Heidelberg Pharma AG (FSE: WL6) announced today that it has received a milestone payment from its cooperation partner Link Health Co., Guangzhou, China. The transaction follows the approval of the Chinese National Medical Product Administration (NMPA) to conduct clinical trials with the product candidate MESUPRON(R).
The approval was granted in accordance with the new NMPA regulations, which permit the use of safety data from previous studies with MESUPRON(R), and thus make it possible to directly conduct a Phase II study. However, due to the new regulatory situation, Link Health will have to revise the clinical study protocol for this purpose. This is planned for the coming months.
Information on MESUPRON(R) and the uPA-program
The uPA-inhibitor MESUPRON(R) (INN: Upamostat) inhibits the Urokinase Plasminogen Activator (uPA) system. In 2014, the rights for the development and commercialization of MESUPRON(R)were out-licensed to Link Health Co., Guangzhou, China, for the region comprising China, Hong Kong, Taiwan and Macau. The out-licensing was based on data from two Phase IIa trials (proof of concept) in locally advanced pancreatic cancer (2010) and metastatic breast cancer (2012) indications that showed the safety and activity of the drug candidate in combination with chemotherapeutic agents. The mode of action of MESUPRON(R) could provide a new approach in cancer therapy by specifically blocking tumor metastasis in solid cancers.
About Heidelberg Pharma
Heidelberg Pharma AG is a biopharmaceutical company based in Ladenburg, Germany. Heidelberg Pharma is an oncology specialist and the first company to develop the toxin Amanitin into cancer therapies using its proprietary Antibody Targeted Amanitin Conjugate (ATAC) technology and to advance the biological mode of action of the toxin as a novel therapeutic principle. This proprietary technology platform is being applied to develop the Company’s proprietary therapeutic ATACs, as well as in third-party collaborations, to create a variety of ATAC candidates. The proprietary lead candidate is HDP-101, a BCMA ATAC for multiple myeloma.
Former clinical assets MESUPRON(R) and REDECTANE(R) were partnered for further development and commercialization. Heidelberg Pharma AG is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6. More information is available at www.heidelberg-pharma.com.
About Link Health Group
Link Health is a leading Chinese pharmaceutical company based in Southern China, focusing on the development of innovative drugs for unmet medical needs.
Link Health has created a highly professional team with diverse expertise in drug development, medical affairs and regulatory affairs. Leveraging deep understanding of China’s market, favorable regulatory environment and strong network with global biopharmaceutical companies, Link Health is well positioned to bring innovative drugs to the market efficiently. More information can be found at http://www.healthinlink.com.
| Contact Heidelberg Pharma AG Sylvia Wimmer Tel.: +49 89 41 31 38-29 Email: investors[at]hdpharma.com Schriesheimer Str. 101, 68526 Ladenburg |
IR/PR support MC Services AG Katja Arnold (CIRO) Managing Director & Partner Tel.: +49 89 210 228-40 Email: katja.arnold[at]mc-services.eu |
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Source: Biospace
