September 29, 2013

FDA approval far away from Achillion’s hepatitis C drug as clinical hold remains

September 28, 2013 10:00 am by Staff


(Reuters) - Achillion Pharmaceuticals Inc said the U.S. Food and Drug Administration decided not to lift a clinical hold it had placed on the firm's hepatitis C drug, sovaprevir, leaving an uncertain fate for the company's most promising drug.

The news caused Achillion's shares to plunge 45 percent in after-market trade on Friday.

The FDA asked the company to halt development of sovaprevir in June, after detecting elevated liver enzymes, an indication of liver damage, in multiple patients who were given the drug in a clinical study.

The regulator asked for some clinical data on the drug, and while Achillion submitted that, the agency concluded that removal of the clinical hold was not warranted, Achillion said in a statement on Friday.

"While we are disappointed that we were not able to resolve the clinical hold at this time despite having addressed all the issues, we believe the breadth of our portfolio allows us to quickly advance other all-oral combination regimens for the treatment of HCV," Achillion's Chief Executive Milind Deshpande stated.

Achillion is among a number of drugmakers developing a new class of drugs to treat the liver-hampering virus by using a drug regimen that does not include the conventional hepatitis C drug constituent, interferon, which causes flu-like symptoms.

However, multiple drugmakers have suffered regulatory and development setbacks over the past year.

Most recently in July, Vertex Pharmaceuticals Inc, which already sells the market-leading hepatitis C treatment Incivek, said U.S. health regulators placed a partial clinical hold on a mid-stage study of its experimental oral hepatitis C treatment, VX-135, because of potential liver problems.

Vertex said it is working with the agency to resolve issues.

Achillion on Friday also reported interim results from an ongoing mid-stage clinical trial testing a combination of its experimental drugs, including sovaprevir.

Initial data from this mid-stage study showed that 79 percent of patients with the most common and difficult to treat genotype 1 form of hepatitis C achieved rapid virologic response, or undetectable virus levels after four weeks of treatment.

Trading in Achillion's shares was halted at 1643 ET on Friday, pending release of the news. After resumption, Achillion's shares hit a low of $3.95 in extended trade.

(Reporting by Zeba Siddiqui in Bangalore; Editing by Ken Wills)


Also See: Achillion Provides Pipeline Update

Non-governmental groups launch program against hepatitis   2013-09-29 16:55:18

BEIJING, Sept. 29 (Xinhua) -- A number of non-governmental organizations on Sunday launched a joint project for the prevention and cure of hepatitis in China.

China Viral Hepatitis Prevention and Control Center Project will publicize information and provide training to improve both public awareness of the disease and capabilities of grassroots doctors.

The Chinese Foundation for Hepatitis Prevention and Control is in charge of the five-year project. Yang Xizhong, deputy head of the foundation, said at the launch ceremony that the project will train 400 doctors in the oil city of Karamay in northwest China's Xinjiang Uygur Autonomous Region.

It will also open a facility for chronic hepatitis patients in Shanghai, and train grassroots doctors in Tibet, said Yang.

U.S.-based Bristol-Myers Squibb Foundation will input more than 1.13 million U.S. dollars into the project in the next three years. Other groups joining the project include Shanghai Charity Foundation and Wu Jieping Medical Foundation among others.

China has almost 100 million hepatitis virus carriers, and 30 million hepatitis B and hepatitis C patients. The public know little about the disease, especially hepatitis C.


New Medical Device Extremely Effective at Preventing HIV in Women

Provided by Science Daily


Previous studies have demonstrated that antiviral drugs can prevent HIV infection, but existing methods for delivering the drug fall short. Pills must be taken daily and require high doses; vaginal gels that must be applied prior to each sex act are inconvenient, yielding poor usage rates. The new ring is easily inserted and stays in place for 30 days. (Credit: Northwestern University)

Sep. 27, 2013 — It's often said that the HIV/AIDS epidemic has a woman's face. The proportion of women infected with HIV has been on the rise for a decade; in sub-Saharan Africa, women constitute 60 percent of people living with disease. While preventative drugs exist, they have often proven ineffective, especially in light of financial and cultural barriers in developing nations.

