Biora AB Announces Voluntary Withdrawal of Emdogain in Japan

Seikagaku Corp, Biora's partner in Japan, has failed to report changes in the production process of Emdogain to the Japanese health authority, MHW, leading to Seikagaku's decision to voluntarily withdraw all deliveries of Emdogain in Japan. This move is aimed at complying with national regulations, despite the product's successful use on over 200,000 patients. Biora expects to deliver Emdogain in Japan after MHW approval, which may be obtained within a few months. The company's sales of Emdogain in Japan are not expected to be negatively impacted in the short term, with the direct financial consequences of the withdrawal falling on Seikagaku.

Key Takeaways:

• Biora's partner in Japan, Seikagaku Corp, has omitted to report changes in the production process of Emdogain to the Japanese health authority, MHW.
• As a result, Seikagaku has voluntarily withdrawn all deliveries of Emdogain in Japan, pending MHW approval.
• The changes in production process, including heat treatment, are already in place in Europe and may be approved by MHW within a few months.
• Emdogain has been used successfully on over 200,000 patients, with no reported health problems.
• Biora's sales of Emdogain in Japan are not expected to be negatively impacted in the short term.
• 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.
• The company aims to become a world leader in biology-based products for specialized dental therapy.

Statistics:

• Over 200,000 patients have used Emdogain without reported health problems.
• Biora has American Depository Shares listed on the Nasdaq National Market in the US.
• Biora's ordinary shares are listed on the "O-list" of the Stockholm Stock Exchange in Sweden.

Sources:

• "Biora AB Announces Voluntary Withdrawal of Emdogain in Japan," Business Wire, Nov. 16, 2000.