truffles are made in the shape of the Hepatitis C virus. “These delicious truffles do not carry hepatitis C,” the artist’s website explains. “Each one was lovingly handmade from 72% Belgian roasted cocoa in attempt to befriend the virus.” Other Viral Confections installation pieces include large apothecary jars, decked out with a frilly, soothing variant of the biohazard logo, and filled with model boxed truffles; Berrigan conducts “tea parties” at installation sites, where the conversation inevitably tends toward illness, with exceptions like molecular biology shoptalk and empathy. During last month’s event, Berrigan’s hepatitis-shaped truffles were scarfed down before the conversation ever got started. “Within the first five minutes, this group of people came over and ate all the chocolates,” Berrigan says. “I think they were tourists. I was left with maybe six truffles, and they didn’t stay for the presentation.” The artist presented Viral Confections anyway, and talked about Hepatitis C, which affects 200 million people worldwide.
“I’ve been working in the activist community for several years, and it gets really depressing, because there’s really no awareness of the disease at all,” Berrigan says. “I’m trying to pique people’s interest, re-examine our relationship to viruses, and raise some awareness about Hepatitis C.” Berrigan’s hepatitis-shaped chocolate truffles are part of a larger series, Sentimental Objects in Attempts to Befriend a Virus. Berrigan plans to produce handmade booklets with basic information about the disease, and to eventually build a functional, geodesic-domed greenhouse made in the shape of Hepatitis C.
Hepatitis C is a virus that causes liver disease and is transmitted through blood-to-blood contact, such as through blood transfusions and IV needles; Berrigan contracted the disease from a blood transfusion she received when she was four months old. She started the Sentimental Objects series to mediate the largely separate cultures of disease, treatment, and public perception of her illness. “The tactics of fear are really important to raise awareness,” she says, “but there’s too much fear in the environment now.” One of the ideas behind the Viral Confections series, the artist says, is “to help determine what is really important about fighting the virus, which many times is just people’s negligence and ignorance, their own fear.”
Berrigan, who has a chocolate tempering machine and other equipment in her Brooklyn studio, had worked previously with the medium of chocolate. “I cast my nipple, lips and tongue,” she says, “and sold these tiny boxes with my body parts inside.” For a show in France, Berrigan and another artist created a 5-foot marzipan tampon that invariably angered spectators. Another piece in the same show featured a for sale, by-the-slice dress made out of prosciutto, worn by a leggy model. “The dogs got really excited about her, which freaked her out,” Berrigan says, reluctantly. The art in that show was based on the subversion of ideas already prevalent in culture, but largely unaddressed. To a degree, says Berrigan, “media are already selling the body in cannibalistic ways,” and edible projects impel spectators to “consume these beautiful bodies in a more literalistic, cannibalistic kind of way.”
This weekend, Caitlin Berrigan will present at the New York portion of the Bent Festival, at Eyebeam Atelier. “I’m going to be taking different lipids and fats and putting them in jars,” she says, “so that people can manipulate contact mikes and listen to the sounds the lipids or fats make inside the jar.” Lipids make noise? “Everything makes noise. These grad students and artists at UCLA did a project listening to yeast cells,” Berrigan says. “The yeast had a pleasant, ‘om’ ringing when they were happy and healthy. Then they were put to high temperatures, burned, and the noise got more and more scream-like,” says Berrigan, laughing a little. “It was horrible.”
Photos: Berrigan in her kitchen; the Viral Confections Apocathary jar. The Bent “Circuit Bending Festival,” featuring Caitlin Berrigan’s Aural Viscosity, takes place Thursday through Saturday at Eyebeam Atelier, 540 West 21st Street. Berrigan’s work can also be seen on her website. For more information on Hepatitis C, go here, here, or here.
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Ghana: Neglect of Hepatitis C Leaves People With HIV Vulnerable
http://allafrica.com
Ghanaian Chronicle (Accra)
Bobby Ramakant
IN COMMUNITIES where sharing of injection equipment drives the HIV epidemic, a parallel epidemic often lurks quietly in the shadows. Greater awareness about hepatitis C, more investment of resources, cheaper diagnostic and treatment services, and improved hepatitis-related treatment literacy, are all urgently needed by people co-infected with the hepatitis C virus and HIV.
"Hepatitis C treatment is mostly left out since AIDS activists are so focused on ARVs [antiretroviral drugs] or other prevention and treatment services," said Umesh Sharma, who has just completed a course of hepatitis C treatment.
Hepatitis C is a blood-borne, infectious, viral disease that is caused by the hepatitis C virus (HCV). The infection can cause liver inflammation that is often asymptomatic, but chronic hepatitis can lead to cirrhosis and liver cancer. HCV transmission occurs when traces of blood from an infected person enter the body of a HCV-negative person. Like HIV, HCV is spread through sharing injection equipment, through needle stick or other sharp injuries, or less frequently from infected mothers to their babies.
HCV transmission rates are higher than that of HIV, and the condition is often more severe in drug users. People who share injection equipment are vulnerable to HCV and HIV infection, and in many places co-infection is not uncommon.
For Umesh the key was largely having access to the information he needed. Already aware of his positive HIV status, he went for a routine general health check-up during a trip to London in 1995. He discovered he was also infected with HCV. Until then he had no symptoms of HCV. This is not an unusual story; up to 80% of people with HCV usually develop no symptoms. Initial symptoms, when they appear, can include jaundice, fatigue, dark urine, abdominal pain, loss of appetite and nausea.
TESTS
There are three types of tests for HCV, which all use polymerase chain reaction (PCR) technology:
- HCV PCR viral detection test: This qualitative test is designed to detect the hepatitis C virus.
- HCV PCR viral load test: This quantitative test estimates the level of HCV in the blood. It helps to monitor the effectiveness of treatment.
- HCV PCR genotype test: This determines the specific genotype (genetic 'make-up') and subtype of HCV. This information is important in selecting a course of treatment. For example, treatment with interferon is more often effective for people with HCV genotype 2 or 3.
