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Alan Franciscus
Editor-in-Chief
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated September 17, 2014

Wednesday, October 1, 2014

Did Achillion Pharmaceuticals, Inc. Get Left Out in the M&A Cold?

Achillion (NASDAQ: ACHN  ) investors are probably shaking their heads wondering what's wrong with their company following Johnson & Johnson's (NYSE: JNJ  )  acquisition of the privately held Alios for $1.7 billion this week.

On the surface, J&J's willingness to fork over so much money for the unproven nucleotides percolating in Alios' pipeline would seem to support a higher valuation for Achillion, which has two hepatitis C drugs in phase 2 trials and boasts a market cap of just $1.1 billion. But instead of climbing, Achillion shares retreated following the announcement, so let's take a closer look.

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Novartis AG (NVS) Ditches Hepatitis C Drug Dreams, Breaks $440 Million Enanta Pharmaceuticals, Inc. Deal

EDP-239 inhibits the NS5A non-structural viral protein that is essential to the replication of hepatitis C within the body. The inhibitor has shown that it has additive or synergistic antiviral activity when use in combination with other anti-hepatitis C virus therapeutics. 

Swiss bipharma behemoth Novartis AG (NVS) has announced that it will give full rights of its hepatitis C inhibitor to Enanta Pharmaceuticals, Inc. just as the drug, EDP-239, is currently in phase 1 development for the hepatitis C virus.

Enanta Pharmaceuticals works on small molecule drugs in the infectious disease industry. Enanta and Novartis entered a collaboration to advance EDP-239 in February 2012 but now appear to be parting ways as Novartis revamps its portfolio.

“Novartis notified Enanta that as part of an ongoing portfolio transformation, HCV research would no longer be a strategic focus for Novartis,” said Jay Luly, president and chief executive of Enanta Pharmaceuticals. “We appreciate Novartis’ contributions to the clinical development of EDP-239 and its ready agreement to return the NS5A program to us. Enanta is now positioned with three wholly-owned HCV programs from which future drug combinations can be explored.” 


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UC to Combat Spread of Hepatitis C Among Drug Users

A University of Cincinnati professor is combating the spread of hepatitis C among young adults in Southern Ohio who inject heroin with a $900,000, three-year grant from the Centers for Disease Control and Prevention. 

The purpose of the grant is to identify interventions for young adults ages 18-30 “who inject drugs and either already have hepatitis C or are at risk of contracting hepatitis C,” said Judith Feinberg, professor of internal medicine at UC and principal investigator on the grant.

With the grant funds, researchers will hire and train outreach workers to recruit young injection drug users at risk for or currently with hepatitis C, and who reside within one of 21 counties across Southern Ohio. Those counties are: Adams, Athens, Brown, Butler, Clermont, Clinton, Fayette, Gallia, Greene, Highland, Hocking, Jackson, Lawrence, Meigs, Montgomery, Pike, Preble, Ross, Scioto, Vinton and Warren, according to the university’s press release.

AbbVie Demonstrates Commitment to Continued Research in Hepatitis C with Investigational Data from Clinical Program Being Presented at The Liver Meeting®

Data from 25 accepted abstracts include results from:

-- AbbVie's investigational treatment in liver transplant recipients with recurrent genotype 1 (GT1) chronic hepatitis C virus (HCV) infection and in GT1 HCV patients with human immunodeficiency virus type 1 co-infection

-- Abstracts evaluating AbbVie's investigational treatment combining two direct-acting antivirals with or without ribavirin (RBV) in patients with genotype 4 chronic HCV infection

-- Trials of other pipeline compounds ABT-493 and ABT-530 in GT1 chronic HCV infection
Oct 1, 2014

NORTH CHICAGO, Ill., Oct. 1, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that data from its ongoing Phase 1 through Phase 3 hepatitis C clinical development programs will be presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 7-11, 2014.

