Author Archives: Dan Stanton

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

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),…

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

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…

WuXi Biologics adds Bayer drug product plant to growing network

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…

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

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…

Amgen thanks BMS-Celgene merger in creating China opportunity

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)…

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

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…

Merck: 2023 the inflection point to address Gardasil demand

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…

Tessa and CellVec both set up Singapore plants to support cell & gene therapies

Tessa Therapeutics will open a plant in Singapore for its CAR-T programs, while CellVec has opened a viral vector facility on the island state to support customers’ gene therapy projects. Singapore-based biotech Tessa is developing its own autologous cellular therapies and has told us it plans to open a 90,000 square-foot plant to support clinical and commercial efforts. “Tessa will use the new facility for the clinical and future commercial manufacturing of our late-stage clinical programs,” the firm said, adding…

Novartis opens its largest gene therapy plant to support Zolgensma

The doors have opened at a facility in Longmont, Colorado nine months after Novartis acquired it to support its gene therapy business unit AveXis. In April 2019, Novartis bought the Longmont facility from fellow Big Biopharma player AstraZeneca in efforts to grow out its gene therapy production network. Nine months on and the Swiss Biopharma has confirmed the site is open and prepped to support its AveXis unit in the production of therapies including Zolgensma (onasemnogene abeparvovec-xioi1), which was approved…

In with the new… Deal completions from Catalent, CRL and Janssen

It’s a happy new year for Catalent, Charles River and Janssen, which have closed their respective acquisitions of a fill/finish facility, cell therapy services firm and an investigative mAb. In December, Roche completed its $4.3 billion (€3.9 billion) acquisition of commercial gene therapy firm Spark Therapeutics, 10 months after the deal was announced. But the Swiss Biopharma is not the only firm to begin 2020 with new assets, as several others in the life science space have announced the completion…