Therapeutic Class

Alnylam: ‘Onpattro will springboard us into a global biopharma firm’

Alnylam says it is on course to becoming “a global multiproduct commercial biopharma company” by 2020 as sales of its messenger RNA interference therapeutic Onpattro (patisiran) begin to ramp-up. Alnylam Pharmaceuticals made history in August 2018 when Onpattro (patisiran), its product for the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis, became the first small interfering ribonucleic acid (siRNA) treatment to be approved by the US Food and Drug Administration (FDA). Reporting its first quarter 2019 financials, the firm described the milestone…

Buoyed by CGT growth, Bio-Techne plans plant to supply $200m of reagents

Bio-Techne will invest $40 million to construct a GMP facility in Minneapolis expected to feed the growing demand for reagents in the cell and gene therapy space. The life sciences services and consumables firm reported a 12% growth in sales year-on-year in its third quarter FY2019 within its Protein Sciences segment. The segment – which supplies proteins such as cytokines and growth factors, immunoassays, antibodies and reagents to the biopharma industry – pulled in $138 million in the quarter. Its…

Gilead lets Kite fly solo to compete in competitive CAR-T space

Giving cell therapy unit Kite autonomy will “foster agility, innovation and entrepreneurialism,” says recently appointed Gilead CEO Daniel O’Day. Gilead Sciences entered into the advanced therapy space in August 2017 through the $11.9 billion (€10.6 billion) acquisition of Kite. Just weeks later, the firm saw regulatory success with Yescarta (axicabtagene ciloleucel), which became the second chimeric antigen receptor (CAR) T-cell therapy to be commercialized in the US. Close to two years on, the firm has announced it intends to run…

Breathing space: Inhalable biologics interest prompts Intertek expansion

Interest in inhaled biologics is increasing says Intertek, which has announced plans to expand its testing facility in Melbourn, near Cambridge. Intertek will double capacity with a new 20,000 square-foot lab kitted out with technologies use to assess inhaled and nasal formulations of large molecule drugs. It also plans to hire 100 employees over the next four years. “As companies are increasingly looking at biologics for non-invasive delivery platforms like inhaled and nasal, there is expected to be an increased…

FDA pledges to support cell and gene therapy manufacturing innovation

Manufacturers aiming to follow Yescarta and Kymriah to market can count on FDA support after the agency said it will help cell and gene therapy firms adopt better production methods. A US Food and Drug Administration (FDA) spokesman told Bioprocess Insider the agency’s emerging technology team has been tasked with working with cell and gene therapy firms to “identify innovative approaches for efficient product manufacturing.” The move is part of a wider FDA effort to support modernization of drug manufacturing…

AAV, easy as M-A-b? CEVEC fundraiser to scale-up production

Germany’s CEVEC claims it can produce adeno-associated viral (AAV) vectors as easily as monoclonal antibodies (MAbs), and has raised funds to expand and commercialize its production platform. While the total raised from new and existing investors in the Series D financing has not been disclosed, Cologne, Germany-based CEVEC says it will be used to advance its CAP GT-based stable AAV vector production platform and move it towards commercialization. As more gene therapies enter the clinic, there is high demand for…

Seattle Genetics in ‘good shape’ after restoring Adcetris inventory

After suffering an $18 million inventory write off, Seattle Genetics says its business as usual for the manufacturing of its lead antibody-drug conjugate (ADC) Adcetris. In its fourth quarter 2018, Seattle Genetics reported an increase in its cost of sales attributed to an $18.1 million (€16.2 million) inventory write-off related to in-process production that did not meet manufacturing specifications and did not impact availability of product supply required to meet demand for its ADC product Adcetris (brentuximab vedotin). Three months…

Success for Bioepis as FDA approves a second Enbrel biosimilar

The US Food and Drug Administration (FDA) has approved a second biosimilar of Amgen’s Enbrel (etanercept), Samsung Bioepis’s Eticovo. Korea’s Samsung Bioepis has seen regulatory approval for its etanercept biosimilar in numerous markets, including Korea, Europe, Australia, Canada, Brazil, Switzerland and Israel. Now the firm has had the molecule approved in the US under the brand name Eticovo. This is the second biosimilar of Amgen’s autoimmune disease drug Enbrel to be approved by the FDA. In August 2016, Sandoz received…

Lilly inks potential $440m antibody oligo conjugate deal

Eli Lilly has teamed with Avidity Biosciences for the development of a new class of RNA-based drugs, antibody oligonucleotide conjugates (AOCs). The deal sees Big Biopharma firm Eli Lilly pay Avidity Biosciences $20 million (€18 million) upfront and invest a further $15 million into the L Jolla, California-based company. Depending on development, regulatory and commercialization milestones, Avidity could receive a further $405 million. Lilly hopes to use Avidity’s AOC tech platform to generate “new therapeutic targets in disease areas that…

Thermo Fisher allots $125m to expand CDMO buy Brammer

The gene therapy space is growing at an annual rate higher than 25% says Thermo Fisher, which recently agreed to buy CDMO Brammer Bio for $1.7 billion. Thermo Fisher announced last month the agreement to buy contract development and manufacturing organization (CDMO) for $1.7 billion (€1.5 billion), propelling the life sciences services firm into the gene therapy production space. While the deal has not yet closed (expected by end of Q2 2019), Thermo Fisher said on its first quarter financials…