Monday, April 11, 2011

Hepatitis C Making The Monday News; New Technique Tracks Viral Infections

VA whistleblowers: Dirty dentist infected vets
Ohio vets didn’t expect to go a VA dental clinicand get sicker, but authorities are identifying patients believed to have been infected with hepatitis by an unsanitary dentist.

The Dayton Daily News is running a series on Dr. Dwight M. Pemberton’s failure to follow proper infection control protocols, and the VA’s alleged retaliation against two whistleblower lab techs.

Wallace “Ray” and Sherry Perdue say they were investigated after they told VA inspectors that the 81-year-old Pemberton failed to change latex gloves between patients and failed to sterilize instruments.

Sherry Perdue said she showed inspectors a drawer full of dirty dental tools used to adjust dentures.

The newspaper reports that the VA has closed the clinic temporarily and offered testing for hepatitis B, hepatitis C and HIV to 535 patients who received invasive dental work from Pemberton, who has since retired.

Two Hepatitis B cases have been uncovered, and the newspaper carried a report over the weekend of a 52-year-old Army vet who believes he contracted Hepatitis C at the clinic.

Ohio lawmakers are now pressuring VA Secretary Eric Shinseki to investigate facilities statewide.

New Technique Tracks Viral Infections,

Aids Development of Antiviral Drugs

Scientists at the Naval Research Laboratory Center for Bio-Molecular Science and Engineering have developed a method to detect the presence of viruses in cells and to study their growth. Targeting a virus that has ribonucleic acid (RNA) as its genetic makeup, the new technique referred to as locked nucleic acid (LNA) flow cytometry-fluorescence in situ hybridization (flow-FISH), involves the binding of an LNA probe to viral RNA

While individual parts of the technique have been developed previously, Drs. Kelly Robertson and Eddie Chang, in collaboration with researchers at the NRL Lab for Biosensors and Biomaterials, demonstrate for the first time that the combination of LNA probes with flow-FISH can be used to quantify viral RNA in infected cells. This also allows the scientists to monitor the changes in viral RNA accompanying antiviral drug treatment.

Once the probe is bound to the viral RNA inside mammalian cells, it is tagged with a fluorescent dye, then thousands of these tagged cells are measured rapidly by "flow cytometry" - a method for counting and examining microscopic particles, such as cells and chromosomes, by suspending them in a stream of fluid and passing them by an electronic detection apparatus.

"The ability to rapidly measure thousands of cells for the presence of virus, sets this technique apart from currently used methods to monitor viral replication," said Robertson.

Traditionally, antibodies used to detect viruses must be produced and calibrated for each specific strain and are highly susceptible to viral mutations. Assays commonly used for quantifying viral loads and for drug development can be time consuming and rely on visible signs of cell damage, which is not produced in all viruses and can take long periods of time to occur.

Techniques such as quantitative reverse transcription-polymerase chain reaction (qRT-PCR), microarrays, and enzyme-linked immunosorbent assays (ELISAs), while highly sensitive, involve the lysis [the breaking down] of cells prior to measurement and are therefore unable to provide information about cellular viability, infected cell phenotypes, percentage of infected cells or the variation in infection among a cell population. The LNA probe differs from traditional nucleotide probes by binding more tightly to its target RNA.

LNA-flow FISH presents a fast and easy way to screen for compounds with antiviral activity and could be adapted for monitoring infections in the blood for vaccine therapy and development. This method adds a necessary tool for several emerging areas in cell biology that enables the use of high throughput measurements for entire populations and improves statistical analyses.

"This method can be expanded by adding more than one kind of LNA probe to enable multiple detection of different viral and host RNA," adds Robertson. "The multiplexing enhancement can be used to better understand infectious agents, allowing this technique to be used to aid in the development of antiviral drugs for a variety of viruses."

LNA flow-FISH offers an advantage over other techniques due to its simplicity and superiority. Methods involving genetic recombination of the virus to express a fluorescent protein as a means to mark the presence of virus can utilize flow cytometry for large-batch analysis of infected cells. However, an exception to this approach is viral strains that have not acquired genetic mutations, known as wild-type viruses (such as strains of Human Immunodeficiency Virus-HIV), which would require a large initial investment of labor for engineering each virus of interest


UPDATE 1-Medivir in BioPhausia bid, eyes hepatitis drug boost

Medivir looking for launch pad for hepatitis drug

* Says BioPhausia revenues will help pay for R and D

* Offer recommended by BioPhausia board

(Adds details, share price reaction)

STOCKHOLM, April 11 (Reuters) - Pharmaceuticals firm Medivir offered $90 million for BioPhausia on Monday, hoping its Nordic peer's sales and marketing skills will help in the launch of Medivir's treatment for hepatitis C.

Medivir said in a statement the acquisition would expand its activities in the Nordic countries and create a platform for the expected launch and commercialization of TMC435.

