November 30, 2010

The World's Illuminated in Red for World AIDS Day

By Shyla Batliwalla
Tuesday, November 30, 2010 6:05 PM ET

Eighty monuments around the world will turn red in support of the (RED) campaign's 2015 goal to have zero children born infected with HIV.

There are currently over 33 million people worldwide living with AIDS. In 2009, nearly half a million babies were born HIV positive; 90 percent of those babies were in Africa. While these statistics might seem grim, there is hope. With proper treatment, spreading HIV to an unborn baby is 99 percent preventable.

Wednesday, Nov. 1 is World AIDS Day. Governments around the world are gearing up to show their support and commitment to ending the AIDS pandemic. In honor of the ongoing fight, over one dozen countries will light up 80 of the most famous landmarks on the planet to promote awareness.

This global movement is sponsored by (RED), an organization that brings together key international corporations to raise funds for HIV/AIDS prevention programs in Africa. Brands like Nike, Starbucks, Gap, American Express and Armani create and sell products exclusively for the (RED) campaign. Fifty percent of the proceeds generated from sales are donated directly to (RED).

Since its inception in 2006, (RED) has generated over $150 million towards the fight against AIDS. The World AIDS day campaign underlines their achievable goal to end mother-to-child transmission of HIV by 2015. When this goal is realized, the first AIDS free generation in 30 years will be created.

As evening sets in Sydney, Australia, the iconic Opera House will be illuminated in red with U2's Bono kicking off the campaign. Time zone by time zone, similarly significant attractions will turn red for just one night. From Table Mountain in South Africa and the London Eye in London to the Empire State Building in New York and LAX in LA, on Wednesday the world will see red as a symbol of hope that an end to the fight against AIDS is near.

(RED) CEO Susan Ellis said, "This is a time of great hope and promise in the battle against AIDS, because we are on the verge of ensuring that virtually no child will come into the world carrying the burden of HIV. Our World AIDS Day awareness campaign, 'The AIDS Free Generation is Due in 2015' is a reminder to everyone that we must work together to overcome the financial challenges at this critical juncture and to keep the world focused on this issue and this achievable goal."

Show your solidarity on Global AIDS day by using Twitter, Facebook, FourSquare and MeetUp to send images and words of support. (RED) will be collecting the data on a map to show how the world is united in the fight against AIDS. With enough support, (RED)'s goal to have zero children born with HIV in 2015 will become a reality.


Study finds anti-microbials a common cause of drug-induced liver injury and failure

Public release date: 30-Nov-2010

Contact: Dawn Peters

Disproportionate number of women and minorities affected

New research shows that anti-microbial medications are a common cause of drug-induced liver injury (DILI) leading to acute liver failure (ALF), with women and minorities disproportionately affected. While ALF evolves slowly, once it does occur a spontaneous recovery is unlikely; however liver transplantation offers an excellent survival rate. Full findings of this ten-year prospective study are published in the December issue of Hepatology, a journal of the American Association for the Study of Liver Diseases.

Patients with liver failure resulting from DILI may experience deep jaundice, fluid retention, advanced coagulopathy and coma. More than 1100 drugs, herbal remedies, natural products, vitamins, minerals, dietary supplements, and recreational and illicit compounds are known to cause liver injury, which reportedly affect 1 in 100,000 to 1 in 10,000 patients. Prior research shows DILI is a frequent cause of hepatitis, and accounts for 5%-10% of hospitalizations for jaundice and 12% of all cases of ALF (excluding acetaminophen).

In the current study, researchers investigated liver injury and failure caused by drugs other than acetaminophen. Detailed case reports were collected from 1,198 subjects with ALF enrolled at 23 sites participating in the National Institutes of Health-funded Acute Liver Failure Study Group, led by Principal Investigator, William M. Lee, M.D., from the University of Texas Southwestern Medical Center in Dallas, TX. Researchers identified 133 patients with DILI with 71% of those cases in women.

"Our findings confirm prior medical evidence that found a high female predominance in DILI ALF, suggesting that women may be more susceptible to liver injury or use more prescription drugs than men," said Dr. Adrian Reuben, Professor of Medicine at the Medical University of South Carolina and lead study author.