A new intravaginal ring filled with an anti-retroviral drug could help. Developed with support from the National Institute of Allergy and Infectious Diseases by Northwestern University visiting associate professor Patrick Kiser, the ring is easy to use, long lasting, and recently has demonstrated a 100 percent success rate protecting primates from the simian immunodeficiency virus (SHIV). The device will soon undergo its first test in humans.

"After 10 years of work, we have created an intravaginal ring that can prevent against multiple HIV exposures over an extended period of time, with consistent prevention levels throughout the menstrual cycle," said Kiser, an expert in intravaginal drug delivery who joined Northwestern from the University of Utah, where the research was conducted.

Kiser is a new faculty member in Northwestern's McCormick School of Engineering's Department of Biomedical Engineering and visiting associate professor of obstetrics and gynecology in the Feinberg School of Medicine.

The research was published September 16 in the Proceedings of the National Academy of Sciences (PNAS).

Previous studies have demonstrated that antiviral drugs can prevent HIV infection, but existing methods for delivering the drug fall short. Pills must be taken daily and require high doses; vaginal gels that must be applied prior to each sex act are inconvenient, yielding poor usage rates.

The new ring is easily inserted and stays in place for 30 days. And because it is delivered at the site of transmission, the ring -- known as a TDF-IVR (tenofovir disoproxil fumarate intravaginal ring) -- utilizes a smaller dose than pills.

The device contains powdered tenofovir, an anti-retroviral drug that is taken orally by 3.5 million HIV-infected people worldwide, but that has not previously been studied topically. But the ring's strength stems from its unique polymer construction: its elastomer swells in the presence of fluid, delivering up to 1,000 times more of the drug than current intravaginal ring technology, such as NuvaRing, which are made of silicon and have release rates that decline over time.

The upcoming clinical trial, to be conducted in November at Albert Einstein College of Medicine in New York, will evaluate the ring in 60 women over 14 days. The trial will assess the ring's safety and measure how much of the drug is released and the properties of the ring after use.

Other drugs could potentially be integrated into the ring, such as contraceptives or antiviral drugs to prevent other sexually transmitted infections -- a feature that could increase user rates, Kiser said.

"The flexibility to engineer this system to deliver multiple drugs and change release rates is extraordinary and could have a significant impact on women's health," he said.

Story Source:

The above story is based on materials provided by Northwestern University.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

  1. J. M. Smith, R. Rastogi, R. S. Teller, P. Srinivasan, P. M. M. Mesquita, U. Nagaraja, J. M. McNicholl, R. M. Hendry, C. T. Dinh, A. Martin, B. C. Herold, P. F. Kiser. Intravaginal ring eluting tenofovir disoproxil fumarate completely protects macaques from multiple vaginal simian-HIV challenges. Proceedings of the National Academy of Sciences, 2013; DOI: 10.1073/pnas.1311355110


Drug Found to Eradicate HIV Permanently from Infected Cells

Provided by Science Daily

Sep. 23, 2013 — The topical anti-fungal drug Ciclopirox causes HIV-infected cells to commit suicide by jamming up the cells' powerhouse, the mitochondria -- according to a study by researchers at Rutgers New Jersey Medical School. And unlike current anti-HIV drugs, Ciclopirox completely eradicates infectious HIV from cell cultures, with no rebound of virus when the drug is stopped. The study has been published in the journal PLOS ONE.

of patients with HIV has been revolutionized by the advent of combination anti-retroviral drugs. But although these drugs are highly effective at keeping HIV at bay, they must be taken for the life of the patient and never eliminate the infection completely. This is illustrated by the often rapid resurgence of virus in patients who stop taking these medications. The persistence of HIV is partially due to the ability of the virus to disable the cell's altruistic suicide pathway, which is normally activated when a cell becomes infected or damaged.

A team of researchers from three departments at New Jersey Medical School, led by Michael Mathews and Hartmut Hanauske-Abel, previously showed that Ciclopirox, commonly used by dermatologists and gynecologists to treat fungal infections, inhibits the expression of HIV genes in culture. The group now shows that the drug works against HIV in two ways: It inhibits the expression of HIV genes and also blocks the essential function of the mitochondria, thereby reactivating the cell's suicide pathway. Healthy, uninfected cells examined during this study were spared. And remarkably, the virus did not bounce back when Ciclopirox was removed.