It said the drug was "Medivir's most promising Phase 3 clinical project for the treatment of Hepatitis C, in the Nordic region where full commercial rights have been retained".

Medivir said it was offering a mixture of cash and new class B Medivir shares, valuing BioPhausia at around 565 million crowns ($90.14 million) or 1.65 crowns per share.

It said the offer premium was 44 percent over the volume weighted average price of BioPhausia shares over the last 30 days and that BioPhausia's board had unanimously backed the bid.

Shares in Medivir were down 2 percent at 143.50 crowns per share at 0821 GMT, underperforming the wider Stockholm index. BioPhausia shares were up 33 percent at 1.52 crowns per share.

It added that BioPhausia's revenues and profit "will significantly offset the ongoing investments in Medivir's R&D portfolio".

BioPhausia does not do its own research but improves and refines licensed and parallel-imported products and focuses on marketing and sales.

BioPhausia had sales of 553 million crowns in 2010 but made a loss before interest, tax, depreciation and amortisation of 16 million crowns. The result was hit by a 102 million one-off cost.

Medivir said it was evaluating additional licensing and acquisition opportunities of complementary products for the enlarged group.

Biophausia's two biggest owners, Skandia Liv and Originat AB, have said they will accept the bid. ($1=6.268 Swedish Crown) (Editing by Jon Loades-Carter)

Doctors Are Losing Faith In Johnson and Johnson

Given the ongoing problems at the healthcare giant - and the tremendous attention this has generated - it is hardly surprising that some physicians have their doubts about Johnson & Johnson management. You know, the problems include a consent decree; manufacturing gaffes that led to the recalls of tens of milions of products; an alleged cover up of the problems; government probes and reduced sales.

And so a Wall Street analyst - David Maris of Credit Agricole Securities - posed a simple question to 100 doctors: Has Johnson & Johnson lost its way?

British man jailed after record fake medicine bust
Ben Hirschler

(Reuters) - A British man was jailed for eight years on Friday for his role in supplying more than 2 million doses of fake medicines in the most serious known case of counterfeit drugs getting into the European supply chain.

Faking prescription drugs is a lucrative and growing criminal business and Peter Gillespie, 64, was involved in a global network stretching from China to Belgium and Mauritius to supply drugs and launder money, a British court heard.

Investigators from Britain's medicines watchdog said the case was particularly alarming given the serious conditions for which the medicines were used -- schizophrenia, heart disease and prostate cancer.

A total of 25,000 packs containing 700,000 fake doses of Eli Lilly's Zyprexa, Sanofi-Aventis's Plavix and AstraZeneca's Casodex reached pharmacies and patients in care centers, hospitals and at home across Britain in 2007.

A further 47,000 packs were either seized by the Medicines and Healthcare products Regulatory Agency (MHRA) from a warehouse or recalled from the supply chain.

Four other men were acquitted in the case, the MHRA said in a statement.

Nimo Ahmed, head of intelligence at the MHRA, said the bogus drugs had put the health of thousands of Britons in jeopardy, since they contained only 50-80 percent of active ingredient plus unknown impurities, though no deaths or adverse events had been definitively linked to the incident.

Gillespie and associates stood to make a profit of more than 3 million pounds ($4.9 million) from the drugs, which were manufactured in China and had a retail value of 4.7 million pounds.

Plans were also well under way to bring in three other counterfeit medicines for Alzheimer's, epilepsy and schizophrenia -- Pfizer's and Eisai's Aricept, UCB's Keppra and Johnson & Johnson's Risperdal.

"They didn't get to bring them in but they were definitely well on the way to being prepared to receive them," Mick Deats, the MHRA's head of enforcement, told reporters.


The three fake drugs that did get in -- shipped via Hong Kong, Singapore and Belgium -- were all packaged as French medicines and were designed for sale in Britain through so-called parallel trade.

The drugs industry has long complained that the legal practice of parallel trade -- in which drugs are bought and repackaged for resale in countries where prices are higher -- is a weak link in the supply chain.

The MHRA, however, said this was the first known case of counterfeiters using parallel trade. It came to light because a licensed repackager noticed that an embossed number on a blister pack was reversed and reported it to the authorities.

Another person connected to the case had already been convicted in the United States after trying to sell counterfeit medicines there. Kevin Xu was jailed for 6-1/2 years in June 2008 after discussing a supply deal with undercover agents
Counterfeit medicines are common on unregulated websites and are also rife in the developing world, where they represent a major health hazard, according to the World Health Organization.

They are rare in Europe. However, the MHRA has conducted one recall in Britain since the 2007 case and several consignments have been intercepted en route into the country.