Furthermore, the research team documented a disproportionately high number of minorities with DILI ALF, including African-American (16%), Hispanic (15%) and other minority groups (12%). "We observed inexplicably high numbers of minority patients with DILI ALF. This racial disparity is atypical for acetaminophen-induced ALF in the U.S. and further studies should explore this discrepancy," commented Dr. Reuben.

Researchers identified 61 different agents that, alone or in combination, could cause liver injury and failure in the study population. Anti-microbial agents were found to be the most common cause of DILI ALF cases and included anti-tuberculosis drugs (25), sulphur-containing drugs (12), nitrofurantoin (12), other antibiotics (7), antifungal agents (6), and anti-retroviral drugs (4). Patients who develop ALF after taking these drugs typically do not experience a spontaneous recovery—the transplant-free survival rate in this study was 27%.

There were 56 eligible subjects who underwent liver transplantation of whom all but four survived, giving an overall survival for the entire cohort 66.2%. The authors highlight that the 23.3% of transplantation waitlist deaths attest to the urgent need for donor organs in this setting. "Liver transplantation offers excellent survival for ALF patients, however further investigation should include more detail on drug use duration, and the impact of alcohol use and diabetes, to provide additional understanding of idiosyncratic drug-induced liver injury and failure," Dr. Reuben concluded.


Article: "Drug-Induced Acute Liver Failure: Results of a United States Multicenter, Prospective Study." Adrian Reuben, David G. Koch, William M. Lee and the Acute Liver Failure Study Group. Hepatology; Published Online: October 14, 2010 (DOI: 10.1002/hep.23937); Print Issue Date: December 2010.

This study is published in Hepatology. Media wishing to receive a PDF of this article may contact

About the Journal

Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit

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Mymetics HIV Vaccine Shows Strong Preliminary Phase I Data


Nov. 30, 2010, 8:10 a.m. EST

HIV-1 Vaccine Designed to Block Early Transmission and Infection Events, Preventing Virus From Settling and Spreading Within the Body; In Phase I Trial, Vaccine Generated Both Serum Antibodies and Mucosal Antibodies in the Genital and Intestinal Tracts

EPALINGES, SWITZERLAND, Nov 30, 2010 (MARKETWIRE via COMTEX) -- Mymetics Corporation /quotes/comstock/11k!mymx (MYMX 0.13, +0.01, +8.33%) , a pioneer in the development of vaccines preventing mucosal transmission of human infectious diseases, announced today strong preliminary results of a Phase I trial on its promising HIV vaccine, MYMV101. Unlike most current vaccines, seeking to eliminate pathogens once they have already entered the bloodstream, Mymetics' vaccines are designed to block early transmission and infection events, preventing virus from settling and spreading within the body. This represents a highly promising but, until now, poorly investigated approach to preventing HIV infection.

The Phase I trial was conducted on 24 healthy women. The vaccine was well tolerated and immunogenic in both low and high dose vaccinated groups. The majority of volunteers developed not only serum antibodies but also mucosal antibodies in the genital and intestinal tracts.

"These new results represent a major achievement for Mymetics," commented Sylvain Fleury, CSO of Mymetics. "Very few HIV vaccine candidates developed over the last 25 years could elicit both blood and mucosal antibodies as a front-line defense mechanism against the entry of HIV-1 across mucosal tissues."

Jacques-Francois Martin, CEO of Mymetics, added, "Our vaccine represents a first line of defense before the virus can settle in the tissue and spread within the body. These preliminary Phase I results in HIV-1/AIDS represent an important validation of our pioneering work and approach. They also confirm a previous preclinical study where the vaccine provided unprecedented 100% protection in primates."

The Phase I trial, started in December 2009, is a placebo-controlled, double-blind, single-site study, conducted by Prof. G. Leroux-Roels at the Center for Vaccinology (CEVAC) at the University of Ghent (Belgium), under the supervision of Kinesis-Pharma, a CRO under contract with Mymetics. During the vaccination, women received high or low dose vaccinations. The first two injections were performed intra-muscularly and the last two via intra-nasal spray. The final clinical report is expected in January 2011, which will then also include the analysis of the neutralizing characteristics of the antibodies.