The utility of Ciclopirox in patients with HIV, for instance after topical application to reduce sexual transmission of the virus, awaits verification in future clinical trials. However the fact that Ciclopirox is already approved for treatment of patients by the FDA and by its European counterpart, the EMA, and therefore considered safe for human use, may eliminate much of the time and expense ordinarily involved in the drug development process.

Indeed, the authors note the speed with which a second FDA-approved drug believed to have promise in subduing HIV, Deferiprone, has moved directly from tests in culture to a phase I human trial conducted in South Africa, thanks to previously published results now reinforced by additional research in culture described in the current paper. Studies in animals were safely skipped, creating a model for rapid transition from drug effect in a plastic dish to drug effect in patients. In contrast to Ciclopirox, approved for topical use, Deferiprone is FDA- and EMA-approved for systemic use (in certain thalassemia patients with iron overload). The discovery that two drugs, each well-tolerated by patients when used as indicated, are deadly to HIV-infected cells, may open a new chapter in the fight against HIV/AIDS that moves the world closer to the eradication of HIV-1 infection.

Story Source:

The above story is based on materials provided by Rutgers Biomedical and Health Sciences.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

  1. Hartmut M. Hanauske-Abel, Deepti Saxena, Paul E. Palumbo, Axel-Rainer Hanauske, Augusto D. Luchessi, Tavane D. Cambiaghi, Mainul Hoque, Michael Spino, Darlene D'Alliessi Gandolfi, Debra S. Heller, Sukhwinder Singh, Myung Hee Park, Bernadette M. Cracchiolo, Fernando Tricta, John Connelly, Anthony M. Popowicz, Richard A. Cone, Bart Holland, Tsafi Pe’ery, Michael B. Mathews. Drug-Induced Reactivation of Apoptosis Abrogates HIV-1 Infection. PLoS ONE, 2013; 8 (9): e74414 DOI: 10.1371/journal.pone.0074414


10 Cases Of Liver Failure Linked To Dietary Supplements In Hawaii

Posted: 09/27/2013 7:20 pm EDT  |  Updated: 09/27/2013 7:20 pm EDT

Follow: Center For Disease Control, Food And Drug Administration, Banned Diet Pills, Banned Steroids, Bodybuilding, Centers For Disease Control And Prevention, Diet Pill Deaths, Diet Pills, Dietary Supplements, Epidemiology, Hawaii Department Of Health, Hydroxycut, Liver Failure, Liver Failure Hawaii, Liver Transplants, Steroids, Steroids Bodybuilding, Healthy Living News

Ten young, seemingly-healthy people have been admitted into Hawaii hospitals in the last five months for varying degrees of liver inflammation and failure, and they only have one thing in common: They all took a certain dietary supplement for weight loss and/or muscle growth.

Yesterday, the Hawaii State Department of Health (DOH) announced an investigation into what could be causing the hospitalizations, some of which are “extremely severe” and even require liver transplants, according to State Epidemiologist Dr. Sarah Park.

The only common finding among all cases ... is the use of a dietary or nutritional supplement for the purpose of weight loss and/or muscle gain in the past six months,” the DOH stated in a press release yesterday.

Representatives from the Department of Health are not releasing information as to what supplement the patients were taking or what ingredient could be at fault. According to KHON, the DOH cautions that a number of factors could be at fault: a bad batch of the supplement, a particular toxic ingredient, or the supplement as a whole.

The U.S. Centers for Disease Control and Prevention and the Food and Drug Administration are participating in the investigation.

In 2009, the FDA recalled 14 products made by the diet supplement manufacturer Hydroxycut after the product was linked to at least 23 cases of severe liver damage and the death of a teenage boy.


Leading Liver and ID Experts to Develop Hepatitis C Practice Recommendations

28/09/2013 02:21:00

Leading Liver and ID Experts to Develop Hepatitis C Practice Recommendations

Recognizing the rapid development of hepatitis C medications coupled with increasing numbers of people being identified with hepatitis C virus (HCV) infection, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) are collaborating to develop clinical recommendations for the management of hepatitis C.

