NEW YORK, Nov. 3, 2004 (PRIMEZONE) -- Bioaccelerate (OTCBB:BACL) portfolio company Enhance Biotech, Inc. (Pink Sheets:EBOI), a developer of a portfolio of products focused on lifestyle drugs, announced today that its new merger partner Ardent Pharmaceuticals, Inc., the world leader in the discovery and development of delta receptor compounds, entered into a Feasibility Study, Option and License Agreement with ALZA Corporation for the development of DPI-125, Ardent's lead drug candidate for moderate-to-severe pain.
DPI-125 is a novel mixed delta/mu opioid receptor agonist that has successfully completed a Phase 1 clinical trial for its intravenous formulation. Pre-clinically, DPI-125 has shown similar efficacy to strong analgesics such as morphine and fentanyl, with the potential for reduced respiratory depression, emesis and addiction over those agents.
In consideration of an initial fee payable upon signing of the agreement, Ardent grants ALZA a 12-month option for an exclusive, worldwide license to the compound. During the 12-month period, ALZA will conduct feasibility studies. If ALZA exercises the option, ALZA will proceed with development of at least two potential products, an intravenous formulation for acute pain and at least one formulation for chronic pain. ALZA may also elect to develop other formulations of DPI-125. The agreement also provides ALZA with exclusive options to license additional analgesic compounds from the Ardent portfolio. Development and commercialization expenses for the products will be borne by ALZA.
In addition to the option fee upon signing the agreement, Ardent will receive further payments should ALZA exercise its option following feasibility studies, and will also be eligible for development milestone payments and royalties. Ardent will also obtain the right to co-promote the intravenous product in the U.S.
The market for moderate-to-severe pain opioid analgesics exceeded $4 billion in 2003. Intravenous formulations are generally used for acute pain management, and are marketed primarily to hospitals. Oral and transdermal patch formulations have utility for chronic use and thus have potential to address a significantly larger marketplace.
Ken Chang, the Chairman and CEO of Ardent, commented, "Ardent is pleased and excited to have reached agreement with ALZA concerning Ardent's analgesia portfolio. ALZA is a leader in drug delivery technology, which we believe will be well-suited for delivery of DPI-125. ALZA has a tremendous history in this area of having developed the very successful fentanyl patch Duragesic. In addition to their technology expertise, ALZA has the development resources and experience, to help maximize the potential of the Ardent pain portfolio."
About Ardent
Ardent is the world leader in the discovery and development of delta receptor compounds. As a private company it has developed a substantial knowledge of the chemistry and pharmacology of the delta receptor, including a library of approximately 1,000 compounds that demonstrate specific opiate receptor activity. From this expertise Ardent has discovered and is developing compounds in moderate-to-severe pain, urinary incontinence, premature ejaculation, depression and cardioprotection. Development stages for these products range from pre-clinical target compound selection through to Phase 1. Ardent has an extensive research facility based in North Carolina's Research Triangle Park. For more information on the company please see the company's website at http://www.ardentpharma.com/.
Ardent recently entered into an agreement to merge with Enhance Biotech, Inc. (EBOI.PK), a New York based drug development company focused on lifestyle products for sexual dysfunction and dermatology. (http://www.enhancelifesciences.com/) The combined company will develop a broad pipeline of lifestyle products in the areas of urology, dermatology and CNS.
Certain statements contained herein are 'forward-looking' statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Potential risk factors include, but are not limited to: risks associated with preclinical and clinical development of new drugs by biopharmaceutical companies generally; the risks of potential failure of Ardent's particular compounds under development to prove safe and effective for treatment of disease; uncertainties related to Ardent's dependence on third parties and partners; acquisitions, divestitures, mergers, licenses or strategic initiatives that change Ardent's business, structure or projections, including its proposed combination with Enhance Biotech, Inc.; the development of competing products; and those risks described in the filings with the SEC, including those of Enhance Biotech, Inc and Bioaccelerate Holdings Inc. Ardent, Enhance Biotech, Inc and Bioaccelerate Holdings, Inc., disclaim any obligation to update these forward-looking statements.