Why This Report is Essential
Expect a revolution in the treatment of nonalcoholic steatohepatitis (NASH) as a number of new therapies compete to become the first approved treatment for a disease that has high unmet clinical need. Nonalcoholic Steatohepatitis: KOL Insight reveals the critical views of US and European KOLs whose insights hold key lessons for pharma. Gain insights on products in the pipeline and how they could revolutionise the treatment algorithm.
Among the pipeline products analysed in this report is Intercept's/Dainippon Sumitomo Pharm's FXR agonist, obeticholic acid, Genfit's PPAR alpha/delta agonist, GFT505 and Gilead's Simutuzumab. Others vying for market voice include Tobira Therapeutics's dual CCR2/CCR5 antagonist, cenicriviroc (TBR-652) and in the paediatric sector, Raptor Pharmaceuticals' delayed-release cysteamine bitartrate.
The upcoming products vary in their effectiveness in resolving the steatohepatitis and controlling fibrosis associated with NASH. Combination therapy is likely to shape the treatment paradigm in the future, as none offer a single solution.
Nonalcoholic Steatohepatitis: KOL Insight gives exclusive insights on what leading NASH specialists think about the emerging clinical benefits and disadvantages of key pipeline programmes and what will influence prescribing decisions. In addition, specialists voice their opinions on optimal clinical trial designs, including endpoint selection, which could help clarify future treatment decisions.
Understand the clinical insights of current treatment strategies and formulate effective strategies for new product positioning and clinician communication.
Map new treatment options to the NASH spectrum, including patient sub groups, in preparation for market planning activities.
Identify what emerging product attributes and patient characteristics KOLs think will be most important in terms of influencing prescribing decisions.
Discover which clinical trials, including designs and endpoints, the KOLs believe will have a significant impact on future treatment decisions and their likely outcomes.
Evaluate the evolving NASH competitive landscape to get an edge on potential licensing opportunities in the future.
Answers to Critical Questions
Intercept's/Dainippon Sumitomo Pharma's obeticholic acid addresses NASH on many levels but how will adverse reactions impact its approval and the future use of the drug?
What key clinical differentiators could Genfit exploit for GFT505, its PPAR alpha/delta agonist?
What pricing strategy should Gilead consider for anti- lysyl oxidase-like-2 (LOXL2) mAb, simtuzumab?
Preliminary results for Tobira's dual CCR2/CCR5 antagonist, cenicriviroc, are seen as encouraging by KOLs, but what do KOLs think are the best combination approaches with this product?
Raptor Pharmaceuticals' RP103 is expected to be first-to-market for paediatric NASH, but cost and competition from other therapies which gain the same indication remain challenges for the future; how might the company best meet these?
What role will biomarkers play in shaping the NASH treatment landscape?
The use of combination therapy looks set to deliver the best outcomes for patients with NASH, but which products and MOAs are looking compatible at this stage?
Hear the detailed opinions of leading front line clinicians on current and future treatments for NASH, and what they see as the critical advantages/disadvantages affecting their decision to use.
Understand important clinical and market factors that will shape the NASH sector and identify key areas for strategic and tactical action.
Benchmark current thinking on how the new therapies will fit into the treatment paradigm.
Review KOL attitudes to important clinical trials such as FLINT, GOLDEN, CENTAUR, ORION, CyNCH, and LEAN.
Key Opinion Leaders
Scott L. Friedman, Professor, Icahn School of Medicine at Mount Sinai
Brent A. Neuschwander-Tetri, Professor, Saint Louis University School of Medicine
Stephen A. Harrison, University of Texas Health Science Center in San Antonio and Brooke Army Medical Center, Fort Sam Houston, Texas
Philip Rosenthal, Professor, University of California, San Francisco
Mary Rinella, Northwestern University Feinberg School of Medicine
Joel Lavine, Morgan Stanley Children's Hospital and Columbia University Medical Center
Vlad Ratziu, Professor, Université Pierre et Marie Curie and the Hôpital Pitié-Salpêtrière Medical School in Paris
Elisabetta Bugianesi, S. Giovanni Battista Hospital, University of Torino
Giulo Marchesini Reggiani, Professor, University of Bologna
Fabio Marra, University of Florence
Guruprasad P. Aithal, Nottingham Digestive Diseases Centre, University of Nottingham
Anonymous German KOL
Update Bulletins Offer Ongoing Benefits
The world of pharma is ever changing and executives must always be up-to-date with new developments that could affect their own products, position and research. That is why FirstWord’s guarantee to keep Therapy Trends clients up to date with Update Bulletins offers a real commercial advantage.
Update Bulletins include expert insight and analysis based on FirstWord analyst re-engagement with the KOLs after major events such as product approvals, key data releases and major conferences to deliver the most valuable insights with each update.
Your Therapy Trends Report purchase entitles you to receive three Update Bulletins, which are published approximately every three months for 12 months following the report's publication date, March 2015.
You will receive a copy of each Update Bulletin once available, which are issued each quarter after the publication date.
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