-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DW+8T3JtpnSSsLTHFPrArERkFAwi2PVftcmlIIQWmXQExrQvtjFF+WRXXX5nrPR9 oaYlGg1zRdjK3QHYYKC3Nw== 0000950134-04-019877.txt : 20050207 0000950134-04-019877.hdr.sgml : 20050207 20041223164515 ACCESSION NUMBER: 0000950134-04-019877 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20041214 ITEM INFORMATION: Other Events FILED AS OF DATE: 20041223 DATE AS OF CHANGE: 20050207 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOTIME INC CENTRAL INDEX KEY: 0000876343 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943127919 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12830 FILM NUMBER: 041224666 BUSINESS ADDRESS: STREET 1: 935 PARDEE ST CITY: BERKELEY STATE: CA ZIP: 94710 BUSINESS PHONE: 5108459535 MAIL ADDRESS: STREET 1: 935 PARDEE STREET CITY: BERKELEY STATE: CA ZIP: 94710 8-K 1 f04268e8vk.htm FORM 8-K e8vk
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SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): December 14, 2004.

BioTime, Inc.

(Exact name of registrant as specified in its charter)
         
California
(State or other jurisdiction
of incorporation) 		  1-12830
(Commission File Number) 		  94-3127919
(IRS Employer
Identification No.)

935 Pardee Street
Berkeley, California 94710
(Address of principal executive offices)

(510) 845-9535
(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[   ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[   ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[   ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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Item 8.01 Other Events.
SIGNATURES

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     Statements made in this Report that are not historical facts may constitute forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those discussed. Such risks and uncertainties include but are not limited to those discussed in this report and in BioTime’s Annual Report on Form 10-K filed with the Securities and Exchange Commission. Words such as “expects,” “may,” “will,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions identify forward-looking statements.

Section 8-Other Events

Item 8.01 Other Events.

     On December 14, 2004, BioTime submitted a request to withdraw its application to the Swedish Medical Products Agency (“SMPA”) for approval to market Hextend in Sweden. When BioTime filed the application in August 2000, it hoped to obtain approval based upon its U.S. clinical trials of Hextend, which compared Hextend to 6% hetastarch in saline solution. BioTime did not intend to do any additional clinical studies for SMPA approval. However, the Hextend formulation includes a high molecular weight, high degree of substitution hetastarch, and the SMPA has only approved plasma volume expanders that contain lower molecular weight, lower degree of substitution starch. Subsequently, the SMPA asked BioTime for clinical data comparing Hextend with a plasma volume expander containing a lower molecular weight, lower degree of substitution starch already approved in Sweden. BioTime has determined that conducting a large scale clinical trial would not be economical for the purpose of obtaining regulatory approval in Sweden, and elected to request the withdrawal of its application.

     BioTime is also developing PentaLyte, a plasma volume expander that has a formulation similar to Hextend but uses a starch that has a molecular weight and degree of substitution similar to that of a starch used in a product approved for use in Sweden. BioTime is developing PentaLyte to complement Hextend in its product line in order to provide physicians with a choice of products formulated with starches having different molecular weights and degrees of substitution. However, BioTime is first beginning its U.S. Phase II clinical trial of PentaLyte and does not yet have the kind of clinical data that would be needed to obtain approval of PentaLyte in Sweden at this time.

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SIGNATURES

     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

         
    BIOTIME, INC.
     
Date:   December 23, 2004   By   /s/ Steven Seinberg
Chief Financial Officer

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