The Haifa, Israel-based drugmaker uses stromal cells extracted from donated placenta to make therapies for a range of conditions, including inflammation, ischemia, hematological disorders, and radiation damage.
Production involves a variety of manufacturing techniques and Pluristem’s strategy is to seek patent protection “in projected future markets and manufacturing centres” according to Karine Kleinhaus, divisional VP for North American.
The patents secured this week cover separate manufacturing, culturing and media methods as well as various applications of cell therapy, however, as Kleinhaus explained, there is some overlap.
“The most similar of the recently granted patents are the Israeli and the South Korean patents, which relate to very similar subject matter although the claims of even these two patents are not identical.
“Otherwise, the recently granted patents cover various aspects of Pluristem’s core technology and methodology, the cells produced thereby, and particular therapeutic uses of the cells” she added.
According to Kleinhaus, Pluristem intends to “build our own manufacturing facilities in different territories and we may partner with a third party to establish joint ventures in certain territories.”
EU and Japan
While working to secure its intellectual property, Pluristem is also seeking regulatory approval for its cell therapies.
Kleinhaus told us “we are simultaneously pursuing regulatory approval of our cells in multiple markets, any of which might ultimately be the first to grant marketing approval” citing the firm's admission to the European Union's Adaptive Pathways project pilot as an example.
“The EU [programme offers] the possibility of conditional approval for therapies targeting certain indications and with a successful Phase II trial there we could potentially receive conditional marketing authorization as early as 2018.”
Pluristem has also used the recently introduced regenerative medicines pathway in Japan according to Kleinhaus, who explained that the quality of cell therapies made at its plant in plant have met with PDMA requirements meaning they could be used in a local trial.