HIV-1, the virus that causes AIDS, is primarily transmitted through sexual contact, exposing the mucosal tissues of the genital organs as the first entry door for the virus before it reaches the blood. HIV-1 infected about 2.7 million new people in 2008, while an estimated 2 million people died of AIDS in the same year. HIV-1-related illness remains one of the leading causes of death globally and is projected to remain a significant cause of premature mortality in the coming decades.

Mymetics' vaccine strategy The vast majority of pathogens enter their target hosts through mucosal surfaces such as the respiratory, genito-urinary or gastrointestinal tracts. Once they have reached the blood, pathogens can migrate to various organs where they replicate. Most current vaccines seek to eliminate pathogens once they have already entered the bloodstream, by which time control of the pathogen can be significantly more challenging (e.g. HIV-1). Classical vaccines work by inducing mostly blood antibodies (mainly IgG) and are poor at triggering the antibodies that predominate in all mucosal tissues (mainly IgA).

Mymetics has created a vaccine against HIV-1, using its virosome technology and judicious antigen design. The vaccine primarily induces mucosal antibodies, preventing HIV-1 attachment to epithelial cells and providing an efficient first line of defense on mucosal surface such as the genital tract. The vaccine also induces blood antibodies, which will ideally function as a complementary second line of defense. By minimizing homology between the vaccine and native human proteins, Mymetics further aims to avoid auto-immune complications resulting from cross-reactivity.

About CEVAC The Center for Vaccinology (CEVAC) is an academic research unit affiliated with Ghent University and located in the Ghent University Hospital (Ghent, Belgium), and that provides a wide array of services to the biotech industry and vaccine manufacturers. CEVAC conducts Phase I, II and III clinical vaccine trials according to ICH-GCP standards and offers a panel of laboratory services in the field of immunology and vaccinology, such as serological tests, cytokine measurements, B and T lymphocyte detection and function assays. More information can be retrieved at

About Kinesis Kinesis Pharma B.V. (founded 1997) is an independent, privately owned drug development consultancy and contract research organization. Kinesis operates internationally with headquarters in Breda (The Netherlands) and a regional office in Singapore. The organization leverages the expertise and experience of its highly-skilled, multi-disciplinary workforce to accelerate drug development. Kinesis Pharma facilitates fast and high quality development and registration of medicinal products with consultancy services in Chemistry, Manufacturing and Control- (CMC), non-clinical- and clinical development and regulatory support. Kinesis operates in close collaboration with pharmaceutical, nutraceutical and biotech companies and has successfully managed the development and registration of pharmaceutical and biotechnology-derived products in different therapeutic areas, including infectious diseases.

About Mymetics Mymetics Corporation is a Swiss-based biotechnology company registered in the US /quotes/comstock/11k!mymx (MYMX 0.13, +0.01, +8.33%) developing next-generation preventative vaccines for infectious diseases. Mymetics' core technology and expertise are centered on the use of virosomes, lipid-based carriers containing functional fusion viral proteins, in combination with rationally designed antigens. The company's vaccines are designed to induce protection against early transmission and infection, focusing on the mucosal immune response as a first-line defense, which for some pathogens may be essential for the development of an effective vaccine. Mymetics is led by an experienced, international management team and is supported by a strong Scientific Advisory Board composed of renowned experts. The company has established contacts with world leaders in vaccine development.

Mymetics currently has 5 vaccines in its pipeline: HIV-1/AIDS, Influenza, Respiratory Syncytial Virus, Malaria and Herpes Simplex Virus. The company's HIV vaccine is entering a new proof-of-concept preclinical trial following unprecedented results in a first study, and is completing a Phase I clinical trial in human volunteers. A Phase 1b clinical trial for its Malaria vaccine on children in Tanzania has been completed, while RSV and HSV vaccine candidates are in the preclinical phase. The Influenza vaccine has been out-licensed to Solvay Pharmaceuticals (now Abbott). For further information, please visit

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The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements, which are identified by the words "believe," "expect," "anticipate," "intend," "plan" and similar expressions. The statements contained herein which are not based on historical facts are forward-looking statements that involve known and unknown risks and uncertainties that could significantly affect our actual results, performance or achievements in the future and, accordingly, such actual results, performance or achievements may materially differ from those expressed or implied in any forward-looking statements made by or on our behalf. These risks and uncertainties include, but are not limited to, risks associated with our ability to successfully develop and protect our intellectual property, our ability to raise additional capital to fund future operations and compliance with applicable laws and changes in such laws and the administration of such laws. See Mymetics' most recent Form 10-K for a discussion of such risks, uncertainties and other factors. Readers are cautioned not to place undue reliance on these forward- looking statements which speak only as of the date the statements were made.Contact:

