Achillion Enters Into Worldwide Collaboration for Hepatitis C With Janssen

- Transactions include up to $1.1 billion in potential development, regulatory and sales milestone payments and a separate equity investment -

- Achillion eligible for tieredroyalties between mid-teens and low-twenties on future worldwide sales -

- Janssen responsible for all development costs within the collaboration and all subsequent costs related to commercialization of the assets -

- Conference call scheduled for today at 5:00 p.m. ET -

NEW HAVEN, Conn., May 19, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that it has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize one or more of Achillion's lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422, and sovaprevir.

"We are excited to collaborate with Janssen for the worldwide development of our HCV assets in combination with their HCV portfolio. We believe that Janssen's renowned expertise in HCV development and commercialization enables a synergistic opportunity to rapidly advance our combined HCV assets toward the market while simultaneously achieving an optimized treatment regimen for all HCV patients," said Milind Deshpande, Ph.D., President and Chief Executive Officer of Achillion. "Furthermore, we believe that their investment in Achillion through Johnson & Johnson Innovation - JJDC allows us to maximize the value from our HCV portfolio and also positions us to become a leader in complement factor D inhibition, applying our broad platform to a wide number of complement-related diseases. We believe this strategy provides an ideal scenario to create further value for our shareholders."

Under the terms of the agreement, Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Achillion is eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones. Achillion is also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales. Janssen will be responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets.

A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration.

Additionally, in an equity transaction separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation - JJDC, Inc. will invest $225 million in Achillion and, in return, receive approximately 18.4 million newly issued, unregistered shares of Achillion at a price of $12.25 per share.

The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. Transitional clinical development and technology transfer activities under the collaboration are expected to take place over the next several months.

Centerview Partners acted as exclusive financial advisor to Achillion. Leerink Partners also advised the Company. WilmerHale acted as legal counsel for Achillion in connection with the transactions.

Conference Call
Achillion will host a conference call and simultaneous webcast on Tuesday, May 19, 2015 at 5:00 p.m. Eastern time. To participate in the conference call, please dial (866) 205-4820 in the U.S. or (419) 386-0004 for international callers. A live audio webcast of the call will be accessible at http://www.achillion.com or http://ir.achillion.com. Please connect to Achillion's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

A replay of the webcast will be available for 30 days on www.achillion.com. Alternatively, a replay of the conference call will be available starting at 8:00 p.m. Eastern time on May 19, 2015, through 11:59 p.m. Eastern time on May 25, 2015 by dialing (855) 859-2056 or (404) 537-3406. The replay passcode is 51773113.

Read the rest of this press release here: http://ir.achillion.com/releasedetail.cfm?releaseid=913980

Scientists identify crucial step in helping to prevent Hepatitis C virus replicating

New research from the University of Southampton has identified how changes in the cell membrane play a pivotal role in how the Hepatitis C virus replicates.

By understanding this process, the researchers hope to investigate how to prevent the changes and potentially develop therapeutic drugs to combat the Hepatitis C virus (HCV), which infects an estimated 170 million people globally.

When HCV infects a cell it uses one of its proteins, NS4B, to form a lipid-rich structure called the 'membranous web'. This structure contains 'reaction centres', where the virus can replicate protected from the host cell's antivirus defences.

More information: "Interaction between the NS4B amphipathic helix, AH2, and charged lipid headgroups alters membrane morphology and AH2 oligomeric state—Implications for the Hepatitis C virus life cycle," Biochimica et Biophysica Acta (BBA) - Biomembranes, Volume 1848, Issue 8, August 2015, Pages 1671-1677, ISSN 0005-2736, dx.doi.org/10.1016/j.bbamem.2015.04.015

Read more at: http://phys.org/news/2015-05-scientists-crucial-hepatitis-virus-replicating.html#jCp

Chronic Liver Disease Foundation and Walgreens to Launch Hepatitis C Testing Campaign

CLDF to Support Free HCV Testing at 60 Walgreens Stores across the U.S.

CLARK, N.J., May 19, 2015 /PRNewswire/ -- The Chronic Liver Disease Foundation (CLDF) announced today that it's collaborating with Walgreens to offer free hepatitis C (HCV) testing with the OraQuick® HCV Rapid Test at more than 60 Walgreens retail pharmacies in 12 major cities throughout the country.

The program, which is slated to launch this August and run through January 2016, will offer free rapid HCV testing on specific days and times each week to patients at risk for HCV. Rapid testing and patient education will be conducted by trained healthcare professionals on site at each retail location and individuals who test positive will be linked directly to one of CLDF's 75 Hepatology Centers of Expertise throughout the U.S.

"The rapid hepatitis testing program demonstrates our commitment to helping patients access important information that can help to improve their health," said Glen Pietrandoni, RPh, AAHIVP, senior director, virology, Walgreens. "We are proud to collaborate with the Chronic Liver Disease Foundation on this initiative. Through this testing program we can help people become educated on the risk factors, identify people infected with HCV and help them get linked to appropriate care."

"Today, approximately 5.2 million Americans have hepatitis C and the vast majority does not know it," said Dr. Willis C. Maddrey, President of the Chronic Liver Disease Foundation. "However, new therapies are now available that can effectively treat and cure hepatitis C.

Each year, about 17,000 Americans become infected with hepatitis C. Up to 75 percent of people with chronic hepatitis C infection were born during 1945-1965, and up to three out of four people infected with hepatitis C are unaware of their infection.

