Tag Archives: biotech

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.

Regeneron Soars After Drug Clears Eczema, Sparks Market Size Debate

Big biotech Regeneron Pharmaceuticals ( REGN ) and its big pharma partner Sanofi ( SNY ) said Friday that their potential blockbuster eczema drug candidate sailed through late-stage trials and would be submitted for approval in Q3 of this year. Regeneron shares spiked Friday, headed for their best one-day percentage gain in years. Regeneron’s and Sanofi’s drug dupilumab cleared or nearly cleared the symptoms of atopic dermatitis (eczema) in more than a third of patients, compared with less than 10% of patients in the placebo group, in two clinical trials comprising a total of 1,379 people. Patients on dupilumab in general average around a 70% improvement in the Eczema Area and Severity Index (EASI), whereas the placebo group improved in the 30% to 40% range. “There are no approved systemic therapies in the U.S. for people with moderate-to-severe atopic dermatitis, underscoring the clear unmet need,” Sanofi R&D head Elias Zerhouni said in a statement. “In the U.S., where dupilumab in AD (atopic dermatitis) has been granted Breakthrough Therapy designation by the U.S. FDA, we plan to submit a regulatory application in the third quarter of this year and will work to bring this innovative therapy to patients as quickly as possible.” Evercore ISI analyst Mark Schoenebaum wrote that analysts’ consensus peak annual sales estimate for dupilumab is $4 billion, but there’s quite a bit of variation between individual analysts. “We believe that the current debate for dupilumab is focused on the size of commercial opportunity — it is also in late stage studies for severe asthma (where dupilumab demonstrated high efficacy in phase two in an all-comers population) as well as chronic sinusitis with nasal polyps and eosinophilic esophagitis,” Schoenebaum wrote in an email to clients. “A/D is a relatively new market segment and dupilumab is one of the first therapeutic candidates that could address the high unmet need. … The commercial opportunity in severe asthma may be similarly attractive; however, dupilumab will be facing a more crowded competitive landscape in asthma.” Regeneron shares shot up 13.5% in afternoon trading on the stock market today to about 409, moving over its 50-day moving average for the first time in 2016. Regeneron stock touched a 17-month low below 349 on March 17. Sanofi stock rose a fraction, above 40.

Regeneron-Sanofi Drug Clears Eczema, Sparks Debate On Market Size

Big biotech Regeneron Pharmaceuticals ( REGN ) and its big pharma partner Sanofi ( SNY ) said Friday that their potential blockbuster eczema drug candidate sailed through late-stage trials and would be submitted for approval in Q3 of this year. Regeneron’s and Sanofi’s drug dupilumab cleared or nearly cleared the symptoms of atopic dermatitis (eczema) in more than a third of patients, compared with less than 10% of patients in the placebo group, in two clinical trials comprising a total of 1,379 people. Patients on dupilumab in general average around a 70% improvement in the Eczema Area and Severity Index (EASI), whereas the placebo group improved in the 30% to 40% range. “There are no approved systemic therapies in the U.S. for people with moderate-to-severe atopic dermatitis, underscoring the clear unmet need,” Sanofi R&D head Elias Zerhouni said in a statement. “In the U.S., where dupilumab in AD (atopic dermatitis) has been granted Breakthrough Therapy designation by the U.S. FDA, we plan to submit a regulatory application in the third quarter of this year and will work to bring this innovative therapy to patients as quickly as possible.” Evercore ISI analyst Mark Schoenebaum wrote that analysts’ consensus peak annual sales estimate for dupilumab is $4 billion, but there’s quite a bit of variation between individual analysts. “We believe that the current debate for dupilumab is focused on the size of commercial opportunity — it is also in late stage studies for severe asthma (where dupilumab demonstrated high efficacy in phase two in an all-comers population) as well as chronic sinusitis with nasal polyps and eosinophilic esophagitis,” Schoenebaum wrote in an email to clients. “A/D is a relatively new market segment and dupilumab is one of the first therapeutic candidates that could address the high unmet need. … The commercial opportunity in severe asthma may be similarly attractive; however, dupilumab will be facing a more crowded competitive landscape in asthma.” Regeneron stock was up more than 4% in early trading on the stock market today , near 378, but Sanofi stock was down a fraction, near 40. Regeneron stock touched a 17-month low below 349 on March 17.