Item 8.01 Other Events.

On April 23, 2009, the Company received approval from the U.S. Food and Drug Adminstration for the Company's supplemental new drug application to update the prescribing information for TREANDAŽ (bendamustine HCl) for Injection. The Company will finalize and implement the updated prescribing infromation for TREANDA in early May 2009. The Company has identified two postmarketing cases of Stevens Johnson Syndrome ("SJS")/toxic epidermal necrolysis ("TEN") in patients treated concomitantly with TREANDA and allopurinol; one of these cases was fatal. Allopurinol is known to cause SJS/TEN. In the non-fatal case, the patient also received other drugs that can cause SJS.

TREANDA's prescribing information will be updated to include these serious skin reactions. These updates communicate safety warnings when TREANDA is used in combination with allopurinol. Although the relationship between TREANDA and SJS/TEN cannot be determined, there may be an increased risk of severe skin toxicity when TREANDA and allopurinol are administered concomitantly. This update is similar to the labeling that currently exists with certain other agents used to treat indolent non-Hodgkin's lymphoma and/or chronic lymphocytic leukemia, such as RITUXANŽ (rituximab), REVLIMIDŽ (lenalidomide) and cyclophosphamide, all of which also reference SJS/TEN in their current respective prescribing information.

RITUXANŽ is a registered trademark of Genentech, Inc. and Biogen Idec Inc. REVLIMIDŽ is a registered trademark of Celgene Corporation.

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