SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
Date of Report: November 16, 2000
BIORA AB
SE-205 12 Malmo, Sweden
Telephone: (011) 46-40-32-13-33
Indicate by a check mark whether the registrant files or
will file annual reports under cover of Form 20-F or Form 40-F.
|X| Form 20-F |_| Form 40-F
Indicate by check mark whether the registrant by furnishing
the information contained in this Form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
|_| Yes |X| No
If "Yes" is marked, indicate below the file number assigned
to the registrant in connection with Rule 12g3-2(b):
Not applicable.
This Form 6-K consists of a press release issued by Biora AB
on November 16, 2000 regarding altered production process for Japan.
[BIORA LOGO]
PRESS RELEASE FROM BIORA AB (PUBL), NOVEMBER 16, 2000
FOR IMMEDIATE RELEASE
NO14 /00
ALTERED PRODUCTION PROCESS FOR JAPAN
Malmo, Sweden November 16, 2000 - Biora AB (NASDAQ: BIORY, SSE: BIOR)
announced today that Biora's partner in Japan, Seikagaku Corp, has
unintentionally omitted to report to the Japanese health authority, MHW,
changes in the production process of Emdogain that were introduced for
markets outside Japan. As a result Seikagaku decided on Wednesday, Nov.15
to make a voluntary withdrawal of all deliveries of Emdogain in Japan. It
is Seikagaku's intention to apply to MHW for approval of the process
changes, including heat treatment, which are already in place in Europe. It
should be possible to obtain MHW approval of the European standard for the
production process within some months.
In a commentary Biora's President and CEO Rickard Soderberg stated:
"Seikagaku is merely complying with the rules of the national
authorities, but at the same time points out in their notice to
customers that no health problems whatsoever have been reported as a
result of using Emdogain. The product has been used successfully on more
than 200,000 patients. We are now awaiting their requirements following
their evaluation, and will be able to deliver Emdogain immediately after
such approval. In the short term we do not foresee any negative impact
on Biora's sales of Emdogain to Japan. The direct financial consequences
of the withdrawal will be taken by Seikagaku"
Biora develops manufactures and sells products for the treatment of
periodontal disease and for use in oral surgery. Using its proprietary
technology and expertise, Biora aims to become a world leader in
biology-based products for specialized dental therapy. Biora's American
Depository Shares are listed on the Nasdaq National Market in the US and
Biora's ordinary shares are listed on the "O-list" of the Stockholm Stock
Exchange in Sweden.
This press release may contain certain forward-looking statements that
relate to future events or future business and financial performance. Such
statements can only be predictions and the actual events or results may
differ from those discussed. The Company cautions that these statements are
subject to important factors that could cause actual results to differ
materially from those expressed or implied in such forward looking
statements and are more fully discussed in periodic reports filed with
Securities and Exchange Commission.
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For further information, please contact:
- Rickard Soderberg, President and CEO of Biora, tel: +46 (0) 40 32 13 59
- Elisabeth Lavers, Biora US-investor relations, tel: +1 203 977 7797
