Therapeutic Class

Amgen on Soliris: Low patient population but high biosimilar potential

The high cost of Alexion’s ultra-orphan disease MAb Soliris (eculizumab) drove Amgen’s decision to develop a biosimilar version, says SVP of Global Development Elliott Levy. Soliris (eculizumab) is an approved treatment for orphan diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (a-HUS) treatment. The monoclonal antibody (MAb) was – until the arrivals of CAR-T and gene therapies Kymriah, Yescarta and Luxturna last year – the most expensive drug in the world, and netted Alexion $3.1 billion (€2.8 billion)…

Axovant looks to CDMO Yposkesi for gene therapy scale up

Axovant Sciences has selected French CDMO Yposkesi as a strategic partner to help bring its neurologic and neuromuscular gene therapy candidates through the clinic. Contract development and manufacturing organization (CDMO) Yposkesi will utilize its adeno-associated virus (AAV) and lentiviral vector production capabilities to service the strategic agreement with Axovant. Swiss biotech Axovant has a pipeline of gene therapies targeting neurological and neuromuscular diseases. Financial details have not been divulged, but Alain Lamproye, CEO of Yposkesi, said it is a straight…

Teva settles with Roche to launch first Rituxan biosimilar in US

Truxima becomes the 15th biosimilar, and the first version of Rituxan (rituximab), to be approved in the US. A settlement agreement with Roche will allow Teva to market the product but the launch date has not been revealed. The US Food and Drug Administration (FDA) gave the thumbs up to Truxima this week, making it the first biosimilar version of Roche/Genentech’s Rituxan to be approved in the US. The product is manufactured by South Korean firm Celltrion but will be…

Aji Bio enters ‘rapidly growing’ ADC space

Ajinomoto Bio-Pharma Services has launched a bioconjugation technology it says has high productivity and short conjugation reaction times. According to contract development and manufacturing organization (CDMO) Aji Bio-Pharma, its AJICAP technology lets antibody-drug conjugates (ADC) developers better control the location of payload conjugation to an antibody and fine tune the quantity of payload attached. “The technology deploys a proprietary affinity peptide to direct controlled conjugation to a specific sites on the antibody in a relatively straight forward synthetic process,” Jason…

Boehringer Ingelheim abandons biosimilars outside the US

German drugmaker Boehringer Ingelheim will not commercialize its approved adalimumab product Cyltezo in Europe and is discontinuing all biosimilar development activities outside the US. Earlier this month, an article published in Bioprocess Insider considering the impending exit of Big Pharma from the biosimilars space brought a lot of attention from industry and investors. The piece drew on Merck KGaA’s abandonment of its biosimilars programs in 2017 as an example, and now fellow German Big Pharma firm Boehringer Ingelheim is contemplating…

Small molecule M&A round-up: Roche buys Jecure, Arsanis and X4 merge

Bored of biologics? Tired of T-cells? Well BioProcess Insider takes a look at some of the big developments in the small molecule world. First up in this compendium is Swiss pharma giant Roche. The firm has acquired San Diego, California-based Jecure Therapeutics through its Genentech division. While Genentech is synonymous with biologics, Jecure’s business focuses on small-molecule therapeutics for the treatment of non-alcoholic steatohepatitis (NASH) and liver fibrosis. Its lead candidate is an inhibitor of Nucleotide-binding oligomerization (NOD)-like Receptor Family…

Continuous gene therapy production targeted in UK collaboration

Cobra Biologics and the Cell and Gene Therapy (CGT) Catapult have teamed with Pall to explore continuous manufacturing of gene therapies. The project builds on a concurrent collaboration which looks to reduce the cost of adeno-associated virus (AAV) vectors. The collaboration received a £1.5 million ($1.9 million) shared grant from Innovate UK, the United Kingdom’s innovation agency, to investigate continuous manufacturing of adeno-associated virus (AAV) for gene therapy applications. “The project is a joint collaboration between Cobra, Pall and the…

Founding member Amgen turns back on Biosimilars Forum

Amgen withdrew its membership from advocacy group The Biosimilars Forum in September after disagreeing on how best to support the US biosimilar market. Nonprofit organization The Biosimilars Forum was setup in 2015 “to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care… [by providing] evidence-based information to inform and support public policies that encourage awareness, access, and adoption of biosimilars,” according to its mission statement. The founding 11…

Celgene investing in ‘vein to vein supply chain’ to support CAR-T biz

Fresh from acquiring CAR-T firm Juno Therapeutics, Celgene is investing in patient treatment centers and building out its manufacturing capacity. In March, Celgene Corporation completed the $9 billion (€7.9 billion) acquisition of Juno Therapeutics, adding chimeric antigen receptor (CAR) T-cell technology and manufacturing capabilities, along with a pipeline of hematology and oncology therapies. Speaking at the Credit Suisse 27th Annual Healthcare Conference last week, CFO David Elkins said its numerous CAR-T collaborations – the firm has a co-development deal with…

StemGenex warned as FDA clamps down on stem cell ‘bad actors’

Marketing unapproved stem cell therapies and cGMP deviations have landed California’s StemGenex Biologic Laboratories with a US Food and Drug Administration (FDA) warning letter. The letter cites issues in good manufacturing practice (GMP) and the unlawful marketing of an unapproved stromal vascular fraction (SVF) stem cell therapy, processed from autologous adipose tissue. It was sent on October 31, following an FDA inspection at StemGenex Biologic Laboratories’ (SGBL) facility in San Diego, California in January this year. According to the Agency,…