Therapeutic Class

Beyond approvals: Top 10 cell and gene therapy milestones

M&A, global partnerships and product approvals have all propelled regenerative medicines into the public discourse. We present the breakthroughs of 2018 and look at where the sector will head in 2019. The “new frontier of medicine” arrived in the US in 2017 through the approval of chimeric antigen receptor (CAR) T-Cell therapies Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), and gene therapy Luxturna (voretigene neparvovec). But it was last year, 2018, which delivered the true potential of this burgeoning sector into…

Pfizer looks to oncology biosimilars to break US market

Biosimilar uptake in the US has been stifled in the inflammation and immunology (I&I) space but Pfizer expects a different dynamic for oncology products. Pfizer’s biosimilar business had a robust year in 2018. The firm reported a 41% operational growth in the sector over the year prior, with total sales of $769 million (€674 million). The company attributed much of this growth to sales of Inflectra, its version of J&J’s Remicade (infliximab), which pulled in $642 million worldwide including $259…

Janssen enters $440m retinal gene therapy partnership

J&J has licensed a clinical stage inherited retinal disease portfolio from MeiraGTx in a deal that could be worth $440 million (€385 million). Johnson & Johnson’s Janssen division has paid $100 million upfront to MeiraGTx, a London-UK based clinical stage company, to access and codevelop the firm’s gene therapy programs. Development and sales milestones for MeiraGTx’s could net the firm a further $340 million. Under terms of the deal, the two firms aim to develop, manufacture and commercialize several candidates…

Hitachi brings cell therapy biz to Europe through $86m apceth buy

Hitachi Chemical will add two production plants and 600m2 of cleanroom through the acquisition of German cell therapy manufacturing firm apceth Biopharma. The deal, expected to close in April, sees Japanese firm Hitachi acquire all shares of apceth for JPY 9.4 billion ($86 million) from Santo Holding GmbH, FCP Biotech Holding GmbH and other individual shareholders. apceth has around 120 employees operating from its site in Munich, Germany. The site includes two GMP/BSL2 cell and gene therapy production facilities, including…

Finding closure: Lowering the costs of cell and gene therapies

Fully closed and automated platforms are key to reducing the current high costs of cell and gene therapy manufacturing, say industry experts. Cell and gene therapies (CGTs) have come a long way over the past two years, resulting in two chimeric antigen receptor (CAR) T-cell therapies – Kymriah and Yescarta – and the novel gene therapy Luxturna reaching commercialization. But now these therapies have proved themselves, the major talking point among delegates at the Phacilitate conference in Miami, Florida last…

Merck and MIT look to continuous cell-based vaccines in NIIMBL project

An 18-month project partners Merck & Co. with vendor Repligen and academia to develop approaches for continuous cell-culture based vaccine manufacturing. The program, entitled ‘The Continuous Cell Culture for Viral Vaccines’ is being led by the Massachusetts Institute of Technology (MIT), will bring together Big Biopharma firm Merck & Co. (known as MSD outside North America), bioprocessing vendor Repligen, Massachusetts Life Sciences Center, and the University of Massachusetts Medical School. It is one of 22 projects recently announced by the…

Phacilitate: Cell & gene industry flocks to Miami

The cell and gene therapy industry congregated in Miami to discuss supply chain strategies, regulatory rationale and the high manufacturing costs of advanced therapies. BioProcess Insider attended the Phacilitate Leaders World Summit, co-located with the World Stem Cell Summit, in Miami, Florida last week. The conference reflected on the first full year where three advanced therapies – Kymriah, Yescarta, and Luxturna – proved themselves on the commercial stage, heralding in a new frontier for regenerative medicines. But industry quickly rose above…

Gamma Delta T GMP: TC Biopharm creates allogeneic cell banks

TC Biopharm has formulated its first Gamma Delta T (GDT) cell banks it says provides the firm with the technology to develop next-generation allogeneic CAR-T therapies. Supported by a €4 million ($4.5 million) grant from the European Union’s Horizon 2020, Scotland, UK-based biotech TC Biopharm has completed formulation of its first GDT cell banks intended to help rapidly progress its allogeneic therapies through the clinic. “GDT cells are a subset of white blood cells and are part of the innate…

Manufacturing costs the ‘biggest threat’ to cell and gene therapies

This is the first time in history that we can make more effective medicines than we can afford, says Dark Horse Consulting. The Phacilitate conference took place in Miami this week, and in the plenary session Anthony Davies, founder of cell and gene therapy specialist firm Dark Horse Consulting, described the latest developments in the field of regenerative medicine. With the approvals of Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel) and Luxturna (voretigene neparvovec) in 2017, “this field finally had the year…

Lower infliximab revenues but J&J still holds 93% share

There have been two infliximab biosimilars available in the US for over a year, but Johnson & Johnson says reference biologic Remicade still holds a 93% volume share. In 2016, Pfizer launched Inflectra in the US. The following year, Merck & Co. launched Renflexis. With the ensuing price war, the infliximab biosimilars had been touted to end reference biologic Remicade’s market dominance. But after the first full year with all three infliximab products on the market, J&J has reported in…