HACKENSACK, N.J., Feb. 12 /PRNewswire-FirstCall/ -- DOV Pharmaceutical, Inc. announced today that it held a DOV-initiated strategy meeting with the U.S. Food and Drug Administration (FDA) regarding DOV's chronic pain program for bicifadine, its novel analgesic.
Significant outcomes of the meeting include: * DOV's current Chronic Low Back Pain (CLBP) program design - including the long term safety database - will be sufficient for the Company to submit the planned New Drug Application (NDA) for bicifadine * DOV confirmed that the use of a single primary endpoint in its two pivotal Phase III clinical trials (study 020 and 021) of bicifadine in CLBP - reduction in pain from baseline to end of treatment as measured by the Visual Analog Scale - is acceptable to the FDA * DOV will perform a QTc study in humans as it appears this is an emerging standard for all New Molecular Entities - a QTc study measures intervals in the QT portion of an electrocardiogram and assesses a drug's potential to produce changes in cardiac rhythm. To date, there have been no electrocardiogram - or other - safety concerns in DOV's preclinical studies or in clinical studies involving more than 2,500 subjects treated with bicifadine.
As a result of the meeting, DOV reiterates its expectation to submit its NDA for bicifadine in the first half of 2007.
"This was a key first meeting with the newly-merged FDA division responsible for analgesia drugs," said Dr. Leslie Hudson, CEO of DOV. "The meeting and its outcomes represent an important milestone in our development of bicifadine. To date, we have seen very encouraging data from our open label Phase III trial and we continue to believe that bicifadine could meet a very significant medical need for a safe and effective analgesic."
The ongoing results from DOV's long term open label trial (study 022) of bicifadine in CLBP suggest that bicifadine is at least as effective as standard of care in treating CLBP and is safe and well-tolerated. The data trends reported by DOV at its Third Annual Scientific Symposium in October and in a year-end update provided by the Company in December 2005 are continuing, with dosing now spanning 12 months and total patients enrolled in study 022 exceeding 700.
As part of its ongoing bicifadine development plan, DOV also announced that it has closed the highest dose arm - 400 mg t.i.d. - in its second pivotal Phase III clinical trial (study 021) of bicifadine in CLBP because open label data from the Company's long term safety and efficacy trial (study 022) of bicifadine in CLBP indicate no incremental benefit at this higher dose. Closing this study arm will allow DOV to focus its development efforts on the dosing regimens it believes show the highest likelihood of success in CLBP - 200 mg, 300 mg and 400 mg b.i.d. The closing of the 400 mg t.i.d. arm will shorten the time to completion of the clinical trial and DOV now expects to report the results of the 021 study earlier in the fourth quarter of 2006 than previously planned.
Bicifadine is currently being evaluated in four Phase III clinical trials: three in CLBP patients and one in patients suffering pain after vaginal hysterectomy and two Phase II clinical trials: one in patients with osteoarthritis of the hip or knee and one in patients with painful diabetic peripheral neuropathy. Phase III clinical trials have already demonstrated that bicifadine is effective in treating severe to moderate pain following dental surgery and bunionectomy.
Conference Call
DOV will host a conference call on Feb. 13, 2006 at 9:00am EST to discuss the outcomes of the FDA meeting. The audio Web cast can be accessed at http://www.dovpharm.com under Investor Relations and will remain archived on the Web site for 90 days. The dial-in numbers for the live teleconference are as follows: (Toll Free): 877-407-8031 and (International): 201-689-8031.
Presentation at BIO CEO & Investor Conference 2006
The Company also announced today that CEO Dr. Leslie Hudson will present at the BIO CEO & Investor Conference 2006 on Tuesday, Feb. 14, 2006. Dr. Hudson's presentation is scheduled to begin at 2 p.m. EST at the Waldorf=Astoria in New York City. He will discuss the development and commercialization strategy for DOV's leading product candidates and data from the Company's late stage clinical development programs. Dr. Hudson's presentation will also be archived and available on the Investor Relations section of the DOV Web site after the conference.
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 trials, (v) regulatory approval for our product candidates may not be received or may be delayed, (vi) our licensees and collaborative partners on whom our success depends may not fulfill their obligations to us and (vii) financings that require SEC approval may be delayed. 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, and Form 10-Q filed on November 9, 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: Keri P. Mattox, Director, Investor Relations and CorporateCommunications of DOV Pharmaceutical, Inc., +1-201-968-0980
Web site: http://www.dovpharm.com/
