Correction: A prior version of this article misidentified Heartcel as the potential subject of the deal between Daiichi Sankyo and Hitachi Chemical.
- Daiichi Sankyo Co. Ltd. announced it will team up with Hitachi Chemical Co. Ltd. for the manufacturing of Daiichi's clinical candidates for regenerative medicine.
- Hitachi Chemical plans to start manufacturing Daiichi's unnamed clinical product at its new process development/contracting facility in Yokohama City, Kanagawa Prefecture in April 2018 using PCT, its global cell therapy manufacturing and development service platform.
- Thanks to changes enacted by the Pharmaceuticals and Medical Devices Act (PMDA) in Japan in November 2014, investigational regenerative medicine and cell therapy products will benefit from an accelerated approval pathway, meaning life-threatening illnesses can be treated with drugs that are technically unapproved and available only on a conditional basis.
Japan, the third-largest pharmaceutical market in the world, is actively creating new opportunities for itself in the field of regenerative medicine — and Daiichi Sankyo is jumping into the regenerative game head first with its manufacturing partnership with Hitachi.
The announcement followed the news of Hitachi's manufacturing alliance with SanBio. The statement did not disclose the specific product on which Daiichi and Hitachi will work.
Daiichi Sankyo, though, has other efforts in regenerative medicine underway.
In May 2016, for example, Celixir licensed Heartcel to Daiichi Sankyo for an upfront fee of £12.5 million (approximately $17 million) and additional milestone payments and royalties. Daiichi Sankyo will develop, market and commercialize the drug in Japan only, while Celixir will retain worldwide rights outside of Japan and will be responsible for the global manufacturing of the product.
The cardiac regenerative therapy is an allogenic immune-modulatory progenitor (iMP) cell therapeutic agent that is meant to be injected directly into cardiac scar tissue during bypass surgery. It is derived from somatic stem cells isolated from healthy individuals. After retrieval, the healthy stem cells are modified before they are administered to the patient.
Cell Therapy Limited was the drug's original developer, but the company underwent a rebrand in July 2016 to become Celixir.
In the UK, approval was granted by the Medicines and Healthcare Products Regulatory Agency to initiate a Phase IIb trial for Heartcel. Celixir has also completed European Phase 2 trials using the iMP-cell based medicine. The Heartcel Phase 2 results met all of its endpoints with statistical and clinically significant results; major adverse cardiac event-free survival was observed in 100% of patients during the 12-month period following treatment.
Celixir said additional trials for Heartcel are set to begin in early 2018, and the company is also planning a Phase 2 trial in Kawasaki disease.
A Celixir statement in January 2018 noted that in 2017, the company completed "the FDA pre-IND process," suggesting Heartcel is looking to the U.S. market.
Regenerative medicine includes tissue-engineered products, cellular therapy products, processed animal cell products and gene therapy products.
The PMDA significantly shortened the pathway to market for these types of therapies in Japan — it allowed phased clinical trial periods for regenerative medical products to be shortened. And investigational medications can now also be used on a conditional authorization basis more quickly as a result — which will help companies address serious and life-threatening diseases.