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Octapharma Announces octagam® 5% Again Available for U.S. Purchase
Date:11/30/2011

unity for patient tolerability," said Octapharma USA President Flemming Nielsen. "We have seen over the last year that there are industry-wide concerns over TEEs connected with multiple immune globulin products that remained on the market while we have implemented enhanced safety measures for octagam® 5%. Industry-wide, immune globulin products can lead to TEEs in approximately 1 individual or less for every 10,000 treatments. But our 10-month analysis of octagam® in nearly 60,000 treatments internationally showed that octagam® outperformed this industry benchmark with no reported TEEs."

Octapharma's estimate of 60,000 octagam® 5% and octagam® 10% patient treatments is based on reported global sales of 1.7 million grams, not on actual recorded patient treatment sessions. The number of treatments is based on average patient utilization per treatment. The data has not been submitted to the FDA for evaluation.

The FDA approval to return octagam® 5% to the U.S. market was based on changes Octapharma has made in the manufacturing process and the company's decision to implement a quality control test on every batch of product that is released to the marketplace for the absence of thrombogenic potential. Additionally,

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