Key Developments For DURECT Corporation
DURECT Corporation (DRRX.O) (Consolidated Issue listed on NASDAQ Global Market)
DURECT Corporation Announces Sale of 4,444,444 Shares of Common Stock, Raising Proceeds of $10 Million
DURECT Corporation announced that it has entered into a privately negotiated transaction to sell 4,444,444 primary shares of common stock to affiliates of Venrock at a price of $2.25 per share, raising net proceeds to DURECT of approximately $10 million. DURECT expects the financing to close on or about September 18, 2009, subject to customary closing conditions.
DURECT Corporation Signs Long Term Excipient Supply Agreement With King Pharmaceuticals for REMOXY
DURECT Corporation announced that it has signed an exclusive long term excipient supply agreement with respect to REMOXYwith King Pharmaceuticals, Inc. 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.
DURECT Corporation Announces License Of ADHD Drug Candidate In Selected Asian And South Pacific Countries To Orient Pharma Co., Ltd.
DURECT Corporation announced that it has signed a development and license agreement with Orient Pharma Co., Ltd., under which DURECT has granted to Orient Pharma development and commercialization rights in selected Asian and South Pacific countries to a drug candidate based on DURECT's ORADUR Technology and one specified active pharmaceutical ingredient for the treatment of attention deficit hyperactivity disorder (ADHD). This drug candidate (ORADUR-ADHD) is intended to provide once-a-day dosing with added tamper-resistant characteristics to address common methods of abuse and misuse of these types of drugs. North American, European, Japanese and select other countries' rights to this drug candidate are retained by DURECT. Under this agreement, the parties will collaborate to perform a clinical development program through a Phase II study intended to produce a data package that will support later stage development of the drug candidate by DURECT as well as Orient Pharma in their respective territories. DURECT will be responsible for formulation and study design of the pre-defined clinical program which Orient Pharma will fund and execute. Orient Pharma would be responsible for all remaining development and commercialization activities for this ORADUR-ADHD product in the licensed territory. If commercialized, DURECT would receive a royalty on sales of ORADUR-ADHD by Orient Pharma.
DURECT Corporation Reports Positive Phase IIb Data From TRANSDU-Sufentanil Clinical Program
DURECT Corporation announced positive results from a 74 patient Phase IIb clinical trial conducted by Endo Pharmaceuticals of TRANSDUR-Sufentanil, a seven day patch under development for the treatment of chronic pain. The development program for this drug candidate was reviewed with the U.S. Food and Drug Administration (FDA) during a successful end-of-Phase II meeting with the FDA on February 19, 2009. The TRANSDUR-Sufentanil Phase IIb clinical trial was an open label, two-stage study to explore the titration (conversion) schedule for transitioning opioid-experienced patients with non-malignant moderate to severe chronic pain from current oral (e.g., OxyContin) and transdermal opioid (e.g., Duragesic) therapies to TRANSDUR-Sufentanil. In this study, approximately half (36 out of 74) of the screened patients successfully entered the maintenance period, which is consistent with expectations for the study and with other chronic pain studies of a similar nature. After exploring multiple dose titration regimens, two acceptable dose titration intervals have achieved the desired analgesic effect and side-effect profile, and therefore are expected to be utilized in Phase III. As a result of converting screened patients to stable pain control and into the maintenance period, the conversion ratios from oral morphine equivalents at baseline to TRANSDUR-Sufentanil dosage strengths were established and are expected to be utilized in the Phase III program.
Endo Pharmaceuticals Holdings Inc. Returns Product Rights To TRANSDUR-Sufentanil To DURECT Corporation
DURECT Corporation announced that Endo Pharmaceuticals Holdings Inc. has given notice that it is returning to DURECT Corporation Endo's rights in the U.S. and Canada to develop and commercialize TRANSDUR-Sufentanil, a 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 DURECT Corporation 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.