"The cost of these PCR tests is prohibitive", says Umesh. He had to pay close to US$100 for the tests. People co-infected with HCV and HIV also need to monitor indicators of HIV progression, such as their CD4 count. If the CD4 count falls below 200, then HCV treatment is less effective, and its side effects may be more pronounced. Umesh suggests that those people with HIV who are taking antiretroviral (ARV) drugs should consult their doctors to find out if they need to change their ARV combination before starting HCV treatment.
Another challenge is the limited availability of PCR tests. In India for example, the test is available in only one city (Mumbai), although blood samples are collected from other parts of the country and sent there for diagnosis. The results can take more than a month to be returned.
Over ten years after his initial diagnosis, Umesh has just completed a course of hepatitis treatment, but getting through the treatment was not without its challenges. "We clearly need more HCV diagnostic facilities," added Umesh. "Particularly in areas with high levels of injection drug use."
TREATMENT
HCV can often be treated successfully, including among PLHIV, but the treatment is not easy to endure. Treatment for HCV uses a single drug, or a combination of two drugs, and usually takes between six and twelve months. Umesh points out that there is no standardized treatment protocol and clinical practice varies considerably between individual doctors. This can add to uncertainty and confusion for patients.
The treatment for HCV is also very expensive - costing on average approximately US$250 per week. Interferon injections are given weekly, in addition to ribavirin tablets. The tablets may be provided free for people paying for interferon injections. On purchasing four interferon injections, one extra is often provided free as a 'discount'. But in countries such as India, people have to bargain with representatives of pharmaceutical companies or doctors, remarks Umesh. A cheaper alternative is to use interferon injections alone, although this is reported to be less effective. Umesh comments that high-profile donor agencies including the Clinton Foundation and the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) are yet to dedicate resources to providing treatment for HCV.
Another dispute among clinicians surrounds the diagnostic value of a liver biopsy. In well-resourced countries, a liver biopsy is usually performed to determine the extent of hepatitis-related liver damage, whereas in Asian countries such as India, China, Vietnam, and Thailand, doctors usually avoid this procedure. Consensus is needed around the diagnostic utility of liver biopsy, if nothing else in order to eliminate additional confusion for patients.
There is no vaccine to prevent HCV infection and even after successful completion of treatment, HCV reinfection can occur. During and after treatment, HCV PCR viral load testing is done at six-month intervals to monitor HCV control.
Umesh says that people with HCV considering treatment should connect with those who have previously been through it. The initial days of the regime can be very frustrating and challenging, including loss-of-appetite and flu-like symptoms - it helps to talk to those who have completed the regimen before. Even after successful completion of HCV treatment, it is vital to keep the HCV viral load low. Umesh recommends that drug and alcohol use should be avoided in order to protect liver functions. Also people with HCV need to take care of their livers by avoiding spicy or fatty foods.
Umesh recalls, "I learnt from my doctor, Dr Samiran Panda, in the early 1990s, who taught me how to take care of myself and monitor my own health."
Umesh has proactively sought information over the years, in order to look after his own well being as well as possible. As a result, he has developed a comprehensive understanding of issues around HIV, injection drug use, as well as HCV.
Developing these kinds of self-management abilities is vital: To monitor and control symptoms of hepatitis C, to minimise other complications or opportunistic infections, or hopefully to prevent their onset entirely.
For people co-infected with HCV and HIV, self-management and treatment literacy skills may be all the more crucial.
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Schering-Plough Sued in NJ for Marketing Drugs for Off-Label Uses
http://www.law.com
Mary Pat Gallagher
New Jersey Law Journal
A raft of lawsuits centered in New Jersey allege that Schering-Plough Corp. offered bribes, kickbacks and other incentives to doctors to get them to prescribe its hepatitis and cancer drugs for uses not approved by the Food and Drug Administration.
Of six lawsuits filed, five are pending with U.S. District Judge Stanley Chesler in Newark, N.J., and the Kenilworth, N.J., drug company wants the cases tried in that state.
But plaintiffs in the sixth suit, filed on March 27 in Arizona, are asking the Judicial Panel on Multidistrict Litigation that the matter be centralized in Arizona or Massachusetts, where a federal investigation into off-label marketing by Schering ended last year in a plea bargain and a $180 million criminal fine.
On Thursday, Schering-Plough and two wholly owned subsidiaries, Schering Sales Corp. and Schering Corp., which have also been sued, filed a motion in Arizona asking that the case be transferred to New Jersey for the convenience of parties and witnesses and in the interest of justice, including New Jersey's interest in regulating conduct within its borders.
Schering-Plough has already prevailed on three similar motions in the Eastern District of Pennsylvania, where three of the cases pending in New Jersey were originally filed. Plaintiffs in those cases had asked the multidistrict-litigation panel to centralize the cases there, but the panel denied the motions as moot because of the transfer to New Jersey.
The five consolidated cases, captioned In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 06-Civ.-5774, are filed by health insurers, unions and consumers.
The drugs at the center of the litigation are Intron A and Temador. Intron A, approved to treat hepatitis, has been prescribed for such off-label uses as superficial bladder cancer. Temador, approved for certain brain tumors, has been widely used for other illnesses like metastic melanomas.
The plaintiffs claim Intron A and Temador are more expensive than the approved drugs, leading them to pay hundreds of millions of dollars more than they would have. For example, an Internet search yielded prices for Temador ranging from $7.50 for a 5-milligrams capsule to $353.28 for a 250-milligram capsule.
The plaintiffs are hoping to get a leg up as a result of the federal investigation into Schering's marketing practices that began in 2001 and culminated in the plea deal in Massachusetts on Aug. 29, 2006.
The deal called for Schering Sales to pay a criminal fine of $180 million and to plead guilty to one count of conspiracy to make false statements to the government in response to a July 2001 inquiry by the FDA about Schering's off-label marketing activities. Schering Sales is also excluded permanently from participating in federal health care programs, and it admitted it was guilty of the broader criminal conduct charged in a related criminal information.
