Tag Archives: regn

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.

Amgen Wins Patent Suit Against Regeneron/Sanofi Drug Praluent

Amgen ( AMGN ) won a patent suit against its fellow biotech Regeneron Pharmaceuticals ( REGN ) and partner Sanofi ( SNY ) related to their rival cholesterol drugs Wednesday. Amgen sued in October 2014, charging that Regeneron’s and Sanofi’s co-developed drug Praluent violated patents that Amgen held on its drug Repatha. The two drugs are similar, both being proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Amgen had been slightly ahead in its development timeline, but Regeneron bought a priority-review voucher that let it launch Praluent last July, about a month ahead of Repatha. The case went to a jury, which on Wednesday ruled in favor of Amgen that its patents were valid. Amgen also asked for a permanent injunction, which will be decided in a hearing scheduled for March 23-24. Regeneron’s general counsel, Joseph LaRosa, said in a press release that the companies will appeal. “This is a complex area of law and science, and we believe the facts and controlling law support our position,” said LaRosa. “We look forward to taking our case to the Federal Circuit Court of Appeals, the U.S. appellate court that hears all biopharmaceutical patent appeals.” Evercore ISI analyst Mark Schoenebaum wrote that the appeal could take an additional 12 to 18 months. “Recall, no new arguments are able to be presented in the Appeals Court (appeal is fact-based) and so the bar is relatively high,” he wrote in an email to clients. Analysts have expected the likeliest outcome to the suit would be a royalty paid to Amgen on Praluent sales. Schoenebaum estimated that a 5% royalty could peel 1% off Regeneron’s 2020 EPS. Trading on Regeneron shares were halted midday in the stock market today while the news came out, after rising 2.6% in morning trading. When trading resumed in the early afternoon, Regeneron stock was down more than 1%. Amgen stock, meanwhile, was down a fraction Wednesday afternoon, near 143, while Sanofi stock, which was not halted, was down nearly 2%, near 40.50.

Regeneron/Sanofi Drug Beats Humira In Rheumatoid Arthritis Trial

A drug candidate that Regeneron Pharmaceuticals ( REGN ) and Sanofi ( SNY ) jointly developed has beaten AbbVie ’s ( ABBV ) best-selling rheumatoid-arthritis (RA) drug in a late-stage study, the companies said Friday. Regeneron and Sanofi said that their monoclonal antibody sarilumab met the trial’s main goal of improving symptoms after 24 weeks of a biweekly dosing regimen. Some 72% of patients on sarilumab achieved at least a 20% improvement in signs and symptoms based on American College of Rheumatology criteria, in contrast to 58% of the patients in the Humira group. Both groups experienced about the same rate of negative side effects, though the sarilumab group showed a higher rate of neutropenia, or lowering of white blood cells. Humira is currently the top-selling RA drug and, indeed, the top-selling drug of any kind in the world today, but its number of competitors is rising. Last fall baricitinib, a drug that Eli Lilly ( LLY ) and Incyte ( INCY ) co-developed, also beat Humira in a head-to-head trial; unlike the injectable Humira and sarilumab, it is delivered orally. Roche ’s ( RHHBY ) intravenous medicine Actemra has also bested Humira in trials. Regeneron and Sanofi have already applied for FDA approval of sarilumab based on earlier data, with a decision due by Oct. 30. RBC Capital Markets analyst Adnan Butt called the news a “modest positive” but added that investors are still concerned with some nearer-term issues with Regeneron’s stock. Among them is a pilot program to test changes in Medicare Part B , announced this week, that could affect a great deal of the reimbursement for Regeneron’s flagship drug Eylea, and a patent lawsuit that Amgen ( AMGN ) filed over another monoclonal antibody in the Regeneron/Sanofi partnership, Praluent. “All else being equal, beating Humira is certainly better than not beating it, but at least some of the discussed overhangs may need clearing before the pipeline receives more credit,” wrote Butt in a research note. By late morning on the stock market today , AbbVie stock was up almost 3% near 58. Sanofi was up 2% near 41, while Regeneron stock was up a fraction near 381.