Thumbs Up/Down

Let’s rethink Clinton’s war on pharma; The FDA can’t order the genie back into the magic lamp

Endpoints assesses the big biopharma R&D stories of the week, with a little added commentary on what they mean for the industry.

thumb Survey says!

Ever since I first started thinking about partnering up with Arsalan Arif on Endpoints News, I wanted to do a quarterly survey of a substantial number of biotech execs to keep my thumb on the industry’s pulse. Now, 4 months from our launch, we did the first E100 survey that found the pulse is quite strong. Yes, there is some fluttering evident when you bring up topics like future financings, IPOs, access to talent, and so on. But by and large, biotechs are expanding their teams and planning to go into 2017 with ambitious plans. We’ll follow up with a special 2017 forecast in January. No one knows this industry better than the E100 combined. And you won’t want to miss what they have to say in the future.

thumb down Hillary Clinton’s war on pharma was no chance event.

The latest batch of emails from WikiLeaks includes the background discussion that occurred among Hillary Clinton’s campaign staff around her attack of Martin Shkreli, who still wears the black hat in biotech after he decided to jack up the price of Daraprim by more than 5,000%. Clinton called it price gouging in a Tweet, triggering a rout in biotech shares as the implications over some kind of price controls sank in. “FYI—We have started the war with Pharma!!” exclaimed senior adviser Ann O’Leary. “Great!” replied Mandy Grunwald. There are better ways to have this discussion than singling out one bad actor to slime an industry. Biotech is not Martin Shkreli, and the price of real innovation in drugs will not be cheap. But that’s not price gouging. It’s time we separated drug development and the price of new drugs from the notorious practice of routine price hikes — or overnight profiteering — on old therapies. Maybe Clinton could Tweet about it some time. There’s no question now that she’s the odds-on favorite to win this election.

thumb Kite is flying high as its pioneering biologics application heads to the FDA

When Kite Pharma’s Arie Belldegrun took to the stage in New York earlier this week to spearhead a discussion on the company’s ambitious plans to launch the world’s first CAR-T, you could hear plenty of grumbling on the sidelines. The data are early. We all know that 3 months of responses in their pivotal study is a quick read. Some want to wait for 6 months. We’ll see how that discussion plays out. But while the competition at Juno and Novartis has fallen well behind, Kite continues to aggressively press forward, not willing to give an inch unless regulators require it. Win or lose, you have to admire the spirit and competence behind that.

thumb down The FDA can’t make the Sarepta fallout just disappear

Now that the FDA has actually approved Sarepta’s eteplirsen for Duchenne muscular dystrophy, the agency is trying to blunt the fallout. Step one, for senior FDA official John Jenkins, was to spell out all the bad things that the biotech had done and then essentially insist that no other biotech will win an OK under similar circumstances. Whip up advocates to the extent they attack FDA reviewers? Bad idea, says Jenkins. Use suspect data from a woefully inadequate study to insist on an approval? Uh-uh. The list goes on and on. Whatever the FDA says now, though, will do nothing to dispel the lessons to be learned from eteplirsen. And the next time a biotech comes along with an angry mob of supporters behind it, the FDA – and Janet Woodcock – will have no one to blame but themselves. This story is just beginning.

thumb down CRISPR: Losing some of the glitter

It was inevitable. The third big IPO in gene editing didn’t play out all that well, formally ending gene editing’s rep as the hottest thing in biotech. Nothing, of course, stays hot. But CRISPR Therapeutics had to be disappointed this week that its timing was off. Editas and Intellia had both made it out in big IPOs, only to see their shares fade over the year. Gene editing is still a preclinical field, with lots of changes in the tech to come. Development efforts will be slow and painstaking, and it’s asking a lot of investors to stick through everything that has to happen before we see any actual products come out of it. Revolutions never come fast or easy in biotech. Now comes the hard part. But it’s also the most valuable stage for what comes next.

thumb down Gilead misses, again.

Gilead has plenty of resources to do R&D right. So it was kind of oddly funny to see its messy data from a tiny mid-stage program on a slate of indications for GS-4997, including a positive snapshot for NASH. The problem, though, was that the picture proved too fuzzy to make out any exact ideas about its potential. Gilead needs to prove now that it can do something dramatically great. This little stumble comes at a particularly bad time.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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