Drug Development

Thumbs Up/Thumbs Down: Amgen’s silence is deafening; The drug pricing mob is back


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


thumb down Amgen bugs out, and they’re making everyone in biopharma look bad.

Just about everyone engaged in drug development loves to talk about positive data and how the most important thing about success is always the patient who benefits. But when the light turns red on a setback, the death star mentality dominates and oozing compassion disappears as they clamp down and hunker down in silence. I’ve seen it a thousand times. Amgen, though, just took the bug-out shuffle to a whole new extreme. Their kidney disease drug Parsabiv (etelcalcetide) was cheered through a big Phase III program, leaving everyone waiting for the inevitable approval. But this week we learned that it was rejected by the FDA. Why? Amgen won’t say, or even hint at it. Those patients they recruited to test the drug for the good of all (and to protect a key revenue source for Amgen)? Well, they don’t need to know either. Frankly, the whole thing disgusts me. Want to know why Big Biopharma has such a seedy rep? It’s shady events like this that put it into perspective. To Amgen: At least try to hold yourselves accountable and explain what happened here honestly. Shame on Amgen CEO Robert Bradway and R&D director Sean Harper for allowing it to happen. You need to do better. Much, much better.  There are public responsibilities involved in drug development, and you’re shirking them.

thumb down The mob is back, will the industry ever effectively tackle the drug pricing controversy?

It’s quite clear now that if there’s one issue that is guaranteed to trigger a furious public outcry, it’s price gouging on old products. Martin Shkreli, Valeant, now Mylan have all proved that. Buying old products and then marching up the price for a windfall profit can incite a digital lynch mob. And one day the pitchforks won’t stay focused on just one company. They’ll come for everyone, and it will not be ignored by the political elite. Because the fact is that the majors have generally adopted this strategy. The price increases may be a more modest 100% to 200%, but the controversy they’re inviting is clear. I’ve said it before, and I’ll say it again, high prices on new, significant therapies are justified and needed to sustain biotech and provide the next wave of treatments. It’s time, as someone I know alluded to recently, for the leaders in the industry to stop fighting fires and figure out how to get rid of the matches. Or it may be your biotech house that burns next. And biotech isn’t the bad guy in this drama.

thumb  The $14B Medivation buyout offers an industry-wide lift after a tough H1.

It wasn’t AstraZeneca or Allergan, but Pfizer did finally get a buyout done with the Medivation acquisition. Yes, they probably paid too much. But Medivation is the kind of company that makes a good target for a deal: Small pipeline, marketed product, easy to bolt on without disrupting big, established R&D groups. It was good to see that there are buyers willing to pay a premium for buyouts like this. Score one for biotech — and star dealmaker David Hung — after an ugly first half of the year. Frankly, we all benefit by a big score like this.

thumb down Sanofi comes up short, again.

Sanofi knew it needed the Medivation buyout when CEO Olivier Brandicourt decided to go after it as his first big growth move. It failed, which isn’t all that surprising given its track record of the past few years. Where Sanofi succeeds is through its collaborations. Internal R&D remains a disappointment. As a top 10 global R&D operation, Sanofi has to start proving that it can acquire late-stage assets and get them over the goal line alone. Maybe next time they won’t be left at the altar. There’s a lot riding on a turnaround.

thumb What a great week for innovation lovers in biotech.

I started off the week with a piece on Axel Bouchon, the point man at Bayer for starting a whole portfolio of ambitious new biotech ventures. Casebia will help define that new group with its 5-year, $335 million research budget and a new home on Kendall Square. Then there were stories on Krishna Yeshwant’s strategy at GV (Google Ventures) and a new venture from some young entrepreneurs fresh out of Brown. To help wrap the week, Denali’s executive crew took some time to review Chapter Two at the neurodegeneration startup, which has now raised close to $350 million as it preps its first clinical trial. I love the forward-looking thinking. A mix of big and little players also offers some perspective on where we are now in biotech; a no-longer-young industry in constant need of new ideas and new ventures. And they keep coming.

thumb Ike the mouse is aging R&D’s new mascot.

Or, he would be if he wasn’t dead. Ike lived to the ripe old age of 1,400 days, 140 years in human longevity. Matt Kaeberlein and his team of investigators in Seattle accomplished this with rapamycin, a dangerous drug that no one needs to think of as the spring of youth. But there are pathways and mechanisms involved here that will help inspire the next round of research into human longevity and healthy living. I triggered quite a dust-up on Twitter with comments like that. The FDA has to get in line (no easy task!)  and there’s more to think about than extending our lives by hundreds of years. Getting 90 good years would be a great start. Make no mistake, aging R&D is on its way to becoming a big field in biotech. Things take time in this world, though. So don’t look for any overnight revolutions.

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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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