Tuesday, June 7, 2016

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, your daily source of takes hot and cold on the world of biotech. Today we talk to the FDA commissioner about poaching, a biotech VC about pitch originality, and BIO about its nutritional decisions. Need more? Check out

Hey, biopharma! Dr. Robert Califf kindly requests that you not poach his employees

Dr. Robert califf wants to keep the best and brightest at the FDA. problem is,those folks are "highly valuable to just about any company that would deal with the FDA." and the companies pay more.(Pablo Martinez/AP)

The Food and Drug Administration’s newest head honcho sat down for a chat with STAT here at the BIO conference in San Francisco, powering through a bout of conjunctivitis caught from the grandkids. He talked about a lot of lofty goals. And one not-so-lofty goal: Improving HR at the FDA. Seriously, he's on a mission to speed up hiring and ward off the private-sector poachers who like to steal his staff out from under him. One big challenge: The corporate world pays more. Another: “It’s not like what the FDA does is the only exciting thing in town."

Califf also talked a lot about precision medicine; stay tuned for Meghana's piece on that later today. While he waxed eloquent on polymorphism and informatic pipelines, Califf made clear he did not want to talk about other pressing issues in FDA land, including:

  • Off-label drug usage
  • Sarepta Therapeutics ("This is just a very unusual situation.")
  • Claims that the White House took it easy on e-cigarette companies
  • The methodology of the Baseline study that Google's life science company, Verily, aims to use to transform medicine. Califf worked with Verily on Baseline when he was at Duke. Asked about criticism of the project, he responded: "I probably shouldn't say."

Want to impress VCs? Maybe cool it with the buzzwords

Your bold plan to disruptively transform the culture of innovation is unlikely to move Canaan Partners' Nina Kjellson. (Canaan Partners)

The BIO International Convention may not be fertile territory for big deals, but it is prime hunting ground for venture capitalists on the prowl for promising startups. Among them: Nina Kjellson, a veteran biotech investor at Canaan Partners who expects to hear more than two dozen formal and informal corporate pitches this week. STAT's Rebecca Robbins wanted to know how she puts up with all the earnest disruptors.

What drives you crazy in a pitch deck?

I’m a little bit fatigued by “disruption,” “innovation,” “transformation.” Buzzwords can be a distraction from a really good, pithy message.

So what should they do instead?

In one slide, I should be able to get a very quick idea of what a company is doing, why it matters, and some insight into why they are credible stewards of that business idea. In five slides, I should get a good sense of what they’ve accomplished to date and what they will achieve in the near-term. And then by the 15th slide, I should be told, among other things, who else is trying to go after the same problems — and why this company is differentiated and better.

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Biotech’s favorite millennial rides again

Myovant Sciences founder Vivek Ramaswamy has been described as "handsome," "charming," and "any parent's dream." Anyway he has a new company. (Axovant)

Vivek Ramaswamy, the 30-year-old CEO behind one of biotech’s biggest and most controversial IPOs, has said he wants to make his company “the Berkshire Hathaway of drug development” by picking up unwanted drugs from pharma and spinning them into Wall Street successes. 

And now he’s found another opportunity to cash in.

Ramaswamy’s latest effort is called Myovant Sciences, and it has acquired the outside-Asia rights to a Takeda-developed therapy. The drug, relugolix, has shown mid-stage promise in uterine fibroids and it could have a future in endometriosis and prostate cancer, too, the company says.

Ramaswamy made his name — and a fair amount of money — on a similar gambit in Alzheimer’s disease last year. One of his other companies, Axovant Sciences, bought a discarded, once-failed treatment from GlaxoSmithKline for just $5 million and then, without producing any new data on the drug, pulled off an IPO that valued Axovant at the hefty sum of around $3 billion. This was, depending on whom you asked, a sign that nimble startups could succeed where lumbering pharma could not — or the glistening needle waiting to pop the biotech bubble.

The same questions surrounding Axovant apply to Myovant. For instance, if that drug’s so great, why is its inventor so willing to part with it? Are experimental treatments like fantasy football players, able to retain their value despite being swapped from one team to another? And is committing to the suffix “-vant” really a wise branding strategy, long-term? 

Cancer immunotherapy getting mighty crowded

Sometimes it feels like every cancer-focused drug company is working in the field of checkpoint inhibition, developing treatments that seek to unleash the body's natural defenses. And that's pretty much the case, as this basically illegible chart from immunologist Vanessa Lucey illustrates.

Bad news for biotech’s most expensive drug

Alexion’s drug Soliris, which is approved to treat two rare diseases (and which costs about $700,000 a year), has helped turned the Connecticut company into a standard-bearer among biotechs developing drugs for orphan ailments. But it just hit a big clinical setback in its quest to expand usage of Soliris.

Soliris flunked a late-stage trial of patients with the ultra-rare disease refractory generalized myasthenia gravis, which leads to debilitating muscular weakness. It did not meet the goal of significantly improving patients' ability to perform daily tasks, Alexion said yesterday.

Alexion CEO David Hallal told analysts on a conference call that “a reasonable number” of drugs for rare diseases have been approved without hitting their main goals. But he wouldn't project next steps, beyond meeting with US and European regulators.

If Alexion chooses to go before the FDA with what it has now, the company would join the likes of Sarepta Therapeutics and BioMarin Pharmaceutical in seeking approval for an unproven treatment with touch-and-go data. Sarepta, of course, has had a bumpy ride, but its stock price soared after hours Monday after the FDA asked for more data, suggesting it's looking for a way to approve the drug.

More reads

  • Genentech and partner OSI Pharmaceuticals have agreed to pay $67 million to resolve charges that they improperly marketed the cancer drug Tarceva. (STAT)
  • Taking a page from Top Chef, Johnson & Johnson has launched an R&D QuickFire challenge, promising up to $500,000 in grant funds for researchers with promising early-stage ideas. (Press release)
  • Microbiome upstart Vedanta Biosciences raised $50 million in equity to support its work on drugs that target the body's ecosystem of gut bacteria. (Press release)
  • Syros Pharmaceuticals, headquartered in Cambridge, Mass., filed to raise $69 million in an IPO. It's working on treatments designed to fight cancer by modifying gene expression. (Filing)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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