Endo Pharmaceuticals Returns Product Rights to TRANSDUR(TM)-Sufentanil to DURECT

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CUPERTINO, Calif., Feb. 27 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) today reported that Endo Pharmaceuticals (Nasdaq: ENDP) has
given notice that it is returning to us Endo’s rights in the U.S. and Canada
to develop and commercialize TRANSDUR(TM)-Sufentanil, a proprietary
transdermal patch in development intended to treat chronic pain. Endo and
DURECT recently completed a successful end-of-Phase II meeting with the FDA.
Endo has notified us of its intention to terminate the license agreement
entered into between Endo and DURECT, and has committed to assist in an
orderly and rapid transition of this program back to DURECT.

(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)

“We are disappointed to lose Endo as a partner for the U.S. and Canada,
but understand that the program is no longer a strategic fit for them,” stated James Brown, President and CEO of DURECT. “However, we appreciate the fact
that Endo substantially advanced this program such that it is now Phase III
ready. With the worldwide rights to this program restored to us, we believe we
have an attractive asset to partner or to progress it ourselves.”

Endo recently successfully completed a Phase II program for TRANSDUR-
Sufentanil in which they evaluated the conversion of patients on oral and
transdermal opioids to TRANSDUR-Sufentanil. The most recent Phase II study met
its primary and secondary objectives of establishing a successful dose-
titration regimen and dose potency relationships, demonstrating safety and
tolerability at the therapeutic dose, and achieving effective analgesic pain
control. The Phase II data, extensive non-clinical data that had been
generated by Endo and detailed proposed protocols for Phase III were reviewed
with the FDA at an end-of-Phase II meeting on February 19, 2009. As a result
of that meeting, we believe we have a clear idea of the anticipated regulatory
pathway for the Phase III program and approval, which will follow a 505(b)2
pathway as discussed with FDA.

DURECT anticipates now recognizing in the fourth quarter of 2008
additional revenue as a result of accelerating the remaining amortization of
the Endo upfront license fee. Correspondingly, the net loss for the fourth
quarter of 2008 and for the fiscal year will be less than previously reported
in DURECT’s earning release on February 9, 2009. These are non-cash financial

About TRANSDUR-Sufentanil

TRANSDUR-Sufentanil is intended to provide continuous delivery of
sufentanil for up to seven days from a single application, as compared to the
three days of relief provided by currently available opioid patches. We
anticipate that the small size of our sufentanil patch (potentially as small
as 1/5th the size of currently marketed transdermal fentanyl patches for a
therapeutically equivalent dose) and longer duration of action may offer
improved convenience and compliance for patients. In addition, we believe that
the improved product profile relative to existing fentanyl patches may make
these patches an attractive alternative for many patients currently on
extended release oral opioids.

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.

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 TRANSDUR-Sufentanil, its
potential attributes, its potential as an alternative to extended release
opioid products, possible Phase III program, our intentions to enter into
collaborations or further develop the program and anticipated regulatory
pathway for this program 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 uncertainty and costs associated with the
development and commercialization of certain opioid drug products such as
TRANSDUR-Sufentanil due to increased scrutiny and possible new regulations
relating to risk evaluation and mitigation of these drugs, our difficulty or
failure to obtain approvals from regulatory agencies with respect to TRANSDUR-
Sufentanil, design, enroll, conduct and complete clinical trials, complete the
design, development, and manufacturing process development of TRANSDUR-
Sufentanil, consummate collaborative agreements relating to TRANSDUR-
Sufentanil, manufacture and commercialize and obtain marketplace acceptance of
TRANSDUR-Sufentanil, avoid infringing patents held by other parties and secure
and defend patents of our own, and manage and obtain capital to fund our
growth, operations and expenses. Further information regarding these and other
risks is included in DURECT’s Form 10-Q dated November 4, 2008 under the
heading “Risk Factors.”


CONTACT: Matthew J. Hogan, Chief Financial Officer of DURECT
, +1-408-777-4936/
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Web site: http://www.www.durect.com

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