WEST BRIDGEWATER, Mass., Sept. 21 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) and the Consortium for Plasma Science, LLC announced today the extension of their collaborative agreement for the development and commercialization of BBI's proprietary Pressure Cycling Technology (PCT) for inactivating pathogens in human source plasma, the material used in the manufacture of clinically useful plasma-based therapeutics. This extension of the original agreement, signed in December 1999, will allow BBI scientists to continue their research aimed at assessing PCT's ability to retain fragile plasma proteins while inactivating viruses that can be harmful to humans, such as Human Immunodeficiency Virus (HIV), Hepatitis A, B & C Viruses (HAV, HBV & HCV), and Parvovirus B19.
"The risk to the blood supply presented by undetected or unknown viruses remains a matter of genuine concern and necessitates a focused search for a universal sterilization technology that will not destroy the plasma proteins," said Dr. Frederick A. Dombrose, Executive Director of the Consortium for Plasma Science. "PCT is an innovative approach for virus inactivation that may have widespread application in advancing the safety and quality of life-saving plasma-derived therapeutics. The Consortium has been very encouraged by the data we have seen so far and consider PCT a candidate technology."
BBI also announced today that it has been awarded a Small Business Innovation Research (SBIR) Grant by the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), related to its research efforts to evaluate the use of PCT for destroying disease-causing viruses that may contaminate human IVIG, a plasma-derived product used to treat immune system disorders and virus infections. This study will focus on establishing conditions under which PCT will effectively destroy viruses, such as HIV, HBV, and Parvovirus, while maintaining the beneficial therapeutic properties of the immune globulins. The $100,000 Phase I SBIR funding will support feasibility studies over a six-month award period with the expectation that additional Phase II funding for commercialization of the technology will subsequently be requested. This award, the third from the NIH since early August, complements the two previously announced SBIR Grants for the use of PCT in extracting nucleic acid from plasma, cells, and tissues for therapeutic purposes.
"Stringent regulatory oversight coupled with increased global demand has resulted in a shortage of plasma-derived therapeutics, including IVIG, both in the US and worldwide. The worldwide demand for plasma and its derivatives continues to grow with the inactivation portion of the market now estimated to be $825 million. We believe that PCT-mediated viral inactivation offers the potential to be efficiently incorporated into the production process to ensure a supply of safe and efficacious plasma products," said Dr. Sandra Dusing, Director of PCT and Principal Investigator for the virus inactivation projects. "In addition, we expect this methodology to be relatively low in cost, to not require the use of additives, to be without adverse environmental impact, and should be appropriate for use in plasma processing facilities throughout the world."
BBI acquired PCT in late 1998 and has been developing its potential commercial applications, while concomitantly establishing the infrastructure required to take full advantage of opportunities for implementation. In addition to nucleic acid extraction, other potential applications include the use of PCT for the inactivation of pathogens in human plasma, the pre-treatment of clinical samples prior to testing to protect laboratory workers, food safety, and genomics -- such as nucleic acid sequence analysis.
The Consortium for Plasma Science seeks a universal approach to eradicate pathogens from human plasma without destroying the functionality of the plasma proteins and provides R&D funding worldwide. The Consortium is co-funded by four plasma fractionation companies, which share safety as a common goal: Alpha Therapeutic Corporation, a subsidiary of the Japanese pan-national Welfide; Bayer Corporation; Baxter Healthcare Corporation; and Aventis Behring, L.L.C. The Consortium, which is a separate entity from its member companies, hopes to accelerate the emergence of new technologies.
Boston Biomedica, Inc. provides products and services for the detection and treatment of infectious diseases such as AIDS, Lyme Disease, and Viral Hepatitis. The Company has four business units: (1) BBI Diagnostics, an ISO 9001 certified manufacturer and supplier of quality control and diagnostics reagents used to increase the accuracy of in vitro diagnostic tests, (2) BBI Clinical Laboratories, a leading specialty infectious diseases testing laboratory, (3) BBI Biotech Research Laboratories, providing R&D support for the other BBI business units as well as contract research services for third parties, and (4) BBI Source Scientific, an ISO 9001 certified manufacturer of laboratory and diagnostic instrumentation. In addition, the Company is pursuing research and development programs in the areas of Pressure Cycling Technology (PCT) and drug discovery through its subsidiaries BBI BioSeq and Panacos Pharmaceuticals, respectively, with the goal of introducing new solutions for the detection, management and treatment of infectious diseases.
Statements contained in this news release that state the Company's or management's intention, hopes, beliefs, expectations or predictions of the future are "forward-looking" statements. It is important to note that the Company's actual results could differ materially from those projected in such forward-looking statements. Factors that could cause actual results to differ from those projected include the possibility that, due to difficulties in the development of the technology, BBI may not be successful in developing pressure cycling technology into commercially viable products or services; that PCT may never become a better alternative than current methods for nucleic acid isolation or virus inactivation; that BBI may not submit a request for Phase II funding or, if submitted, such a request may not be awarded; that BBI may not submit a request to the Consortium for Plasma Science (CPS) for additional funding or, if submitted, such a request may not be awarded; or that pressure cycling technology may not be adaptable to any other commercially viable applications. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the Company's SEC filing including, but not limited to, the Company's report on Form 10-K for the year ended December 31, 1999 and on Form 10-Q for the periods ended March 31 and June 30, 2000. Copies of these documents may be obtained by contacting the Company or the SEC.
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For further information about the Consortium for Plasma Science,
please visit their web site at www.plasmaconsortium.com .
SOURCE Boston Biomedica, Inc.
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CONTACT: Richard T. Schumacher, CEO & Chairman, or Kevin W. Quinlan, President & COO, or William R. Prather, M.D., Sr. VP Finance & Business Dvlp., all of Boston Biomedica, 508-580-1900, or fax, 508-580-1110