Prosecutors contended that between 1999 and 2003, the Schering companies got doctors to prescribe certain drugs for off-label uses by buying them off with money -- as much as hundreds of dollars per patient -- preceptorships, advisory boards and entertainment. Other alleged means included placing "Schering-funded physician assistants in busy physician practices."
A prosecutor's statement accompanying the plea agreement says the false statements admitted by Schering Sales "were designed to reassure the FDA that the promotional activities were isolated and not directed by the home office, when in fact, the activities were widespread and part of the national marketing plan."
"In addition, the Company sought to falsely lull the FDA into believing that it has taken appropriate steps to reinforce the message with its sales representatives that such promotional activities were prohibited, when in fact the Company knew and expected that those activities would continue."
Last year's settlement tightened the leash placed on the company by a 2004 agreement with federal authorities. Among other provisions, Schering must prohibit off-label marketing by sales personnel, require that inquiries about unapproved uses be directed to headquarters and set up an independent monitor.
The union plaintiffs have asked the Schering defendants to produce the materials that were provided to the government in the criminal investigation in Boston and an earlier one by the U.S. Attorney in Philadelphia that led to the 2004 agreement.
Co-lead plaintiffs counsel John Keefe Jr., of Keefe Bartels in Shrewsbury, N.J., says Schering did not produce the information, which was due Thursday, but said the request was premature and that it would take a while to assemble the materials.
Keefe believes the plaintiffs are entitled to the materials, noting that U.S. District Judge Patti Saris in Boston, discussing the need for restitution to victims at a Jan. 10 status conference in the criminal case, remarked that victims should not have to reinvent the wheel.
Saris also opined that if Schering engaged in a nationwide off-label marketing effort, it might not be necessary for plaintiffs to prove its influence on each doctor who wrote off-label prescriptions.
Keefe's co-lead counsel is Sidney Liebesman of Wilmington, Del.'s Grant & Eisenhofer.
A lawyer for the Schering companies, Joan McPhee, says she does not see the criminal case as preordaining the civil litigation, which she calls "a clean slate."
The only entity to plead guilty was Schering Sales and the only crime pleaded to, "the false statement to the FDA, does not establish anything with respect to the allegations being brought," says McPhee, of Boston's Ropes & Gray. "The allegations about kickbacks have not been tested to, admitted or proved." She calls the Philadelphia investigation unrelated.
Schering disagrees with the government view that off-label sales are illegal, says McPhee. Statements made about off-label uses were truthful and not misleading and had strong scientific support, she says. She terms it a First Amendment issue, noting that off-label usage is common, appropriate and sometimes life-saving.
Federal law requires reimbursement for off-label uses if they are listed in so-called compendia that identify medically accepted uses. McPhee points out that the compendia do list some of the off-label uses at issue.
Keefe says, however, that though doctors are allowed to prescribe off label, drug makers cannot promote those uses.
On April 13, another plaintiffs lawyer, Donald Haviland of Philadelphia, lost a motion to deconsolidate his case and move it to Boston or Arizona. His position is that his case is distinct as the first filed on behalf of consumers.
Consumers have more legal protection than insurers, he notes, adding "when a company pleads guilty to wrongdoing, it's time to pay the consumers what they're owed."
In addition, Haviland says his case is broader than the lead cases filed by unions because it has a longer class period, includes five drugs in addition to Intron A and Temador and names all three Schering entities as defendants, compared with only Schering-Plough in the union cases.
The defendants want to hold off on discovery until the court decides a planned motion to dismiss.
Plaintiffs, on the other hand, are trying to move the case along. Keefe and Liebesman were planning to file an amended complaint on Friday. They also asked on Wednesday for an initial Rule 16 conference to move things along.
In response, lead defense counsel Douglas Eakeley, of Roseland, N.J.'s Lowenstein Sandler asked Chesler to hold off on a Rule 16 conference until a decision on other, threshold issues, such as coordination of the consolidated suits and appointment of class counsel.
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April 25th, 2007
VGX Announces DNA Vaccines License Agreement with University of Pennsylvania
http://www.therapeuticsdaily.com/
BLUE BELL, Pa.--(BUSINESS WIRE)--Apr 24, 2007 - VGX Pharmaceuticals Inc. (VGX) announced today that it has signed a license agreement with the University of Pennsylvania covering novel DNA Vaccines and Therapeutics. Under the terms of the agreement VGX will have exclusive worldwide rights to develop a number of DNA plasmids and constructs with potential for the treatment and/or prevention of HIV, HCV, HPV and Influenza. This new agreement broadens the existing relationship between the two organizations. VGX was founded as a start-up in 2000 based on technology licensed from the University of Pennsylvania. VGX has previously licensed a number of product candidates and technology from the University of Pennsylvania and currently sponsors clinical research and basic research projects at the University.
The underlying technology was developed in the laboratory of Dr. David B. Weiner, Professor of Pathology and Laboratory Medicine at the University of Pennsylvania. Professor Weiner is a pioneer in the field of DNA vaccines and a VGX co-founder. Dr. Weiner's laboratory has developed consensus sequences and antigens for key HIV, HCV, HPV, and Influenza proteins that offer coverage across different viral sub-types or taxonomic groups. Pre-clinical studies have shown that immunization of mice and non-human primates using the consensus DNA constructs for each virus elicits an immune response against multiple sub-types of the HIV, HCV, HPV, or Influenza viruses respectively.
"We are pleased to have access to this exciting technology as this significantly expands our development pipeline of a new generation of DNA-based therapies and vaccines for use in humans," said Dr. J. Joseph Kim, President and CEO of VGX. "The new DNA vaccines, especially those targeting HIV and HCV, will strengthen and complement our infectious diseases programs, with PICTOVIR(TM) and VGX-410C programs currently in Phase II clinical trials in the US. Moreover, our recent acquisition of ADViSYS, Inc. provides VGX access to a proprietary DNA delivery technology and cGMP plasmid manufacturing capabilities. These new activities ensure that VGX will continue to be a global technology leader in this important field. We plan to move these exciting programs into clinical evaluation as soon as possible."
