Pain Therapeutics to Regain Full Rights to REMOXY(R)
AUSTIN, Texas, Oct. 27, 2014 (GLOBE NEWSWIRE) -- Pain Therapeutics,
Inc. (Nasdaq:PTIE) today reported it believes it will regain full
development and commercial rights to REMOXY from Pfizer, Inc. On
Friday, October 24th, Pfizer hosted a conference call with us during
aftermarket hours to inform us of their intention to terminate
development of REMOXY. Actual termination will become effective six
months from today, pursuant to the terms of a Collaboration Agreement.
"We are grateful to Pfizer for their substantial investment in REMOXY
over the years and now for this opportunity to regain full control of
REMOXY", said Remi Barbier, President & CEO. "It's a privilege to
reacquire worldwide rights to an unencumbered Phase III asset that
targets a $2 billion market. We look forward to the prospects of
resubmitting the REMOXY NDA under our control. We are also enthusiastic
about initiating discussions with potential pharmaceutical partners
around this drug asset."
Under the contractual terms of a termination, all data, documents and
remedial work conducted and paid for by Pfizer with respect to REMOXY
will transition to us over the coming months, including results of five
recently completed clinical studies.
Today's Conference Call
We will host a conference call today, Monday, October 27th at 8 a.m.
Central Time/9:00 a.m. Eastern Time to discuss REMOXY and to respond to
questions from investors. Participants may access the call by dialing
1-877-407-4018 in the U.S. or 1-201-689-8471 outside the U.S. The call
will be webcast live on the Company's website at www.paintrials.com. A
replay of this conference call will be available through November 6th
by dialing 1-877-870-5176 in the U.S. or 1-858-384-5517 outside the
U.S. The replay access code is 13594560.
Our lead drug candidate, REMOXY (oxycodone) Extended-Release Capsules
CII, is an oral formulation of oxycodone for the management of
moderate-to-severe pain when a continuous, around-the-clock opioid
analgesic is needed for an extended period of time. We developed REMOXY
to discourage common methods of tampering and misuse.
FENROCK is a new, proprietary abuse-deterrent pain patch in pre-IND
stage of development. Our goal with FENROCK is to mitigate the abuse,
misuse, overdose and death associated with currently marketed fentanyl
patches. The active drug ingredient in the FENROCK patch is fentanyl
(CII), a highly potent synthetic opioid typically used to manage severe
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops
novel drugs. The FDA has not approved our drug candidates for
commercial sale. For more information, please visit www.paintrials.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements about our prospects for growth, intellectual
property protection, market size or growth, competitive position,
regulatory agency action, and the anticipated development, timing, data
readouts and therapeutic scope and value of our development stage
products. You should not place undue reliance on these statements.
These statements involve significant risks and uncertainties. Our
results may differ materially from those contained in such statements,
including, among others: our inability to protect our intellectual
property rights and to have sufficient rights to commercialize our
products; product competition; clinical trials of our products may fail
or not be initiated or conducted in a timely manner; our products may
show insufficient therapeutic effects or unacceptable safety profiles;
adverse decisions by regulatory authorities; existing preclinical and
clinical data with respect to our products may not be indicative of
future clinical or commercial results; and the inability to manufacture
successfully our products. Additional factors that could cause actual
results to differ significantly from those projected in our
forward-looking statements are discussed in our Annual Report on Form
10-K, Quarterly Reports on Form 10-Q and recent Current Reports on Form
8-K. Our forward-looking statements are based on our current beliefs
and expectations and speak only as of the date of this press release.
We do not undertake any obligation to update any forward-looking
statements. The term "Abuse-deterrent" is not intended to designate an
indication or a medical claim but rather a general description of
agents designed to address the misuse, abuse and diversion of opioids.
Oxycodone and fentanyl are controlled-substances (CII) with high
potential for abuse. The active ingredient in all opioids (including
REMOXY and FENROCK are highly addictive.
CONTACT: For More Information Contact:
Peter S. Roddy
Vice President and Chief Financial Officer
Pain Therapeutics, Inc.