(Editing by David Holmes and Will Waterman)

($1=.6103 Pound)

Merck & Co., Inc., and Sun Pharma Establish Joint Venture to Develop and Commercialize Novel Formulations and Combinations of Medicines in Emerging Markets

Joint Venture to Apply Proprietary Technologies to Develop Medicines Designed to Enhance Convenience and Improve Compliance

WHITEHOUSE STATION N.J. and MUMBAI, India, April 11, 2011 - Merck & Co., Inc., (NYSE:MRK), a global health care leader, known as MSD outside the United States and Canada, and Sun Pharmaceutical Industries Ltd., ("Sun Pharma") a leading Indian multinational pharmaceutical company, today announced the creation of a joint venture to develop, manufacture and commercialize new combinations and formulations of innovative, branded generics in the Emerging Markets.

"Merck's Emerging Markets strategy is driven by our overarching focus on applying innovation across our business from introducing novel compounds to broadening our focus on innovative branded generics," said Kevin Ali, president, Emerging Markets, Merck/MSD. "By combining forces with Sun Pharma, we are complementing our innovative product portfolio with a solid foundation for addressing the diverse needs of patients, physicians and governments across the Emerging Markets."

The partnership combines Sun Pharma's proven track record of leadership and expertise in rapid, innovative product development using Sun Pharma Advanced Research Company Ltd's ("SPARC") proprietary platform technologies, and Sun Pharma's world-class manufacturing network with Merck's clinical development and registration expertise and a broad, geographic commercial footprint. The companies said that they will focus on 'innovative branded generics,' that bring together combinations of medicines using platform delivery technologies designed to enhance convenience for patients in Emerging Markets. The joint venture will be structured through Merck and Sun Pharma's respective subsidiaries. Financial details of the joint venture were not disclosed.

"This joint venture reinforces our strategy of partnering to launch products using our highly innovative delivery technologies around the world," said Dilip S. Shanghvi, chairman and managing director, Sun Pharmaceutical Industries Ltd. "Merck has an unrivalled reputation as a world leading, innovative, research-driven pharmaceutical company. We're proud to be associated with them and look forward to working together."

Experts estimate that during the coming decade, the Emerging Markets are expected to drive 90 percent of the world's pharmaceutical growth, with 75 percent of that growth coming from branded generics. In these markets, the growing burden of chronic disease, such as cardiovascular disease, diabetes and hepatitis, along with an increasing population and economic prosperity, is leading to an increased demand for branded generics.

"Merck has a proud legacy of developing innovative medicines and vaccines with proven ability to impact global human health," said Ali. "We are making good progress executing on our Emerging Markets growth strategy by establishing novel partnerships and strategic alliances. This joint venture helps position us for leadership in the fastest growing geographies."

The collaboration between MSD and Sun Pharma will be managed by a Joint Board and leadership team, consisting of members of senior management from both companies.

About Sun Pharmaceutical Industries Ltd.

Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an international, integrated, specialty pharmaceutical company. The company manufactures and markets a large number of pharmaceutical formulations as branded and incrementally innovative generics in India, the United States and across several Emerging Markets. In India, it is the leader across the psychiatry, neurology, cardiology, diabetology, gastroenterology, ophthalmology and orthopedic therapy areas. Additionally, the company possesses strong skills in product development, process chemistry, and the manufacturing of complex active pharmaceutical ingredients (APIs) as well as dosage formulations. More information can be found at .

Healthy You

New review suggests drinking 100 percent fruit juice may offer disease-fighting benefits

Fruit juice linked to reduced risk of cancer, improved markers of heart health and increased antioxidant activity

WASHINGTON, DC (April 11, 2011) – Drinking 100 percent fruit juices could have protective health benefits similar to those of whole fruits, according to research presented in a literature review yesterday at the 2011 Experimental Biology (EB) meeting.

Highlights from a new report summarizing recent research on the potential benefits of fruit juice suggest a positive association between intake of 100 percent juice and reduced risk for several chronic diseases, including cancer, markers for cardiovascular disease and cognitive decline.

"While it is universally accepted that fruit and vegetable intake is protective, there is not a clear consensus about the benefits of consuming the juices that are extracted from them," said the review's author, Dianne Hyson, PhD, MS, RD. "An analysis of the scientific evidence suggests that 100 percent fruit juices retain important bioactive components that may promote good health and aid in disease prevention."

Among the fruit juices included in the review, consumption of apple, citrus, cranberry, grape, and pomegranate juices all showed beneficial effects. Markers of improved health ranged from reductions in urinary tract infections (cranberry) to improvements in age-related cognitive decline (grape and apple) to reduced risk of prostate (pomegranate) and respiratory and digestive (orange, grapefruit) cancers. Additionally, intake of all juices was linked to heightened antioxidant activity.

Research examined in the review, which was completed at the University of California - Davis, included a range of study types, from in vitro to clinical trials (60 papers total), all published in 2005 or later.


For more information on the health benefits of 100 percent fruit juice, please visit .

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