X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    New Delivery Path Brings To Light Efficacy of Immunotherapy

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    New Delivery Path Brings To Light Efficacy of Immunotherapy

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development Research & Development

Allergan Expands Leading Research & Development NASH Program with Novartis Clinical Collaboration

Yuvraj_pawp by Yuvraj_pawp
18th April 2017
in Research & Development

Allergan, a leading global biopharmaceutical company, announced today that it has entered into a clinical trial agreement with Novartis to conduct a Phase 2b study, using Allergan’s cenicriviroc (CVC) and Novartis’ lead FXR agonist for the treatment of non-alcoholic steatohepatitis (NASH).

The Phase 2b study will assess the safety, efficacy and tolerability of this multi-therapy treatment approach for NASH. The financial details of this transaction are not disclosed.

“Our clinical collaboration with Novartis brings together our collective scientific and development expertise in NASH to focus on multi-therapy treatment, which is expected to be the most likely approach based on the multi-factorial aspects of this disease,” said David Nicholson, Chief Research & Development Officer, Allergan. “Collaboration with companies like Novartis will help us improve our understanding of the disease and deliver effective, high-value medicines for NASH patients. This is also another terrific example of Allergan’s Open Science Research & Development model in action.”

NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes.i NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage.ii The inflammation can result in fibrosis (scarring) of the liver and eventually lead to complications such as cirrhosis, portal hypertension, liver cancer and liver failure.ii There are currently no approved treatments for NASH.


CVC is a once-daily, oral, Phase 3 ready potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways. In the Phase 2b CENTAUR study, CVC demonstrated a clinically meaningful improvement in fibrosis of at least one stage without worsening of NASH after one year of treatment, which is one of only two approvable Phase 3 endpoints. With its unique Mechanism of Action (MOA) and its favorable safety profile, CVC represents an ideal candidate to become the backbone of NASH multi-therapy treatment. CVC has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in patients with NASH and liver fibrosis.


Novartis is developing Farnesoid X receptor (FXR) agonists for the treatment of chronic liver diseases, including NASH. The most advanced investigational compound is a potent, non-bile acid FXR agonist, which recently received Fast Track designation from the FDA and is in a Phase 2 clinical trial. As part of this agreement, Novartis and Allergan will conduct a Phase 2b clinical trial to assess the safety, efficacy and tolerability of a multi-therapy treatment for NASH.


About Non-Alcoholic Steatohepatitis (NASH)

NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes.ii NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage.ii The inflammation can result in fibrosis (scarring) of the liver and eventually lead to complications such as cirrhosis, portal hypertension, liver cancer, and liver failure.ii


NAFLD and NASH affect approximately 30 percent and 5 percent, respectively, of the U.S. population and NAFLD affects more than 20 percent of the population worldwide.iii NASH is the fastest growing cause of liver cancer and liver transplant in the U.S.iv The increasing prevalence of NASH is related to the growing obesity epidemic and the disease is often diagnosed in patients who have diabetes, high cholesterol or high triglycerides.iii There is currently no approved treatment for NASH.


About Allergan NASH Programs

Allergan has demonstrated leadership in the gastrointestinal (GI) category and shown a continued commitment to innovate and advance science and treatments for unmet medical needs. Currently, NASH is an extension of Allergan’s broad GI portfolio and represents one of the greatest unmet medical needs.


In 2016, Allergan acquired cenicriviroc (CVC), evogliptin and AGN-242266 (formerly AKN-083), three programs targeting different mechanisms for the treatment of this multi-factorial disease. CVC is a once-daily, oral Phase 3 ready, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways. AGN-242266 is a potentially best-in-class, Phase 1 ready farnesoid X receptor (FXR) agonist expected to be highly complementary to CVC and Evogliptin. Allergan expects to advance AGN-242266 into a Phase I clinical trial in the first half of 2017. Allergan is committed to advancing its overall portfolio of NASH programs, to focus on bringing forward effective treatments for this critical disease area.


About Allergan plc

Allergan plc , headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.


Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.


Allergan is an industry leader in Open Science, the Company’s R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.


Our Company’s success is powered by our more than 16,000 global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.


With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan’s website at www.Allergan.com

 

ALLERGAN:

Investors:

Karina Calzadilla

(862) 261-7328


Media:

Mark Marmur

(862) 261-7558

Previous Post

Medical fair thailand 2017 reflects the bullish growth of the Medical industry in the region

Next Post

Roche to present new data at AAN reinforcing efficacy and safety of newly FDA-approved OCREVUS

Related Posts

Tumors Can Get Destroyed By Bacteria-Aid To Immune System
News

Tumors Can Get Destroyed By Bacteria-Aid To Immune System

16th March 2023
News

Researchers Develop Revolutionary Treatment In Bone Cancer

10th March 2023
News

T Cells Are Fruitful In Thwarting-Off Chronic Infections

10th March 2023
News

Randomness Drives Tumour Cells Response To Chemotherapy

10th March 2023
Featured

Animal Testing Could See An End With An Artificial Model

28th February 2023
Featured

Germany Rolls First CAR-T Push For Muscle Inflammation Cure

27th February 2023
Next Post

Roche to present new data at AAN reinforcing efficacy and safety of newly FDA-approved OCREVUS

Latest News

Drug Development

New Delivery Path Brings To Light Efficacy of Immunotherapy

1st April 2023
Cathay Cargo signs global airline partnership with Tower Cold Chain
Packaging & Logistic

Cathay Cargo signs global airline partnership with Tower Cold Chain

31st March 2023
Quotient Sciences completes integration of drug substance into Translational Pharmaceutics Platform
Facilities & Operation

£277m Funding Set To Benefit UK Life Sciences Manufacturing

31st March 2023
Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In