HACKENSACK, N.J., Nov. 3 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. held its Third Annual Scientific Symposium on Friday, Oct. 28, 2005 in New York City. The event featured presentations from DOV’s senior management team regarding the Company’s strategies and timelines for its leading product candidates, new data from its late stage clinical development programs and updates about its preclinical pipeline. There were more than 120 attendees on site and participating in the live Webcast.
Bicifadine in the Treatment of Chronic Low Back Pain
Significant new data were presented and timelines were confirmed for DOV’s novel, non-opiate analgesic bicifadine as a treatment for chronic low back pain (CLBP). Data collected during the first six months of dosing in DOV’s ongoing open label CLBP trial indicate that the efficacy of bicifadine 800 mg/day in reducing pain and improving behavioral functioning is at least equivalent to standard of care (an average of 2.5 concurrent medications). These open label trial data also show that the subset of patients who “rolled over” following completion of a prior three-month DOV Phase III double-blind placebo-controlled clinical trial of bicifadine in CLBP entered the open label trial with a mean pain score of approximately 40 on a visual analog scale (VAS). This is compared to a mean VAS score of about 70 for de novo (newly- enrolled, bicifadine-naive) patients. Further, the de novo patients showed marked improvement over the first two weeks, to a VAS score of approximately 50, and continued to lower their collective scores down to about 30 during 18 weeks of dosing. Additionally, the open label trial data collected demonstrate that bicifadine was well-tolerated. After presenting these data, DOV reaffirmed its plans to submit a CLBP NDA filing in the first half of 2007. As part of its market expansion strategy for bicifadine, the Company announced that it will initiate Phase II pilot trials in osteoarthritis and neuropathic pain in the fourth quarter of 2005.
Additional Data and Timelines Presented * Bicifadine in the Treatment of Acute Pain -- Three acute pain placebo-controlled trials have been completed with each demonstrating a statistically superior analgesic effect for bicifadine. -- One of these three trials is the recently-completed Phase III double-blind trial in patients with moderate to severe pain following bunionectomy surgery. This trial demonstrated the efficacy of bicifadine and an active control (tramadol) relative to placebo: bicifadine’s analgesic action showed rapid onset within approximately 30 minutes, was superior to placebo, comparable to that of tramadol and well-tolerated. -- DOV plans to submit an sNDA filing for acute pain during the fourth quarter of 2007. * Triple Reuptake Inhibitor Program -- Phase II trial data presented show that patients with moderate to severe depression who were dosed for up to two weeks with either DOV 216,303 or citalopram (Celexa) demonstrated reductions of greater than 40% from baseline in the total Hamilton Depression rating scores; adverse event rates were similar for these two groups. -- A Phase II efficacy trial with DOV 21,947 in major depression will be initiated in 2006. -- DOV presented data indicating that 102,677 produced a potent and robust reduction in the volitional consumption of alcohol in a well-established preclinical model of alcohol abuse. Based on these data, DOV has decided to start a pilot Phase II trial for DOV 102,677 in alcohol abuse in 2006. * GABAA Modulator Program -- Development of ocinaplon has been discontinued for generalized anxiety disorder due to an unacceptable rate of liver enzyme elevations. DOV will select a follow-on candidate from one of the back-up compounds in its preclinical program. * Indiplon -- DOV partnered this compound in 1998 to Neurocrine and is entitled to receive 3.5% on net worldwide sales. -- PDUFA dates are February and March 2006 for the two NDAs filed for the use of indiplon for the treatment of insomnia.
“The Scientific Symposium provided DOV with an opportunity to discuss the development of our product candidates and preclinical compounds and allowed attendees to actively engage in dialogue with the Company’s senior management team to learn more about recently-completed and ongoing clinical trials and what they mean for DOV’s overall strategies,” said Dr. Leslie Hudson, CEO and president of DOV. “For example, we are extremely pleased with the data collected from the first six months of dosing in our ongoing open label CLBP trial and what they might predict for the bicifadine commercial development program. The Symposium gave us a forum to disclose the data thus far and discuss bicifadine’s potential efficacy for a patient population with a large unmet medical need. We are looking forward to continuing these updates as more data become available.”
The Symposium also included a keynote address from international pain expert Gerald M. Aronoff, M.D., who discussed pain management, unmet clinical needs and the opportunity for a safe and effective pain treatment to satisfy these unmet needs. The Webcast of the Symposium and its presentations will be archived and available in the Investor Relations section of the DOV Web site: http://www.dovpharm.com for 90 days. Additional information, including slides used at the Symposium, have been furnished with the Company’s recent 8-K and 8-K/A filings on October 28, 2005 and have been installed on the Company’s Web site.
About DOV
DOV is a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of novel drug candidates for central nervous system and other disorders, including cardiovascular, which involve alterations in neuronal processing. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, pain and depression. Our partner Neurocrine has filed two NDAs for the use of DOV’s compound indiplon for the treatment of insomnia.
Cautionary Note
Statements in this press release that are not historical facts constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act, each as amended, including statements regarding our expectations with respect to the progress of and level of expenses for our clinical trial programs. You can also identify forward-looking statements by the following words: may, will, should, expect, intend, plan, anticipate, believe, estimate, predict, potential, continue or the negative of these terms or other comparable terminology. We caution you that forward-looking statements are inherently uncertain and are simply point-in-time estimates based on a combination of facts and factors currently known by us about which we cannot be certain. Actual results or events will surely differ and may differ materially from our forward-looking statements as a result of many factors, some of which we may not be able to predict or may not be within our control. Such factors may also materially adversely affect our ability to achieve our objectives and to successfully develop and commercialize our product candidates, including our ability to:
* Demonstrate the safety and efficacy of product candidates at each stage of development; * meet our development schedule for our product candidates, including with respect to clinical trial initiation, enrollment and completion; * develop an acceptable development plan under and otherwise achieve the results contemplated by the recent amendment to the existing license agreement with Merck; * meet applicable regulatory standards and receive required regulatory approvals on our anticipated time schedule or at all; * meet obligations and required milestones under our license and other agreements; * obtain and maintain collaborations as required with pharmaceutical partners; * obtain substantial additional funds; * obtain and maintain all necessary patents or licenses; and * produce drug candidates in commercial quantities at reasonable costs and compete successfully against other products and companies.
Factors that may cause our actual results to differ materially from our forward-looking statements include (i) one or more of our product candidates could be shown to cause harmful side effects, (ii) one or more of our product candidates may not exhibit the expected therapeutic results, (iii) we or the FDA may place on clinical hold one or more of our clinical trials, and neither we nor the agency may determine to lift such hold, (iv) patient recruitment may be slower than expected or patients may drop out of our clinical (v) regulatory approval for our product candidates may not be received or may be delayed, and (vi) performance of our licensees and collaborative partners on whom our success depends may not fulfill their obligations to us. You should also refer to the risks discussed in our other filings with the Securities and Exchange Commission including those contained in our annual report on Form 10- K filed on March 15, 2005. We qualify all our forward-looking statements by these cautionary statements. There may be other factors that may materially affect our forward-looking statements and our future results. Readers should not, therefore, place undue reliance on our forward-looking statements. We do not undertake any obligation and do not intend to update any forward-looking statement.
DOV Pharmaceutical, Inc.
CONTACT: Alan Beckhard, Manager, Investor Relations and CorporateCommunications for DOV Pharmaceutical, Inc., +1-201-968-0980
Web site: http://www.dovpharm.com/
