Without a doubt, the cell therapy industry is coming of age. In addition to growing numbers of cell therapy clinical trials, numerous cell therapy products have been approved by regulatory agencies worldwide and 150+ cell therapy companies are competing within the global marketplace. These metrics are extremely important because they indicate that the market for cell therapy products is expanding.
However, one of the most telling trends within the industry is a growing interest among Big Pharma in cell therapy companies.
Big Pharma Investment into CAR-T Therapies
At its core, pharmaceutical company investment into CAR-T cell therapies is a way to diversify product development pipelines. For example:
- Gilead Sciences received approval for Yescarta in October 2017, as a result of its Kite Pharma acquisition for $11.9B.
- Johnson & Johnson paid $350 million to partner with Chinese firm Nanjing Legend Biotech after the company released promising CAR-T data at the ASCO annual meeting.
- Gilead acquired Cell Design Labs, a biotech company developing novel CAR-T and T-cell receptor therapies in a deal valued at up to $567 million.
- Bluebird bio entered a broad strategic collaboration with Celgene Corporation to commercialize CAR T-cell programs
- Pfizer established a CAR-T collaboration with Cellectis accompanied by $80 million upfront payment and up to $185 million per product with royalties
- Bellicum Pharmaceuticals and Agensys, an affiliate of Astellas Pharma, entered global license agreement that allows Bellicum to commercialize adoptive cell therapies, including CAR-T cells, for tunors expressing Prostate Stem Cell Antigen (PSCA).
There have also been more than a dozen CAR-T deals between pharmaceutical companies and academic institutions, with the best known being the partnership between Novartis and the University of Pennsylvania (UPenn). In August 2017, the U.S. FDA announced that Kymriah™ would be the first CAR-T cell therapy to be approved in the U.S., an accomplishment that resulted from a 5-year collaboration between UPenn and Novartis.
However, this deal-making isn’t limited to CAR-T cell therapy deals. A full review of “big pharma” investment into cell therapy companies is explored below.
CAR-T Investments by Pharma Companies
In addition to the strategic partnerships above, key investments by the pharmaceutical sector into cell therapy companies are highlighted below:
- Takeda Pharmaceutical Company announced its intent to acquire TiGenix for €520m in January 2018. TiGenix is exploring anti-inflammatory properties of allogeneic stem cells (lead product, Cx601).
- Gilead announced in December 2017 that it is acquiring Cell Design Labs, a biotech company developing novel CAR-T and T cell receptor therapies in a deal valued at up to $567 million.
- Johnson & Johnson is paying $350 million upfront to partner with Chinese firm Nanjing Legend Biotech. As a result of the December 2017 deal-making, J&J’s biotech unit (Janssen) will get a global license to commercialize LCAR-B38M in multiple myeloma.
- Japanese drugmaker Otsuka Holdings acquired a 10% (1 billion yen) stake in Megakaryon, a venture that creates platelets out of induced pluripotent stem cells in December 2017.
- Amgen Ventures participated in Fortuna Fix’s USD $25 million Series B financing in November 2017. Fortuna fix is using its direct reprogramming technology to repair neural tissue.
- Astellas Pharma funded a development program with Universal Cells to utilize its Universal Donor Cell Technology in October 2017.
- Gilead Sciences acquired Kite Pharma in August 2017 for $11.9B, thereby securing access to Kit’es lead CAR T therapy candidate, Yescarta (Axicabtagene Ciloleucel), which was approved by the FDA in October 2017.
- Hitachi Chemical bought PCT cell therapy, a cell therapy CDMO, in May 2017.
- FUJIFILM purchased a 10% equity stake in January 2017 in Cynata Therapeutics, the company responsible for the world’s first clinical trial worldwide involving an allogeneic iPSC-derived therapeutic product (CYP-001).
- Bayer AG spun off BlueRock Therapeutics with funding of $225 million in December 2016.
- Mallinckrodt Pharmaceuticals acquired Stratatech Corporation in August 2016.
- JCR Pharmaceuticals Co. Ltd. and Mesoblast on December 3, 2015.
- AMAG Pharmaceuticals bought Cord Blood Registry for $700 million in June 2015. CBR is the largest umbilical cord blood bank in the U.S with 700K+ cord blood and tissue units in storage.
- Celgene took a $45 million minority stake in Mesoblast in April 2015. Mesoblast is an Australian-based regenerative medicine company that is a leader in MSC therapeutics.
- Novartis has an equity stake in Gamida Cell Ltd. Specifically, Novartis invested $35 million in 2014, $5 million in 2015, and has previously talked about buying Gamida Cell for $600 million.
- FUJIFILM bought Cellular Dynamics International (CDI), the world’s leading iPSC company, for $307 million in April 2015.
- Johnson & Johnson bet $12.5 million on Capricor Therapeutics cell therapy program for cardiovascular applications (CAP-1002) through its subsidiary, Janssen Pharmaceuticals, in January 2014.
- PerkinElmer bought ViaCord for $300 million in October 2007. ViaCord is the 2nd largest an umbilical cord blood bank in the U.S.
- Teva Pharmaceuticals entered a joint venture (JV) with Gamida Cell Ltd (2005).
Much of this partnering activity has been supported by accelerated regulatory pathways that have been passed in major healthcare markets worldwide, including the U.S., Japan, and South Korea. In Japan, the government passed the “Act on the Safety on Regenerative Medicine” and making revisions to the “Pharmaceutical and Medical device Act” in late 2014, giving a major boost to cell therapy development within Asia. Additionally, the EU has a program for product acceleration – the Adaptive Pathways.