DNA-based vaccines and therapeutics deliver the immunogen or the therapeutic protein in the form of plasmid DNA encoding the protein of interest. The body then produces the protein of interest and elicits an immune response. Vaccination with DNA has multiple potential advantages over the present technology used for vaccination against a variety of infectious diseases. DNA vaccines are easier to manufacture, can be stored at room temperature and have the potential to more easily combine multiple antigens in one injection that would provide protection against multiple diseases or multiple targets from the same organism.
About VGX Pharmaceuticals
VGX Pharmaceuticals is a biopharmaceutical company with small molecules and biologics product candidates for the treatment of infectious diseases, cancer and inflammatory diseases. The Company's clinical development programs include PICTOVIR(TM) for HIV infection and VGX-410C for chronic HCV infection, both of which are currently in Phase II clinical trials. In addition, Phase I clinical trials will be initiated in 2007 for VGX-150 for the treatment of Melanoma and VGX-1027 for inflammatory diseases. The product candidates and technology programs are protected by the Company's extensive global intellectual property portfolio. More information about VGX can be found at www.vgxp.com .
Contact
VGX Pharmaceuticals Inc.
Kevin W. Rassas
Senior Vice-President
Tel: 267-440-4208
Fax: 267-440-4242
E-mail: Rassas@vgxp.com
www.vgxp.com
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Debio 025 Cyclophilin Inhibitor for the Treatment of HCV
http://www.therapeuticsdaily.com
PR Newswire Europe
LAUSANNE, Switzerland, April 19 /PRNewswire/ -- Debiopharm Group (Debiopharm), a global independent biopharmaceutical development specialist in oncology and serious medical conditions, presented additional results of a previous phase Ib, 15 day study with cyclophilin (Cyp) inhibitor Debio 025 in HIV/HCV (hepatitis C virus) co-infected patients. The data were presented at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain. Mathematical modelling of the viral decay shows that Debio 025 has a unique viral kinetics profile without signs of emerging resistance during short term treatment.
Other data from the same study showed that during treatment, Cyp-B levels decreased significantly in peripheral blood mononuclear cells (PBMCs) after treatment with Debio 025. The drop in Cyp-B levels paralleled the 3.6 log10 decrease reported earlier in this study. These human data confirm previous in vitro results that have shown that Cyp-B inhibition leads to the depletion of intracellular Cyp-B levels in the HCV replicon, as well as in other cell culture models. These are the first preliminary human data that support the hypothesis that intracellular CypB depletion is associated with significant anti-HCV activity and that CypB inhibition is a valid new target for the development of anti-HCV drugs.
"We are very excited about these results. To date, we have finalised the first two cohorts of our phase IIa study in treatment-naive mono-infected HCV patients, where we examined the effect of increasing doses of Debio 025 in combination with pegylated interferon. The Data Management Committee has analysed all safety and efficacy data and authorised the initiation of the cohort with the highest dose in the protocol," said Kamel Besseghir, CEO of Debiopharm S.A.
About Debio 025
Debio 025 is a synthetic first-in-class Cyp inhibitor, being tested in humans as a potential anti-HCV drug. Debio 025 binds strongly to cyclophilins, host cell proteins thought to confer a replication advantage to HCV. Its potent inhibitory activity on the HCV replication was shown in preclinical studies.
Previous results of the phase Ib study demonstrate that Debio 025 monotherapy for 15 days induced a strong anti-HCV effect (3.6 log10 reduction) in HIV-1/HCV coinfected patients. CypA and CypB levels were measured in patients' PBMCs to investigate the relationship between CypA/CypB inhibition and antiviral effect. (October 31, 2006 press release).
About HCV
HCV is the most prevalent liver disease in the world and is considered by the World Health Organization as an epidemic. Because HCV can infect a patient for decades before being discovered, it is often called the "silent" epidemic. Studies suggest that over 200 million people worldwide are infected with HCV, an overall incidence of around 3.3% of the world's population. In the US alone, nearly 4 million people are or have been infected with HCV and of these, 2.7 million have an ongoing chronic infection, the majority being between 40 to 60 years old. A fourfold increase in the number of adults diagnosed with chronic HCV infection is projected from 1990 to 2015, since most persons with chronic HCV infection have yet to be diagnosed but are likely to come to medical attention in the next decade.
About Debiopharm Group
Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates. Debiopharm develops its products for global registration and maximum commercial potential for out-licensing to pharmaceutical partners for sales and marketing.
Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed three products with global combined sales in excess of $2.6 billion in 2006.
For more information on Debiopharm Group, please visit: http://www.debiopharm.com/ .
CONTACT:
Debiopharm S.A. Contacts: Kim Bill, VP, Business & Licensing,
Tel.: +41-21-321-01-11, Fax: +41-21-321-01-69, kbill@debiopharm.com;
Rafael Crabbe, Medical Project Director, Tel.: +41-21-321-01-11, Fax: +41-21-321-01-69, rcrabbe@debiopharm.com ;
Additional Media Contacts
In London, Maitland, Brian Hudspith, Tel: +44-(0)20-7379-5151,
bhudspith@maitland.co.uk ;
In New York, Noonan Russo, Wendy Lau, Tel:+1-212-845-4272, Fax: +1-212-845-4260, wendy.lau1@eurorscg.com
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Vigil to mark hep C awareness month
http://www.pgfreepress.com
By Teresa Mallam
May is Hepatitis C Awareness Month. On May 1, the Prince George New Hope Society marks the occasion with its first annual Hepatitis C Candlelight Vigil in Prince George. Alison Paul of the Hepatitis C Council of B.C. says the statistics – scary as they are – speak for themselves.
Our province has been hard hit by the devastating disease, said Paul.
“More than double Canada’s national average are infected with the virus in British Columbia. There are more than 60,000 people living with hepatitis C in B.C. – twice the national average. Despite being entirely preventable, we’ll see another 1,500 to 2,400 new infections this year in B.C. alone.”
She hopes people from the community will come out May 1 to commemorate those who are living with and those who have died from this disease.
