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.
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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
(http://www.durect.com/wt/durect/page_name/Publications).
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
FDA.
About Alpharma
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