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.
“We are delighted to add RAPVIAB to our product portfolio” said Dr John Anderson, General Manager and Senior Vice-President of bioCSL. “RAPIVAB is a specialty pharmaceutical that addresses an unmet medical need for the treatment of acute influenza in the hospital emergency room setting. It provides us with the opportunity to extend our influenza franchise to include both prevention and treatment options in seasonal and pandemic settings”.
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.
About RAPIVAB® (peramivir injection)
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.
RAPIVAB is not approved or available in Australia.
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst currently has several ongoing development programs: oral inhibitors of plasma kallikrein for hereditary angioedema, including BCX4161, BCX7353 and several second generation compounds; and BCX4430, a broad spectrum viral RNA polymerase inhibitor. For more information, please visit www.biocryst.com.
About CSL Limited
CSL Limited (ASX:CSL) is a global biopharmaceutical company that develops, manufactures and markets biotherapies to prevent and treat rare and serious human diseases. CSL owns major facilities in Australia, Germany, Switzerland and the US, and employs over 13,000 people in more than 27 countries. CSL operates two subsidiary businesses, CSL Behring and bioCSL, which are underpinned by a significant Research and Development effort. For more information, please visit www.csl.com.
Headquartered in Australia, bioCSL has been developing and manufacturing influenza vaccines for more than 50 years. It operates one of the world’s largest influenza vaccine production facilities and supplies both seasonal and pandemic influenza vaccines to global markets. bioCSL also markets a comprehensive range of vaccines and pharmaceuticals in the Australasia region and manufactures specialised Products of National Significance for Australia. Find more information at www.seqirus.com.au.
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CSL Acquires Exclusive Rights to Influenza Treatment (0.20Mb)
Sharon McHale, Head of Public Affairs, CSL Limited
Phone: +613 9389 3425 or +61 409 978 314
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Mark Dehring, Head of Investor Relations, CSL Limited
Phone: +613 9389 3407 or +61 423 780 328