Daiichi Sankyo Exercises Option With Aussie Biotech Biota For Second-Gen Flu Drug
This article was originally published in PharmAsia News
Executive Summary
PERTH, Australia - Daiichi Sankyo has exercised its option to manufacture and market in Japan its second-generation influenza long-acting neuraminidase inhibitor CS-8958, co-owned with Autralian biotech Biota. The agreement is contingent upon successful completion of pivotal Phase III trials and approval, Biota announced March 30
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PERTH, Australia - Daiichi Sankyo has exercised its option to manufacture and market in Japan its second-generation influenza long-acting neuraminidase inhibitor CS-8958, co-owned with Autralian biotech Biota. The agreement is contingent upon successful completion of pivotal Phase III trials and approval, Biota announced March 30. Although the molecule was discovered by Daiichi Sankyo, Biota would receive an undisclosed royalty on sales and milestone payments based on Japanese sales. All other key markets for CS-8958 remain available for licensing by both Biota and Daiichi Sankyo and would be shared 50/50. CS-8958 is a follow-on LANI to Relenza (zanamivir), which was developed by Biota and is marketed by GlaxoSmithKline (Also see "Aussie Biotech Biota Completes Phase II Trials for Relenza Follow-On; Phase III To Be Conducted In Japan, Taiwan, Hong Kong and Korea" - Scrip, 3 Aug, 2008.). "Given Daiichi's decision to exercise its rights, it gives us more confidence that some licensing deal is likely for the rest of the world," ABN AMRO Morgans analyst Scott Power wrote in a research note to clients. In 2003 Biota and Daiichi Sankyo combined their LANI research programs, including CS-8958 and a number of other LANI compounds such as FluNet, which are co-owned by Biota and Daiichi Sankyo. Patient enrollment of the key Phase III trials being conducted in Japan, Taiwan, Hong Kong and Korea have completed and results are expected mid-year, according to Biota. "Our best guess on timing is that sales into Japan could commence in 2011. At this stage we will make no changes to our forecasts," Power said, noting that the next milestone will be the release of GSK quarterly results April 23. "We expect to see a substantial increase in royalties from Relenza given the recent success in securing major orders from the UK and Japanese Government," Power wrote. Biota announced in February that Relenza partner GSK was awarded a contract by the U.K. Department of Health for 10.6 million treatment courses of the flu drug. Japan's Ministry of Health, Labor and Welfare also ordered more vaccine from GSK - enough to treat 3 million people (Also see "UK Orders 10.6 Million Doses of GSK/Biota Relenza To Cope With Tamiflu-resistant Flu" - Scrip, 4 Feb, 2009.). "This is the first of the second-generation products, which are characterized by having a long action: once-only for treatment and once-weekly for prophylaxis and that has a substantial compliance advantage compared to the first-generation products, which are daily," Biota CEO Peter Cook told PharmAsia News in an earlier interview (Also see "Daiichi Sankyo And Aussie Biotech Biota Begin Phase III Asian Trials For Second-Generation Flu Drug" - Scrip, 18 Nov, 2008.). First-generation products include Relenza, Roche's Tamiflu (oseltamivir) and BioCryst's peramivir, which is in Phase II trials. - Tamra Sami ([email protected]) |