Author Archives: Dan Stanton

Merck and MIT look to continuous cell-based vaccines in NIIMBL project

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An 18-month project partners Merck & Co. with vendor Repligen and academia to develop approaches for continuous cell-culture based vaccine manufacturing. The program, entitled ‘The Continuous Cell Culture for Viral Vaccines’ is being led by the Massachusetts Institute of Technology (MIT), will bring together Big Biopharma firm Merck & Co. (known as MSD outside North America), bioprocessing vendor Repligen, Massachusetts Life Sciences Center, and the University of Massachusetts Medical School. It is one of 22 projects recently announced by the…

January 25, 2019

Phacilitate: Cell & gene industry flocks to Miami

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The cell and gene therapy industry congregated in Miami to discuss supply chain strategies, regulatory rationale and the high manufacturing costs of advanced therapies. BioProcess Insider attended the Phacilitate Leaders World Summit, co-located with the World Stem Cell Summit, in Miami, Florida last week. The conference reflected on the first full year where three advanced therapies – Kymriah, Yescarta, and Luxturna – proved themselves on the commercial stage, heralding in a new frontier for regenerative medicines. But industry quickly rose above…

January 25, 2019

Manufacturing costs the ‘biggest threat’ to cell and gene therapies

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This is the first time in history that we can make more effective medicines than we can afford, says Dark Horse Consulting. The Phacilitate conference took place in Miami this week, and in the plenary session Anthony Davies, founder of cell and gene therapy specialist firm Dark Horse Consulting, described the latest developments in the field of regenerative medicine. With the approvals of Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel) and Luxturna (voretigene neparvovec) in 2017, “this field finally had the year…

January 23, 2019

Lower infliximab revenues but J&J still holds 93% share

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There have been two infliximab biosimilars available in the US for over a year, but Johnson & Johnson says reference biologic Remicade still holds a 93% volume share. In 2016, Pfizer launched Inflectra in the US. The following year, Merck & Co. launched Renflexis. With the ensuing price war, the infliximab biosimilars had been touted to end reference biologic Remicade’s market dominance. But after the first full year with all three infliximab products on the market, J&J has reported in…

January 22, 2019

Alvotech raises $300m to advance biosimilar pipeline

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After building out its manufacturing network, Iceland-based biosimilar developer has raised $300 million to support biosimilar R&D through a private bond offering. “A unit of Morgan Stanley from London was the lead investor acquiring approximately 75% of the total,†Alvotech pokesperson Halldor Kristmannsson told BioProcess Insider. “They in turn syndicated the majority of this to a small number of institutional investors.†While Kristmannsson could not disclose the actual names of those investors, he said the remaining bonds were purchased by a combination…

January 22, 2019

COGS factor in Amgen’s exit from $540m Advaxis deal

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Advaxis says Amgen’s withdrawal from a 2016 personalized immuno-oncology partnership is due to portfolio rationalization, high cost of goods, and the high-risk of commercialization. In 2016, Amgen teamed up with New Jersey-based Advaxis to co-develop and commercialize Advaxis’ investigational cancer immunotherapy ADXS-NEO in a deal worth up to $540 million (€475 million). But after paying out $78 million, Amgen sent written notice last month alerting Advaxis it is terminating the partnership, effective from February 8, said Advexis in an SEC…

January 22, 2019

Trastuzumab triple: FDA approves Merck and Samsung Bioepis biosimilar

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The FDA has approved Ontruzant, the third version of Roche’s cancer drug Herceptin, and the second US biosimilar approval for Samsung Bioepis. The product will be marketed by Merck & Co. Europe approved Ontruzant in November 2017 as a biosimilar to Roche’s Herceptin (trastuzumab), and 14 months on the US Food and Drug Administration (FDA) has given the oncology biologic the regulatory thumbs up. Ontruzant becomes the seventeenth biosimilar to be approved in the US, and the first of 2019.…

January 21, 2019

Bavarian Nordic to validate fill/finish plant using $44m US gov option

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The US Biomedical Advanced Research and Development Authority (BARDA) has exercised a second option in its smallpox vaccine contract with Bavarian Nordic. In September 2017, the US government’s Biomedical Advanced Research and Development Authority (BARDA) awarded Danish vaccine manufacturer Bavarian Nordic contract for the manufacturing and storage of its smallpox vaccine worth upwards of $539 million (€474 million). To support the agreement, BARDA exercised an option in 2017 to cover development costs associated with the Phase III study of the…

January 18, 2019

Lilly’s speedy $8bn Loxo buy ‘not competitive,’ says analyst

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It took Eli Lilly 18 days from expressing its interest in Loxo Oncology to executing an $8 billion merger agreement. Being a “significant premium over the market price†and with no other bidders, the deal’s competitiveness has been questioned. Earlier this month, Eli Lilly announced it had agreed to buy Loxo Oncology for $235 (€206) per share in cash, totaling around $8 billion. The deal increases Lilly’s oncology portfolio, including lead candidate LOXO-292, an oral RET inhibitor being studied across…

January 18, 2019

Pfizer: ‘Dropped preclinical programs do not change commitment to biosimilars’

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In the latest example of a Big Biopharma reducing its biosimilar presence, Pfizer has abandoned five of its preclinical programs. The decision is part of an R&D review set to cut 150 jobs in Illinois and India. In November 2018, Bioprocess Insider reported claims that Big Pharma is set to exit from the biosimilars space over the next five years. Within weeks of publishing, Boehringer Ingelheim joined the likes of Germany’s Merck KGaA and Novartis division Sandoz in abandoning elements…

January 17, 2019