“There will be speakers from the community, refreshments and time to share stories,” she said, adding they hope to raise awareness about hepatitis C in the community. The problem is not so much about treatment, she said, because treatments are available, but that many affected people are not accessing that treatment.
“Hepatitis C is both preventable and treatable. It’s time to deal with it. That’s why we hope people will join us on May 1. Dr. Lawrence Fredeen who heads up the hepatitis C clinic in Prince George is keynote speaker and he will be discussing his clinic as well as various aspects of hepatitis C so he will have a lot of information for us.”
Paul cited cited reports which indicate that with proper treatment supports, the virus can be effectively treated in over 50 per cent of cases. However, only about one per cent of infected British Columbians receive treatment annually. Time is running out for many British Columbians who can benefit from treatment.
“A prolonged condition without treatment is potentially fatal.”
Aside from human cost, the economic burden of the disease is expected to double before 2010, she said, adding that an investment in new strategies can prevent new infections and improve the treatment and health outcomes of those already infected.
The first annual Hepatitis Candlelight Vigil in Prince George will be held on May 1 at 7 p.m., at the Prince George New Hope Society, 1046 Fourth Ave. Refreshments provided. Phone 250-552-0890 for more information.
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April 26th, 2007
Idenix Pharmaceuticals Reports First Quarter Financial Results
http://www.earthtimes.org
Category : PressRelease
CAMBRIDGE, Mass., April 26 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. , a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases, today reported unaudited financial results for the first quarter ended March 31, 2007. At March 31, 2007, Idenix's cash, cash equivalents and marketable securities totaled $161.9 million.
For the first quarter ended March 31, 2007, Idenix reported total revenues of $24.8 million, compared with total revenues of $13.1 million in the first quarter of 2006. Total revenues for the first quarter of 2007 consist of reimbursement by Novartis Pharma AG of expenses incurred by Idenix in connection with the development of Idenix's product and product candidates, TYZEKA(R) (telbivudine) and valtorcitabine for the treatment of hepatitis B and valopicitabine (NM283) for the treatment of hepatitis C; the amortization of the up-front fees received by Idenix in connection with Novartis' license of telbivudine, valtorcitabine and valopicitabine; a regulatory milestone payment from Novartis; and product sales. Idenix reported a net loss of $11.6 million, or a loss of $0.21 per basic and diluted share, for the first quarter ended March 31, 2007, compared to a net loss of $17.2 million, or a loss of $0.31 per basic and diluted share, for the first quarter ended March 31, 2006. The increase in total revenue and decrease in net loss for the period ended March 31, 2007 compared to the same period in 2006 are primarily related to the recognition of a milestone payment for TYZEKA/SEBIVO(R) (telbivudine) from Novartis.
Business Highlights Accomplishments realized to date in 2007 include: * Telbivudine, which is marketed as TYZEKA in the United States and SEBIVO in the rest of the world, has now received regulatory approval in more than 15 countries around the world. In the first quarter of 2007, SEBIVO was approved in China, one of the largest hepatitis B markets, triggering a regulatory milestone payment from Novartis. In February, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of SEBIVO in Europe; a final decision from the European Commission is pending. Regulatory decisions are also pending in additional regions around the world. * In April, data was presented from two phase IIb studies of valopicitabine in combination with pegylated interferon in treatment- naive and treatment-refractory hepatitis C patients at the annual meeting of the European Association for the Study of the Liver (EASL). The company is now investigating the triple combination regimen of valopicitabine, pegylated interferon and ribavirin compared to standard of care (pegylated interferon and ribavirin) in a 12-week study. This study is fully enrolled with 117 patients dosed and, to date, there have been only three discontinuations. * In April, an electronic investigational new drug (eIND) application for IDX899, a non-nucleoside reverse transcriptase inhibitor (NNRTI) drug candidate for the treatment of HIV, was filed to support a phase I study in healthy volunteers.
"We are pleased with the speed at which regulatory approvals are being received for TYZEKA/SEBIVO around the world," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "As we work with our partner Novartis to successfully commercialize TYZEKA in the United States and prepare for the potential launch of SEBIVO in the European Union, we are also focused on defining a clear development path for valopicitabine and building our pipeline with novel hepatitis C and HIV drug candidates. We believe the filing of an eIND for IDX899 is yet another example of the strength of our comprehensive discovery program in producing next-generation antiviral therapeutics."
2007 Financial Guidance
The company continues to expect to end 2007 with between $100 million and $110 million of cash, cash equivalents and marketable securities. Included within this guidance are $20 million in regulatory approval milestone payments from Novartis Pharma AG related to TYZEKA/SEBIVO (telbivudine 600mg tablets), $10 million of which was received in April 2007. The remaining milestone payment is related to regulatory approval of telbivudine in the European Union, which the company anticipates receiving in the second quarter of this year.
