CUPERTINO, Calif., Oct. 29 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today that the previously announced development and
license agreement with Alpharma Ireland Limited, an affiliate of Alpharma Inc.
(NYSE: ALO), granting such party the exclusive worldwide rights to develop and
commercialize ELADUR(TM), DURECT’s investigational transdermal bupivacaine
patch, has cleared review under the Hart-Scott-Rodino (HSR) Antitrust
Improvements Act of 1976 and has become effective.
Under the terms of the agreement between Alpharma Ireland Limited and
DURECT, Alpharma has paid DURECT an upfront license fee of $20 million, with
possible additional payments of up to $93 million upon the achievement of
predefined development and regulatory milestones spread over multiple clinical
indications and geographical territories as well as possible additional
payments of up to $150 million in sales based milestones. If ELADUR is
commercialized, DURECT would also receive a royalty on product sales.
Alpharma will control and fund the development program.
“We’re pleased to be working on the development and commercialization of
this product candidate with a team at Alpharma that has been very creative and
aggressive in building a leading pain franchise,” stated James E. Brown,
President and CEO of DURECT.
ELADUR is an investigational transdermal drug patch intended to deliver
bupivacaine for up to 3 days from a single application. DURECT has previously
announced positive results for ELADUR from a 60 patient Phase IIa clinical
trial of patients suffering from PHN. A poster describing this study was
presented at the 27th Annual Scientific Meeting of the American Pain Society
on May 8, 2008 and is accessible on DURECT’s website
The US Food and Drug Administration (FDA) has granted to DURECT orphan
drug designation for bupivacaine for relief of persistent pain associated with
post-herpetic neuralgia (PHN). Bupivacaine is a long-acting, local anesthetic
drug used in regional anesthesia for local tissue infiltration, nerve block,
and epidural and intrathecal anesthesia. If ELADUR is the first bupivacaine
product approved for PHN, under the 1983 Orphan Drug Act, ELADUR would receive
seven years of market exclusivity following the approval of the product by the
Alpharma Inc. (NYSE: ALO) is a global specialty pharmaceutical company
with leadership positions in products for humans and animals. Alpharma is
presently active in more than 80 countries. Alpharma has a growing branded
pharmaceutical franchise in the U.S. pain market with its KADIAN(R) (morphine
sulfate extended-release) Capsules, and the FLECTOR(R) Patch (diclofenac
epolamine topical patch) 1.3%. Alpharma is also internationally recognized as
a leading provider of pharmaceutical products for poultry and livestock.
About DURECT Corporation
DURECT is an emerging specialty pharmaceutical company developing
innovative drugs for pain and other chronic diseases, with late-stage
development programs including REMOXY(R), POSIDUR(TM), ELADUR(TM), and
TRANSDUR(TM)-Sufentanil. DURECT’s proprietary oral, transdermal and
injectable depot delivery technologies enable new indications and superior
clinical/commercial attributes such as abuse deterrence, improved convenience,
compliance, efficacy and safety for small molecule and biologic drugs. For
more information, please visit http://www.www.durect.com.
NOTE: KADIAN(R) is a registered trademark of Alpharma Pharmaceuticals LLC.
FLECTOR(R) is a registered trademark of IBSA Institut Biochimique SA.
POSIDUR(TM), ELADUR(TM) and TRANSDUR(TM) are trademarks of DURECT Corporation.
REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates under
development and have not been approved for commercialization by the US Food
and Drug Administration or other health authorities.
The statements in this press release regarding ELADUR, its anticipated
attributes and commercial potential, its potential to receive seven years of
market exclusivity as an orphan drug and the milestone and royalty payments
and other consideration that may be potentially paid to DURECT under DURECT’s
license agreement with Alpharma Ireland Limited are forward-looking statements
involving risks and uncertainties that can cause actual results to differ
materially from those in such forward-looking statements. Potential risks and
uncertainties include, but are not limited to, the risk that ELADUR may not be
the first bupivacaine product approved for PHN, Alpharma’s and DURECT’s
ability to design, enroll, conduct and complete clinical trials, complete the
design, development, and manufacturing process development of ELADUR, obtain
product and manufacturing approvals from regulatory agencies and manufacture
and commercialize ELADUR, marketplace acceptance of the product candidate and
that the agreement may be terminated under conditions specified in the
agreement. Further information regarding these and other risks is included in
DURECT’s Form 10-Q dated August 8, 2008 filed with the Securities and Exchange
Commission under the heading “Risk Factors.”
SOURCE DURECT Corporation
CONTACT: Matthew J. Hogan, Chief Financial Officer, DURECT Corporation,
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