Ronald Kempers
Mymetics Corporation
Tel: +41 21 653 4535

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Linnden Communications
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On Eve of World AIDS Day, UNICEF Report Says Virtual Elimination of Pediatric HIV/AIDS Appears Within Reach

WASHINGTON, Nov. 30, 2010 /PRNewswire-USNewswire/ -- As the world prepares to commemorate World AIDS Day on December 1, UNICEF released their report, "Unite for Children, Unite Against AIDS," declaring that the achievable goal of eliminating HIV infections in children is the new global measure of success in the fight against pediatric AIDS.

Children and AIDS: Fifth Stocktaking Report, 2010 offers key insights into the changing landscape of HIV/AIDS prevention, care, and treatment for children, and documents that those on the frontlines of the epidemic have turned a significant corner in scaling-up prevention of mother-to-child transmission (PMTCT) of HIV services worldwide.

"The momentum of the global health community behind the elimination of pediatric HIV and AIDS should be applauded," said Charles Lyons, President and CEO of the Elizabeth Glaser Pediatric AIDS Foundation. "We must build on our success, scale-up what we know works, and encourage new innovations to overcome even the greatest of obstacles."

The UNICEF report highlighted that while overall progress is real and should be recognized, many challenges remain. Although a majority of HIV-positive pregnant women in low- and middle-income countries are receiving antiretroviral (ARV) drugs to prevent transmission of the virus to their infants, the report suggests that all pregnant women living with HIV must have access to the more complex drug regimens called for under the new World Health Organization (WHO) guidelines for PMTCT. Implementing and sustaining these benefits worldwide will require full integration of PMTCT services within national maternal and child health programs.

The report also cites significant gains in PMTCT coverage, but also notes that only one-third of infants born to HIV-positive mothers receive ARVs to prevent transmission, increasing only slightly from 2008. Significant improvements are needed for mothers and mother-baby pairs to ensure that services continue during breastfeeding, all babies are tested early for HIV, and every HIV-infected infant get onto therapy as soon as possible.

Pioneering solutions must also be employed to better engage communities and create demand for these services and ensure that women and babies remain in care. While the goal is to have every woman deliver in a health facility, obstacles such as severe weather or lengthy travel distances often result in women delivering their babies at home. As a way to overcome some of these issues, the Elizabeth Glaser Pediatric AIDS Foundation joined with UNICEF last month to launch the Mother Baby Pack (MBP). Created to tackle logistical challenges in delivering critical medicines to pregnant mothers and their newborn babies, the MBP is given to mothers during their first prenatal visit, and contains the antiretroviral drugs (ARVs) and prophylactic antibiotics needed to prevent HIV transmission from mother to baby.

"There are still more than 1,000 babies newly infected with HIV every day. Virtually every one of those infections is preventable," said Lyons. "Reaching mothers and babies around the world with the services they need to prevent the spread of HIV is not only the right thing to do, it will also help us realize a generation born free of HIV."

About the Foundation:

The Foundation is a global leader in the fight against pediatric HIV and AIDS, and has reached nearly 10 million women with services to prevent transmission of HIV to their babies. It works at 5,000 sites in 17 countries to implement prevention, care, and treatment services; to further advance innovative research; and to execute strategic and targeted global advocacy activities in order to bring dramatic change to the lives of millions of women, children, and families worldwide.

SOURCE Elizabeth Glaser Pediatric AIDS Foundation



Walgreens and Greater Than AIDS Mark World AIDS Day with Commitment to Outreach, Education and Accessibility


Nov. 30, 2010, 11:00 a.m. EST

More than 800 Walgreens pharmacists specially trained to help patients living with HIV/AIDS

DEERFIELD, Ill., Nov 30, 2010 (BUSINESS WIRE) -- Walgreens (NYSE, NASDAQ: WAG) is marking World AIDS Day with an increased commitment to HIV/AIDS outreach, education and accessibility by partnering with Greater Than AIDS, a national movement that brings together the public and private sectors in response to the HIV/AIDS crisis in the United States.

