SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
November 12, 2014
(November 11, 2014)
Date of Report
(Date of earliest event reported)
DURECT CORPORATION
(Exact name of Registrant as specified in its charter)
| Delaware | 000-31615 | 94-3297098 | ||
| (State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
10260 Bubb Road
Cupertino, CA 95014
(Address of principal executive offices) (Zip code)
(408) 777-1417
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01 Other Events
On November 11, 2014, DURECT Corporation, a Delaware corporation (“DURECT”), issued a press release providing an update on its and POSIDUR™ program. A copy of DURECT’s press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
99.1 Press Release of DURECT Corporation dated November 11, 2014
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| DURECT Corporation | ||||||
| Date: November 12, 2014 |
By: |
/s/ James E. Brown | ||||
| James E. Brown | ||||||
| President and Chief Executive Officer | ||||||
INDEX TO EXHIBITS
| Exhibit |
Description | |
| 99.1 | Press Release of DURECT Corporation dated November 11, 2014 | |
Exhibit 99.1
DURECT Provides Update on POSIDUR™ Program
Cupertino, Calif., November 11, 2014 /PRNewswire-FirstCall/ — DURECT Corporation (Nasdaq: DRRX) announced that it has received meeting minutes from its face-to-face meeting with the FDA on September 23, 2014 regarding the POSIDUR™ program. In the February 2014 Complete Response Letter (CRL), FDA indicated that multiple safety trials would be required to support a broad indication. DURECT inquired whether it would be possible to expedite approval by pursuing an initial indication of soft tissue post-surgical analgesia without conducting additional trials. FDA has indicated that in this scenario, it should be acceptable to conduct only one additional soft tissue clinical trial, the size of which is not yet defined, to generate the data required for product approval, including safety data for POSIDUR compared to a non-SABER containing comparator(s) and also product efficacy (to go along with the efficacy already demonstrated in our pivotal hernia trial).
“Based on the Complete Response Letter we anticipated that we would be required to do additional safety trials,” stated James Brown, President and CEO of DURECT. “Over the coming months, we expect to have further communications with the FDA to refine the path forward.”
About POSIDUR
POSIDUR is an investigational post-operative pain relief depot that utilizes our patented SABER technology and is intended to deliver bupivacaine to provide up to three days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to POSIDUR, for which we hold worldwide rights, while at the same time we are preparing to be in a position to commercialize POSIDUR ourself in the U.S. in the event that we determine that is the preferred route of commercialization.
On February 12, 2014 we received a Complete Response Letter for POSIDUR from the FDA. Based on its review, the FDA has determined that they cannot approve the NDA in its present form, stating the NDA does not contain sufficient information to demonstrate that POSIDUR is safe when used in the manner described in the proposed label, and the FDA indicated that additional clinical safety studies need to be conducted.
About DURECT Corporation
DURECT is a specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including REMOXY®, POSIDUR™, ELADUR®, and TRANSDUR®-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.
DURECT Forward-Looking Statement
The statements in this press release regarding potential additional trials for POSIDUR, the potential resubmission of the NDA for POSIDUR to the FDA, the
potential regulatory approval of POSIDUR by the FDA, potential licensing transactions for POSIDUR, the potential benefits and uses of POSIDUR, and the potential uses and benefits of DURECT’s other 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, the risk that additional trials and
studies will not have satisfactory outcomes, the risk of adverse decisions by regulatory agencies, including product non-approval, delays and additional costs due to requirements imposed by regulatory agencies, potential adverse effects arising from
the testing or use of POSIDUR, the potential that data submitted in response to the complete response letter will not be deemed sufficient by FDA or other regulatory agencies to support regulatory approval of POSIDUR, and the risk of obtaining
marketplace acceptance of POSIDUR, avoiding infringing patents held by other parties and securing and defending patents of our own, and managing and obtaining capital to fund our growth, operations and expenses. Further information regarding these
and other risks is included in DURECT’s
Form 10-Q for the quarter ending September 30, 2014, filed with the Securities and Exchange Commission on November 4, 2014, under the heading “Risk Factors.”
NOTE: POSIDUR™, SABER® and TRANSDUR® are trademarks of DURECT Corporation. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.
| SOURCE: | DURECT Corporation | |
| CONTACT: | Matthew J. Hogan, Chief Financial Officer, DURECT 408-777-4936 | |