New medications approved by the Food and Drug Administration in recent years have increased HCV cure rates, and several additional medications are expected to be approved in the next three to five years. At the same time, new HCV testing guidelines are expected to increase the number of patients diagnosed with hepatitis C, many of whom currently are HCV-infected but unaware of their status. Ensuring that patients receive the new, effective treatment will be critical in increasing cure rates for hepatitis C. "We can finally say that cure of HCV infection has become a real possibility for the majority of individuals infected with this deadly virus," said Gary Davis, MD, of AASLD.

"Members of AASLD and IDSA are committed to ensuring that patient care keeps pace with rapidly advancing science," said David Relman, MD, president of IDSA. "This effort is an important step toward advancing that goal and comes at an important time as we all work to raise awareness of hepatitis virus infections on World Hepatitis Day on July 28."

Through this collaboration, the societies will review current treatment recommendations and use evidence-based, consensus guidance to develop updated recommendations for managing patients. Recommendations will be updated regularly and made available online. "A web-based system of new recommendations coupled with a published annual update will afford the greatest opportunity for both rapid and comprehensive output," said Donald M. Jensen, MD, of AASLD.

About Hepatitis C

Hepatitis C is a liver disease resulting from chronic infection with the hepatitis C virus (HCV). It is estimated that between 3 million and 4 million Americans are infected with HCV and have chronic liver disease as a result. Because symptoms of HCV infection may not appear for many years, more than 70 percent are unaware they are infected.

Earlier this year, the Centers for Disease Control and Prevention recommended an age-based screening strategy consisting of a one-time test for HCV for those at highest risk, including everyone born between 1945 and 1965. This recommendation was endorsed by the U.S. Preventive Services Task Force in June 2013. The broader testing recommendations likely will detect a substantial number of people who are unaware they are infected.

According to a July 10, 2013 article published in The Journal of The American Medical Association (JAMA), deaths from liver disease increased from 1990 to 2010. HCV is the most likely cause of the emergence of liver disease as a growing threat to Americans. Early testing enables people who are infected to receive treatment as soon as possible, and prevent progression to more serious disease, such as cirrhosis and liver cancer.

Currently available drugs and the next generation of direct-acting antivirals that will likely be available later this year offer the potential to treat and cure most patients with HCV infection. Therefore, up-to-date recommendations for the medical management of these patients and their treatment are critically important.


About the AASLD

AASLD is a medical subspecialty society representing clinicians and researchers in liver disease. The work of our members has laid the foundation for the development of drugs used to treat patients with viral hepatitis. Access to care and support of liver disease research are at the center of AASLD’s advocacy efforts.

\AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD was founded in 1950 by a small group of leading liver specialists and has grown to an international society responsible for all aspects of hepatology.

Press releases and additional information about AASLD are available online at

About IDSA

The Infectious Diseases Society of America (IDSA) is an organization of physicians, scientists, and other health care professionals dedicated to promoting health through excellence in infectious diseases research, education, prevention, and patient care. The Society, which has nearly 10,000 members, was founded in 1963 and is based in Arlington, VA. For more information, see

Visit to access IDSA’s extensive collection of resources on hepatitis C, including the Society’s Core Curriculum for HPV at


These 2 Hepatitis-C Drug Developers Are Getting Left in the Dust

Provided by Daily Finance


by Sean Williams, The Motley Fool Sep 29th 2013 5:15PM
Updated Sep 29th 2013 5:16PM

Whether you realize it or not, we're in the middle of a very transformative period for treating hepatitis-C.

Before May 2011, the primary standard of treatment for hepatitis-C, a disease of the liver that can lead to cirrhosis of the liver or liver cancer and affects an estimates 150 million people worldwide, was peginterferon alfa and ribavirin. This therapy often gave patients nasty side effects, such as feeling you have the flu for 48 straight weeks, and induced a response in less than 50% of patients.

Times are rapidly changing
Then along came Vertex Pharmaceuticals with Incivek. Although it still needed to be administered in combination with interferon, Incivek was a pill, and it marked a rapid turning point in researchers understanding of the hep-C virus, how to treat it, and how to improve patient quality of life. With Incivek, hepatitis-C patients went from less than a 50% chance of responding to a sustained virologic response after 24 weeks (i.e., no detectable levels of the virus) of 79% -- a clean 20% to 45% better than the previous standard of treatment. Not surprisingly, Vertex's Incivek quickly rose to the rafters and became the quickest drug to go from launch to $1 billion in lifetime sales ever!

