Author Archives: Dan Stanton

Catalent’s Next 5 Years: Biomanufacturing Demand to Outstrip Supply

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Catalent says it is evaluating separating out its biologics business after investments and M&A have propelled the CDMO out of the sub-5,000 L space. Catalent has reported revenues of US$628 million (€524 million) for its third quarter fiscal 2018. The contract development and manufacturing organization (CDMO) attributed 18% year-on-year jump to “robust organic growth†in its biologics business and the acquisition of Cook Pharmica last October. The $950m deal added an 875,000ft2 production and fill/finish site in Bloomington, Indiana, complementing…

May 2, 2018

WuXi Biologics Takes ‘First Giant Step’ Out of China with 54,000 L plant

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WuXi Biologics will invest €325 million (US$390 million) in its first production site outside of China. The Irish site will be fully disposable, the CDMO told BioProcess Insider.   The contract development and manufacturing organization (CDMO) is looking to construct a single-use site with 54,000 L of disposable bioreactor capacity through a €325 million investment in Mullagharlin, County Louth, Ireland. When GMP ready in 2021, the site will be equipped with twelve 4,000-L fed-batch bioreactors and six 1,000-L bioreactors for…

May 1, 2018

Beyond Adcetris: Seattle Genetics Aiming for Big Biopharma Status

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Profitability will be placed on the backfoot as Seattle Genetics looks to grow into a “powerful big expansive company,†the firm says. For the first quarter 2018, total revenues grew to US$141 million (€116 million) compared to $109 million in the same period last year. This was attributed to a 36% increase in sales of Seattle Genetics’ antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin), which pulled in $95 million of sales. Total costs for the quarter, meanwhile, jumped by almost 30%…

April 30, 2018

Complex Sandostatin Manufacturing Holding Off Competition, Novartis

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The complexity to manufacture the growth hormone inhibiting peptide Sandostatin will ensure protection from competition, says Novartis. 2017 sales of the acromegaly peptide Sandostatin (octreotide) were down slightly on the previous year, but still brought in US$1.6 billion (€1.3 billion) for Swiss biopharma Novartis. During the firm’s recent first quarter financial call, board member Elizabeth Doherty told stakeholders that while the firm is always looking at potential risks from competition, “we know ourselves with our own experience how difficult it…

April 27, 2018

AbbVie Braces for 20% Erosion as EU Humira Biosimilars Assemble

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AbbVie expects impact from Humira (adalimumab) biosimilars in Europe beginning the fourth quarter but remains confident there will be no direct US competition until 2022. AbbVie is preparing for Humira biosimilar entrants beginning in the fourth quarter 2018, the firm said during a first quarter conference call. A settled lawsuit with Samsung Bioepis earlier in the quarter laid the way for the Korean firm’s adalimumab biosimilar Imraldi to be launched as soon as October 16 by commercialization partner Biogen. Meanwhile,…

April 26, 2018

Another Biosimilar CRL for Pfizer, but Manufacturing not the Cause

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Pfizer has received a US FDA complete response letter (CRL) for its proposed version of Roche’s breast cancer monoclonal antibody Herceptin (trastuzumab). Pfizer announced its biologics license application (BLA) for PF-05280014 has been turned down by the US Food and Drug Administration (FDA), with the agency highlighting the need for additional technical information in the CRL. The requested information does not relate to safety or clinical data, Pfizer said in a release. The news comes less than a year after…

April 26, 2018

Out with the Old, In with the New Tech as J&J Eyes CAR-T Investment

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Johnson & Johnson says it needs to invest in tech and capacity in areas like CAR-T as it looks to restructure its supply chain restructure. J&J announced the supply chain restructure as part of its first quarter 2018 financials, telling investors the action would refocus resources towards “critical capabilities, technologies and solutions necessary to manufacture and supply its product portfolio of the future.†The restructure will free between $600 and $800 million (€501 and €668 million) annually by 2022, though…

April 25, 2018

Patheon Doubling Global Biologics Capacity in $50 Million Missouri Spend

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Thermo Fisher’s CDMO business Patheon will add 16,000 L of single-use capacity through a US$50 million (€41 million) expansion at its St Louis facility. Contract development and manufacturing organization (CDMO) Patheon will expand its St Louis, Missouri bioproduction site by 64,000 ft2 on the back of what it says is “extremely strong growth in demandâ€Â  for commercial biologic manufacturing. The facility was added to Patheon’s network through the 2014 acquisition of Gallus Biopharmaceuticals. The investment will not only add 16,000…

April 24, 2018