09 Aug NASH|The hepatic Artery Disease
It is a significant form of chronic liver disease in adults and children. It usually results as a consequences of an excessive accumulation of fats in the liver, which affects a large and growing number of people, on a scale called to be universal.
Experts don’t yet know why, some people with a buildup of fat in the liver get NASH and some don’t. It could be that something in the environment triggers the inflammation in those people. Or maybe it runs in their families.
Usually Linked to three factors playing in its favor (obesity, overweight and junk food), this disease is growing strongly, especially in Western countries.
As the number of patients affected is expected to explode in the years to come. By 2015, 30% of the world’s population was already overweight, according to a study published this week in the New England Journal of Medicine.
What are the symptoms?
The scaring part is that,have no symptoms in the early stages of NASH. Most people who have NASH feel fine and don’t know that they have it. You only realise when it too late; Fatigue, weight, loss, General weakness can be noticed
Who gains from this ?
NASH could represent a pharmaceutical market of more than $ 25 billion by 2026 in the United States, Western Europe and Japan, with an average annual growth rate of 45% per year, according to GlobalData.
An abnormal accumulation of fat in the liver can trigger the first stage of the disease, a chronic inflammation of the liver, which already affects 12% of Americans and 6% of Europeans, according to epidemiological studies.
Inflammation slowly destroys the cells of this organ, eventually engendering a scar tissue, fibrosis. It may itself degenerate into non-alcoholic cirrhosis or liver cancer.
“In the United States, the first cause of liver transplantation is already NASH, and it is also very soon to be the case in Europe,” warns Cécile Rabian, medical director France of the Gilead laboratory.
In France, NASH recently gained notoriety with a mediated patient, sports journalist Pierre Ménès, saved by a double transplant of the liver and kidney.
Rumors of redemption
The big pharma acquisitions in NASH began in 2015. The palm is back for the moment to the American Allergan which bought the Californian biotech Tobira for $ 1.7 billion last year.
“As NASH involves several steps, it will probably be necessary to combine several mechanisms of action, bi-therapy or triple therapy to try to be even more effective,” says Rabian. This undermines the buyback operations in the sector.
Three companies are leading the way, with Phase III drug candidates, the final clinical stage before commercialization: Americans Gilead and Intercept, and a French biotech, Genfit.
Rumors of redemption often inflame the title of this company Lille, listed on the Paris Stock Exchange. Its stock market valuation now exceeds 900 million euros.
“The probability of being acquired by a major pharmaceutical group remains very high,” says Jean-François Mouney, CEO of Genfit. “But we do not stay on our chair waiting for the customer to knock on the door, we advance, and the more we advance, the more we envy.”
Preliminary Phase III results are expected around mid-2019 on its drug candidate Elafibranor, which aims to reduce or even stop inflammation and degeneration of liver cells by targeting two nuclear receptors regulating genes involved in its functioning.
Mr Mouney hopes for early marketing authorizations in Europe and the United States “at the end of 2019 or early 2020”.
A worrying cost
For now, only one method of diagnosis in NASH is approved by the health authorities: liver biopsy, a tissue sample from the liver. An expensive process, complicated to generalize and which is not without risk for the patient.
Hence the efforts of manufacturers to develop blood diagnostic or imaging tests, otherwise the market will experience a “bottleneck”, AFP Arnaud Guérin, an analyst at Portzamparc, told AFP.
The costs of future treatments may also cause cold sweats to health systems, while some laboratories hope to negotiate prices of several tens of thousands of dollars per year per patient.
Ultimately prices in NASH are expected to reach those of oral antidiabetic drugs, around 13-15,000 dollars a year in the United States and about half as much in Europe, according to Mouney.
Health authorities need to step up efforts to prevent obesity. Because the best current remedy against NASH is also the cheapest: lose weight with a diet low in sugars and doing regular sports.