Thumbs Up/Down

Thumbs Up/Down: Brent Saunders has the right idea on drug pricing, let’s support that

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

thumb Brent Saunders signs off on a pricing manifesto the biopharma industry needs to adopt now.

Once someone prominent stands up and publicly adopts a responsible pricing policy on drugs, promising to hold the lid on annual price hikes, people pay attention. Credit Allergan CEO Brent Saunders with that stand. It’s not everything that needs to be done, but it is a big, big step toward finally lancing the boil of public anger that has been directed against Mylan and pharma in general for routinely pursuing simple price gouging schemes. This isn’t pure altruism. Biopharma needs to protect aggressive pricing models for novel drugs that make a difference. And unless the industry agrees on this one, and follows the Saunders path forward, that crucial strategy is directly threatened. Let’s poll the majors and see how fast we can get a consensus.

thumb down BIO’s bold position on pricing? We haven’t seen it yet.

If there was ever an issue that BIO needed to get out in front of, it’s drug pricing. While Saunders was proposing that drug makers do something real, BIO started promoting the feel-good side of things in a campaign that highlights the good drugs do. In a country where more than half of all people are on a drug, I think it’s safe to say that most people already understand that. What causes the outrage is when they, or someone they know or read about, can’t afford the drugs they need. There’s no easy way out of this showdown. BIO is wasting its money. But maybe there’s still hope for 2017.

thumb The R&D race in cancer belongs to the bold.

We saw that spirit again this week as Celgene and its partner Agios mapped out plans for a quick pivot to the FDA for two closely matched therapies. Celgene will start its hunt for an FDA approval on AG-221 for AML before the end of this year. That faster-than-expected timeline underscores just how open the FDA is to providing accelerated approvals, a trend that has helped drive billions of dollars in investments in oncology R&D. The whole trial process in cancer is being upended, and that’s a good thing.

thumb down The Novartis line: Never call it a retreat

Novartis has been struggling to convince us that its decision to disband its cell therapy unit and lay off 120 staffers is not a signal of any kind of retreat on that front. Contrast that move, though, with the latest from Kite Pharma, where we see a concentrated effort at gaining a pioneering OK followed by a commitment to do better with new tech now coming online. The move at Novartis follows David Epstein’s departure and includes an exit by Oz Azam, Novartis’s high-profile cell therapy team leader. The reality it is a retreat. The only question is whether this is just one big step toward a withdrawal from a field they helped pioneer. We’ll keep watching.

thumb Moderna outlines the next, $474M chapter in mRNA

For a biotech that’s raised close to $2 billion, it’s amazed us how much negative chatter you hear about Moderna, a private biotech which is threatening no small investors with their enthusiasm. No doubt any failures will be met with considerable schadenfreude by the critics waiting on the sidelines. But let’s accept the fact that the jury is out on their effort to revolutionize medicine and give them — and their partners — credit for making a monumental effort to achieve it. If the company succeeds, we should be ready to applaud the progress. And if it fails, the noise will be heard in every pocket of this industry. From my perspective, I’ll be tracking every big move to come, whatever may come. The data will tell us everything we need to know.

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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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