Deal-Making

Still Space for Multiple Neulasta Biosimilars, says Pfenex

Pfenex has deprioritized its pegfilgrastim biosimilar program but is reevaluating the market after Mylan’s recent success in the US. In June, the US Food and Drug Administration approved Mylan’s Fulphilia on its second attempt. While Fulphilia has become the first biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), there are several other firms looking to tap the market, including Coherus and Novartis subsidiary Sandoz. Clinical-stage development and licensing biotech Pfenex too has a pegfilgrastim biosimilar in its pipeline, PF529, but announced…

Entegris: ‘Flex Acquisition Helps Supply Chain Security’

Entegris has acquired Flex Concepts, adding upstream tech to its bioprocessing equipment offering. The deal – financial details of which have not been divulged – will see Entegris add bioprocessing single-use bags and fluid transfer solutions to its life sciences offering. “Flex Concepts manufactures quick turn custom configured products primarily for the biopharmaceutical industry. They sell products to some of the top pharma and biopharma companies,” Eric Isberg, director of Life Sciences for Entegris, told BioProcess Insider. “Flex had primarily…

Mustang Opens $7m CAR-T Manufacturing Plant

Mustang Bio has opened a CAR-T cell manufacturing facility in Massachusetts it says has capacity to treat up to 800 patients annually. Fortress Biotech-owned Mustang has several chimeric antigen receptor T cell therapies in its pipeline and has opened a facility in Worcester, Massachusetts to support their development. “Total investment into the facility, including the build out and equipment was between US$5 million (€4.3 million) and $7 million,” Mustang Bio’s chief technology officer Knut Niss told BioProcess Insider. The current…

GE Healthcare Spin-Off: “A Major M&A Chip Off the Table”

GE will separate its Healthcare division over the next two to three years in efforts to reduce debt. The news may disappoint acquisition-hungry life science rivals Thermo Fisher and Danahar, say analysts. John Flannery, chairman and CEO of General Electric (GE) announced today plans to separate GE Healthcare, along with industrial services firm BHGE, in efforts to “unlock both a pure-play healthcare company and a tier-one oil and gas servicing and equipment player.” The industrial conglomerate GE has struggled over…

Pfenex: Bacterial System Overcomes Protein Challenges, Inhouse and Out

“The more you engineer a protein, the less natural it becomes,” says Pfenex executive Patrick Lucy. The firm is using its clinically validated microbial expression platform to overcome these challenges for both its own product pipeline and its partners. In May, Pfenex announced positive Phase III data showing its lead candidate PF708 is comparable with Eli Lilly’s osteoporosis drug Forteo (teriparatide). The candidate – classed as a biosimilar in Europe but being filed in the US as a therapeutic equivalent…

BioSymphony No. 1: Oncobiologics Wins First CDMO Deal

Sonnet BioTherapeutics has contracted Oncobiologics to develop and manufacture four undisclosed biologic compounds. The Master Services Agreement (MSA) with Sonnet BioTherapeutics is the first to leverage Oncobiologics’ BioSymphony Platform, consisting of in-house monoclonal antibody (mAb) development and manufacturing capabilities. Lawrence Kenyon, Oncobiologics’ CFO, told BioProcess Insider the platform is used in a small biotech company setting, which results in a “more efficient and timely process for bringing mAbs forward.” He continued: “Our goal, and the purpose of the platform, is…

Sanofi: ‘Ablynx Nanobody Tech Will Fuel Innovation’

Sanofi has completed the acquisition of Ablynx and says it will use the ‘small antibody’ tech platform to drive innovation across a range of therapeutic areas. After rebuffing offers from Novo Nordisk, Belgian biotech Ablynx agreed to an acquisition bid of €3.9 billion (US$4.5 billion) from Sanofi in January. This week, the French pharma giant closed the deal and spoke about its integration plans. “Sanofi and Ablynx have already initiated efforts to better understand the company’s respective areas of expertise…

Sanofi Inks $850m mRNA Vaccines Deal with Translate Bio

Sanofi Pasteur has teamed with Translate Bio to develop messenger RNA (mRNA) vaccines for up to five infectious disease pathogens. Under terms of the deal, French vaccine developer Sanofi Pasteur will make an upfront sum of US$45 million (€38 million) to Massachusetts-based firm Translate Bio but total payments could reach $850 million on the back of developmental milestones and royalties. The R&D for the undisclosed vaccine targets will be jointly conducted during an initial three-year period. mRNA vaccines work by…

Automated Tech Ups Hitachi’s Cell Therapy Interest

Recent entrant to the regenerative medicine space Hitachi Chemical has partnered with Invetech to commercialize the Counter-Flow Centrifugation system – an automated platform for cell therapy manufacturing. The partnership will allow customers of Hitachi Chemical Advanced Therapeutics Solutions (HCATS) to access Invetech’s Counter-Flow Centrifugation (CFC) system in the clinical and commercial manufacturing of cell-based therapies using closed single-use disposables. Hitachi entered the regenerative medicine space in 2017 through the $US75 million (€64 million) acquisition of cell therapy contract development and…

Longstanding Bio Partner Celltrion Launches Full CDMO Unit

The Korean firm, which boasts Teva and Pfizer as partners, has consolidated its third-party services to offer a full CDMO platform. Celltrion announced at BIO in Boston last week it is launching a “Bio CDMO” (contract development and manufacturing) business. According to the South Korean biologics maker, the service consolidates its current third-party offerings, combining cell line development and production process, with clinical and commercial biomanufacturing. Spokesperson Gunhyuk Lee told BioProcess Insider: “You could consider this CDMO business as a…