Author Archives: Dan Stanton

Gardasil pulls in $1.5bn, driving vaccine business for Merck

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Merck & Co. says sales of its human papillomavirus (HPV) vaccine franchise Gardasil could double by 2030 as “significant†capacity investments come online. For the full year, 2021, vaccines pulled in around $9.7 billion in sales revenues for Merck. The division was driven by Gardasil and Gardasil 9, which saw sales of $5.7 billion for the 12 months, up 44% on the year prior. As CFO Caroline Litchfield said during the firm’s end-of-year conference call, “underlying global demand for Gardasil…

February 14, 2022

Twist leaves gene production problems behind; looks to ‘Factory of the Future’

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Twist Bioscience reported a robust first quarter, having overcome a gene production issue last year that led a temporary halt in supply. For the first quarter fiscal year 2022, DNA synthesis firm Twist Bioscience reported revenues and orders of $42 million and $49.6 million, up 50% and 48% year-on-year, respectively. This included around $13.5 million in gene production for Twist’s partner with SynBio, a deal inked in 2017 that sees the firm manufacture synthetic DNA up to 3.2 kilobases in…

February 9, 2022

WuXi Bio: COVID-delayed inspections blamed for addition to US Unverified List

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The addition of two WuXi Biologics sites to the US Government’s Unverified List will have no impact on its business, the CDMO says. On Monday, the US Commerce Department added 33 Chinese companies to its Unverified List (UVL) including two subsidiaries of contract development and manufacturing organization (CDMO) WuXi Biologics based in Shanghai and Wuxi. As supply chain consultants BDP put it: “The UVL lists names of companies that the Bureau of Industry Security (BIS) could not verify as bona…

February 8, 2022

Sanofi overcomes CDMO issues with sutimlimab approval

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The US FDA approval of Enjaymo (sutimlimab) comes 13 months after Sanofi was hit by a complete response letter citing deficiencies at a third-party manufacturer. The US Food and Drug Administration (FDA) approved Enjaymo Friday, a treatment for patients with rare blood disorder cold agglutinin disease (CAD). The drug, which will be made available in the US at a wholesale acquisition cost of $1,800 per vial, is a humanized monoclonal antibody designed to selectively target and inhibit C1s in the…

February 7, 2022

Abecma clocks $164m for Bristol-Myers but supply constraints remain

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Bristol-Myers Squibb says it expects viral vector supply to ramp up later in the year as third-party and inhouse capacity come online. Bristol-Myers’ Abecma (idecabtagene vicleucel, commonly referred to as ide-cel) was approved in March 2022 as the first cell-based gene therapy for the treatment of multiple myeloma. “Abecma generated revenues of $164 million since its launch in May of last year,†David Elkins, Bristol-Myers’ CFO said during the firm’s fourth quarter call. “Revenues reflect very strong demand for the…

February 7, 2022

Oxford Biomedica enters US through $180m Homology JV

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The UK-based gene therapy services firm and Homology Medicines will establish an adeno-associated virus (AAV) manufacturing and innovation joint venture. The deal, expected to close in the next few weeks, will see Oxford Biomedica pay biotech Homology $130 million upfront and invest $50 million in the new entity, ‘Oxford Biomedica Solutions.’ The UK-based gene therapy firm and contract development and manufacturing organization (CDMO) will take an 80% stake in the entity, while Homology will own 20% of the company. The…

January 31, 2022

Lilly pumping $1.45bn into its biomanufacturing network

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Eli Lilly will invest $1 billion and create nearly 600 jobs at a site in North Carolina. Concurrently, the firm will build a $446 million biologics plant in Ireland. The new facility in Concord, North Carolina will make injectable products and devices, supporting the company’s capacity for its product portfolio and future pipeline. The investment will create nearly 600 jobs and was welcomed by North Carolina state governor Roy Cooper who stated that “Lilly’s choice brings more good jobs to…

January 31, 2022

Biogen pulling out of Bioepis JV in $2.3bn Samsung Bio deal

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Samsung Biologics will take full ownership Samsung Bioepis 10 years after forming the biosimilar developer with Biogen. In 2012, the relatively new contract development and manufacturing organization (CDMO) Samsung Biologics teamed up with Biogen Idec (now just Biogen) to form a joint venture aimed at developing, manufacturing and marketing biosimilars: Samsung Bioepis. Over the past decade, the share of the entity has shifted – Samsung Biologics began with an 85% share, which later increased to 94.6% before Biogen paid $670…

January 31, 2022

eBook: Antibody–Drug Conjugates —
A New Generation of Approaches Is Changing the Game

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Combining large proteins with linkers and cytotoxins, antibody–drug conjugates (ADCs) may be the most complex drug molecules in development today. Despite early promise and product approvals, a number of technical concerns arose during product and process development. Characterizing and ensuring consistency in the number of small molecules that attach to the antibody — as well as ensuring their proper attachment and biophysics — all present significant challenges to ADC developers. Solving early problems associated with product quality has introduced a…

January 26, 2022

Novartis looks to gene therapy 3.0 with an eye on lowering COGS

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Novartis is confident the manufacturing costs of gene therapies will fall as it improves processes and brings on board next generation technologies such as CRISPR and gene editing. Swiss Pharma giant Novartis has “always been a company that is multi-modality in really trying to address an unmet need in a number of diseases,†Shephard Mpofu,  chief medical officer at Novartis Gene Therapies said yesterday. Highlighting the firm’s success in small and large molecules, he reminded delegates at Phacilitate’s Advanced Therapies…

January 26, 2022