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Eli Lilly on M&A: Balancing the science with the shareholders

Many early-phase acquisitions do not make sense for shareholders despite having promising assets, says Lilly’s CFO Joshua Smiley. About a third of Lilly’s pipeline comes from M&A. Speaking to attendees at the Morgan Stanley Healthcare Conference Broker Conference Call this month, Eli Lilly CFO Joshua Smiley said his firm is “interested in doing early stage clinical deals where we see compelling scientific rationale in our key therapeutic areas and that we can upgrade our pipeline.” But deals also need to…

Biocad teams with SPH to build Chinese biomanufacturing plant

by Dan Stanton

Russian drugmaker Biocad and Shanghai Pharmaceuticals Holding (SPH) have formed two joint ventures to develop and make originator and biosimilar antibodies in China. At the Eastern Economic Forum (EEF), a memorandum of understanding has been signed between the two companies, establishing two joint ventures aimed at developing and manufacturing several monoclonal antibodies intended for the Chinese market. “The project itself is focused on four molecules and two original products,” Biocad spokesperson Irina Kenyukhova told BioProcess Insider. “Due to the fact…

Sanofi prepped for production after EU Nanobody success

by Dan Stanton

Ten weeks after acquiring Ablynx, Sanofi has received European approval for lead Nanobody-based drug Cablivi (caplacizumab). In June this year, Sanofi acquired Belgian biotech Ablynx for €3.9 billion ($3.5 billion), adding the firm’s pipeline of biotherapeutics based on the small-sized antibody, or Nanobody, technology. Now the French biopharma firm is set to commercialize lead product caplacizumab (anti-vWF Nanobody) in Europe under the brand name Cablivi after the European Commission granted it marketing authorization for the treatment of rare blood-clotting disorder…

Vendors ‘awakening’ to the needs of cell and gene therapy makers

by Dan Stanton

Equipment suppliers are vying to fill gaps in processing say cell and gene therapy experts, but understanding what end-users need will be central for success. In 2017, the US FDA approved two chimeric antigen receptor T (CAR-T) cell therapies. Since then there have been several other cell and gene therapies approved across several markets, including Europe’s first allogeneic stem cell in the form of Takeda’s Alofisel (darvadstrocel). And with several hundred cell and gene candidates moving through the clinical stages…

False biosimilar communications: Originators rebuff Pfizer’s claims

by Dan Stanton

Pfizer has accused Amgen, J&J and Roche of sending misleading communications about biosimilars in a Citizen Petition asking the US FDA to issue guidance on such behavior. In a Citizen Petition published on August 22, Pfizer said communication tools intended to incentivize the adoption of and switching of biosimilars have led to a robust uptake of biosimilars in Europe, but in the US “payer reimbursement policies are in fact impeding adoption of biosimilars.” The firm continued: “Dissemination of false or misleading…

KBI boosts analytical services with Belgium expansion

by BPI Staff

The laboratories in Belgium will help international biopharma firms consolidate their outsourced analytical work to meet EU regulations, says KBI Biopharma. Contract development and manufacturing organization (CDMO) KBI Biopharma has opened laboratories in Leven, Belgium offering analytical development, formulation development, biopharmaceutical characterization and cGMP quality control testing. According to CEO Tim Kelly, the lab expansion was first announced in 2015, when the CDMO was acquired by JSR Corporation. “JSR’s decision to expand its A3 production capacity in Leuven created an…

Sartorius opening life sciences launchpad to grow German talent and innovation

by BPI Staff

Bioprocessing vendor Sartorius has launched a Life Science Factory in Göttingen, Germany offering labs, co-working spaces and consulting services for life science entrepreneurs. Life Science Factory, an independent non-profit division of Sartorius, aims to set-up a launch pad for life science startups in Germany. According to spokesperson Timo Lindemann, the project will begin next year with more than 500m2 for co-working, experiments and events, available for rent by entrepreneurs, before being transferred to a new 3,000m2 nearby facility in 2021.…

Gilead says CA plant will supply Yescarta to EU until 2020

by Dan Stanton

Kite’s manufacturing plant in El Segundo, California, will supply Europe with the newly approved CAR-T therapy Yescarta while a facility in The Netherlands is being prepared. Gilead Sciences has received marketing authorization from the European Commission (EC) for its chimeric antigen receptor T (CAR-T) cell therapy Yescarta (axicabtagene ciloleucel). The therapy is approved to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL). “Across the European Union, it is estimated that…

Novartis constructing $92m CAR-T plant as Kymriah arrives in EU

by Dan Stanton

Up to 450 jobs will be created as Novartis commits to a production site for cell and gene therapies in Switzerland. The investment will support CAR-T drug Kymriah, which received European approval this week. A year after the US Food and Drug Admistration (FDA) approved Kymriah (tisagenlecleucel), the European Commission (EC) has granted the Novartis’ therapy approval to treat B-cell acute lymphoblastic leukemia (ALL). In the US, the chimeric antigen receptor T cell (CAR-T) product is manufactured at Novartis’ Morris…

Bioreactors from Ireland to China: ABEC gains second license

by Dan Stanton

ABEC has received approval to supply bioprocessing equipment to China from its facility in Kells, Ireland. Bioreactor and bioproduction equipment vendor ABEC has been supplying the Chinese market for the best part of a decade, after its Springfield, Missouri facility obtained a China Manufacture License (CML) in 2010. Now the firm can supply its tech from a second facility, the Kells plant in County Meath, Ireland, after the government granted the plant a China Manufacture License (CML) to manufacture pressure…