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Thursday, March 8, 2018

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews.

Consumer genomics is so hot right now. Should it be?

There's lots of money sloshing around in consumer genomics. Just how much money? All told, U.S.-based consumer genomics companies have raised more in the past 14 months than they did collectively in the six years prior, according to Rock Health.

But in these heady days for companies like 23andMe and Helix, there’s an uneasy and unsettled question gnawing at even the most bullish of investors: Are these bets going to pay off?

“What is not risky about these businesses? They’ve got clinical risk. They’ve got underlying scientific risk. They’ve got regulatory risk. They’ve got risk on the demand side,” said Andrew Matzkin of the consulting firm Health Advances.

Read more.

Allergan’s deal with Mohawks not playing well in Washington

Allergan's attempt to transfer patents for its best-selling Restasis eye treatment to the St. Regis Mohawk tribe — and thus block patent challenges from generic drug makers — has displeased a number of parties, including a federal judge. 

Yesterday, five senators made clear they, too, were unimpressed, introducing legislation that would prohibit tribal sovereign immunity from being used to block certain types of patent challenges in the future. Sen. Claire McCaskill (D-Mo.) filed similar legislation in October, but the new bill goes further because it would limit the ability of a company to transfer patent rights to a foreign country as well.

"This bill will make sure unscrupulous patent holders can’t game the system and block their competitors from entering the market," said Sen. Tom Cotton, one of the sponsors. 

Read more.

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Sometimes stocks go down on 'positive' data

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(Jennifer Keefe/STAT)

Esperion Therapeutics, the small company hoping to shake up the market for lipid-lowering drugs, succeeded in the first of five late-stage trials it needs to apply for FDA approval. And then it's stock price fell 2 percent on the day.

And no one really knows why. The drug hit its main goal of lowering bad cholesterol more than the now-generic Zetia, and the big concern affixed to Esperion's therapy — that it might lead to dangerous liver side effects — proved to be not much of a concern at all, at least in this first Phase 3 study. The prevailing explanation is one that always frustrates investors: People bought the run-up and then sold on the news.

Anyway, Esperion's incremental victory is cause to update our scorecard of binary events in biotech this quarter. Coming this weekend: Regeneron Pharmaceuticals will tell the world whether its injected cholesterol treatment — one Esperion hopes to unseat — can actually improve patients' lives over a matter of years.

Scott Gottlieb isn't fond of 'Kabuki' drug pricing

There's a “rigged payment scheme” in the world of biosimilars, allowing payers to collect "monopoly rents" while drug companies make noise with "finger-pointing that ignores shared complicity for pricing practices that are eroding trust."

Those words come not from some biosimilar company or drug pricing activist, but rather from Dr. Scott Gottlieb, who happens to be the commissioner of the FDA.

Gottlieb has long since broken with his predecessors by speaking openly about drug pricing and the role the FDA can play in reducing the cost of medicine, but his speech on biosimilars, delivered yesterday, touched on marketplace issues that are usually the purview of his counterparts at the FTC.

Read more.

More reads

  • Hemophiliacs can more easily play soccer thanks to this drug? FDA says not so fast. (STAT Plus)
  • HHS official who spread conspiracy theories allowed back on job. (Politico)
  • SF tech startup Atomwise gets $45 million for AI-powered drug design software. (Endpoints)
  • Controversial study challenges scientific consensus that adult brains make new neurons. (STAT)

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Thanks for reading! Until tomorrow,

Damian

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