Thumbs Up. Thumbs Down: On rookie mistakes, a class action suit and getting past failure


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 Portola makes a rookie mistake, and gets hammered by a CRL

If any company looked to be sitting in the right place at the right time with a new drug application, it was Portola. The FDA had already given the company a breakthrough designation, offering ready access that company execs say they took advantage of regularly. But when it came down to the PDUFA date, the biotech was forced to announce that the agency had rejected the application. Why? In a call with analysts, Portola’s crew sounded like they had fundamentally misjudged the FDA’s attitude on manufacturing and data issues. Points they thought could have been clarified after an approval couldn’t wait. And now it will spend some time answering the FDA’s CRL rather than marketing its anti-anticoagulant. This was a simple rookie mistake, but we’ve seen repeated rejections this year based on CMC issues. Other developers should take very careful note of it.

thumb Sometimes, a lawsuit may be just what the doctor ordered

Class action lawsuits in the wake of a biotech setback are a dime a dozen. They cluster like flies on an open wound, regardless of what caused the wound. So why did I stop and write up a recent bit of litigation about Juno?  Mostly because there are still some very important unanswered questions about how the FDA handled the deaths of patients from cerebral edema in Juno’s JCAR015 study. The first death went unreported, though Juno execs talked it over with the agency. More deaths followed. And when the agency did drop its clinical hold, it only lasted for a few days. Juno’s ready explanation, that adding fludarabine to the regimen for prepping patients, was seemingly swallowed whole. The FDA, of course, refused to explain their position on this. But this is something that needs to be carefully examined and explained. By all means, let Juno proceed with its work. But leaving this one in the gray zone is irresponsible. Maybe a lawsuit will help clarify matters.

thumb down Let’s set a higher bar on biopharma takeover stories

There was a time when the business press prided itself on a good takeover scoop. Secret bids. Boardroom squabbles. It made for great reading. Now, any old rumor will qualify for a story: An executive at company A asked an executive at company B about a possible tie up? A bit of water cooler chatter during a break? It’s all fodder for the beast now, with expressions of interest and casual overtures, or just simple rumors, triggering stories and follow-up stories. Reuters and Bloomberg have good cause to hustle, with both looking to get the juicy stuff up on terminals first. But there should be some kind of standard on what qualifies for a story. This is out of control.

thumb Sometimes people fail in biotech. Get over it.

Congrats to Andrew Hirsch for landing a new job as CFO at Agios. Hirsch was left to handle the unwelcome task of putting Bind Therapeutics in the ground after it was forced into Chapter 11. The lead drug proved to be a disappointment. Debt had accumulated. And this is no time to look for investors to bail you out of a tight spot. Biotech failure is a real threat to everyone in this business, regardless of the size of a company or its level of expertise. Hirsch dealt with it and moved on. And that’s easier to do in the US than, say, the UK, where no one ever forgets. Plus one for the US model. These experienced biotech vets have made Boston and San Francisco into thriving global hubs. They’re needed to get new generations of startups to the finish line. Let the dead bury the dead. It’s time to move on.

thumb down Where are the deals?

Not to be a churlish observer, but I have to admit I’m more than a little disappointed by the slow pace of dealmaking we’ve seen this year. There are some big outfits that have been holed up for far too long. Big companies rely on the biotech food chain to keep their pipelines interesting. And after the big drop in biotech stocks, this is the time to move. I’m betting that we get hit with a burst of deals in the fall. There’s plenty of cash behind that dam of desire. It’s time to put it in circulation.

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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Director Process Development
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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