Tag Archives: nash

Gilead Sciences Broadens Liver Program With Nimbus Acquisition

Big biotech Gilead Sciences ( GILD ) added to its fatty-liver-disease portfolio Monday by acquiring a line of biotech drugs in a deal potentially worth $1.2 billion. Gilead acquired Nimbus Therapeutics ‘ Nimbus Apollo division for $400 million upfront, plus up to $800 million in milestones if Nimbus’ drugs successfully make it through the development process. And the deal seemed to spark the shares of another drugmaker targeting nonalcoholic steatohepatitis,  Intercept Pharmaceuticals ( ICPT ). Nimbus Apollo has a pipeline of  acetyl-CoA carboxylase (ACC) inhibitors, the most advanced of which is NDI-010976 for nonalcoholic steatohepatitis (NASH), a common but currently untreatable condition causing liver damage through fat buildup. Phase-one trial results for NDI-010976 are due to be presented in a couple of weeks at the annual International Liver Congress. NASH is seen by analysts as a potentially enormous untapped market, and Gilead has been compiling a portfolio of drugs in the space to build on the liver-disease infrastructure it created to sell its massively successful hepatitis C drugs. In January 2015, the company bought Phenex Pharmaceuticals for its program targeting a different receptor, on top of its in-house development simtuzumab, which is in midstage testing for NASH. “These molecules will complement and further strengthen Gilead’s pipeline and capabilities to advance a broad clinical program in NASH that includes compounds targeting multiple key pathways involved in the pathogenesis of the disease,” Gilead Chief Scientific Officer Norbert Bischofberger said in a statement Monday. Credit Suisse analyst Alethia Young wrote that Gilead probably expects NASH to ultimately be treated with a combination therapy. The ACC approach has a bit of a checkered past, however. “This is a target that has been tried before by big pharm and has failed due to binding sites and difficulties in making it a drug-able target,” Young wrote in a research note. Young also wrote that she was “not surprised” that Gilead chose to buy Nimbus Apollo instead of Intercept, which has what is generally seen as the leading contender for NASH with its drug candidate obeticholic acid (OCA). Intercept has been bandied about as a buyout target by Gilead and other players in liver disease, but analysts say it’s unlikely that anyone will buy it before OCA is approved, and certainly not before this Thursday’s FDA advisory committee meeting on OCA . Intercept stock was nonetheless up 6% in strong volume in early afternoon trading on the stock market today , near 138. Gilead stock was up nearly 1%, near 95.

Intercept Pharma Gets Dueling Initiation Reports As FDA Panel Nears

Shares of biotech Intercept Pharmaceuticals ( ICPT ) were up in twice-average volume Wednesday, after two analysts launched coverage ahead of a crucial FDA panel vote. Credit Suisse’s Alethia Young initiated with a buy rating, while Salveen Richter at Goldman Sachs initiated with a neutral rating, though they agreed on the general outlines of the investment thesis. Intercept’s lead drug candidate, obeticholic acid (OCA), is up for an FDA advisory committee discussion on April 7 as a treatment for primary biliary cholangitis (PBC), a rare, chronic liver disease. If approved by the FDA’s May 29 deadline, it would be Intercept’s first commercial product. Young estimates that annual sales for obeticholic acid could hit $259 million in 2018, though Richter forecasts it at only $170 million at peak. Both analysts, however, agree that the really big potential market for OCA is in nonalcoholic steatohepatitis (NASH), a much more common liver disease without a current treatment. That could draw $3.5 billion a year, Richter estimates, but that’s a ways in the future: The next batch of data from the NASH clinical trial isn’t expected until 2018. Between the panel meeting and the NASH data, Richter sees “a dearth of catalysts” to drive Intercept’s stock, leading him to set his price target at 114. Young, however, says approval and launch for treatment of PBC, both in the U.S. and Europe, could provide more upside for the stock. Her peak sales estimate in NASH is almost twice Richter’s at $6.5 billion. She set her price target at 200. Intercept stock rose 5% in early trading on the stock market today , but by early afternoon it was up 1%, near 125.50. Shares hit a 19-month high above 314 last May.

Intercept Pharma NASH Drug Disappoints In Japan

Biotech Intercept Pharmaceuticals (ICPT) was trading down sharply Wednesday morning after the first Japanese trial of its fatty-liver-disease drug produced mixed results. The midstage trial, conducted by Intercept’s Japanese partner Dainippon Sumitomo Pharma, divided 200 patients with non-alcoholic steatohepatitis (NASH) into three different dosage groups taking obeticholic acid (OCA), along with a placebo group. The endpoint was an two-point