CARLSBAD, Calif.—International Stem Cell Corp. (ISCO), a company focused on developing novel stem cell-based therapies, has taken several steps toward expanding the reach of its pathogenesis technology in Asia and Europe. The company has announced a research agreement with Rohto Pharmaceutical Co., a global Japanese pharmaceutical company that develops new technology for the medical and cosmetics markets, and an expansion of the Asian distribution network of its subsidiary, Lifeline Cell Technology.
The company has also overcome a potential roadblock in European markets with a court victory from the advocate general for the Court of Justice of the European Union (CJEU) that upheld a pending patent on the company’s core technology.
“A favorable ruling in this case opens up all 28 countries in the EU to our stem cells,” Simon Craw, ISCO’s executive vice president of business development, tells DDNews. “We’re seeing progress in the area of intellectual property at the same time that we’re benefiting from the scientific validation of finding a good pharmaceutical partner in Japan, which is already our biggest market.”
ISCO’s core technology is parthenogenesis, a process which results in the creation of pluripotent human stem cells from unfertilized oocytes. This new class of stem cells features the desirable characteristics found in both embryonic stem cells and adult stem cells. These human parthenogenetic stem cells offer an alternative to the use of embryonic stem cells, which faces restrictions due to the ethical concerns raised by the destruction of fertilized human embryos. ISCO’s parthenogenetic, homozygous stem cell line reportedly has the advantage of providing a source of therapeutic cells for individuals of differing genders, ages and racial backgrounds with minimal immune rejection after transplantation.
The agreement with Rohto Pharmaceutical, a company with $1.3 billion in annual sales, will allow the Japanese company to evaluate in preclinical animal models differentiated human cells derived from ISCO’s collection of stem cells known as UniStemCell. If Rohto is pleased with the results of its research using these cells, and the companies agree on remaining terms, a definitive license agreement is likely to be signed at the end of the 12-month period covered by the research agreement. Certain key terms, including the target disease areas and intellectual property rights, have been already been established in the current research agreement, though the companies have not made this information public.
“If Rohto is pleased with the results, after taking a year to evaluate the potential of our stem cells, we will be in a position to sign a more traditional research agreement,” says Craw. “We already have considerable experience demonstrating that our cells are effective in animal models of various diseases, so we don’t anticipate any negative surprises coming out of this evaluation.”
ISCO will also be expanding its reach in Asia through its subsidiary, Lifeline Cell Technologies, which specializes in the development and manufacture of purified primary human cells and optimized reagents for cell culture. The company will extend its sales network by adding a number of new distributors in Asia and Oceania. “Expanding our footprint in the fast-growing Asian marketplace has been a key strategic goal for the company,” according to Craw. “With these new distributors, we have increased the number of countries where scientists can purchase our high-quality cell culture products.”
The favorable ruling in the CJEU secures approval of the patent on ISCO’s parthenogenetic stem cells. The EU court was asked to clarify whether its interpretation from a previous case excluded ISCO’s core technology from patentability under EU law. The court’s ruling three years ago in the previous case, Brüstle vs. Greenpeace, banned the patenting of the human body in any stage of development. It stated that patenting cells taken from a human embryo violated human dignity. The recent ruling on ISCO’s technology clarified this position, finding that it should not prohibit the patenting of parthenogenetic stem cells. “This is an extremely significant case that will have important implications for the potential of our technology and for the entire industry,” says Craw.