* FDA puts study on hold after joint damage observed in a
* Leerink analysts reduce probability of drug's success to
* Brokerage cuts Regeneron price target to $513 from $530
(Adds analyst comments; updates shares)
By Natalie Grover
Oct 17 Regeneron Pharmaceuticals Inc
and partner Teva Pharmaceutical Industries Ltd said
the U.S. health regulator placed a clinical hold on a study
testing their pain treatment, dealing another blow to companies
looking to develop a safer alternative to opioid painkillers.
The Food and Drug Administration (FDA) imposed the hold in
the mid-stage trial in patients with chronic lower back pain,
after a form of joint damage was observed in an advanced
osteoarthritis patient who was given a high dose of the
injectable drug, fasinumab.
Monday's announcement suggests fasinumab will be plagued by
the same limitations as other drugs in its class, including
heightened scrutiny, repeated delays, and labeling restrictions,
Leerink Partners' Geoffrey Porges said.
The brokerage reduced its probability of success for the
drug to zero, and cut Regeneron's price target to $513 from
The treatment is designed to block nerve growth factor
(NGF), a protein involved in transmission of pain signals.
Fasinumab has the potential to be an alternative to
prescription opioids, that are effective for pain relief but are
associated with high rates of addiction, overdose and death.
Following the FDA decision, Regeneron has completed an
unplanned interim review of data and has stopped dosing
patients, the companies said.
The analysis showed clear evidence of an improvement in pain
scores in patients dosed with fasinumab, compared with placebo.
Regeneron was "lucky" to sell half the drug to Teva in a
timely fashion," noted Sanford C. Bernstein's Ronny Gal.
The news of the hold comes less than a month after Regeneron
announced the up to $1.3 billion deal with Teva to co-develop
The two drugmakers now plan to discuss with the FDA a
late-stage study for chronic lower back pain, excluding patients
with advanced osteoarthritis.
Fasinumab is also being tested for use in
Rival drugmakers Eli Lilly and Co and Pfizer Inc
plan by 2018 to seek approval for their similar
treatment, tanezumab, which is being tested as part of a $1.8
Regeneron has been attempting for years to develop an
anti-NGF drug for pain, but has been stymied by safety concerns.
The FDA had placed fasinumab and other experimental agents
targeting NGF on partial clinical hold in late 2012, after
reports that animals on the drugs had suffered nerve damage.
The hold has since been lifted.
(Reporting by Natalie Grover in Bengaluru; Editing by Anil