Abstracts will be presented highlighting results from AbbVie's investigational treatment combining three direct-acting antivirals (ABT-450/ritonavir, ombitasvir and dasabuvir) with or without ribavirin (RBV) in patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. These abstracts include a Phase 2/3 study in patients co-infected with human immunodeficiency virus type 1 (HIV-1) (TURQUOISE-I) and a Phase 2 study in liver transplant recipients without cirrhosis (CORAL-I). 

Additionally, Phase 2 data will be presented from investigational studies evaluating the combination of ABT-450/ritonavir and ombitasvir with or without RBV in genotype 4 (GT4) patients (PEARL-I). AbbVie will also be presenting data from its two additional pipeline HCV compounds, ABT-493 and ABT-530.

Key AbbVie HCV Data at AASLD 2014 includes:
  • TURQUOISE-I: SVR12 data in HCV/HIV-1 Co-infected Patients Treated with ABT-450/r/Ombitasvir and Dasabuvir and RibavirinPoster # 1939
    November 11, 2014, 8:00 a.m.12:00 p.m. EST, Poster Hall
    This study evaluates a treatment of ABT-450/ritonavir, ombitasvir and dasabuvir plus RBV in treatment-naïve and peginterferon/RBV-experienced adults co-infected with GT1 HCV and HIV-1, with and without cirrhosis (Child-Pugh A).
  • Sustained Virologic Response Rates in Liver Transplant Recipients with Recurrent HCV Genotype 1 Infection Receiving ABT-450/r/Ombitasvir + Dasabuvir Plus RibavirinOral Presentation at the Hepatitis Plenary Session
    November 11, 2014, 9:15 a.m.9:30 a.m. EST
    This ongoing Phase 2 study examines safety and efficacy of ABT-450/ritonavir, ombitasvir and dasabuvir plus RBV in non-cirrhotic HCV treatment-naïve since liver transplant recipients with recurrent GT1 HCV infection.
  • Interferon-Free Regimens of Ombitasvir and ABT-450/r with or without Ribavirin in Patients with HCV Genotype 4 Infection: PEARL-I Study ResultsPoster # 1928
    November 11, 2014, 8:00 a.m.12:00 p.m. EST, Poster Hall
    The PEARL-I study assesses safety and efficacy of an all-oral regimen of ABT-450/ritonavir and ombitasvir with or without RBV in treatment-naïve and peginterferon/RBV-experienced non-cirrhotic patients with GT1b and GT4 HCV infection.
Additional HCV Data Highlights
  • Antiviral Activity of ABT-493 and ABT-530 with 3-Day Monotherapy in Patients with and without Compensated Cirrhosis with Hepatitis C Virus (HCV) Genotype 1 InfectionPoster # 1956
    November 11, 2014, 8:00 a.m.12:00 p.m. EST, Poster Hall
    This study evaluates antiviral activity, safety, and tolerability of ABT-493 and ABT-530 administered as monotherapy for three days in treatment-naive adults with chronic GT1 HCV infection with and without compensated cirrhosis.
  • Pharmacokinetics and Safety of Pan-Genotypic, Direct Acting Protease Inhibitor, ABT-493, and NS5A Inhibitor, ABT-530, Following 3-Day Monotherapy in HCV Genotype-1 Infected Subjects with or without Compensated CirrhosisPoster # 1986
    November 11, 2014, 8:00 a.m.12:00 p.m. EST, Poster Hall
    This study explores the safety, pharmacokinetics and antiviral activity of ABT-493 and ABT-530 administered as monotherapy for three days in GT1 HCV infected patients with or without compensated cirrhosis.
The full list of accepted abstracts for The Liver Meeting can be accessed on www.aasld.org.

