Bio Roundup: DIY Biohacking, PCSK9 Data, Solid Setback & More

Xconomy National — 

Drug prices are top of mind for many patients. Some of them have to cut back on basic needs just to pay for treatments that seem to rise in price each year. That made a recent announcement by Regeneron Pharmaceuticals particularly unusual.

The Tarrytown, NY, drugmaker plans to cut the price of its cholesterol-lowering drug alirocumab (Praluent) if it can get concessions from payers. Regeneron made the move after data from a heart study suggested its drug might reduce the risk of death in those who have recently suffered a heart attack or stroke, and are at high risk of having another one.

Alirocumab is part of class of cholesterol-lowering drugs whose high list prices—around $14,000 per year—have led to significant pushback from payers. Regeneron hopes to change things by lowering its drug’s price to align with an assessment from an independent nonprofit organization, the Institute for Clinical and Economic Review. It’s the second time Regeneron has taken ICER’s input into account with a pricing decision, but these instances are outliers. It remains to be seen whether the gambit will work and drive adoption of alirocumab, or whether other drugmakers will follow suit.

In other news this week, a leading “biohacker” explained his approach to do-it-yourself biotech, the FDA stopped a study of a gene therapy for Duchenne muscular dystrophy, and investors kept on pouring money into immuno-oncology. Let’s get to the rest of the week’s news.


—Regeneron Pharmaceuticals (NASDAQ: REGN) and partner Sanofi (NYSE: SNY) unveiled data from their massive cardiovascular study Odyssey Outcomes and unexpectedly cut the price of their cholesterol-lowering medicine alirocumab (Praluent). Regeneron reported the drug cut the risk of death for some patients. The results came with caveats, but cardiologists told Xconomy that insurers might be more willing to cover the drug.

—Xconomy’s Corie Lok reported that a few patient advocate groups are wading into the fight over high drug prices, even at the risk of upsetting pharma companies that donate to their cause.

—Bay Area biohacker Josiah Zayner has attracted attention with his self-experimentation, including a public injection of CRISPR-Cas9. Xconomy’s Alex Lash profiled Zayner, who is rethinking his own role—in public, as usual—on the do-it-yourself biotech frontier.

—The Securities and Exchange Commission revealed that it charged Theranos and its two top executives with “elaborate, years-long fraud.” CEO Elizabeth Holmes has settled the charges in part by paying a $500,000 fine and surrendering her majority equity stake. Former president Ramesh Balwani will go to trial.

—The saga of former pharmaceuticals executive Martin Shkreli concluded with a seven-year prison sentence handed down for securities fraud.

—The FDA suspended a clinical test of a gene therapy from Solid Biosciences (NASDAQ: SLDB), the latest sign of trouble for the firm. The company reported that the first Duchenne muscular dystrophy patient dosed in the study was hospitalized for several days. Solid shares plummeted 64 percent.


—A year after GlaxoSmithKline (NYSE: GSK) bailed on a partnership with Ionis Pharmaceuticals (NASDAQ: IONS) for a transthyretin amyloidosis drug, Ionis sent the drug, inotersen, to spinout Akcea Therapeutics (NASDAQ: AKCA). Like a rival drug, patisiran, inotersen is under FDA review.

—Biogen (NASDAQ: BIIB) paid $150 million up front to acquire a Pfizer (NYSE: PFE) schizophrenia drug ready to start Phase 2 studies.

—Arcus Biosciences (NYSE: RCUS) raised $120 million in an initial public stock offering. Proceeds will finance clinical testing of the Hayward, CA, company’s two lead cancer immunotherapies.

Crinetics closed a $63.5 million round of financing to support … Next Page »

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