Advocates: Gilead Exploited Patent System By Delaying Development Of Safer HIV Drug In Order To Reap Profits

Gilead suspended development of the safer drug for five years, in what advocates claim was a tactic to extend its monopoly on the profits from the older treatment. In other pharmaceutical news: Biogen tries to make a case for its Alzheimer's drug but some remain unpersuaded; Sage Therapuetics' shares plummet after bad news on depression treatment; biotech investors say they're not worried about Congress; and more.

The Washington Post: Gilead Delayed Safer HIV Drug To Extend Monopoly Profits, Advocates Allege

In 2005, Gilead Sciences notified federal regulators that it was suspending development of a potentially safer, more potent HIV-fighting drug than the one on the market. The company did not restart its Food and Drug Administration application until 2010. Now the five-year delay of a promising drug is at the core of accusations by advocates that Gilead improperly exploited the patent system at the expense of patient health. (Rowland, 12/5)

The Associated Press: Experts Split Sharply Over Experimental Alzheimer’s Drug

A company that claims to have the first drug to slow mental decline from Alzheimer's disease made its case to scientists Thursday but left them sharply divided over whether there’s enough evidence of effectiveness for the medicine to warrant federal approval. Excitement and skepticism have surrounded aducanumab since its developers stopped two studies earlier this year because it didn't seem to be working, then did a stunning about-face in October and said new results suggest it was effective at a high dose. (Marchione, 12/5)

The Wall Street Journal: Biogen Details Case For Controversial Alzheimer’s Drug

The presentation was highly anticipated by investors and physicians, but some weren’t persuaded. “It remains very uncertain whether signals of potential activity within a complex and flawed dataset would be enough to warrant approvability—though we believe [Biogen] incrementally strengthened their argument with an additional new data analysis,” Brian Abrahams, an RBC Capital Markets analyst, said in a note to investors. (Walker, 12/5)

Stat: Data On Biogen's Alzheimer's Drug Raise More Questions Than Answers

The drug, known as aducanumab, was tested in two identically designed late-stage studies. Biogen had halted both of those trials in March because the drug appeared to have failed. But in October, the company announced that a new analysis reflecting previously unavailable data showed that the drug actually reduced decline in patients with early-stage Alzheimer’s in one of the studies, called Emerge. The other study, called Engage, failed.(Robbins and Herper, 12/6)

Stat: Sage’s New Antidepressant Faces Major Setback In New Study

An experimental pill from Sage Therapeutics (SAGE) that aimed to treat depression more rapidly than existing drugs failed its first large study in patients in major depression, a significant setback for the firm. The drug, called SAGE-217, did not show a statistically significant, anti-depressive benefit compared with a placebo. (Herper and Feuerstein, 12/5)

The Wall Street Journal: Sage Therapeutics Shares Plummet On Subpar Depression-Treatment Study Results

Sage Therapeutics Inc.'s share price was cut by more than half Thursday, erasing more than $4 billion in market value after the company said its treatment for depression failed in a late-stage trial. The biopharmaceutical company said Thursday its Phase 3 study of the Sage-217 treatment in adults with major depressive disorder didn’t meet its primary endpoint of a statistically significant improvement in a scale that tracks 17 parameters, including anxiety and paranoia, at day 15. (Sebastian, 12/5)

Stat: Eli Lilly Places The Team From Loxo In Charge Of Its Cancer Research

Eli Lilly’s $8 billion purchase of Loxo Oncology in January wasn’t supposed to be a tech-style acqui-hire. But it’s turning into one. On Thursday, the drug giant announced that it is renaming its early cancer drug development arm Loxo Oncology at Lilly, and that the new unit will be helmed by Josh Bilenker, who had been Loxo’s CEO, along with his whole team from the biotech startup, including Jacob Van Naarden, who was the company’s chief operating officer, and Nisha Nanda, its chief development officer. The group is also hiring Dr. David Hyman, the Memorial Sloan Kettering oncologist who spearheaded the company’s early cancer trials, as chief medical officer. (Herper, 12/5)

Stat: Experts Say Acquisitions, Not Congress, Will Chart Biotech’s Course In 2020

Washington has never before been so focused on lowering prescription drug prices. But these biotech investors aren’t worried. “Politics is politics,” Affinity Asset Advisors senior research analyst Patrick Nosker said of drug pricing legislation at a STAT event Tuesday in New York. “The whole political overhang is definitely going to be noise throughout the next year.” (Sheridan, 12/6)

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