Tag Archives: oca

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 Spikes On Report That It’s Exploring A Sale

Shares of biotech Intercept Pharmaceuticals ( ICPT ) spiked 30% in early-afternoon trading Friday on a report that the company is exploring a sale. Reuters cited anonymous sources in its report that Intercept has been working with investment bankers this week after it received interest from other companies. Reuters did not name any of the suitors, but Intercept has been a perpetual source of buyout speculation. Gilead Sciences ( GILD ) is a popular choice of buyer due to its overlapping work in liver diseases, and so are big pharmas working in that space such as Bristol-Myers Squibb ( BMY ), Johnson & Johnson ( JNJ ) and Merck ( MRK ). Intercept shares were up about 31% on the stock market today , near 123. An imminent deal would be oddly timed, however, given that Intercept’s lead drug is tied up in a long and uncertain FDA review. Initially the agency set a deadline of Feb. 29 to decide whether to approve Intercept’s obeticholic acid (OCA) for primary biliary cirrhosis (PBC). In December, however, the FDA pushed the deadline out to May 29 to provide time for an advisory committee, or adcom, to review and vote on the application on April 7. The FDA generally calls such committees when it has unresolved issues with the data. Intercept is also studying OCA for the potentially much bigger market in nonalcoholic steatohepatitis (NASH), but safety issues have arisen in its trials. “We doubt that Intercept could or would be acquired before at least an adcom panel to discuss the risk/benefit of the drug for PBC approval, and any indications of interest by an acquirer would be more to just do due diligence and explore scenarios and valuations first,” wrote RBC Capital Markets analyst Michael Yee in a research note. Yee added that an acquirer would likely have to pay up to $5 billion for Intercept but wouldn’t be able to make money off the deal for years since the drug is expected to ramp slowly. This uncertainty over the last few months has helped tamp down Intercept’s stock even more than other biotechs’, as it’s trading at only about a third of its May high of 314.88. Image provided by Shutterstock .