But the hits just kept on coming, even after Vertex brought Incivek to market. In 2012 we finally got a good look at just how quickly hepatitis-C treatment options were expanding when we received mid-stage clinical study results of Gilead Sciences sofosbuvir and AbbVIe's direct-acting antiviral combo drug. For Gilead, sofosbuvir delivered a perfect SVR after just 12 weeks in 25 of 25 patients. AbbVie's mid-stage study was a bit more expansive but proved just as exciting, with 77 of 79 patients experiences an SVR after 12 weeks.

In other words, in a two-year timespan we've seen the current standard of treatment go from a less than 50% response rate, to a 79% SVR over 24 weeks, to near perfection in a mid-stage trial for two separate companies in just 12 weeks' time. Furthermore, both sofosbuvir and AbbVie's DAA combo drug are all-oral pills that require no interferon -- and no interferon means fewer side effects! At the moment, sofosbuvir is currently under review by the Food and Drug Administration for possible new drug approval, while AbbVie's DAA combo is in late-stage trials, although it's received the highly coveted "breakthrough therapy" designation.

Two companies getting left in the dust
But it's not all fun and games for every company in the hepatitis-C sector. And I know what you're thinking - you're expecting me to point the finger at Bristol-Myers Squibb for its absurd purchase of Inhibitex in January 2012 for $2.5 billion and rake it over the coals once again. I'm not going to do that this time, because there are, in fact, two companies in far worse shape that, no matter how hard they try, can't seem to keep their foot in the door.

The first is Achillion Pharmaceuticals . At this time last year it looked as if Achillion could have a novel oral therapy on its hands to treat hep-C known as sovaprevir (previously ACH-1625). Following Bristol-Myers' BMS-986094 disaster, nucleotide-based inhibitors were expected to come under increased scrutiny while protease inhibitors like sovaprevir were expected to shine.

In July of this year, that house of cards came tumbling down, when the FDA placed a clinical hold on sovaprevir following an early stage study of drug-to-drug interactions with atazanavir. Though no serious adverse events were reached in the trial, ALT liver enzymes rose, causing the FDA to place the drug on clinical hold until further notice. Then came word just this Friday after the bell that the FDA had decided to continue its clinical hold on sovaprevir, even though Achillion noted in its press release that it met all of the FDA's requests in its previous clinical hold letter. Achillion does have three other experimental HCV drugs in its pipeline, but sovaprevir is, without question, its most promising candidate.

The second company, and perhaps the most unlucky biotech ever, is Idenix Pharmaceuticals , which is no stranger to the FDA's clinical hold process. It all began in 2010, when Idenix's lead compounds IDX184 and IDX320 were placed on clinical hold by the FDA. IDX184 would eventually be allowed to continue on while IDX320 was scrapped. In 2012, IDX184 was placed on clinical hold yet again along with IDX19368 following the death of a patient on Bristol-Myers' BMS-986094. Both of Idenix's experimental nucleotide-based therapies worked along the same pathway as BMS-986094, so the FDA decided to halt their study as well. Not too long after, Idenix would scrap both of these drugs. Finally, and to rub salt in the wound, earlier this year the FDA placed a clinical hold on its now lead drug IDX20963 until the company turns in additional preclinical safety data on the drug. It'd almost be a comical malady of events if it wasn't true!

The stark truth of the matter is that even if Achillion and Idenix manage to get their lead compounds off clinical hold, sofosbuvir and AbbVie's DAA-combo drug will more than likely make it to market two or three years before either sovaprevir or IDX20963 would even get reviewed by the FDA. Even though there's a wide moat of opportunity in treating hep-C, the window of opportunity for both companies is closing rapidly. In other words, if they don't get their foot in the door within the next 12 months, I'd just as soon lock the door of opportunity and throw away the key!

Being revolutionary is the best way to succeed as a biotech investor
The best way to play the biotech space is to find companies that shun the status quo and instead discover revolutionary, groundbreaking technologies. In The Motley Fool's brand-new free report "2 Game-Changing Biotechs Revolutionizing the Way We Treat Cancer," find out about a new technology that Big Pharma is endorsing through partnerships, and the two companies that are set to profit from this emerging drug class. Click here to get your copy today.

The article These 2 Hepatitis-C Drug Developers Are Getting Left in the Dust originally appeared on