"The most significant events for
REMOXY, an investigational drug, is a long acting oral formulation of oxycodone intended to treat moderate to severe pain. Based on
-- 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
-- ELADUR(TM) (TRANSDUR(TM)-Bupivacaine). In
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
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
NOTE: POSIDUR(TM), SABER(TM), ORADUR(R), TRANSDUR(TM), and ELADUR(TM) are
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,
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.
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