On Dec. 1, World AIDS Day, Walgreens will kick off its collaboration with Greater Than AIDS by streaming HIV messaging on the Walgreens digital board that rises 341 feet above midtown Manhattan in New York's Times Square. In addition, more than 200 Walgreens drugstores in heavily-affected communities across America are debuting new signage and informational materials that carry a Greater Than AIDS message. All materials encourage customers to learn more about HIV and ways they can be Greater than AIDS by going to In June 2011, Walgreens will team up with Greater Than AIDS to support "HIV Take Action" Month with special promotions, and participating Walgreens pharmacies will offer in-store services -- including HIV testing. And throughout the year, Walgreens digital billboards in Times Square and Las Vegas will post photos submitted by every day Americans that celebrate personal "deciding moments" in response to HIV/AIDS.

"Pharmacists are some of the most trusted health care professionals in the nation," said Walgreens president of pharmacy services Kermit Crawford. "It's our job to not only provide information about medication options but to also listen to patient needs. Our pharmacy staff will help play a large role in our effort with Greater Than AIDS to promote HIV/AIDS awareness and prevention, especially among African Americans and other disproportionately affected groups."

"What is particularly powerful about the partnership between Greater Than AIDS and Walgreens is that it brings HIV information to people where they live, along with other health issues," said Drew Altman, Ph.D., president and CEO of the Kaiser Family Foundation, which provides direction to Greater Than AIDS.. "Walgreens is setting a powerful example of corporate leadership by putting its brand and vast retail footprint behind an issue of such public health importance."

More than 800 Walgreens pharmacists at retail and medical facility locations across the country and call centers are specially trained to help patients living with HIV/AIDS. Over the next year, Walgreens plans to add another 150 locations that offer special HIV/AIDS services. Online, patients can find more HIV/AIDS information regarding treatment, medications and support services at

Last May, Walgreens joined the Global Business Coalition (GBC) on HIV/AIDS, Tuberculosis and Malaria, bringing its experience as a trusted pharmacy, health and wellness provider to the leading business movement on global health. GBC brings together businesses across various sectors to help fight global epidemics. As a resource for those impacted by HIV/AIDS, Walgreens is actively driving awareness around medication adherence, sensitivity and support through local outreach from its network of more than 7,600 community pharmacies and partnerships with local organizations across the country.

About Walgreens

Walgreens ( is the nation's largest drugstore chain with fiscal 2010 sales of $67 billion. The company operates 7,608 drugstores in all 50 states, the District of Columbia and Puerto Rico. Each day, Walgreens provides nearly 6 million customers the most convenient, multichannel access to consumer goods and services and trusted, cost-effective pharmacy, health and wellness services and advice in communities across America. Walgreens scope of pharmacy services includes retail, specialty, infusion, medical facility and mail service, along with pharmacy benefit solutions and respiratory services. These services improve health outcomes and lower costs for payers including employers, managed care organizations, health systems, pharmacy benefit managers and the public sector. Walgreens Take Care Health Systems subsidiary is the largest and most comprehensive manager of worksite health centers and in-store convenient care clinics, with more than 700 locations throughout the country.

About Greater Than AIDS

Greater Than AIDS ( is an unprecedented collaboration among a broad coalition of public and private sector partners united in response to the HIV/AIDS crisis in the United States, in particular among Black Americans and other disproportionately affected groups. Through a national media campaign and targeted community outreach, Greater Than AIDS aims to increase knowledge and understanding about HIV/AIDS and confront the stigma surrounding the disease.

SOURCE: Walgreens

Vivika Vergara, (847) 914-2923


Pharmasset Initiates Dosing in a Combination Study of PSI-7977 and PSI-938 for Chronic Hepatitis C

- Phase 1 combination study of a pyrimidine (PSI-7977) and purine (PSI-938) nucleotide analog in patients with chronic hepatitis C

- Interim data expected in first quarter of 2011

PRINCETON, N.J., Nov. 30, 2010 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that dosing has begun in Part 2 of a Phase 1 study. This is the first clinical study combining a purine (PSI-938) and a pyrimidine (PSI-7977) nucleotide analog for HCV, and is designed to evaluate once daily doses of PSI-7977 and PSI-938 in patients with HCV who have not been treated previously.