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward- looking statements can be identified by the use of forward-looking terminology such as "will," "to be," "expect," "anticipates," "advance," "pending," "encouraging," "believe," or similar expressions and implied statements with respect to Idenix clinical development programs or commercialization activities in HIV, hepatitis B or C, or any potential pipeline candidates and expectations with respect to additional milestone payments and cash balances at the end of 2007. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees that Idenix will successfully commercialize TYZEKA or SEBIVO (telbivudine), advance any clinic product candidate or other component of our potential pipeline in the clinic or in the regulatory process. In particular, management's expectations could be affected by unsuccessful efforts to commercialize TYZEKA or SEBIVO; unexpected regulatory actions or delays; uncertainties relating to results of clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the company's dependence on its collaboration with Novartis Pharma AG; the ability of the company to attract and retain qualified personnel; competition in general; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for its other product candidates and its discoveries. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" in the company's annual report on Form 10-K for the year ended December 31, 2006 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company's expectations only as of the date of this release and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
IDENIX PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) (UNAUDITED) Three Months Ended March 31, 2007 2006 Revenues: Collaboration revenue - related party $24,351 $13,055 Product sales 425 - Government research grants 30 56 Total revenues 24,806 13,111 Operating expenses (1): Cost of sales 70 - Research and development 22,554 22,068 Selling, general and administrative 15,840 10,640 Total operating expenses 38,464 32,708 Loss from operations (13,658) (19,597) Investment income, net 1,978 2,135 Loss before income taxes (11,680) (17,462) Income tax benefit 111 280 Net loss $(11,569) $(17,182) Basic and diluted net loss per share: ($0.21) ($0.31) Shares used in calculation of basic and diluted net loss per share: 56,126 55,891 (1) Stock-based compensation expenses included in operating expenses amounted to approximately: Research and development $1,168 $766 Selling, general and administrative 1,237 1,362 IDENIX PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) (UNAUDITED) March 31, December 31, 2007 2006 ASSETS Cash and cash equivalents $61,370 $55,892 Marketable securities 57,390 71,251 Receivables from related party 22,605 12,035 Other current assets 7,963 8,427 Total current assets 149,328 147,605 Property and equipment, net 18,416 17,448 Marketable securities, non-current 43,092 59,208 Other assets 4,619 4,204 Total assets $215,455 $228,465 LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable and accrued expenses $23,319 $23,429 Deferred revenue, related party 10,796 13,490 Other current liabilities 564 527 Total current liabilities 34,679 37,446 Long-term obligations 7,483 8,523 Deferred revenue, related party, net of current position 40,484 40,471 Total liabilities 82,646 86,440 Stockholders' equity 132,809 142,025 Total liabilities and stockholders' equity $215,455 $228,465
Idenix Pharmaceuticals' Contacts:
Media: Teri Dahlman (617) 995-9905
Investors: Amy Sullivan (617) 995-9838
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April 27h, 2007
Celera Publishes Data Validating Cirrhosis Risk Score As a Predictor of Cirrhosis in Chronic Hepatitis C Patients
http://www.redorbit.com/
Celera (NYSE: CRA), an Applera Corporation business, today announced the publication of data from a research study validating its multi-gene Cirrhosis Risk Score (CRS) that predicts future risk of developing cirrhosis in patients with chronic hepatitis C (CHC). This paper is scheduled to appear in the August 2007 edition of Hepatology, published on behalf of the American Association for the Study of Liver Diseases, and is expected to be available on the publication's website at www3.interscience.wiley.com/cgi-bin/jhome/106570044. The lead author of this paper was Hongjin Huang, Ph.D., Associate Director, Liver Diseases, at Celera.
This research study demonstrates that a constellation of seven single nucleotide polymorphisms (SNPs) predicts the risk of cirrhosis in Caucasian patients with CHC, and may be a significantly better predictor than some of the presently known clinical risk factors, such as age, gender and alcohol consumption, in differentiating high risk versus low risk for cirrhosis.
"The Cirrhosis Risk Score offers a real opportunity to change the way in which we evaluate and select patients for anti-viral therapy," said Ramsey C. Cheung, M.D., Associate Professor of Medicine, Division of Gastroenterology and Hepatology at Stanford University, and co-author on this paper. "It fills an unmet need to stratify actual cirrhosis risk to determine the urgency of anti-viral therapy without using liver biopsy as a surrogate marker. Use of this information to select and treat the patients at higher risk for progression earlier may help prevent irreversible liver damage and improve cost-effectiveness. Patients will also benefit from knowing their risk."
"This study confirms that the genetic makeup of each patient is a critical factor in determining who is likely to develop cirrhosis," said Thomas J. White, Ph.D., Chief Scientific Officer at Celera, and a co-author on the paper. "These results may also enable more cost-effective and timely demonstration of the efficacy for antifibrotic therapies by enriching clinical trials with those individuals likely to progress more rapidly to cirrhosis."
The seven SNPs were identified and validated through multiple research studies conducted over five years involving 1,020 individuals infected with HCV, whose samples were tested for the presence of approximately 25,000 SNPs as part of a functional genome scan. SNPs identified as associated with risk for cirrhosis through initial studies, and that survived replication by testing with additional samples, were used to select the optimal combination of seven SNPs. A Cirrhosis Risk Score was calculated based on the seven-SNP constellation to estimate the risk of developing cirrhosis for each patient.
The source of SNPs for building the signature was derived from two initial research studies: a discovery study involving 537 subjects that was performed with collaborators at the University of California in San Francisco, and a replication study involving 483 subjects with collaborators at Virginia Commonwealth University. The resulting constellation was independently tested on 448 CHC subjects enrolled in studies at Stanford University, University of Illinois Chicago and California Pacific Medical Center. This validation sample set was not involved in selecting the SNPs or in building the CRS.
"This publication underscores the potential clinical value of Celera's genetic discoveries," said Kathy Ordoñez, President of Celera. "The genetic markers described in this paper have been licensed on a non-exclusive basis to Specialty Laboratories, which has developed, validated and commercialized a testing service, HCV Liver Fibrosis GenotypRTM, incorporating these findings. Celera also intends to seek review of an in vitro diagnostic product based on the CRS with the U.S. Food and Drug Administration and other applicable global regulatory agencies."
Celera is currently pursuing this program independently, outside its strategic alliance with Abbott.
About Cirrhosis and Hepatitis C infection
Hepatitis C virus is a very serious medical problem in the United States and throughout the world. Almost four million Americans are infected with the hepatitis C virus, of whom 2.7 million have chronic infection. If undetected and untreated, hepatitis C infections can lead to chronic liver disease and fibrosis, leading to cirrhosis and liver cancer. Hepatitis C infections are the second leading cause of liver cirrhosis and the leading indication for liver transplantation in the United States.1
Projections based on the current prevalence of infection and anticipated rates of progression raise concerns over the impact of HCV in the next 2 decades. A computer cohort simulation of the US population for 2010-2019 suggests that the morbidity and mortality associated with CHC will increase dramatically, resulting in 165,900 deaths from chronic liver disease, 27,200 deaths from hepatocellular carcinoma (HCC), and $10.7 billion in direct medical expenditures related to HCV2 by 2019.
