Kazia Therapeutics Ltd (ASX:KZA) (NASDAQ:KZIA) (FRA:NV9) has entered into a licensing agreement with Simcere Pharmaceutical Group Ltd (HKSE:2096) to develop and commercialise Kazia’s investigational new drug, paxalisib, in Greater China.
Simcere will assume responsibility for the development, registration and commercialisation of paxalisib in Greater China - which includes mainland China, Hong Kong, Macau, and Taiwan.
Under the terms of the agreement, Kazia will receive an upfront payment of US$11 million in cash and shares, and contingent milestone payments of up to US$281 million, with further milestones payable for indications beyond glioblastoma.
One of world’s largest pharma markets
Kazia chief executive officer Dr James Garner said: “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.”
Need for new therapies in brain cancer in China
Simcere senior vice president Dr Renhong Tang 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.”
Terms of deal
The terms of the deal include:
- Simcere will assume responsibility for the development, registration, and commercialisation of paxalisib in Greater China;
- 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;
- Kazia will receive an upfront payment of US$11 million (about A$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 (about A$362 million) for glioblastoma, with further milestones payable for indications beyond glioblastoma; and
- Simcere will additionally pay mid-teen percentage royalties on commercial sales.
Simcere
Simcere is one of China’s leading pharmaceutical companies, with more than 40 marketed products and an extensive development pipeline.
It was incorporated in 1995 and is listed on the Hong Kong Stock Exchange.
Simcere’s primary areas of strategic focus are in oncology, central nervous system disease, and autoimmune disease.
Paxalisib
Paxalisib is a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is disordered in the vast majority of patients with glioblastoma, the most common and most aggressive form of primary brain cancer.
In a Phase II study in patients with newly diagnosed glioblastoma with unmethylated MGMT promotor status, paxalisib has shown highly encouraging signals of clinical efficacy.
In January 2021, patient recruitment commenced for paxalisib in the GBM AGILE platform study, which is expected to serve as the basis for registration in key territories.
Paxalisib is currently the subject of six additional studies in other forms of brain cancer beyond glioblastoma.