March 18, 2024

The need-to-know this morning

Bluebird Bio, in the early stages of a commercial launch of a gene therapy for sickle cell disease, raised up to $175 million in debt financing with Hercules Capital.

real estate

Boston's empty life sciences labs

As the pandemic took off, real estate developers went into overdrive building life-science laboratories across Boston. While most office work was at a standstill, companies like Moderna were expanding and needed more and more space. Billions of dollars poured in to support the feverish demand. But now, as these buildings near completion, most will be empty.

"People were chasing that pot of gold at the end of the Covid life-sciences rainbow," one life sciences real estate expert said. "A lot of new construction is going to have a very, very hard time getting leased," said another.

Car-t

FDA advisers recommend expanding CAR-T use in blood cancers

An FDA advisory committee voted 11-0 to expand the use of Carvykti, a CAR-T medicine for blood cancers made by Johnson & Johnson and Legend Biotech. The same panel voted 8-3 in favor of Abecma, a blood cancer CAR-T developed by Bristol Myers Squibb and 2seventy Bio. The experts said Carvykti could be used in patients whose cancers resisted initial treatment; with Abecma, they recommended attempting the cellular therapy in patients who had tried at least two lines of treatment.

There was some concern about the severe side effects linked to these powerful therapies — patients had a higher likelihood of dying early into treatment than with standard of care — but data showed that the risk may be worth it. Carvykti delayed the risk of disease progression or death by 59% compared to standard treatment. And Abecma patients survived for 13.4 months without disease progression at median, compared to 4.4 months with standard therapy.

"I really think this is a case of front-loaded risk, much like we see with many other things in medicine," one panelist said. "As long as patients understand the magnitude of that risk, I think it's acceptable."

ipo

Contineum Therapeutics files for IPO

Contineum Therapeutics has filed a $150 million IPO — adding to the growing list of biotechs with plans to go public this year. The clinical-stage San Diego biotech, which used to be called Pipeline Therapeutics, is developing small molecules for diseases like depression and idiopathic pulmonary fibrosis. The company was founded in 2009.

Last year, Contineum received $50 million from Johnson & Johnson Innovative Medicine to license the experimental PIPE-307, which is being tested in a Phase 2 trials for multiple sclerosis. According to the prospectus, Contineum will also kick off a Phase 2 study for the novel drug, which is a selective inhibitor of the M1 receptor, in depression later this year.

Pbm

CVS created 'rebate credits' to retain profit after biosimilar rollout

Last year, biosimilars for the blockbuster immunosuppressive drug Humira hit the market. CVS Caremark, one of the largest pharmaceutical benefit managers, told its employer clients that it anticipated "more lower-cost products (including specialty biosimilars) may become preferred products" — clearly referring to Humira and its new, cheaper subsitutes, experts tell STAT.

Since drug rebate dollars from Humira would disappear as biosimilars took hold, CVS told clients it would calculate rebates in a different way — ultimately protecting CVS' profit, STAT reports. They called these "rebate credits."

"This feels like an example where PBMs are exerting their ability to say to employers, 'We need to change the terms of our contract because something else happened, and we can't deliver on what we had kind of agreed to in the past,'" one health economist told STAT. "It's fair for that to be met with skepticism by employers, by regulators, and by stakeholders."