Drug Development

Thumbs Up/Thumbs Down: The FDA backs another R&D scheme, Kite shows its speed while Eli Lilly and Astra stumble again


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 Another price-gouging alert for the FDA

Let’s face it. Biopharma has a bad rep. New drugs come along with jaw-dropping prices and the public feels like it’s getting fleeced. The problem, though, has nothing to do with truly innovative new drugs or their price. The US can well afford the high cost of innovation – with all its benefits. It’s being taken to the cleaners for the ever rising price of old meds that needs to be the focus. This week’s story on Marathon’s move to gain an approval for an ancient steroid called deflazacort sums it all up. Never approved in the U.S., Marathon tested it as a muscle strengthener for Duchenne muscular dystrophy. And they have scored a slew of advantages at the FDA, including its selection as a rare pediatric therapy. You can be sure that Marathon plans to charge much more than the buck-a-pill price charged by online pharmacies in Canada. The agency should reserve its favors for really great new drugs. And the industry needs to learn how to shape an argument that can actually win the public over.

thumb Kite Pharma takes the CAR-T lead.

A week can make a huge difference in biotech. Or six days. That’s how long Juno’s JCAR015 was on hold, and it ended up pushing back its launch plans from 2017 to 2018. Kite, racing ahead on manufacturing operations, says it could be ready to go later this year, after announcing an aggressive plan for a 30-day review of the first 50 patients enrolled in its pivotal trial. Rushing ahead can increase the risk of a bad stumble, but Kite appears confident that it can quickly capitalize on its breakthrough rep and score a pioneering approval well before its rivals show up. That’s a bold move.

thumb down Eli Lilly’s latest pipeline stumble

The pharma giant has survived its trek through a legendary R&D drought, coming up with some important late-stage efforts that deserve a reassessment of Lilly’s prospects. But when its CDK 4/6 drug abemaciclib failed to hit paydirt at the interim analysis, this drug lost a considerable amount of sheen. Pfizer got to the market first with an early win for Ibrance. Novartis looks to be right on track after ending its rival pivotal study early. And now Lilly won’t be able to file before next year, unable to declare a similar win. For longtime observers, it’s another sign of the slows at a company that needs badly to move fast.

thumb Here’s a thumbs-up to a clear message maker.

Allergan’s Brent Saunders went right back to singing the same tune about deals once the merger with Pfizer fell through. He’s going to stay focused on key areas, snap up programs preferably after Phase II and (without hitting this too hard) staying away from discovery work and most of the nitty-gritty in Phase I. He likes to buy things, rather than rent-to-own, and he’s thinking high deal volume, not one big, knockout M&A punch. Those rumors about buying Biogen? Not going to happen. Oh, and he has lots of cash for the right kinds of deals. Got it? OK then.

thumb down AstraZeneca now 0 and 2 on selumetinib

The UK company’s stock has enjoyed a renaissance recently after some rumors about a possible Novartis takeover began to circulate. But this company has a history of missteps in the pipeline that continues to dog its R&D rep. This week, its cancer drug selumetinib raised its head for the second time as a Phase III loser. And that, once again, raised Pascal Soriot’s prediction that this drug is a blockbuster in the making. Soriot has been wrong about a lot of things in the pipeline, with the exception of Tagrisso. Chances are that this drug will either be cut loose or sold for scrap, like brodalumab and lesinurad.

thumb The Endpoints 100

Forgive us our unashamed self-promotions. We’re halfway through the recruitment process for our new, ongoing quarterly confidence survey of the biotech industry, bringing together 100 top industry execs to track hiring trends, access to capital, the regulatory environment and more. Covering this industry can’t rely solely on reporting the news as it happens. We aim to keep our thumb on the pulse.

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John Carroll, Editor and Co-Founder

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