BIOTECHS TARGETING NASH

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The list is not exhaustive and will be completed at the discretion of news flow


THE COMPETITORS IN THE RACE

The NASH treatment market is focused by laboratories all around the world and almost every week, there is an article announcing the will of a laboratory to test one of their molecules on the disease.

 



The following list try to compile the drugs promoted by labs as NASH potential treatment !

You can click on the names in the list to get more information on the drug

Starting the race does not mean passing the finish line, to date only four laboratories have finished their Phase 2b clinical and launched their Phase 3   : 'INTERCEPT Pharmaceutical,  GENFIT, GILEAD and ALLERGAN.

In ambush with other molecules, laboratories are ongoing Phase 2a or 2b: GALMED, IMMURON,CONATUS, NOVARTIS  being the most advanced of the challengers.

NOVO NORDISK seams to focus on NASH also with its GLP1 analog !


PROGRESS IN THE RACE TO REACH THE MARKET

The list below is not exhaustive because it is growing every week. Below is an attempts to give an overview of the most dynamic players and their progress (click magnifier to enlarge it)


The race to the treatment of NASH - inventory (© G Divry dec 2016)


Clinical studies announced or launched by laboratories often have sizes, designs and brought very different and this has a significant impact on their ability to convince health agencies in terms of the relevance of marketing.

The main criteria requested by the FDA for a Phase 2b or Phase 3 treatment for NASH are a primary endpoint demonstrating the reversion of the NASH no worsening of fibrosis. The only method to assess with certainty the evolution of NASH thus the NAS score and the fibrosis is liver biopsy before and after the study. the definition of the revertion was updated recently and favoured GENFIT treatment instead INTERCEPT one.

A centralized reading of all the biopsies is the reference method.

For short studies with few patients, the FDA also accepts metabolic and non histological criteria. However, these studies can not demonstrate direct impact on NASH. The laboratory must necessarily propose a study with histological information in the absence of validated biomarkers.

This is essential because as we have seen, NASH is a link in a chain that goes from NAFLD to cirrhosis and a simple action on NAFLD may mechanically impact the NASH therefore many laboratories that advertise a study of the NASH target actually NAFLD, which is not the same.


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THE PROBABILITY OF SUCCESS

Success is never guaranteed for molecules in clinical trial phases. There nevertheless are statistical studies that provide different probabilities of success according to the phases of studies and targeted pathologies.

Note that the particularism of clinical analyzes in NASH is the absence of treatment on the market and the need to seek a treatment quickly, eliminating the need to prove in Phase 3 a greater effect than a drug already on the market and improves the probability of obtaining a marketing after this phase.

On the basis of consensual statistical rate of success of the pharmaceutical industry in terms of clinical study phases, we try in the table below to assess the statistical probability of access to the market of each of the more advanced players.

It is considered that those arriving on the market in 3rd position will have to demonstrate their increased efficiency to face newly marketed molecules.

Similarly, the known risk factors on a molecule (increased cardiovascular risk) decrease the probability of market access. 


Based on these tables, each competitor will gradually be analyzed in the following pages with the view of the author.

A fuller analysis of the competitors performed by a small carrier (pwelcome) is available here

DRUG TARGETS ARE SEGMENTING THE MARKET

A study of the positioning and the market share of each drug is possible on the basis of targets reported in clinical studies without prejudice to the reduction or possible extension of these targets in subsequent studies. 

A more detailled segmentation will be soon available.

On this basis we can estimate the annual turnover generated by the respective drugs when all of these will be on the market. 

It is interesting to correlate these figures with the projected schedule of access to the market of each drug, based on the progress of clinical trials phases and providing for a sales ramp-up of 4 years.

We must take these as basic projections trying to integrate the known market elements of the action of drugs and their arrival on the market previsional calendar. Wide value, in particular, may be affected by the downward care rate, which depends, among other things, of the evolution in the diagnosis methods.

A failure in clinical studies, restriction or an expansion of indications, the arrival of a new player, are unpredictable factors that can change these forecasts significantly. Similarly, market size of each segment can be set to change with the advances of scientific research on NASH.




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