Tag Archives: lly

Lilly Changes Endpoint For Alzheimer’s Drug Trial; Stock Falls

Big pharma Eli Lilly ( LLY ) changed its goals for a much-anticipated clinical trial of its Alzheimer’s disease drug Tuesday, sending the stock down in a bad day overall for drug stocks. Lilly’s phase-three trial of its drug solanezumab, called Expedition-3, had previously targeted two primary endpoints: a slowing of cognitive decline, and a slowing of functional decline. On Tuesday, Lilly said it was going to keep cognitive decline as the primary endpoint, but functional decline would become a key secondary endpoint. Lilly is expecting to report its first results from the trial late this year, and make a decision about filing for approval based on the outcome. “Emerging scientific evidence supports the idea that cognitive decline precedes and predicts functional decline in Alzheimer’s disease, particularly in earlier stages of the disease,” Lilly said by way of explanation in its press release. Lilly added that “regulators globally will continue to view both cognitive and functional endpoints as necessary for clinical trials in people with mild Alzheimer’s dementia, and regulatory guidance has been to include these as co-primary endpoints,” so it’s not clear how much difference this will make to the drug’s approvability. Nonetheless, a trial that failed a co-primary endpoint would still be a failed trial. “Sounds like Lilly is doing everything they can to improve the success rate of Expedition-3,” wrote Evercore ISI analyst Mark Schoenebaum in an email to clients. Schoenebaum said Lilly told him the decision wasn’t based on data from the trial itself, which the company hasn’t yet seen. Lilly did analyze data from its earlier solanezumab studies Expedition-1 and Expedition-2, however, “and other datasets in the field.” Schoenebaum added that the phase-three trial of a possible competitor from Biogen ( BIIB ), aducanumab, is using a different test that measures both cognitive and functional decline as its sole primary endpoint. Lilly stock hit a 52-week low of 69.60 on the stock market today , on a day when stocks in general and drug stocks in particular were taking a hit. By midday,  it was down 3.5% near 71. Biogen stock was down 2.5% near 250.

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.

Novo Nordisk Pops As Diabetes Drug Cuts Heart Disease Deaths

Shares of diabetes giant Novo Nordisk ( NVO ) jumped Friday after the company said its drug Victoza reduced heart attacks and strokes. Novo released few details about the results of the study, which it’s saving for the next American Diabetes Association meeting in June. However, it did say that there was a statistically significant reduction in all three of its metrics — heart attack, stroke and death from all cardiovascular causes — among the 9,000 patients taking the diabetes drug over five years, compared to the placebo group. The subjects were all over age 50 and either had cardiovascular disease or multiple risk factors. Novo Nordisk’s stock was up about 8% in afternoon trading on the stock market today , near 57. It’s the highest-rated stock in the low-rated Medical-Ethical Drugs group, with a Composite Rating of 82. The effect of diabetes drugs on cardiovascular health has been the subject of several studies lately, notably from Eli Lilly ( LLY ), whose drug Jardiance reduced deaths from heart failure by 32% in a similar large, long-term study reported last September. On the other hand, Merck ‘s ( MRK ) Januvia showed no effect either good or bad in its outcomes trial reported a few months earlier. A similarly neutral result was reported for an outcomes trial of the  Sanofi ( SNY ) drug Elixa, which is noteworthy because Elixa is in the same class as Victoza. Both are glucagon-like peptide-1 (GLP-1) analogs, similar to Bydureon from  AstraZeneca ( AZN ) and Lilly’s Trulicity, while Jardiance is an sglt2 inhibitor, in the same class as Invokana from  Johnson & Johnson ( JNJ ) and Farxiga from AstraZeneca. Merck’s Januvia belongs to another class, called DPP-4 inhibitors. On a conference call with analysts Friday, Novo’s Chief Scientific Officer Mads Thomsen said that the different results may have come from subtle differences between the drugs, which he thinks extend to Victoza’s planned successor, semaglutide. “It’s not only the question of being a member of the given class of GLP-1 agonist,” said Thomsen. “It’s also a part of the kinetics, dynamics, distribution, half-life, and so on. And as we got semaglutide, we have done rather detailed investigations. . . . There is nothing from the animal pharmacology to negate the notion that semaglutide should do at least as well on cardiovascular performance.”