Drug Development

Protocols: Snubbed at the FDA, again, Chiasma chops staff, again; J&J lands second BTD for depression drug esketamine

A few days after acknowledging that it was slapped down, again, by regulators, Chiasma is chopping nearly half its workforce in a second restructuring. Chiasma CEO Mark Leuchtenberger says the move to ax 44% of its remaining staff was needed so the company can conserve its cash while talking to the FDA about its requirements on proving the efficacy of Mycapssa (octreotide) for acromegaly. The FDA rejected Mycapssa and recently repeated a demand that the biotech design and execute a much better late-stage study. Regulators were unhappy with Chiasma’s single arm study for a drug that is seeking to replace the injectables now in use.

J&J has picked up its second breakthrough drug designation for esketamine. The intranasal version of ketamine, a powerful anesthetic used in party circles as ‘Special K,’ has won another title for depression with an imminent risk of suicide. The drug was handed the original BTD based on its potential for treating major depression. Ketamine has been studied in a host of academic trials, demonstrating a powerful, though typically short-lived, impact on depression as well as suicidal thinking. Other developers like Allergan have their own CDMA receptor rivals in the clinic. The BTD is intended to help speed the regulatory review of a drug with potential to help change the standard of care in its field.

Vedanta Biosciences has  landed a U.S. patent for its pharmaceutical compositions and mixtures of Clostridium live bacterial strains.

As expected, Eleven Bio has wrapped up its $270 million deal with Roche covering the worldwide development and commercialization rights to EBI-031. The deal includes $30 million in upfront cash. This is the biotech’s last remaining pipeline project following the back-to-back trial failures of its lead drug.


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RAPS Regulatory Convergence 2017