Global Markets

Dupixent growth increases Regeneron’s manufacturing costs (again)

Regeneron says higher Dupixent (dupilumab) sales drove an increase in manufacturing and collaboration costs in Q4. In the US, Dupixent brought in revenue of $605 million (€554 million) in the final three months of 2019, up 136% on the comparable period a year earlier. Similarly, global net sales of the drug in the fourth quarter increased to $752 million, up from $319 million in 2018. Regeneron senior vice president Marion McCourt told analysts: “We continue to see strong prescribing trends…

FDA approves Seqirus’ adjuvant cell-based flu vaccine Audenz

Seqirus says it is confident of supply of its newly approved cell-base influenza A (H5N1) vaccine Audenz in the case of a pandemic. The US Food and Drug Administration (FDA) gave the thumbs up to Seqirus for its vaccine Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted), making it the first adjuvanted, cell-based influenza vaccine approved to protect against influenza A (H5N1) in the event of a pandemic. Seqirus, a subsidiary of CSL Limited, is not planning to market the product…

Merck’s biosimilar business to power NewCo spinoff

Merck & Co. reported biosimilar sales of $250 million in 2019 and says the revenues will be used to grow its spinout company NewCo, also comprising of its women’s health and legacy brands. Merck & Co. (known as MSD outside North America) announced the creation of NewCo in line with its Q4 and full year 2019 results. The new entity will group the company’s women’s health assets and legacy brands together, along with its biosimilars business. Left alone, Kevin Ali…

Celltrion pulls plant team out of Wuhan as it tracks coronavirus

Celltrion says it is committed to a biosimilars plant in Wuhan, China but has pulled project team out while it tracks the 2019-nCoV coronavirus outbreak. Celltrion is keeping a close eye on the spread of 2019-nCoV according to a spokesman. He told us “while we remain strongly committed to the project, it is difficult to say how the ongoing outbreak will affect our plans at this moment. “We are closely monitoring the situation and will continue to communicate with the…

Thermo says Chinese Gov policy will drive growth

Thermo Fisher Scientific says Chinese Government support for biopharma will help grow its business in the country. The life science services, tools and technology firm saw full-year revenue increase 5% to $25.54 billion in 2019 according to documents filed with the US SEC last week. The contribution from Thermo’s operations in China increased 13% year-on-year. And China was a major topic of discussion for CEO Marc Casper during Thermo’s fourth quarter call. “Government priorities in China are aligned with the…

Potential Oklahoma anti-vax bill danger to health and industry

Oklahoma has introduced a bill intended to ban the state from prescribing, administering, and making medicinal products and vaccines containing human DNA. Introduced on January 15, Senate Bill 1514 is proposing prohibiting vaccine use and supply in the state of Oklahoma. “No medicine, medical product, vaccine or other injection that contains human DNA shall be prescribed, administered, dispensed, used or offered in this state,” the bill states, placing a date of November 1, 2020 as the when it hopes to…

VGXI to make DNA vaccine in global effort to stymie coronavirus

VGXI will make Inovio Pharmaceuticals’ investigational vaccine as part of a collaborative effort to halt the progress of the coronavirus that has recently emerged in Wuhan, China. At the time of publication, 170 people have died and almost 8,000 people infected by the novel coronavirus (2019-nCoV). Wuhan, the Chinese city where the outbreak began, is under lockdown but cases of infection have been reported across the globe, including in Australia, France, and the US. There is no specific treatment for…

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

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…

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…

Celltrion outlines 120,000L China plant and corporate rejig

Celltrion has confirmed it will build a biosimilars plant in China and may merge its healthcare and pharma units. A spokesman told Bioprocess Insider: “Celltrion plans to build a plant in China in a move to directly advance into the world’s second-largest biopharmaceutical market. Celltrion signed a business agreement with the city government of Wuhan and the provincial government of Hubei Province on 20 January 2020. “The company’s business roadmap centers on building a plant with a production capacity of…