Tag Archives: abbv

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.”

Regeneron Up As Eylea Beats Views; Merck Down As Lead Drugs Slip

Big-cap drugmakers Regeneron Pharmaceuticals ( REGN ) and Merck ( MRK ) were moving in opposite directions in Thursday trading after their Q1 earnings reports, though both companies raised guidance. Regeneron’s quarterly revenue rose 38% over the year-earlier period to $1.2 billion, beating analysts’ consensus by about $240 million, according to Thomson Reuters. Earnings of $2.57 a share were a penny short of estimates and down 11% from last year’s Q1. But on the crucial metric of U.S. sales of flagship drug Eylea, Regeneron reported 44% growth to $781 million, beating consensus by $11 million, and the company raised its full-year growth estimate to 20% to 25% vs. its previous 20%. The earnings miss stemmed from higher spending for selling, general and administrative costs, though spending guidance for the year remained unchanged. Also, cholesterol drug Praluent, which was launched last July, missed consensus again, but its numbers remained small ($13 million) as the company awaited the results of a cardiovascular outcomes trial of both Praluent and rival Amgen ‘s ( AMGN ) Repatha later this year. Regeneron said that payer coverage for Praluent is good so far, with 74% of the commercially insured and 91% of those on Medicare having access to the drug. Regeneron stock was up 5% in midday trading on the stock market today , near 380. Merck Reports Mixed Quarter Merck posted earnings of 89 cents a share, up 5% from the year-earlier period and beating consensus by 4 cents. Sales declined 1% to $9.31 billion, missing Wall Street’s number by $150 million. Merck stock was down 1.5% midday Thursday, near 54. Merck added a few cents to its 2016 EPS guidance range, now $2.65 to $3.77, and also raised the low end of its revenue guidance, now $39 billion to $40.2 billion. Echoing a number of global pharmas this earnings season, Merck cited improving foreign-exchange rates. The revenue shortfall was spread around a number of different drugs, including blockbuster diabetes drug Januvia and immunology drug Remicade. More interesting to analysts was up-and-coming cancer drug Keytruda, which missed estimates in the U.S. but beat slightly worldwide, especially after rival Bristol-Myers Squibb ‘s ( BMY ) Opdivo beat consensus  last week. Bristol-Myers also moved up its reporting date for a trial of Opdivo as a first-line treatment for lung cancer to Q3 from its previously guided Q4, eroding the advantage for Merck, which expects to report results for a similar trial of Keytruda at midyear. Both drugs are now approved only for previously treated patients, so first-line approval could significantly expand the market. Merck also reported $50 million in sales for its hepatitis C drug Zepatier, which just launched in late January. Although that’s tiny compared with the $2.1 billion reported by market leader Gilead Sciences ( GILD ), both Gilead and AbbVie ( ABBV ) said on their earnings calls last week that Merck’s aggressive discounting had affected their own businesses. Nonetheless, RBC Capital Markets analyst Michael Yee wrote that this may not have been directly responsible for Gilead’s miss. “(Merck) suggested negotiations for important parity access remain ongoing, with the exception of the Veterans Administration (10% of the market), which they have good access on … but interestingly suggested many of the commercial payor access deals are for 2017 impact, since 2016 contracts were already completed,” Yee wrote in a research note. “So what Gilead said about their lower sales in U.S. (being) mostly due to just higher gross-to-net from healthier patients coming in (not so much from competition) could be true, realizing price competition is still ongoing and coming and needs to be watched.”