"We are excited to be initiating this combination study with two proprietary nucleotide analogs for HCV," stated Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "Based on our in vitro data, we believe the combination of two nucleotide analogs could provide potent antiviral activity across multiple HCV genotypes and could also have a higher barrier to resistance compared to other DAA combinations. We believe nucleotide analogs have a number of key attributes that may make them ideal partners for other DAA combinations, in addition to a 'nuc-nuc' combination."

About the Phase 1 Trial

In Part 1 of the Phase 1 multiple ascending dose study of PSI-938, suppression of HCV RNA below the limit of detection (LOD, <15 IU/mL) was observed in over half of the patients who received PSI-938 at daily doses of 200 mg or 300 mg for seven days. Part 2 of the study is designed to evaluate the combination of PSI-938 and PSI-7977. The primary objective is to assess the safety, tolerability and pharmacokinetics of PSI-938 administered alone for 14 days, and in combination with PSI-7977 for 7 to 14 days. The secondary objective is to evaluate viral kinetics of HCV RNA during monotherapy and combination nucleotide dosing. Approximately forty patients are expected to be enrolled into four cohorts as follows:

• PSI-938 QD administered as monotherapy for 14 days, followed by;

• PSI-938 QD for 7 days followed by PSI-938 plus PSI-7977 QD for 7 days and

• PSI-7977 QD for 7 days followed by PSI-938 plus PSI-7977 QD for 7 days, followed by;

• PSI-938 plus PSI-7977 QD for 14 days

We expect to report preliminary results from Part 2 of this Phase 1 study during the first quarter of calendar year 2011. We also expect to initiate a Phase 2 study of PSI-938 in combination with PSI-7977 during mid-2011. This Phase 2 study proposes to explore durations of PSI-938 and PSI-7977 in interferon-free combinations with an SVR endpoint.

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have four clinical-stage product candidates. RG7128, a cytosine nucleoside analog for chronic HCV infection, is in two Phase 2b clinical studies in combination with Pegasys(R) plus Copegus(R) and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys(R) and Copegus(R) to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage HCV candidates include PSI-7977, an unpartnered uracil nucleotide analog that has recently initiated dosing in a Phase 2b study in patients with HCV genotypes 1, 2, or 3, and PSI-938, an unpartnered guanosine nucleotide analog which recently completed a 7-day monotherapy study. We also have in our pipeline an additional purine nucleotide analog, PSI-661, in advanced preclinical development.

Pegasys(R) and Copegus(R) are registered trademarks of Roche.

Richard E. T. Smith, Ph.D.
VP, Investor Relations and Corporate Communications
Office +1 (609) 613-4181

Forward-Looking Statements

Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.

SOURCE Pharmasset, Inc.



Research Shows Small Percentage Of Healthcare Professionals Still Reusing Syringes, Performing Injections In Ways That Put Patients At Risk

Article Date: 30 Nov 2010 - 2:00 PST

Although the majority of U.S. healthcare professionals are following recommended safe injection practices, some are putting patients at risk through the reuse of syringes and single-dose vials, according to a peer-reviewed study authored by the Premier healthcare alliance in December's American Journal of Infection Control.

Increasing reports of outbreaks of hepatitis B and C viruses and bacterial infections - more than 50 outbreaks nationwide - have resulted in infections in hundreds of patients and more than 100,000 have potentially been exposed. The majority of these outbreaks resulted from unsafe injection practices and lapses in basic infection control and aseptic technique.

Premier surveyed 5,500 U.S. healthcare professionals to gain a fuller understanding of current injection practice patterns and to guide outreach, education and prevention efforts. Results showed that:

-- Six percent, or 318, "sometimes or always" use single-dose/single-use vials on more than one patient;

-- Nearly 1 percent, or 45, "sometimes or always" reuse a syringe, only changing the needle for use on a second patient; and

-- Fifteen percent, or 797, reported reuse of a syringe to enter a multi-dose vial.

- Of this group, 6.5 percent, or 51, reported saving vials for use on another patient, representing approximately 1 percent of all respondents.