OraQuick® HCV is the first and only FDA-approved and CLIA-waived point of care test for detection of HCV infection in at-risk individuals. The simple, accurate platform enables healthcare providers to deliver an accurate diagnosis in 20 minutes, using venipuncture or fingerstick blood.  The test is manufactured by OraSure Technologies OSUR, -0.16% in Bethlehem, Pa.
 
About the Chronic Liver Disease Foundation
Established in 2001, the Chronic Liver Disease Foundation is a nonprofit 501(c)(3) educational organization dedicated to providing hepatology related continuing medical education, news and information to healthcare professionals across the US. The CLDF is led by a Board of Trustees comprised of nationally renowned liver disease specialists. Furthermore, the CLDF believes that educational programs should be developed by the specialists who are actively involved in the research, treatment and management of a disease. As such the CLDF has developed a network of 75 Centers of Educational Expertise and multiple Advisory Boards who are actively involved in program creation related to specific disease topics which include; hemochromatosis, hepatic encephalopathy, hepatitis B, hepatitis C, hepatocellular carcinoma, HIV co-infection, liver transplantation and NASH/NAFLD. The CLDF's educational opportunities are offered in a variety of formats including an interactive web site, live meetings, teleconferences, print pieces, webcasts and other electronic mediums.  For more information, please visit www.chronicliverdisease.org.   

Media Contact:Contact:Alessandra LaMastro for CLDF973-668-8354alamastro@focusmeded.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/chronic-liver-disease-foundation-and-walgreens-to-launch-hepatitis-c-testing-campaign-300085539.html

SOURCE Chronic Liver Disease Foundation

Copyright (C) 2015 PR Newswire. All rights reserved

Health Department reminds Vermonters to get tested

May 19 is National Hepatitis Testing Day

Press Release

Posted:   05/18/2015 02:29:06 PM EDT

BURLINGTON -- May 19 is National Hepatitis Testing Day. The Health Department reminds Vermonters at risk to get tested for Hepatitis C, a form of viral hepatitis that is spread through blood to blood contact.

Based on national estimates, as many as 18,000 Vermont residents have chronic Hepatitis C, also known as Hep C. About three-quarters of them are unaware of their infection, because it can be years or decades before symptoms develop.

There are two groups of people who are of particular concern when it comes to Hep C. National data indicates that a significant number of baby boomers (people born between 1945 through 1965) have the virus and are unaware of it. People in this age group may have been exposed through blood transfusions or other blood products received before widespread screening of the blood supply began in 1992.

Others may have become infected from sharing injection drug equipment in the past.
The sharing of drug syringes is associated with most new cases of Hep C infection. It is such an efficient route of transmission that injection drug users are at the highest risk of acquiring the virus today.

"Evidence of this behavior-to-virus connection is playing out in rural Indiana in an HIV and Hep C outbreak that's been in the news of late," says Patsy Kelso, state epidemiologist for infectious disease.
According to the CDC, as of April 21, 135 people were diagnosed with HIV in an Indiana community of 4,200 people.
 

Of these, 114 cases were found to be co-infected with Hep C. Injection drug using behavior was reported by 108 of the cases, with four reporting no injection drug use, and another 23 people not yet interviewed.
"Vermonters who inject drugs can be hard to reach with programs designed to help keep them healthy," said Kelso. "There is a high level of stigma directed toward them."

Yet, according to the Health Department, Vermont has some resources in place that might help to decrease the potential for an outbreak of the magnitude that it is occurring in Indiana.

"The Health Department funds four syringe exchange programs throughout the state intended to help people stop sharing injection equipment — the route of transmission for Hep C and HIV," said Kelso. Syringe exchange programs had to be set up on an emergency provisional basis in Indiana. "We provide support for Hep C and HIV testing that is specifically designed to be accessed by injection drug users at syringe exchanges and other support programs in place to help this population," said Kelso.

For more information about Hepatitis C go to healthvermont.gov or visit your local Health Department district office.



Press Release Source:

Gastro Health Suppport Group Sep 19, MIami FL

FDA Reaches Out to Minorities During Hepatitis Awareness Month

Did you know that millions of Americans (mostly baby boomers) are living with chronic Hepatitis and up to 2/3 may not even know they are infected? Annually, in May, the public health community commemorates “Hepatitis Awareness Month” to bring attention to this disease, its symptoms, testing, and treatment options. This year, we are working with the Centers for Disease Control and Prevention (CDC) to conduct outreach for minority groups most affected by Hepatitis: Asian/Pacific Islanders (API) and African-Americans (AA).

Read more...

Hepatitis C is expensive to treat, so curing it could yield huge economic benefit.

While a new generation of safer, more effective oral medications to treat hepatitis C patients may cost tens of thousands of dollars for a 12-week regiment, investing in these new therapies could generate savings estimated at more than $3.2 billion annually in the U.S. and five European countries, according to a new study.

The higher cure rate and lessened side-effects of treating patients with an all-oral combination of ledipasvir and sofosbuvir (LDV/SOF) results in greatly reduced absenteeism and improved workplace productivity that can translate into enormous benefit, according to the new economic model used by researchers at Inova Fairfax Medical Campus, VA.

"From a clinical standpoint, we've long known about the devastating health impacts that chronic hepatitis C has on a patient," said Zobair Younossi, MD, chairman of the department of medicine at Inova and lead researcher on the study. "But given the significant side-effects previously associated with treating the disease, notably fatigue and neuropsychiatric side effects, we were interested in looking at the impact of new treatments on patients' ability to work, and in a broader sense, how this effects employers and overall economies."

Read more: http://www.sciencecodex.com/curing_hepatitis_c_could_yield_huge_economic_benefit-157297#ixzz3aPv0bT24