(Adds detail, analyst comment)
By Natalie Grover
July 7 Endo International Plc and
BioDelivery Sciences International Inc said their
experimental pain drug was found effective in a second
late-stage trial, taking the drug a step closer to a marketing
BioDelivery's shares jumped as much as 20 percent to a new
life-high, while Endo was down 1.7 percent on Monday morning.
BioDelivery Chief Executive Mark Sirgo, who expects to
submit the marketing application for the drug by January 2015,
told Reuters he expects peak sales of about $500 million in the
The company's shares have been on a tear in the past year,
tripling in value, as investors bet on the potential of the
drug, BEMA buprenorphine.
The painkiller was being tested against a placebo in 511
patients, who were on regular opioid therapy, the companies said
Data from another late-stage trial in January showed that
the drug significantly reduced chronic pain in patients who do
not take opioids regularly.
Opioid addiction in the United States has assumed epidemic
proportions but that has not hindered the development of opioid
painkillers, which include formulations of morphine, oxycodone,
fentanyl and Oxycontin, a long-acting form of oxycodone.
These drugs are widely prescribed, including for patients
who have had dental or surgical procedures and those with
chronic back pain or headaches.
New opioid painkillers continue to be introduced, including
Zogenix Inc's long-acting Zohydro. The painkiller has
stirred controversy among U.S. politicians, prosecutors and
medical groups over its potential for abuse.
"The pitch on buprenorphine remains opioid-level pain relief
with less opioid side effects," Roth Capital Partners analysts
said, raising their price target on BioDelivery's stock by $1 to
The treatment, which is delivered using BioDelivery's
flagship BEMA technology, is classified by the United States
Drug Enforcement Administration as a schedule III controlled
This classification, which is defined by a moderate to low
potential for dependence, will make physicians more likely to
prescribe BEMA buprenorphine over Zohydro.
Zohydro's formulation is classified as a schedule II
controlled substance with a higher propensity for addiction.
"We see little in the way of an approval, possibly in the
second half of 2015," Piper Jaffray analyst Charles Duncan said,
adding that he expects peak sales of about $600 million.
The U.S. Food and Drug Administration also approved label
changes for long-acting opioids in April, saying it was
necessary to highlight the danger of abuse and possible death
with these drugs.
BioDelivery, which entered into an agreement with Endo to
develop the drug for the treatment of chronic pain in January
2012, will receive a $10 million milestone payment from Endo as
part of the deal. Its drug for opioid dependence, Bunavail, was
approved by the regulator in June.
Endo International's shares were down 1.5 percent at $68.19,
while BioDelivery's stock was up about 11 percent at $13.28 by
mid-day on the Nasdaq.
(Reporting by Natalie Grover in Bangalore; Editing by Saumyadeb