- Half of the 51 reported working in hospital settings, and the other half reported working in non-hospital settings such as ambulatory surgical centers and physician offices.

Dr. Joseph Perz of the Centers for Disease Control and Prevention (CDC) said, "The survey revealed that a dangerous minority of providers engage in unsafe practices such as syringe reuse. This is not acceptable. Safe practice is not optional; it's a basic expectation anywhere injections are delivered."

CDC guidelines recommend that single-dose vials should not be used for multiple patients. The guidelines also recommend syringes and needles should be used only once, not reused for another patient or to access a medication or solution that might be used for a subsequent patient.

For example, when a syringe is reused to draw up additional medication for a single patient, the medication vial becomes contaminated. Any subsequent use of either the syringe or the vial on another patient places that second patient at risk of infection.

Premier's study confirms that confusion regarding labeling of medication vials, lack of awareness and education about safe practices, and mistaken beliefs about the risks associated with syringe reuse all contribute to the problem

"Reducing risk to patients from unsafe injection practices will require surveillance, oversight, enforcement, and provider and patient education," said Gina Pugliese RN, MS, vice president of the Premier Safety Institute® and co-author of the study. "Most important will be the safety culture of the organization to empower patients to speak up and healthcare professionals to take responsibility for preventing colleagues from engaging in unsafe practices."
Premier also recommends reducing risks through partnerships among professional, governmental and non-governmental organizations with a focus on the redesign of devices, products and processes.
Evelyn McKnight was one of 99 patients who became infected with the hepatitis C virus at an oncology clinic in Fremont, Neb.

"I was infected during chemotherapy for breast cancer due to healthcare professionals not following safe injection practices," said McKnight, president and co-founder of the Hepatitis Outbreaks National Organization for Reform (HONOReform), a national advocacy organization dedicated to safe medical injections for patients. "This survey sheds light on the extent of unsafe practices and the need for a collaborative effort to solve this problem."

HONOReform and Premier are members of the Safe Injection Practices Coalition (SIPC), a collaborative partnership of healthcare-related organizations that promote safe injection practices in all U.S. healthcare settings. SIPC developed the One & Only Campaign, a public health education and awareness program aimed at educating healthcare providers and patients about safe injection practices. A free educational video for healthcare providers, developed by SIPC, is also available from Premier.

Organizations which shared this survey with their members: American Academy of Anesthesiologist Assistants; Accreditation Association for Ambulatory Health Care; American Association of Critical-Care Nurses; American Society of Health-System Pharmacists; Association for Professionals in Infection Control and Epidemiology; Infusion Nurses Society; Pittsburgh Regional Health Initiative; Society for Healthcare Epidemiology of America; Society of Gastroenterology Nurses and Associates; and Innovatix.

Source: Premier healthcare alliance


Caleco Pharma Corp. Files Amendment To EU Patent Office Application


Nov. 30, 2010, 9:04 a.m. EST

Amendments Strengthens Proposed Claims Relating to Compounds Exhibiting Anti-Viral Activity

LONG VALLEY, NEW JERSEY, Nov 30, 2010 (MARKETWIRE via COMTEX) -- Caleco Pharma Corp. ("Caleco") /quotes/comstock/11k!caeh (CAEH 0.06, -0.02, -20.00%) (frankfurt:T3R)(wkn:A0N9Y0) (, a diversified healthcare company with biopharmaceutical and consumer health product development programs that develop products derived from natural sources such as plant extracts, today reports that it has amended its intellectual property (IP) filing with the European Patent Office in The Hague to further secure and strengthen Caleco's anti-viral pipeline.

In response to the EU Patent Office's Examination Report, Caleco reports that the company's European Patent Application number 08725530.3 is amended with regard to compositions comprising derivatives and derivative combinations of Lamiridosin and Iridoid for treatment of Hepatitis C. The molecular specifications required in these amendments resulted in the exclusion of certain derivative claims. However, these claims will not be abandoned, but instead, these claims will be pursued through one or more divisional applications.

John Boschert, Caleco's CEO, said, "By amending our filing we are seeking to solidify our intellectual property position in the billion dollar Hepatitis C and anti-viral marketplace. We plan to continue to pursue a broader pipeline of semi-synthetic derivatives that will be prepared for further testing in 2011. The Hepatitis C patient population remains greatly underserved by existing treatment options and we are eager to move these compounds into the next stage of development."

