Having acquired Shire last month, Takeda is planning to divest non-core assets, representing up to 25% of its business. Takeda closed the $62 billion (€55 billion) acquisition of Shire on January 8th and according to Takeda CFO Costa Saroukos, the “integration of the two companies is now progressing as planned.†Shire brings Takeda greater geography and scale, creating a company with around 35 manufacturing sites, but on a call last week to discuss third quarter FY2018 results, up to a…
Author Archives: Dan Stanton
Roche looks to delivery device to keep Lucentis biosimilars at bay
Roche says its Port Delivery System will keep Lucentis (ranibizumab) competitive against upcoming biosimilar competition. Lucentis pulled in CHF 1.66 billion ($1.66 billion) in US sales for Roche in 2018, up 18% on the year before. The drug is marketed in Europe by fellow Swiss firm Novartis. The firm attributed the increase to the “ongoing rollout of prefilled syringes and sales increases in all approved indications.†The monoclonal antibody, approved for eye conditions including neovascular (‘wet’) age-related macular degeneration, macular…
GSK boosts oncology pipeline through Merck and Tesaro deals
The acquisition of Tesaro and a codevelopment deal with Merck KGaA has helped double the size of GlaxoSmithKline’s clinical oncology pipeline from eight to 16. Earlier this week, GSK formed an alliance with Germany’s Merck to codevelop and commercialize a bifunctional fusion protein immunotherapy intended to treat multiple cancers. Merck has received an upfront payment of €300 million ($340 million) from GSK and could receive a further €500 million in development milestone payments. The candidate, M7824 (proposed International Nonproprietary Name…
Regeneron plans to expand Irish biomanufacturing site again
Regeneron has applied to build a three-storey facility as part of a reported €200 million ($228 million) expansion at its Limerick site. Biopharma firm Regeneron has applied for a 10 year permission to add a three-storey 10,200 m2 administration and laboratory building with associated plant and equipment to its manufacturing site in Ballycummin, Limerick, Ireland. The firm is also hoping to convert a temporary induction/training center and facility workshop to permanent use, as well as build a carpark, Limerick City…
Madison expansion will add commercial capacity, says Catalent
Plans to invest $200 million laid down last year will put Catalent in a position to offer commercial manufacturing from its Madison, Wisconsin facility, the CDMO says. In November 2018, contract development and manufacturing organization (CDMO) Catalent announced its intentions to invest across its two biomanufacturing sites. The board laid down plans to plough $100 million (€88 million) into its Madison, Wisconsin plant to add a fourth and fifth biomanufacturing train. During Catalent’s second quarter FY2019 financial call this week,…
Beyond approvals: Top 10 cell and gene therapy milestones
M&A, global partnerships and product approvals have all propelled regenerative medicines into the public discourse. We present the breakthroughs of 2018 and look at where the sector will head in 2019. The “new frontier of medicine†arrived in the US in 2017 through the approval of chimeric antigen receptor (CAR) T-Cell therapies Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), and gene therapy Luxturna (voretigene neparvovec). But it was last year, 2018, which delivered the true potential of this burgeoning sector into…
Thermo Fisher to make T cells for Torque at new NJ plant
Thermo Fisher will staff and operate a modular and fully-closed cell therapy facility in New Jersey on behalf of Torque. The 10,000 square-foot facility in Princeton, New Jersey is set to come online in 2019 and will support Torque’s immuno-oncology ‘Deep-Primed T Cell’ candidates. The products use the firm’s cell process engineering technologies, which do not require genetic engineering of the T cells, and lead candidate TRQ1501 (Deep IL-15 primed T cells) is set to begin Phase I/II clinical trials…
Pfizer looks to oncology biosimilars to break US market
Biosimilar uptake in the US has been stifled in the inflammation and immunology (I&I) space but Pfizer expects a different dynamic for oncology products. Pfizer’s biosimilar business had a robust year in 2018. The firm reported a 41% operational growth in the sector over the year prior, with total sales of $769 million (€674 million). The company attributed much of this growth to sales of Inflectra, its version of J&J’s Remicade (infliximab), which pulled in $642 million worldwide including $259…
Novo Nordisk DKK 9bn CapEx in 2019 ‘higher than expected’
Novo Nordisk spent $1.5 billion on CapEx in 2018 and expects to pay a further $1.4 billion in 2019 driven by investment in drug substance at its North Carolina site. Danish drugmaker Novo Nordisk had a flat year in 2018, pulling in sales of DKK 112 billion ($17 billion). Net profit remained relatively constant too, with the firm reporting DKK 39 billion ($6 billion). According to CFO Karsten Munk Knudsen, “manufacturing had a fantastic year in 2018. He told stakeholder:…
Vendors highlight another standout year for bioprocessing
Demand for bioprocessing technology remains strong as GE Healthcare, Thermo Fisher, Pall and Sartorius all report high annual growth. With the financial season in full swing, four of the major industry suppliers have reported their Q4s and end-of-year results, and all have one thing in common: high growth across their bioprocessing segments. GE Healthcare, which is being prepped to separate from parent company General Electric, reported revenues of $19 billion (€16.5 billion) for the full year, up 4%. The division…