Date: 2014-03-28
Type of information: Licensing agreement
Compound: Mesupron® (upamostat)
Company: Wilex (Germany) Link Health (China)
Therapeutic area: Cancer - Oncology
Type agreement: development licensing
Action mechanism: uPA inhibitor. Mesupron® (upamostat) is an inhibitor of the Urokinase Plasminogen Activator (uPA) system. The uPA system has been shown to play a key role in tumour cell invasion and metastasis, as well as in primary tumour growth, of various solid tumours. Data from two Phase IIa trials (proof of concept) in locally advanced pancreatic cancer and metastatic breast cancer indications show the safety and activity of the drug candidate in combination with chemotherapeutic agents. In 2014, the rights to the development and commercialisation of Mesupron® were out-licensed to Link Health Co., Guangzhou, China, for the region comprising China, Hong Kong, Taiwan and Macau.
Disease: HER2-negative metastatic breast cancer, non-metastatic pancreatic cancer
Details: * On March 28, 2014, Wilex has announced that it has entered into a licensing and development partnership for Mesupron® with Link Health Co., Guangzhou, China. Link Health will receive the exclusive licensing rights for the development and marketing of Mesupron® in China, Hong Kong, Taiwan and Macao. Link Health will be responsible for performing and financing the entire clinical development of Mesupron® in China in all oncological indications, including HER2-negative metastatic breast cancer and non-metastatic pancreatic cancer, as well as for the regulatory process and product marketing. To receive regulatory approval from the SFDA (Chinese State Food and Drug Administration), the complete clinical development programme from Phase I to Phase III must also be conducted in China. The data generated may be used to support potential further development of Mesupron® in other key markets.
Wilex has developed with Mesupron® as a drug candidate to inhibit the Urokinase Plasminogen Activator (uPA) system. The uPA system has been shown to play a key role in tumour cell invasion and metastasis, as well as in primary tumour growth, of various solid tumours. Data from two Phase IIa trials (proof of concept) in locally advanced pancreatic cancer (2010) and metastatic breast cancer (2012) indications show the safety and activity of the drug candidate in combination with chemotherapeutic agents.
Financial terms: Under the agreement, Wilex will receive a signing fee and milestone payments totalling more than 7 million Euro during clinical development in the first four indications to be developed by Link Health as well as staggered medium single digit royalties. The initial fees received by Wilex under the cooperation will not materially influence the current cash reach of the company.
Latest news: * On January 13, 2016, Wilex announced that its partner Link Health submitted an IND application (Investigational New Drug application) to the CFDA (China Food and Drug Administration) to conduct a Phase I dose escalation study with Mesupron® (upamostat). The open-label, dose-escalation study will investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of Mesupron® in Chinese patients with solid tumours. After this dose escalation study to confirm the biologically effective dose, two Phase II studies in cancer patients are planned. Wilex will receive the remaining amount of the agreed milestone payments totalling € 500 k. A partial amount was already paid in the second quarter 2015 after the transfer of a number of Mesupron® patents, which were needed by Link Health to apply for grants under a national subsidy programme.
