Tag Archives: chrs

AbbVie’s Newly Licensed Drug Scores Against Crohn’s Disease

Big Pharma AbbVie ( ABBV ) said Tuesday that a recently licensed drug candidate succeeded in a phase-two trial of Crohn’s disease, as the company seeks to refresh its blockbuster immunology franchise. In the late morning at the Digestive Disease Week conference in San Diego, AbbVie’s researchers presented results from an ongoing phase-two study of risankizumab, a drug AbbVie licensed from Boehringer Ingelheim during the first quarter, in Crohn’s disease. They said that after 12 weeks of treatment, 24% to 37% of patients were in remission — depending on the dose — compared with just 15% in the placebo group. The treated group also had fewer adverse events than the placebo group. Risankizumab is one of a newer group of drugs targeting interleukins, small proteins in cells associated with inflammation, among the proteins is TNF, or tumor necrosis factor. “These results are particularly encouraging because of the difficult-to-treat population within the study,” researcher Brian Feagan said in a statement. “Our patients had endoscopically confirmed moderate or more severe disease activity at study entry and the majority had previously failed treatment with one or more TNF antagonists.” The most popular TNF blocker happens to be Humira, AbbVie’s flagship drug treating Crohn’s disease as well as other immunological conditions like rheumatoid arthritis and psoriasis. Humira’s patents are under fire , however, and last week AbbVie’s stock tumbled when the patent board agreed to review a challenge to a methods patent brought by Coherus BioSciences ( CHRS ). Other drugs targeting interleukins include Novartis ‘ ( NVS ) Cosentyx, launched early last year for psoriasis, as well as Eli Lilly ‘s ( LLY ) Taltz, approved for psoriasis in March. Those drugs target interleukin (IL) 17, while risankizumab targets IL-23 through a novel mechanism of action. “The efficacy of this drug looks to be as good (as), or perhaps even better than IL-17,” Evercore ISI analyst John Scotti said in a video for clients recorded May 3. “And remember, Cosentyx peak sales in consensus right now are about $4 billion.” AbbVie stock was up 2.5% in afternoon trading on the stock market today , near 61, and shares in the past week have found support at the 50-day moving average line.

AbbVie’s Biggest Drug Gets Patent Setback; Stock Tumbles

Shares of big pharma AbbVie ( ABBV ) nosedived Monday after the U.S. Patent and Trademark Office agreed to review a challenge to a patent on its best-selling drug. The Patent Trial and Appeal Board accepted a request for inter partes review (IPR) by generic-drug startup Coherus Biosciences ( CHRS ) on patent 8,889,135, or the “methods” patent, for rheumatoid-arthritis treatment Humira. The patent is due to expire in 2025, but if Coherus is successful, it could launch its biosimilar version of Humira earlier. That might not happen too soon, though, since the review normally takes a year and is then open to appeal. AbbVie stock, which had opened flat on the stock market today , abruptly dropped 4% after the news came out mid-morning, to near 60, and ended Tuesday’s session at 60.23, down 3.6%. Coherus’ more lightly traded stock jumped 16%, to 18.85. AbbVie is No. 1 in its Industry Group — find out more at IBD Stock Checkup . Humira is currently the top-selling drug in the world, with $14 billion in sales last year. Coherus is one of several companies developing biosimilars of Humira — others include privately held Boehringer Ingelheim, which has some outstanding IPR requests on several different patents, and Amgen ( AMGN ), whose IPR request on a different Humira patent was denied back in January. Coherus has also filed IPR requests on two other patents. “Keep in mind AbbVie also has methods patents which cover other approved Humira indications, such as Crohn’s (disease), and we would expect additional IPRs/litigation to commence prior to potential biosimilar approvals (Amgen’s Humira biosimilar could be approved later this year),” wrote Evercore ISI analyst Mark Schoenebaum in an email. “Thus, these IPRs will likely be the first of many legal actions against AbbVie’s methods patent estate.”

Amgen Biosimilar Rival Delayed After Zarxio Launch

Biotech startup Coherus BioSciences (CHRS) was down more than 4% Friday after it said late Thursday that its biosimilar version of Amgen’s (AMGN) Neulasta will take longer to test than previously expected. Coherus said that it decided to increase the number of subjects in an immunogenicity study required for approval of CHS-1701, its biosimilar version of Amgen’s white-blood-cell boosting blockbuster. The company did this after seeing a slightly