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The Readout

Pharma can’t get its story straight on biosimilars

In Washington, the drug industry has little trouble presenting a united front to Congress. Yes to a streamlined FDA, no to government-negotiated drug prices, etc.

But when it comes to biosimilars, pharma’s house stands divided. As STAT’s Erin Mershon reports, the rise of me-too biologics has blurred the standard lines of battle that used to separate branded manufacturers from their generic interlopers. Now branded companies like Amgen, which is developing a biosimilar of the blockbuster Humira, are at odds with drug makers like AbbVie, which is still enjoying billions in revenue thanks to that blockbuster.

And for PhRMA and BIO, the trade groups tasked with representing companies on both sides, the split can prove paralyzing when it comes to advocating for actual policy.

Read more.

Is GW Pharma’s new drug going to make any real money?


GW Pharmaceuticals made history yesterday, winning the first-ever FDA approval for a therapy derived from cannabis. But is the treatment, approved for two rare and devastating forms of epilepsy, actually a lucrative product?

Analysts expect the drug, Epidiolex, to be a billion-dollar earner by 2021, assumping GW can win follow-on approvals in other forms of epilepsy. But because these are rare disorders, that dollar amount relies on GW’s ability to charge a premium price for Epidiolex and convince payers to go for it.

GW Pharma hasn’t said what it will charge for Epidiolex, and you can imagine the company’s deliberations. If it charges the maximum possible, some payers will push back, denying prescriptions and thereby limiting revenue. But if GW puts a payer-friendly price on a drug indicated for just a few thousand patients, it might struggle to meet Wall Street’s bullish expectations.

Anyway, if you’re interested in any of this be sure to join STAT’s Andrew Joseph, who has covered the development of that drug and a bunch of other cannabis-derived therapies, for a live chat on the future of such treatments. It’s Thursday at 1 p.m. ET, and you can sign up here.

About that whole right-to-get-rich idea


Last week, BrainStorm Cell Therapeutics became the talk of biotech after the company’s CEO told Bloomberg about his plan to profit off of a non-FDA-approved treatment under the letter of that controversial “right-to-try” law.

That was an unnerving proposition to many (including many who read this newsletter), and people who make it their business to understand laws pointed out that right to try doesn’t actually seem to allow for the kind of profiteering BrainStorm had in mind.

Basically there were a lot of questions. And now we might get some answers. 

At 8:30 ET this morning, BrainStorm is hosting a conference call “to announce its policy in regards to the ‘right to try’ legislation.” That’s as specific as the company’s announcement of an announcement got, so your guess is as good as ours.

Does pharma have any business innovating?


Allan Hugh Cole Jr., a 50-year-old living with Parkinson's disease, isn't counting on multinational drug makers to make headway for his condition, and he wasn't dismayed when Pfizer controversially ended its work in neurodegeneration earlier this year.

"I believe that it’s misguided to expect an entity whose main purpose is swift profits and healthy returns to shareholders to make decisions based on benevolence," Cole writes. "... These companies exist to make money for their shareholders."

How the world's largest drug companies can help, according to Cole, is by putting some of that money they've got lying around into the hands of people willing and able to take the risks necessary to develop new treatments for Parkinson's and Alzheimer's. And in that, Pfizer is a shining example: The company just put another $600 million into its venture capital arm, and a quarter of that money is earmarked for startups working in neurology.

Read more.

More reads from STAT

  • The startups waging war against superbugs. (Bloomberg)
  • AbbVie invests in switchable CAR-T therapies for cancer. (C&EN)
  • A federal appeals court upheld the insider-trading conviction of an ex-hedge fund manager. (Reuters)

Thanks for reading! Until tomorrow,


Tuesday, June 26, 2018


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