On March 29, 2021 Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an oncology-focused drug development company, reported that it has entered into a licensing agreement with Simcere Pharmaceutical Group Ltd (Simcere, 先声药业) (HKSE: 2096) to develop and commercialise Kazia’s investigational new drug, paxalisib, in Greater China (Press release, Kazia Therapeutics, MAR 29, 2021, View Source [SID1234577248]).
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Key Points
Simcere will assume responsibility for the development, registration, and commercialisation of paxalisib in Greater China – a territory which includes Mainland China, Hong Kong, Macau, and Taiwan.
Kazia retains rights to the development and commercialisation of paxalisib in all other territories and will continue to drive forward the GBM AGILE pivotal study as planned, including in China.
Under the terms of the agreement, Kazia will receive an upfront payment of US$ 11 million (~AU$ 14.2 million), comprising US$ 7 million in cash and a US$ 4 million equity investment, priced at a 20% premium to recent trading. Kazia will also receive contingent milestone payments of up to US$ 281 million (~AU$ 362 million) for glioblastoma, with further milestones payable for indications beyond glioblastoma. Simcere will additionally pay to Kazia mid-teen percentage royalties on commercial sales.
Transaction proceeds will be applied directly to the further development of paxalisib.
Simcere is one of China’s leading pharmaceutical companies, with over 40 marketed products and an extensive development pipeline. It was incorporated in 1995 and is listed on the Hong Kong Stock Exchange (HKSE: 2096). Simcere’s primary areas of strategic focus are in oncology, central nervous system disease, and autoimmune disease.
Paxalisib is currently the subject of six additional studies in other forms of brain cancer beyond glioblastoma.
Kazia CEO, Dr James Garner, commented, "China is one of the world’s largest pharmaceutical markets, with specific requirements and opportunities for innovative oncology products. We are delighted to partner with Simcere to secure the commercial success of paxalisib in this critical territory. Simcere’s track record of success is unrivalled, and they bring to paxalisib first-class capabilities in clinical development, regulatory affairs, and commercialisation. We look forward to working closely with our new partners to make paxalisib available for Chinese patients as swiftly as possible."
Dr Renhong Tang, Senior Vice President at Simcere, added, "we are tremendously excited by the potential for paxalisib to make a difference in this very challenging disease. The need for new therapies in brain cancer is significant in China, and we share Kazia’s commitment to bringing forward new treatment options for patients."
Kazia has been advised in this transaction by Janette Dixon at JustPartnering and by Dragon Financial Partners.