For more information on the management of Hepatitis C patients, see for example http://digestive.niddk.nih.gov/ddiseases
/pubs/chronichepc/index.htm#H
About Applera Corporation and Celera
Applera Corporation consists of two operating groups. Celera is primarily a molecular diagnostics business that is using proprietary genomics and proteomics discovery platforms to identify and validate novel diagnostic markers, and is developing diagnostic products based on these markers as well as other known markers. Celera maintains a strategic alliance with Abbott for the development and commercialization of molecular, or nucleic acid-based, diagnostic products, and it is also developing new diagnostic products outside of this alliance. Through its genomics and proteomics research efforts, Celera is also discovering and validating therapeutic targets, and it is seeking strategic partnerships to develop therapeutic products based on these discovered targets. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries and develop new pharmaceuticals. Applied Biosystems' products also serve the needs of some markets outside of life science research, which we refer to as "applied markets," such as the fields of: human identity testing (forensic and paternity testing); biosecurity, which refers to products needed in response to the threat of biological terrorism and other malicious, accidental, and natural biological dangers; and quality and safety testing, for example in food and the environment. Applied Biosystems is headquartered in Foster City, CA, and reported sales of over $1.9 billion during fiscal 2006. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.applera.com, or by telephoning 800.762.6923. Information about Celera is available at www.celera.com .
About Specialty Laboratories
Specialty Laboratories supports local pathology and community-based medicine by partnering with pathologists and hospitals to improve patient care and reduce episodes-of-care costs. Specialty offers hospitals an extensive menu of highly advanced clinical tests used by physicians to diagnose, monitor and treat disease and a single-source solution for esoteric testing needs. Specialty's web address is www.specialtylabs.com. Specialty is a wholly owned subsidiary of AmeriPath, Inc.
About Ameripath, Inc.
AmeriPath, a leading national provider of physician-based anatomic pathology, dermatopathology and molecular diagnostic services to physicians, hospitals, clinical laboratories and surgery centers, supports community-based medicine by helping physicians provide excellent and effective care for their patients. AmeriPath's team of more than 400 highly trained, board-certified pathologists and Ph.D. level scientists provide medical diagnostics services in outpatient laboratories owned, operated and managed by AmeriPath, as well as in hospitals and ambulatory surgical centers. AmeriPath's Web address is www.ameripath.com .
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe,""plan," and "should," among others. These forward-looking statements are based on Applera Corporation's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to: (1) Celera's unproven ability to discover, develop, or commercialize proprietary diagnostic products; (2) the risk that studies or trials of products that Celera does discover and develop will not proceed as anticipated or may not be successful, or that such products will not receive required regulatory clearances or approvals; (3) the uncertainty that Celera's products will be accepted and adopted by the market, including the risk that these products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans; (4) legal, ethical, and social issues which could affect demand for Celera's products; and (5) other factors that might be described from time to time in Applera's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
Copyright 2007 Applera Corporation. All Rights Reserved. Celera and Applied Biosystems are registered trademarks, and Applera is a trademark of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries. GenotypR is a trademark of Specialty Laboratories.
1 http://www.cdc.gov/
2 AGA Technical review on the management of Hepatitis C (2006). Gastroenterology. 130: 231-264.
Source: Business Wire
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More UK gay men getting hepatitis C
http://www.gay.com
Gus Cairns
More gay men are getting hepatitis C through sex every year, the 13th BHIVA Conference heard in Edinburgh, Scotland.
Between 2002 and June 2006, there were 389 cases of recently acquired hepatitis C in HIV-positive gay men seen in 15 HIV clinics, said Dr. Murad Ruf of Britain's Health Protection Agency. The clinics serve 85 percent of London's HIV-positive population.
There were also six cases in HIV-negative men seen in London genito-urinary medicine clinics.
But whereas all but one of the HIV centers routinely monitors patients for raised liver function results, which are usually the best sign of hepatitis infection, only three of London's genito-urinary clinics routinely screen for hep C, so there could be more infections going undetected.
The number of hepatitis C cases has increased each year. There were 60 in 2002, 77 in 2003, 85 in 2004, 100 in 2005 and 67 in the first six months of 2006.
This means that hepatitis C infections are increasing by one-third more each year. The overall infection rate in HIV positive men was one infection per 110 clinic patients per year, but by 2006 this had gone up to one infection per 83 patients a year.
The agency's figures don't include information that might rule out other known causes for hepatitis C infection, such as injecting drugs, but Ruf said that as few gay men had other major risk factors for hepatitis C, most of it was probably being acquired sexually.
As hepatitis C is carried in blood rather than semen, the upsurge in hepatitis C cases has been blamed on fisting, something done by between one in 10 and one in 16 gay men last time the Gay Men's Sex Survey asked about it in 2002.
But Ruf told Gay.com, "It could be any kind of sex where there's trauma to the mucous membranes -- rough sex, basically."
We don't know if there's something about having HIV that also makes you more susceptible to hepatitis C, but Ruf pointed out that 85 percent of cases of lymphogranuloma venereum seen since 2002 were in HIV-positive men and 44 percent of the syphilis cases seen since 1999.
A study is under way at a clinic in central London to look at cases of hepatitis C in HIV-negative gay men.
A study from Brighton's genito-urinary clinic last year found five cases of hepatitis C in HIV-negative men, 16 in pos men, and four in men who were untested.
The clinic found that men with HIV were 13 times more likely to get hepatitis C than negative men -- but HIV-negative men were getting it, too.
Once you'd gotten hepatitis C, however, it was a really strong predictor that you were likely to get HIV soon as well, showing that the risk factors are similar.
In one London clinic, at St Mary's Hospital in Paddington, 10 of a group of 155 gay men who had become recently infected with HIV went on to get hepatitis C, too. The average length of time between becoming HIV-positive and hep C-positive was 17 months.
Five of the 10 had symptoms of acute hepatitis and seven had raised liver function tests, but three of the infections would have been missed altogether without careful monitoring for hepatitis C antibodies.
