Savient Pharmaceuticals provided an update on its business activities related to the U.S. launch and commercialization of Krystexxa, a PEGylated uric acid specific enzyme for the treatment of chronic gout. The company is planning to launch the drug in 1Q11. For the launch of Krystexxa, Savient has inventory of the drug at its third party logistics warehouse in the U.S., which the company believes to be adequate to supply market demand through 1Q12.

The company’s third party contract manufacturing organizations in Israel and Indianapolis, IN began regularly scheduled commercial manufacturing to build inventory of pegloticase and Krystexxa. The third party CMO in Israel and Merck Biomanufacturing Network, which Savient is working to qualify as a secondary contract manufacturer, have experienced some batch failures based on one manufacturing specification. The company believes these batch failures are within normal industry failure rates when beginning the commercial manufacture of a biologic. With the help of an outside manufacturing and quality consulting firm, Savient has completed a review of these batch failures and believes it has identified the cause of the problem at both the company’s third party CMO in Israel and Merck, and has begun the process of implementing remediation steps.

Savient plans to repeat its validation campaign batches at Merck in 2011, which the company expects will result in additional costs of approximately $9 to $10 million over a two-year period.