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CSL Aquires Exclusive Rights to Influenza Treatment

CSL Limited today announced it has acquired exclusive rights to commercialise the influenza treatment, RAPIVAB®, from US-based company, BioCryst Pharmaceuticals Inc.

RAPIVAB (peramivir injection) is a single-dose intravenous treatment for acute uncomplicated influenza, which was developed under contract with the US Government as part of pandemic preparedness efforts. RAPIVAB was approved for use in the US in December 2014 and is also licensed for use in Japan and South Korea. It is estimated that approximately 1 million patients have been treated with RAPIVAB to date.

RAPIVAB will be commercialised by CSL’s subsidiary, bioCSL, which specializes in influenza prevention through the supply of seasonal and pandemic vaccine to global markets.

Under the terms of the agreement, bioCSL will obtain exclusive worldwide rights to commercialise RAPIVAB, with the exception of Japan, Korea, Taiwan and Israel. BioCryst will retain responsibility for pandemic stockpiling of RAPIVAB in the US while bioCSL will have exclusive rights to pursue pandemic stockpiling outside the US.

Under the terms of the agreement, BioCryst will receive an upfront payment of $33.7 million which bioCSL will capitalize at the time of payment and subsequently amortize. BioCryst may receive up to $12 million in additional payments related to the successful achievement of certain regulatory milestones. BioCryst will also receive tiered royalties that are contingent upon certain net sales thresholds in the US and rest of the world, and a payment on proceeds from stockpiling purchases outside the US.

Approved by FDA in December 2014, RAPIVAB (peramivir injection) is an intravenous (IV) viral neuraminidase inhibitor for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days. In January 2010, Shionogi & Co., Ltd. launched IV peramivir in Japan under the name RAPIACTA® and in August 2010, Green Cross Corporation announced that it had received marketing and manufacturing authorization for IV peramivir in Korea under the name PeramiFlu®. It is estimated that more than one million patients have received peramivir treatment to date. The recommended dose of RAPIVAB in most adult patients 18 years of age or older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes. RAPIVAB was developed under contract number HHSO10020070032C from the Biomedical Advanced Research and Development Authority (BARDA/HHS), a $234.8 million contract.