Friday, April 6, 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.

Some drug companies are flouting disclosure law

Under federal law, drug makers are required to publicly disclose detailed policies on how they handle patient requests to provide access to experimental drugs outside clinical trials. Are they?

STAT's Erin Mershon reviewed the websites for the 50 pharmaceutical companies with the largest market capitalization and found that about a dozen companies still don’t list their policies on their websites. That list includes Sage Therapeutics, Grifols, Beigene, Galapagos NV, and FibroGen, which are individually working on drugs for rare and life-threatening conditions like spinal muscular atrophy, Duchenne muscular dystrophy, and cancer.

Read more.

Let’s podcast

(Jennifer Keefe/STAT)

What’s it like to be a biotech investor? Do you know where your genetic data are? And what does it mean when the FDA swipes left on your drug?

Listen as we chew over those questions in the latest episode of “The Readout LOUD,” our biotech podcast. There’s a recap of the lively chat about capitalism we had at our event on Wednesday, a dive into the latest CAR-T upheaval, and a discussion of how the FDA’s quote-unquote flexibility might be a little more rigid than biotech thought. Also we talk about Grindr.

You can listen to it here. And you can expect another episode next Thursday evening — and every Thursday evening — so be sure to sign up on iTunes, Stitcher, Google Play, or wherever you get your podcasts.

Shire didn't quite make the best of its freedom

The year is 2014, and shares of Shire are trading at an all-time high on news that AbbVie planned to buy the British drug maker for $54 billion. Then the pesky Obama administration sewed shut the tax loophole that made the deal worthwhile for AbbVie, and Shire’s shares tanked.

But the company, led by CEO Flemming Ornskov, proclaimed itself the owner of a new lease on life, scheming to buy the freshly spun-out Baxalta for $32 billion in 2015, sending its share price to another all-time high.

And then life happened. Bullish projections came to naught. Expectations for more deals we not met. And, gradually, investors seemed to sour on Ornskov. Today, Shire is trading right about where it was before the whole AbbVie theatrics began. 

Now Takeda is weighing an acquisition for the company, and those same investors, once convinced they were in for a $54 billion cash-out, will take whatever they can get.

"The market does not like what Shire is doing, what it did with Baxalta, the fact it's heavily geared and the strategy of the CEO," one investor told Reuters. "A lot of shareholders would probably think if you get a credible bid for the business then ‘thank God’, and we can move on."

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Should Sarepta be worried about this patent thing?

A cadre of patient groups are pressuring the federal government to contest some patents held by Sarepta Therapeutics, claiming the company failed to disclose government funding that fueled the development of its only marketed drug. They want the government to seize those patents and use the resulting leverage to force Sarepta to lower the medicine's cost.

Past efforts to patent troll biopharma companies have gone nowhere, as Gilead Sciences and Vertex Pharmaceuticals can attest. But, as Leerink analyst Joseph Schwartz points out, this one is a bit different. If indeed Sarepta failed to disclose federal funding, it broke federal law. And, considering the small amount of clinical evidence Sarepta used to win FDA approval, that NIH-funded research is arguably key to the drug's success.

But even then, Schwartz wrote in a note to clients, "public interest groups have not even been able to succeed in pushing for guidelines to establish when NIH would exercise its rights ... so we believe today's letter may also fall on deaf ears."

More reads

  • The pharma buyouts of yesteryear don't look so wise in retrospect. (Financial Times)
  • Trials for potential ALS treatment using stem cells spark cautious hope. (STAT Plus)
  • Novo Nordisk buys blood drug licence to boost anaemic biopharma business. (Reuters)
  • Caravans of biotech immigrant executives. (LifeSciVC)

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