About Caleco Pharma Corp.

Caleco is focused on the ongoing research and development of its pipeline of over-the-counter and prescription medications including its proprietary antiviral and "Liver Health" OTC formulations. In addition Caleco is developing Dermatological Products based on the active ingredients found in its proprietary formulation. Caleco's intellectual property covering the Liver Health formulations and derivatives consists of patent applications in the United States, Europe and Canada and four European Drug Master File applications.

Caleco's shares are traded in the United States on the OTC Bulletin Board /quotes/comstock/11k!caeh (CAEH 0.06, -0.02, -20.00%) and in Germany on the Frankfurt Stock Exchange (frankfurt:T3R)(wkn:A0N9Y0).

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BlueWater Advisory Group - Investor Relations
Bryan Crane
Managing Director


Scoring system is 93 percent accurate for diagnosing Wilson's disease in pediatric patients

Public release date: 30-Nov-2010

Contact: Dawn Peters

Penicillamine challenge ineffective for detecting the disease in asymptomatic children

An Italian research team confirmed that the scoring system for Wilson's disease (WD) provides good diagnostic accuracy with 93% positive and 92% negative predictive values, respectively in children with mild liver disease. In asymptomatic children, a urinary copper excretion above 40 μg/24 hours was suggestive of WD, however the penicillamine challenge test (PCT) did not provide an accurate diagnosis in this patient subset. Results of the study appear in the December issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

WD is a rare genetic disorder where excessive amounts of copper accumulate in the liver, kidneys, brain, and eyes (cornea). Patients may experience a brown ring (Kayser-Fleischer ring) around the cornea of the eye, various liver diseases, slurred speech, and tremors, with symptoms appearing between the ages of 5 to 35. According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) approximately one in 40,000 individuals develop WD, which affects men and women equally.

A prompt diagnosis of WD is vital to avoid rapid progression of liver and neurological damage. "Unfortunately, diagnosis of WD is a challenging task, especially in childhood, because conventional criteria established for adults are not always appropriate for children," explained Raffaele Iorio, M.D., of the University Federico II in Italy and lead author of the study.

In order to evaluate the current standard diagnostic criteria and WD scoring system, the research team collected data on 40 children with WD and 58 children with liver disease other than WD, ranging in age from 1 to 21 years of age. Both groups were symptom-free with the predominant sign of liver disease being elevated aminotransferases (higher levels of enzymes from liver cells that when released into the blood, signify liver disease). Molecular analysis and liver copper content test were also performed to confirm the WD diagnosis.
Results showed the optimal urinary copper diagnostic was 40μg/24h which had a sensitivity of 79% and specificity of 88%. Researchers found no significant difference in urinary copper after PCT in either WD patients or control subjects. "The data found by Iorio et al. demonstrates that the current AASLD guideline approach to the diagnosis of WD—obtaining a slit lamp exam, a serum ceruloplasmin and a 24-hour urine copper followed by a liver biopsy in some patients—is useful even in young, clinically asymptomatic children," confirmed Dr. Michael Schilsky, Associate Professor of Medicine and Surgery at Yale University Medical Center, in his and Dr. Rosencrantz's editorial also publishing this month in Hepatology.

Dr. Iorio concluded, "Establishing a WD diagnosis in children with mild liver disease is often problematic. Our study determined that genetic diagnosis is critical and the WD scoring system is a reliable method of analysis for these pediatric patients."


Article: "Re-Evaluation of the Diagnostic Criteria for Wilson Disease in Children with Mild Liver Disease." Emanuele Nicastro, Giusy Ranucci, Pietro Vajro, Angela Vegnente, Raffaele Iorio. Hepatology; Published Online: October 21, 2010 (DOI: 10.1002/hep.23910); Print Issue Date: December 2010.

Editorial: "Mining for a Diagnosis of Wilson Disease in Children: Genetics, Score and Ore." Richard A. Rosencrantz and Michael L. Schilsky. Hepatology; Published Online: November 23, 2010 (DOI: 10.1002/hep.24054); Print Issue Date: December 2010.

These studies are published in Hepatology. Media wishing to receive a PDF of the articles may contact

About the Journal

Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit

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