Author Archives: Dan Stanton

Top 10 advanced therapy milestones of 2019: Patient access takes center stage

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CRISPR, capacity, and consolidation powered the cell and gene therapy space in 2019, but a proactive focus on patient access topped Falcon Therapeutics CEO Susan Nichols’ annual roundup. In what has become one of the most anticipated presentations at the Phacilitate conference, Susan Nichols, CEO of cell therapy firm Falcon Therapeutics, laid out the top 10 events of the previous year that have shaped the regenerative medicine space, driving conversation, investment, and innovation. The top spot in 2019 focused on…

January 27, 2020

CDMO aims ‘big’ in $1.2bn push to deliver capacity to cell & gene space

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The newly formed Center for Breakthrough Medicines is building what it claims to be the world’s largest third-party cell and gene production facility at an ex-GSK site in Pennsylvania. For the production of cell and gene therapies, size matters, according to Brian O’Neill, founder of the Discovery Labs. He announced this week at the Phacilitate Conference in Miami, Florida that a 680,000 square-foot facility at a site in King of Prussia, Pennsylvania – a former GSK R&D campus sold to…

January 23, 2020

Thermo Fisher envisions 25% annual growth for gene therapy biz and no slowdown

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Thermo Fisher claims to be the “leading outsource provider of viral vector manufacturing,†nine months after entering the space through the acquisition of Brammer. In March 2019, Thermo Fisher expanded its presence in the CDMO space by announcing plans to buy viral vector manufacturer Brammer Bio. Weeks later, the $1.7 billion deal closed, propelling Thermo Fisher into the gene therapy manufacturing space. Nine months on and Thermo Fisher CEO Marc Casper said the business has “got off to a good…

January 22, 2020

Phacilitate 2020: FDA commercial cell and gene therapy forecast ‘unlikely’

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Manufacturing issues and a scarcity of new commercial products leave predictions that 10-20 cell and gene therapy approvals each year by 2025 somewhat fanciful, says Dark Horse Consulting. In his plenary address at the Phacilitate conference yesterday, Anthony Davies, founder of cell and gene therapy specialist firm Dark Horse Consulting, reflected on the difficulties the sector has faced since the high of 2017 when three products achieved US Food and Drug Administration (FDA) approval: Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel),…

January 22, 2020

Humira taking 45% hit internationally but US could fare better, Abbvie

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The impact of competition in Europe on its bestseller Humira (adalimumab) has allowed AbbVie to set expectations for when biosimilars enter the US market in 2023. Monoclonal antibody Humira is the top selling drug in the world, pulling in $19.9 billion (€17.9 billion) in sales for AbbVie in 2018. But biosimilar competition has begun making inroads into sales – outside of the US at least. Biogen and Samsung Bioepis, for example, reported last August that its adalimumab product Imraldi exceeded…

January 21, 2020

WuXi Biologics adds Bayer drug product plant to growing network

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WuXi Biologics has leased a drug product plant in Leverkusen, Germany from Bayer and is in negotiations to continue making hemophilia therapy Kovaltry for the Big Biopharma firm. The lease agreement – financials of which have not been divulged – gives Chinese contract development and manufacturing organization (CDMO) WuXi Biologics its first drug product facility outside of Europe. WuXi Biologics has been rampant in building up its manufacturing network, and while it has so far focused on constructing sites, the…

January 17, 2020

Merck pays Just-Evotec $15m for ‘J.POD’ manufacturing capacity

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Merck & Co. has reserved capacity at Just-Evotec’s modular and biomanufacturing facility in Redmond, Washington, which is currently under construction. Months after German services firm Evotec acquired biologics development and manufacturing firm Just.Bio for $90 million (€81 million), plans were drawn up to construct a commercial-scale facility near Seattle in Washington state. While the plant is in the early stages of construction, Just-Evotec has confirmed Merck & Co. (known as MSD outside of North America) has reserved capacity at the…

January 17, 2020

Amgen thanks BMS-Celgene merger in creating China opportunity

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The opportunistic nature of its partnership with BeiGene threw Amgen into the ever-increasingly attractive China market, management said at JP Morgan. At the JP Morgan Healthcare Conference in San Francisco this week, Amgen reflected on its 2019 M&A activity and counted itself as a beneficiary of rival Big Biopharma firm Bristol-Myers Squibb’s (BMS)  Celgene acquisition for $74 billion (€66 billion). From a product perspective, regulatory divestiture demands led Amgen to pick up the global rights to psoriasis drug Otezla (apremilast)…

January 15, 2020

Astrea arises from the Prometic ashes; inks column deal with Thermo

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Astrea Bioseparations will supply prepacked chromatography columns to Thermo Fisher. Formerly known as Prometic Bioseparations, the firm now forms part of KKR life sciences tool platform Gamma Biosciences. Late last year, Bioprocess Insider reported the planned acquisition of Liminal BioSciences’ chromatography and bioprocessing business Prometic Bioseparations by investment firm KKR in a deal worth up to £77 million ($100 million). Now complete, KKR has announced the firm will now be known as Astrea Bioseparations Ltd and is the first company…

January 15, 2020

Merck: 2023 the inflection point to address Gardasil demand

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Two new bulk manufacturing facilities will come online by 2023 to feed the “incredible†global demand for HPV vaccine Gardasil, says Merck & Co. CEO Ken Frazier. Merck & Co. – known as MSD outside of North America – has for some time highlighted the human papillomavirus (HPV) vaccines Gardasil and Gardasil 9 as products with dominant near-term commercial potential. While the two vaccines pulled in $3.2 billion (€2.9 billion) in global sales in 2018, the Big Biopharma firm has spoken…

January 14, 2020