About AbbVie's HCV Clinical Development Program The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating interferon-free, all-oral treatments with and without ribavirin with the goal of producing high sustained virologic response rates in as many patients as possible. AbbVie's multinational Phase 3 program using an investigational treatment combining three direct-acting antivirals includes more than 2,300 patients in over 25 countries. The program is designed to identify ways to maximize response rates in a broad spectrum of GT1 patient populations, including those with compensated cirrhosis, liver transplant recipients and those with human immunodeficiency virus type 1 co-infection. AbbVie's development programs using all-oral investigational treatments combining two direct-acting antivirals are studying additional hepatitis C virus (HCV) genotypes.

AbbVie's pipeline of multiple direct-acting antiviral compounds for the treatment of hepatitis C aims to investigate interferon-free treatments that target multiple HCV genotypes. 

ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

Safety Information for Ribavirin and RitonavirRibavirin and ritonavir are not approved for the investigational uses discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
There are special safety considerations when prescribing these drugs in approved populations.
Ritonavir must not be used with certain medications due to significant drug-drug interactions and in patients with known hypersensitivity to ritonavir or any of its excipients.

Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score >6.

See approved product labels for more information.

About AbbVieAbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

SOURCE AbbVie
For further information: Media: David Freundel, +1 (847) 937-4522, david.freundel@abbvie.com, or Javier Boix, +1 (847) 937-6113, javier.boix@abbvie.com, or Investor Relations: Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com

HIV and hepatitis is on the rise in Europe: Rigshospitalet

There is an urgent need to change our strategy for testing for HIV and hepatitis in Europe. The number of people infected is increasing and many are still not aware that they are infected. The problem is greatest in Southern and Eastern Europe, but it is also an increasing problem in other European countries, and new testing strategies are therefore required. Late diagnosis means a higher mortality rate, greater risk of onward transmission and increased financial costs.

European Union/CIA
European Union/CIA

More than two million Europeans are HIV positive. About 15 million adults are infected with hepatitis C and 13 million with hepatitis B. Most of these people are unaware of their infection. The lack of knowledge about their own infection means that most people are treated too late, and that a great number of people have HIV for many years before infections are discovered. In order to reverse this upward curve, there is an urgent need for European health authorities to change strategy in order to provide HIV and hepatitis testing to far more people than today.

Coupling of two widespread infections
Experience shows that challenges in connection with diagnosing HIV and hepatitis patients have many overlaps. This topic will be debated at a conference in Barcelona on 5-7 October 2014. The ‘HIV in Europe’ initiative, coordinated by CHIP, a research unit under Rigshospitalet, is co-organising the conference.

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Corinna Dan Reflects on Her Commitment to Fighting Viral Hepatitis and Introduces Viral Hepatitis Action Plan

Many of our colleagues in the HIV/AIDS and viral hepatitis fields have both personal and professional commitments to their work, formed by diverse life experiences that continue to inspire them. Recently, we visited with our colleague Ms. Corinna Dan, R.N., M.P.H., who serves as Viral Hepatitis Policy Advisor in the HHS Office of HIV/AIDS and Infectious Disease Policy. During our conversation, she reflected on her prior experience, including serving as the Adult Viral Hepatitis Prevention Coordinator for the Chicago Department of Public Health. Watch Corinna’s reflection below.

 - See more at: http://blog.aids.gov/2014/10/corinna-dan-reflects-on-her-commitment-to-fighting-viral-hepatitis-and-introduces-viral-hepatitis-action-plan.html#sthash.k4su0ght.dpuf

Tuesday, September 30, 2014

J&J goes 'nuc'lear with $1.75 billion buyout of Alios BioPharma

Johnson & Johnson will buy South San Francisco’s Alios BioPharma Inc. in a $1.75 billion cash deal that will boost the big pharmaceutical company’s profile in hepatitis C and other virus fighters.

The deal has been approved by the boards of both companies and is expected to close yet this year.

Partner Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) has an Alios-developed hepatitis C drug, called ALS-2200 or VS-135, in mid-stage human studies, but Alios’ power for J&J may rest deeper in the company’s portfolio. A number of drugs that Alios is studying, as well as VS-135, tap into the hot area of nucleotides.

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