Interestingly, around the time of hepatitis C infection patients had significant rises in their HIV viral load, showing that the two viruses may have an effect on each other.
In a study of hepatitis C treatment at the Chelsea and Westminster Hospital, two-thirds of gay men with recently-acquired hepatitis C responded to treatment with pegylated interferon and ribavirin and were effectively cured -- but five patients went on to get second hepatitis C infections.
Out of 118 patients, 14 percent spontaneously cleared their hepatitis C. Of those offered treatment, three-quarters accepted it.
At north London's Royal Free Hospital, a better cure rate was observed, with 77 percent of recently infected gay men who took hepatitis C treatment responding to it.
Hepatitis C treatment is hard to tolerate.
In the Chelsea and Westminster study, 30 percent of patients complained of psychiatric side effects like depression, and 11 percent stopped their treatment because of them. (Gus Cairns, Gay.com U.K.)
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Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Rebetol
http://www.pharmalive.com
International Nonproprietary Name (INN): ribavirin
LONDON, April 26, 2007-On 26 April 2007 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion** to recommend the variation to the terms of the marketing authorisation for the medicinal product Rebetol. The Marketing Authorisation Holder for this medicinal product is Schering-Plough Europe.
The CHMP adopted a new indication as follows:
Naïve patients
Adult patients: Rebetol is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA, including patients with clinically stable HIV co-infection (see section 4.4).
For information the full indication for Rebetol will be as follows:
Rebetol is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa-2b (adults) or interferon alfa-2b (adults, children (3-years of age or older), and adolescents). Rebetol monotherapy must not be used.
There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i.e., not alfa-2b), or on the use of Rebetol with peginterferon alfa-2b in children or adolescents.
Please refer also to the peginterferon alfa-2b or interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.
Naïve patients
Adult patients: Rebetol is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA (see section 4.4). Additionally, Rebetol is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA, including patients with clinically stable HIV co-infection (see section 4.4).
Relapse patients
Adult patients: Rebetol is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed. Additionally, Rebetol is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have
- Summaries of positive opinion are published without prejudice to the Commission Decision, which will normally be issued within 44 days (Type II variations) and 67 days (Annex II applications) from adoption of the Opinion.
- ** Marketing Authorisation Holders may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.
- previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed(see section 4.4).
The CHMP adopted a new contraindication as follows:
- Initiation of peginterferon alfa-2b is contraindicated in HCV/HIV patients with cirrhosis and a Child-Pugh score > 6.
For information, the full contraindication for Rebetol will be as follows:
- Hypersensitivity to the active substance or to any of the excipients.
- Pregnant women (see sections 4.4, 4.6 and 5.3). Rebetol must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
- Women who are breast-feeding.
- A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months (see section 4.4).
- Severe, debilitating medical conditions, including patients with chronic renal failure, patients with creatinine clearance < 50 ml/minute and/or on haemodialysis.
- Severe hepatic dysfunction or decompensated cirrhosis of the liver.
- Haemoglobinopathies (e.g., thalassemia, sickle-cell anaemia).
- Initiation of peginterferon alfa-2b is contraindicated in HCV/HIV patients with cirrhosis and a Child-Pugh score > 6.
Because of co-administration with peginterferon alfa-2b or interferon alfa-2b:
- Autoimmune hepatitis; or history of autoimmune disease.
Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
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Upping the Ante: SLU Liver Center Leads Record Number of Hep C Research Protocols
http://www.slu.edu
ST. LOUIS -- While many research institutions are suffering from funding cuts, Drs. Bruce R. Bacon and Adrian M. Di Bisceglie are chugging away with their usual tenacity.
As co-directors of the Saint Louis University Liver Center, Bacon and Di Bisceglie are overseeing one of the biggest influxes of research dollars in their tenure as SLU hepatologists - totaling more than $1 million.
All of the research protocols have one thing in common: They're investigating new ways to treat -- and hopefully cure -- hepatitis C, called the "silent killer" because patients display no outward symptoms, allowing the disease to worsen over time, eventually leading to cirrhosis and premature death.
"It's gratifying to have so many trials available to our patients all at once. We hope to contribute to the effective treatment of the millions of people who have hepatitis C," Bacon says. "It demonstrates how important it is for us to find more effective therapies for this difficult disease."
There are currently more than 25 research protocols for treatment of patients with chronic hepatitis C going on at SLU Liver Center, ranging from treatments for "naive" patients, or those who have never received medications for their disease; for non-responders, or those who have tried other forms of therapy with no success; for partial responders and for relapsers.
The Liver Center has research protocols testing protease inhibitors, polymerase inhibitors, immunomodulatory drugs, new interferons, vaccines and new dosing schedules for currently available treatments.
The sheer number of research protocols under way makes it clear to Bacon and Di Bisceglie, two of the world's leading experts in liver disease, that their team has been entrusted as the leading site in St. Louis to continue the fight against hepatitis C.
A blood-borne disease, hepatitis C affects about 5 million Americans, making it five to six times more widespread than HIV. It's estimated that 40,000 people in the St. Louis area are infected with the virus. Saint Louis University School of Medicine is home to the nationally recognized center for the research and treatment of these diseases.
Bacon and Di Bisceglie see the greatest promise in protease inhibitors and polymerase inhibitors, newly developed drugs which are designed to work with the existing combination of pegylated interferon plus ribavirin used to treat hepatitis C. For more information on the ongoing or upcoming hepatitis C trials, please contact the GI/Hepatology Clinical Research Unit at 314-977-9400.
SLUCare is the physician practice of Saint Louis University School of Medicine. Doctors can be reached by calling 314-977-4440 or 1-866-977-4440.
SLUCare consists of physicians, nurse practitioners, medical assistants and related professionals who provide high-quality care for patients locally, regionally and nationally. SLUCare is the only academic medical practice in St. Louis fully accredited by the Accreditation Association for Ambulatory Health Care Inc. This accreditation is a voluntary process through which the quality of SLUCare services and performance is measured against nationally recognized standards. More information is available at www.slucare.edu.
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