CUPERTINO, Calif.,
(Nasdaq: DRRX) announced today financial results for the three months ended
for the three months ended
loss of
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)
At
compared to cash and investments of
figures include restricted investments of
“The most significant events for
interactions with the
Brown
meeting with the FDA was conducted for TRANSDUR(TM)-Sufentanil, and we also
recently received FDA feedback on our POSIDUR program, enabling us to
construct our Phase III development plans. In addition, we are awaiting a
mid-year meeting by
the REMOXY(R) New Drug Application (NDA).”
Recent Highlights:
— Remoxy.
Letter from the FDA in
approved in its present form. According to
indicated that additional non-clinical data will be required to support
the approval of REMOXY but the FDA has not requested or recommended
additional clinical efficacy studies prior to approval. Our
understanding is that
collaborator,
advisors have been evaluating the FDA Complete Response Letter and
there are plans to meet with the FDA in mid-2009, which should provide
our collaborators with a more reliable context with which to make
projections about REMOXY.
REMOXY, an investigational drug, is a long acting oral formulation of
oxycodone intended to treat moderate to severe pain. Based on
ORADUR(R) technology, which is covered by issued patents and pending
patent applications owned by us, REMOXY is designed to resist common
methods of prescription drug misuse and abuse.
— POSIDUR(TM) (SABER(TM)-Bupivacaine). We have recently received detailed
feedback from the FDA on our proposed Phase III program. We are
pursuing a target label for POSIDUR that would allow POSIDUR to be
used for a broad range of surgeries. Based on FDA feedback, in
contrast to the two pivotal efficacy studies that we had previously
planned, we now anticipate conducting one pivotal efficacy study and
several other supportive clinical studies in additional surgical
models to provide greater definition for the settings in which the
product should be used and to support our target label. We currently
expect that the total number of patient exposures that we will submit
to the FDA in an NDA will be approximately 700-800. Under our current
development program, approximately 300 human subjects have been
exposed to POSIDUR. Assuming the program progresses as we expect, we
anticipate that the Phase III program should take approximately two
years from initiation to NDA filing. To review the major planned
activities for POSIDUR in 2009:
— We expect to have data from our approximately 60 patient Phase IIb
clinical study in shoulder surgery this year.
— We plan to conduct a thorough QTc (tQTc) study in 2009. A tQTc study
is a cardiac safety test increasingly recommended by the FDA. To
date, we have not observed any differences in cardiovascular or
central nervous system side effects between the roughly 300 patients
dosed to date with POSIDUR versus approximately 150 placebo
patients.
— Nycomed is conducting a Phase IIb study in hysterectomy patients and
a Phase IIb study in shoulder surgery patients beginning in 2009.
Those studies will be conducted in a different manner than U.S.
studies and will be suitable for European regulatory approval
purposes. We anticipate that these studies will provide data from an
additional surgical model (hysterectomy) and will add to our safety
database.
— Lastly, we are in discussions with various parties about licensing
development and commercialization rights to POSIDUR in the U.S.,
POSIDUR is our investigational post-operative pain relief depot that
utilizes our patented SABER technology to deliver bupivacaine to
provide up to three days of pain relief after surgery. POSIDUR is
licensed to Nycomed for commercialization in
countries, and we have retained commercialization rights in the US,
— ELADUR(TM) (TRANSDUR(TM)-Bupivacaine). In
rights to this program were licensed to Alpharma, which was acquired by
time have involved interacting with the King team on the program such
that specific decisions can be made with respect to the clinical
program.
ELADUR is our proprietary transdermal patch intended to provide
bupivacaine for a period of up to three days from a single application.
— TRANSDUR-Sufentanil. A 74 patient Phase IIb clinical trial of chronic
pain patients using TRANSDUR-Sufentanil was completed during 2008 and
described by us in the first quarter of 2009. In this trial, all of the
primary and secondary objectives were met by showing patients could be
successfully converted from oral opioids such as OxyContin(R) and from
fentanyl patches such as Duragesic(R) to TRANSDUR-Sufentanil, while
also showing a reduction in pain scores on our therapy. A successful
end-of Phase II meeting was held with the FDA in
result of that meeting, we believe we understand the anticipated
regulatory pathway for the Phase III program and approval, which we
expect will follow a 505(b)2 pathway as discussed with FDA. Effective
rights to develop and commercialize TRANSDUR-Sufentanil in the U.S. and
regarding licensing of the program.
TRANSDUR-Sufentanil is our proprietary transdermal patch intended to
provide sufentanil to chronic pain sufferers for a period of up to
seven days from a single application.
