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Wednesday, 11/11/2015 11:44:00 AM

Wednesday, November 11, 2015 11:44:00 AM

Post# of 364613
Oppenheimer Calls Mallinckrodt's New Acthar Data 'Impressive,' Despite This Week's Turmoil

11/11/15, 11:13 AM
Mallinckrodt PLC (NYSE: MNK) shares plummeted 37 percent, declining steeply from August through November.

Oppenheimer’s Akiva Felt maintained an Outperform rating on the company, with a price target of $138.

Two Acthar data presentations demonstrating early, yet impressive responses in RA and DM/PM, Felt mentioned.

Two separate data presentations at ACR “demonstrating early, yet impressive responses in RA and DM/PM,” analyst Akiva Felt said. Talks with the two study investigators indicated optimism regarding the data and “the drug's effects to be real.”

In 10 heavily refractory DM/PM patients, 70 percent had achieved a sustained response through 24 weeks. Meanwhile, in 14 early-stage RA patients, Acthar treatment + methotrexate revealed a 71 percent CDAI improvement through 6 months, with 84 percent responding, including 100 percent response in the biweekly dosing arm.

Related Link: Mallinckrodt CEO Responds To Citron Allegations: 'We Are Playing The Long Game With' Acthar

Results from investigator-sponsored studies could boost Acthar usage and positive data from a well-conducted randomized clinical trial could be a game changer for Mallinckrodt, especially in RA, where patients frequently exhaust available treatments and Acthar penetration is currently minimal.

“In our view, these investigator sponsored pilot studies, while uncontrolled, provide a meaningful initial indication of clinical utility against a vocal bear contingent claiming there's zero data to support Acthar usage,” Felt wrote.

The analyst highlighted that the data train for Acthar was only just beginning. There were more than 25 investigator-sponsored studies on clinicaltrials.gov for various Acthar indications. Felt expects “a steady stream of data presentations” over the next 1-2 years “to fill the perceived data vacuum around the drug.?

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