Message #13 From:
NewsBot Date: December 20, 2005 02:54:00 AM
PBME News Pacific Biometrics, Inc. Awarded Major Research Contract as Part of Global Phase III Osteoporosis Program
SEATTLE--(BUSINESS WIRE)--Dec. 20, 2005--Pacific Biometrics, Inc. (OTCBB: PBME, "PBI") has been awarded a contract with a top multinational pharmaceutical company (the "Sponsor") to provide essential laboratory data for a pivotal, global Phase III osteoporosis program. This contract is part of a series of contracts related to the clinical development of a major new treatment for osteoporosis.
PBI is specifically contracted to provide biomarker testing relating to the mechanism of action of a drug as part of a major, multinational phase III clinical development program. The Sponsor ultimately hopes to file a new drug application (NDA) with the FDA and equivalent filings with regulatory agencies in other jurisdictions. Testing for the newly awarded contract will commence immediately and is expected to continue until the end of the second quarter of calendar year 2006. PBI estimates total revenue over the expected life of this contract at approximately $1.1 million.
"Our inclusion in this pivotal, international phase III osteoporosis program is significant for several reasons," said Ron Helm, Chief Executive Officer of Pacific Biometrics. "First of all, this study will further strengthen our relationship with this Sponsor, who is an important and longstanding member of our customer base. Furthermore, our selection for this project is validation for our worldwide, best-in-class testing of biomarkers as they relate to the diagnosis and treatment of osteoporosis -- a key area of expertise for the Company. Finally, assuming the scope of the trial remains unchanged, the contract should have a meaningful impact on our fiscal 2006 financial results."
Established in 1989, PBI provides specialized central laboratory and contract research services to support pharmaceutical and diagnostic manufacturers conducting human clinical trial research. The company provides expert services in the areas of cardiovascular disease, diabetes, osteoporosis, arthritis, and nutrition. The PBI laboratory is accredited by the College of American Pathologists, and through its non-profit affiliate Pacific Biometrics Research Foundation, is one of only three U.S.-based members of the Centers for Disease Control (CDC) Cholesterol Reference Method Laboratory Network. PBI's clients include many of the world's largest pharmaceutical, biotech, and diagnostic companies.
Pacific Biometrics also owns several patented and patent-pending technologies, including monitoring devices for glucose and changes in bone turnover, an advanced, proprietary, isothermal DNA amplification technology, and a gene-based cell viability technology to distinguish live from dead cells in a broad range of diagnostic applications.
For more information about Pacific Biometrics, visit the company's web site at www.pacbio.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press release includes forward-looking statements including to but not limited to the amount of revenues that we may receive under this contract, the duration, size and scope of this contract, our strategic planning and business development plans, growth in our backlog, impacts on our financial results, our future growth, and the viability and acceptance of our products and services in the market. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ materially from those described in the forward-looking statements. These risks include, but are not limited to, our ability to bid on and win laboratory services contracts, the success of our marketing and business development efforts, competition in the industry, and our ability to manage growth, as well as the risks and other factors set forth in our periodic filings with the U.S. Securities and Exchange Commission (including our Form 10-KSB for the year ended June 30, 2005 and our Form 10-QSB for the quarter ended September 30, 2005).