— Other Business Matters. In an effort to conserve cash during the
current adverse economic environment, in March we implemented a
headcount reduction of 41 positions. This action affected most
functional groups, but we believe this should not affect our key
corporate goals for the year. Our current headcount is approximately
25% lower than at the start of the year.
Earnings Conference Call
A live audio webcast of a conference call to discuss first quarter 2009
results will be broadcast live over the internet at
clicking “Investor Relations.” If you are unable to participate during the
live webcast, the call will be archived on
Archive in the “Investor Relations” section.
About
innovative drugs for pain and other chronic diseases, with late-stage
development programs including REMOXY(R), POSIDUR(TM), ELADUR(TM), and
TRANSDUR(TM)-Sufentanil.
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.www.durect.com.
NOTE: POSIDUR(TM), SABER(TM), ORADUR(R), TRANSDUR(TM), and ELADUR(TM) are
trademarks of
respective owners. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug
candidates under development and have not been approved for commercialization
by the
DURECT Forward-Looking Statement
The statements in this press release regarding our possible licensing of
development and commercialization rights to POSIDUR and TRANSDUR-Sufentanil to
third parties, our collaborators’ anticipated meeting with the FDA regarding
REMOXY, our intended dose, target label and anticipated total patient
exposures, our and Nycomed’s clinical development plans including tQTc and
other clinical studies, potential timing of completion of our Phase IIb
clinical trial and Phase III program for POSIDUR and potential agreements with
third parties about licensing and development rights to our product candidates
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,
failure of our clinical trials to produce intended results, possible adverse
events associated with the use of our drug candidates, delays and costs due to
additional work or other requirements imposed by regulatory agencies for
continued development, approval or sale of our drug candidates,
that of its third party collaborators where applicable) difficulty or failure
to obtain approvals from regulatory agencies with respect to its development
activities and products, design, enroll, conduct and complete clinical trials,
complete the design, development, and manufacturing process development of the
referenced product candidates, consummate collaborative agreements relating to
our product candidates and technologies, manufacture and commercialize the
referenced product candidates, obtain marketplace acceptance of the referenced
product candidates, avoid infringing patents held by other parties and secure
and defend patents of our own, and manage and obtain capital to fund its
growth, operations and expenses. Further information regarding these and other
risks is included in
heading “Risk Factors.”
DURECT CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
Three months
ended
------------
March 31,
-------------
2009 2008
---- ----
Collaborative research
and development revenue $3,745 $4,269
Product revenue, net 2,415 2,169
----- -----
Total revenues 6,160 6,438
----- -----
Operating expenses:
Cost of revenues (1) 824 822
Research and
development (1) 9,903 9,634
Selling, general and
administrative (1) 4,257 3,890
Total operating
expenses 14,984 14,346
------ ------
Loss from operations (8,824) (7,908)
Other income (expense):
Interest and other
income 179 568
Interest expense (11) (455)
--- ----
Net other income 168 113
------- -------
Net loss $(8,656) $(7,795)
======= =======
Net loss per share,
basic and diluted $(0.11) $(0.11)
====== ======
Shares used in computing
basic and diluted net
loss per share 82,023 74,113
====== ======
(1) Includes stock-based compensation
related to the following:
Cost of revenues $78 $35
Research and development 2,281 1,607
Selling, general and
administrative 1,171 775
----- ---
Total stock-based
compensation $3,530 $2,417
====== ======
DURECT CORPORATION
Condensed Balance Sheet
(in thousands)
As of As of
March 31, December 31,
2009 2008 (1)
--------- ------------
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $23,463 $29,445
Short-term investments 18,191 20,836
Short-term restricted
investments 371 624
Accounts receivable 3,392 4,055
Inventories 2,639 3,474
Prepaid expenses and other
current assets 3,153 1,850
----- -----
Total current assets 51,209 60,284
Property and equipment, net 5,435 5,971
Goodwill 6,399 6,399
Intangible assets, net 145 157
Long-term investments 4,520 1,362
Long-term restricted Investments 429 425
Other long-term assets 270 276
--- ---
Total assets $68,407 $74,874
======= =======
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities:
Accounts payable $712 $1,018
Accrued liabilities 4,785 5,204
Contract research liability 645 995
Deferred revenue, current
portion 8,826 9,235
Other short-term liabilities 408 431
--- ---
Total current liabilities 15,376 16,883
Deferred revenue, noncurrent
portion 19,903 19,771
Other long-term liabilities 667 656
Stockholders' equity 32,461 37,564
------ ------
Total liabilities and
stockholders' equity $68,407 $74,874
======= =======
(1) Derived from audited financial statements.
SOURCE
CONTACT:
Corporation
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