DURECT Signs Long Term Excipient Supply Agreement With King Pharmaceuticals for REMOXY(R)

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Thu Aug 27, 2009 8:00am EDT

DURECT Signs Long Term Excipient Supply Agreement With King Pharmaceuticals
for REMOXY(R)



CUPERTINO, Calif., Aug. 27 /PRNewswire-FirstCall/ -- DURECT Corporation
(Nasdaq: DRRX) today reported that it has signed an exclusive long term
excipient supply agreement with respect to REMOXY(R) with King
Pharmaceuticals, Inc. (NYSE: KG). This agreement stipulates the terms and
conditions under which DURECT will supply to King, based on DURECT's
manufacturing cost plus a specified percentage mark-up, two key excipients
used in the manufacture of REMOXY.

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"While we've been providing King with these key excipients starting in 2008,
we're pleased to have now entered into this long term arrangement with King
that formalizes the details of our supply agreement," stated James E. Brown,
DURECT's President and CEO. "Given King's strong presence in pain management
and commitment to be a leader in the development of products designed to
reduce the potential for misuse and abuse, we look forward to supporting
King's efforts to bring REMOXY to market."

REMOXY, based on DURECT's ORADUR(TM) technology, is an investigational drug
that is a unique, controlled release formulation of oxycodone for
moderate-to-severe chronic pain designed to reduce potential risks of
unintended use. In mid-2008, an NDA for REMOXY was accepted by the FDA and was
granted Priority Review. In December 2008, the FDA issued a Complete Response
Letter related to REMOXY. In July 2009, King Pharmaceuticals met with the FDA
to discuss the Complete Response Letter and King Pharmaceuticals has stated
that it anticipates that the resubmission of the NDA could occur mid-year
2010.

About ORADUR(TM) Technology

ORADUR is a proprietary technology designed to transform short-acting oral
capsule dosage forms into sustained release oral products, with the added
benefit of being less prone to abuse (e.g. by crushing or alcohol or water
extraction) than other controlled release dosage forms on the market today.

Corporate Relationships

In December 2002, DURECT licensed to Pain Therapeutics, Inc. the right to
develop and commercialize on a worldwide basis REMOXY and other oral sustained
release drug candidates using the ORADUR technology which incorporate four
specified opioid compounds. Under the license agreement, DURECT is reimbursed
for formulation and other work performed under its agreement, and will receive
additional payments if certain development and regulatory milestones are
achieved with respect to the licensed drug candidates. In addition, if
commercialized, DURECT will receive royalties for REMOXY and the other
licensed drug candidates of between 6.0% to 11.5% of net sales of the drug
candidate depending on sales volume as well as a mark-up on DURECT's supply of
key excipients used in the manufacture of the licensed drug candidates. Pain
Therapeutics sublicensed the commercialization rights of REMOXY and other
licensed drug candidates to King Pharmaceuticals in November 2005.

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 www.durect.com.

NOTE: POSIDUR(TM), SABER(TM), ORADUR(TM), TRANSDUR(TM), and ELADUR(TM) are
trademarks of DURECT Corporation. Other referenced trademarks belong to their
respective owners. 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.

DURECT Forward-Looking Statement
The statements in this press release regarding REMOXY, its potential
attributes and statements related to plans by King Pharmaceuticals for
resubmission of the REMOXY NDA, including the timing of such resubmission, the
potential of FDA approving the REMOXY NDA, as well as the potential royalty
and other payments that may be received by DURECT from REMOXY and other
described products 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 potential that the REMOXY NDA resubmission may not
adequately address all of FDA's concerns, the potential that FDA may not grant
regulatory approval of REMOXY, difficulties or delays in the development,
testing, regulatory approval, production and commercialization of REMOXY, and
unexpected adverse side-effects or inadequate therapeutic efficacy of REMOXY
that could slow or prevent product approval or market acceptance (including
the risk that current and past results of clinical trials and tests are not
necessarily indicative of future results of clinical trials and tests).
Further information regarding these and other risks is included in DURECT's
Form 10-Q dated August 4, 2009 under the heading "Risk Factors."



SOURCE  DURECT Corporation

Matthew J. Hogan, Chief Financial Officer of DURECT Corporation,
+1-408-777-4936
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