NPBI Manufactures BioTime's HexTend for European Approval.Medical & Health Writers BERKELEY, Calif.--(BW HealthWire)--Jan. 11, 2000 BioTime, Inc. (AMEX AMEX See: American Stock Exchange :BTX (Balanced Technology EXtended) A motherboard design from Intel introduced in 2004 that supersedes the ATX. Unlike the ATX, the placement of all chip sockets in the BTX is defined in order to provide sufficient air flow over the processor and display adapter. ) announced today the first European production of Hextend(R) for use in tests needed for regulatory approval in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . Hextend, BioTime's physiologically balanced blood plasma blood plasma n. The yellow or gray-yellow, protein-containing fluid portion of blood in which the blood cells and platelets are normally suspended. volume expander, was manufactured for BioTime by NPBI International BV of the Netherlands. The solutions were manufactured under a joint development program between BioTime and NPBI aimed at gaining regulatory approval for Hextend in Europe and other parts of the world. NPBI is a manufacturer of large volume parenteral parenteral /pa·ren·ter·al/ (pah-ren´ter-al) not through the alimentary canal, but rather by injection through some other route, as subcutaneous, intramuscular, etc. par·en·ter·al adj. 1. solutions sold worldwide. NPBI and BioTime are conducting stability and related tests for BioTime's regulatory applications. BioTime plans to file for European regulatory approval this year. BioTime and NPBI are negotiating the terms of a long term manufacturing agreement. BioTime is in discussion with internationally-based corporations regarding arrangements to market Hextend outside the United States and Canada, and is approaching agreement to license its products in certain of these areas. BioTime, headquartered in Berkeley, California develops blood plasma volume expanders, blood replacement solutions for hypothermic hy·po·ther·mi·a n. Abnormally low body temperature. [hypo- + Greek therm (low temperature) surgery, organ preservation solutions and technology for use in surgery, emergency trauma treatment, and other applications. The matters discussed in this press release include forward-looking statements which are subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated. Such risks and uncertainties include but are not limited to BioTime's ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of and demand for its products; the ability to negotiate favorable foreign licensing or other manufacturing and marketing agreements for its products; the availability of ingredients used in its products; and the availability of reimbursement for the cost of new products (and related treatment) from government health administration authorities, private health coverage insurers and other organizations. These and other risk factors are discussed in BioTime's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed with the Securities and Exchange Commission. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion