In their rush to development new treatments for a largely unknown fatty liver disease called Nash, large drug companies such as Allergan (AGN), Shire (SHPG), Gilead (GILD) and Novo Nordisk (NVO) are spending billions of dollars, reported the Financial Times. At its peak, it's expected to generate $35 billion in annual revenue, making it a huge payout. However, some experts feel the rarity of the disease make all that money a waste. And the fact that these drugs are still not approved yet by the FDA make it an additional challenge.
Obesity Epidemic to Soar
But that won't stop big pharma companies from trying to be the first in line to develop a drug to combat Nash, which is prevalent among overweight individuals and if not treated, could escalate into either liver or heart disease. The big reason has to do with the obesity epidemic, which some analysts, said FT, predict "will rise dramatically in the coming years" and not just in the U.S., but worldwide. Citing data from Bernstein, the news outlet noted that Nash, which causes scarring and inflammation of the liver, is believed to afflict more than 16 million people in the U.S. The U.S. Centers for Disease Control estimates that 20,000 deaths occur per year from liver disease or cirrhosis not related to alcoholism.
Because of these stats, drug companies are working overtime to develop treatments that could effectively treat the disease.
Vying for a Cure
Allergan, known for making botox, is probably ahead of the others having recently acquired San Francisco-based biotech group Tobira for $1.7 billion, reported FT. Tobira has developed a drug Cenicriviroc to fight Nash; it will undergo three trials later this year with results expected as early as 2019. (For more, see also: Allergan Stock Showing Signs of Life.)
And not to just rest on Tobira's laurels, Allergan recently acquired Arkana, another Nash-focused drugmaker that's smaller than its rival, for $50 million.
Also entering the fray is Gilead, which recently acquired West Coast-based biotech company Nimbus for up to $1.2 billion. Gilead is banking heavily on Nimbus as it recently scored success with its treatments for hepatitis C, another potentially fatal liver disease, added FT. (For related reading, see also: Gilead to Focus on NASH and HIV Drugs in 2017.)
Drug makers Novo Nordisk and Shire are also reportedly working on developing drugs to combat Nash albeit at an earlier stage than Allergan and Gilead. And two biotech companies, New York-based Intercept Therapeutics and French rival Genfit, are even further along than the big pharma companies when it comes to developing drugs for late-stage clinical trials.
When word came out last week how advanced Intercept was in its quest to develop an anti-Nash drug, its stock leaped 13%. Unfortunately, for Intercept and for those working hard to develop treatment for Nash, luring patients to participate in the trial has been difficult. Intercept has only enrolled 750 patients versus the original target of 1,400, a recruitment process that took longer than expected. Also compounding the challenge is the FDA imposing a higher burden for Intercept to prove that its drug can either resolve Nash or improve fibrosis, the medical term for liver scarring.
And yet, given the slow progression of the disease and the likelihood that sufferers will die of something else, some experts are looking askance at all this labor and money being invested for a drug that not a lot of people will need nor something they will want to take on an habitual basis.
Speaking to FT, Ronny Gal, an analyst at Bernstein, said: “I’m skeptical as to whether this is actually needed for most people. You’re essentially trying to put into chronic treatment forever a broad population that will probably never develop the most serious form of the disease.”
Given the small number of Nash suffers in the U.S, which is about 1.5 million, health insurers might only want to pay for only the sickest patients, added Gal. According to him, the market here is much smaller than what industry pundits expect for what he characterizes as a "midsize condition," reported FT.