Vertex has acquired Semma Therapeutics adding a program using pluripotent stem cell-derived islets as a potentially treatment for type 1 diabetes. While Semma is yet to have brought a therapy into the clinic, the Massachusetts-based firm has created a process it claims can produce stem cell-derived islets (SC-islets) starting from human pluripotent stem cells capable of developing into any cell type in the body. Its lead candidate has completed preclinical proof-of-concept studies demonstrating evidence of the potential of such technology…
Deal-Making
Batavia selects CHO platform for Zika Ab on the Horizon
A collaboration led by Batavia Biosciences will use Horizon Discovery’s CHO cell technology in the development of an antibody against Zika. Batavia Biosciences, working with Vanderbilt University Medical Center (VUMC) and IDBiologics, is looking to develop a therapy based on a Zika virus neutralizing antibody that was discovered three years ago. Accessing Horizon Discovery’s GS knockout Chinese hamster ovary (CHO) K1 cell line expression system will allow the development of high yield antibody-expressing cell lines, Batavia CEO Menzo Havenga told…
Novartis to take on Biogen with Tysabri biosimilar pact
Novartis division Sandoz has teamed with Polpharma for the commercialization rights to a Phase III biosimilar of Biogen’s multiple sclerosis monoclonal antibody Tysabri (natalizumab). The deal sees Sandoz enter into an agreement with Polpharma Biologics to commercialize and distribute worldwide the Polish biopharma firm’s natalizumab program, currently in Phase III trials. The molecule is being developed as a biosimilar of the relapsing-remitting multiple sclerosis (RRMS) monoclonal antibody Tysabri, which pulled in $1.86 billion (€1.7 billion) for Biogen in 2018. “Polpharma…
Not all about that base: Catalent organic downside offset by M&A
Biologics now represent 32% of Catalent’s revenues, but unfavorable product mix, plant maintenance and a customer moving drug substance in-house hit the CDMO’s pre-existing business in Q4 FY2019. For the fourth quarter fiscal year 2019, Catalent reported revenue of $726 million (€662 million) across all its business units. While the contract development and manufacturing organization (CDMO) saw an 18% increase in sales year-on-year to $231 million within its Biologics and Specialty Drug Delivery segment, removing revenues from the recently acquired…
Dyadic: Deals stack up as industry looks to ‘game-changing’ expression system
Another quarter of deal making by Dyadic International demonstrates how companies are looking to microorganisms instead of CHO to produce affordable drugs, the firm says. Numerous biopharma and biotech firms over the past few years have been turning to Dyadic International to access its C1 fungus-based expression system. The second quarter 2019 was no exception, with Luina Bio, Alphazyme, and the Serum Institute of India inking separate agreements with Dyadic within a two-week period. Such deals reflect Dyadic’s long-term vision…
CMOs to continue picking up Big Pharma non-core facilities
Recent facility acquisitions by Lonza and Catalent show Big Pharma is divesting its non-core assets in a trend that is set to continue, according to PharmSource. In the previous couple of months, contract manufacturing organizations (CMOs) Lonza and Catalent have both increased their production networks through facility acquisitions. Lonza’s expansion incorporates a sterile, multi-product drug product facility in Stein, Switzerland, acquired from fellow Swiss firm Novartis. Catalent, two weeks prior, added its first biologics plant outside the US through a…
AskBio buys Synpromics, plans expansion
Asklepios BioPharmaceutical (AskBio) has bought Synpromics bringing gene control synthetic promoter technology to its AAV gene therapy programs. Under terms of the deal, Edinburgh, UK-based Synpromics will will bring synthetic promoter technology, along with bioinformatics and intelligent data-driven design, to North Carolina’s AskBio’s gene therapy pipeline. AskBio has its own capsid library and a proprietary adeno-associated virus (AAV) manufacturing platform called Pro10 which it uses in its gene therapies. Its lead candidate is in Phase I/II for Pompe Disease. “For…
Lonza to simplify vein-to-vein supply chain with Vineti partnership
The cell and gene therapy industry is at a global inflection point says Lonza as it teams with logistics firm Vineti to remove the supply chain hurdles affecting the space. The non-exclusive partnership will see contract development and manufacturing organization (CDMO) Lonza incorporate Vineti’s real-time end-to-end supply chain platform into its cell and gene therapy offering. “The Vineti and Lonza partnership is a preferred business collaboration to drive manufacturing efficiencies in the C> [cell and gene therapy] manufacturing process by…
Pfizer licenses AAV platform for ataxia gene therapy
Pfizer will use REGENXBIO’s adeno-associated virus (AAV) delivery platform for a gene therapy aimed at treating neurodegenerative disease Friedreich’s ataxia. In REGENXBIO’s second quarter 2019, a major milestone was reached with the approval of Novartis/Avexis’ Zolgensma (onasemnogene abeparvovec). The gene therapy uses the NAV Technology Platform, created and validated by REGENXBIO’s founders and collaborators at the University of Pennsylvania, which uses over 100 adeno-associated viral (AAV) vectors to deliver engineered genes to cells. The firm, which is also developing its…
Novo Nordisk to convert Purdue NC plant to make oral diabetes drug
Novo Nordisk will rebuild a facility in Treyburn, North Carolina acquired from Purdue Pharma to support an oral form of its GLP-1 analogue semaglutide. In an email sent to staff and posted on cafepharma.com, Craig Landau – CEO of OxyContin maker Purdue Pharma – said an evaluation of his firm’s manufacturing operations and capabilities has resulted in the sale of its Treyburn solid oral dose plant to Danish drugmaker Novo Nordisk. Financial details of the deal have not been divulged,…