Oct. 29, 2009 (PR Newswire) -- CUPERTINO, Calif., Oct. 29 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended September 30, 2009. Total revenues were $8.4 million for the three months ended September 30, 2009, compared to $6.6 million for the same period in 2008; revenues in the 2009 period included $3.0 million related to the sale of certain excipients used in REMOXY® to King Pharmaceuticals in 2008 and the first quarter of 2009, all of which was recognized upon the execution of the long term supply agreement between us and King in the third quarter of 2009. Net loss for the three months ended September 30, 2009 was $5.5 million, compared to a net loss of $9.2 million for the same period in 2008.
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At September 30, 2009, DURECT had cash and investments of $47.2 million, compared to cash and investments of $52.7 million at December 31, 2008; these figures include restricted investments of $0.8 million at September 30, 2009 and $1.0 million at December 31, 2008.
"Since our last earnings report, we have continued to advance our development programs and business activities, including completing enrollment in our POSIDUR(TM) Phase II shoulder study, entering into a new collaboration with Orient Pharma that will allow us to generate Phase II data for a new drug candidate for the Attention Deficit Hyperactivity Disorder market (ORADUR®-ADHD) and a long term excipient supply agreement with King Pharmaceuticals with respect to REMOXY," stated James E. Brown, D.V.M., President and CEO of DURECT. "In addition, we enhanced our cash position with a $10 million sale of common stock to affiliates of Venrock, a highly respected institutional investor."
Recent Highlights:
-- Remoxy. According to a King Pharmaceuticals / Pain Therapeutics press
release, King anticipates the resubmission of the NDA for REMOXY
intended to address all FDA comments in the Complete Response Letter
could occur mid-year 2010. King has stated that it remains committed to
the development and commercialization of REMOXY and looks forward to
working closely with the FDA toward approval of the product. During the
third quarter, DURECT and King signed an exclusive long term excipient
supply agreement with respect to REMOXY. 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.
REMOXY is an investigational long acting oral formulation of oxycodone intended to treat moderate to severe pain. Based on DURECT's ORADUR 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). DURECT recently completed
enrollment in our Phase IIb clinical study in shoulder surgery of
approximately 60 patients and we expect to have top line data analysis
completed in December. In addition, Nycomed continues enrollment in a
Phase IIb study in hysterectomy patients and a Phase IIb study in
shoulder surgery patients. At the American College of Surgeons 95th
Annual Clinical Congress on October 12, 2009, we presented a scientific
poster regarding our Phase IIb hernia study; this poster can be accessed
through www.durect.com under "About DURECT" and "Publications." We are
in active discussions with multiple potential partners regarding
licensing of the U.S./Canadian and Asian rights to this program.
POSIDUR is our investigational post-operative pain relief depot that utilizes our patented SABER technology intended to deliver bupivacaine to provide up to three days of pain relief after surgery. POSIDUR is licensed to Nycomed for commercialization in Europe and select other countries, and we have retained commercialization rights in the US, Canada and Asia.
-- ELADUR(TM) (TRANSDUR(TM)-Bupivacaine). In October 2008, worldwide
rights to this program were licensed to Alpharma, which was acquired by
King Pharmaceuticals in December 2008. We continue to interact with the
King team on details associated with next steps in the clinical program,
which King expects to initiate in the first half of next year.
ELADUR is our proprietary transdermal patch intended to provide bupivacaine to treat pain for a period of up to three days from a single application.
-- TRANSDUR-Sufentanil. A successful end-of-Phase II meeting with the FDA
has been conducted for this program that laid out a potential regulatory
pathway for the Phase III program and NDA submission.
