Author Archives: Dan Stanton

Agilent: Established pharma compensating for ‘shut down’ small biotech

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Expected revenue growth from emerging biotech has gone from double-digits to a decline says Agilent Technologies, but mid-to-large pharma remains robust. Instrument and consumable vendor Agilent pulled in $1.72 billion, up 9.5% year-on-year, for its fiscal year 2023 Q2 results. Specifically, revenue for pharma and biopharma grew 11% in Q2 and when Agilent’s Nucleic Acid Solutions Division (NASD) was included it grew 16%. What made these figure more impressive is the “increasingly challenging market environment,” management explained on the call,…

Pfizer expands Epogen biosimilar deal with German CDMO

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Norbitec’s biologics facility in Uetersen, Germany will supply Retacrit – Pfizer’s biosimilar of anemia drug Epogen (epoetin alfa) – to the US market. The approval for Retacrit in May 2018 brought the first US challenge to Amgen’s Epogen. Five years on and Pfizer has made a significant dent in the market, with the epoetin alfa biosimilar pulling in $312 million in US sales in 2022. Pfizer’s manufacturing facility in McPherson, Kansas – added through the $17 billion Hospira acquisition in 2015…

Second CRL leaves Alvotech with potential Humira biosimilar delay

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US approval of Alvotech’s Humira (adalimumab) biosimilar could be delayed by six months after the FDA found further issues at a manufacturing facility in Reykjavik, Iceland. Thanks to a 2017 settlement with AbbVie, Amgen launched the first biosimilar of best-selling monoclonal antibody Humira earlier this year. At the end of next month, up to nine more biosimilars could be competing for a slice of the $18.6 billion market. Iceland-based firm Alvotech has two separate applications for AVT02, with the first Biologics…

Moderna lays out $322m for mRNA manufacturing plant in MA

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Moderna has bought an empty biomanufacturing facility in Marlborough and is planning a 60,000 square-foot expansion as it continues to invest in internal capabilities. The agreement sees messenger RNA (mRNA) titan Moderna add a second facility in Massachusetts, a new but empty plant located at 149 Hayes Memorial Drive, bought from the Oxford Properties Group. The 24-acre parcel of land includes a 140,000 square-foot facility to house manufacturing and office space. According to notes from a City of Marlborough public…

Novartis adding cystinosis gene therapy candidate from AvroBio

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Novartis will pay $87.5 million in cash to add the Phase I/II hematopoietic stem cell (HSC) gene therapy program to its advanced therapy pipeline. Novartis, through its acquisition of AveXis in 2018, is one of a small but growing number of players to bring a gene therapy to market: Zolgensma (onasemnogene abeparvovec) was approved in 2019 for spinal muscular atrophy (SMA). The Swiss pharma giant says it has over 20 gene therapy project in its pipeline and this week is adding…

Catalent limiting CAPEX as part of cost reduction plan

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Ongoing CAPEX projects will cost $550 million but only the most critical projects will be funded going forward as Catalent attempts to put out financial and operational fires. Amid numerous internal issues, contract development and manufacturing organization (CDMO) Catalent delayed its third quarter fiscal year 2023 financials for a third time and instead provided a business update Friday. “This is not at all the call we expected to have now, and we are not at all where we expected to…

Krystal clear: FDA approves redosable gene therapy gel Vyjuvek

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Krystal Biotech has won approval for Vyjuvek (beremagene geperpavec), a topical gel gene therapy to treat the skin condition dystrophic epidermolysis bullosa (DEB). The handful of gene therapies on the market are single-dose injections or infusions, but the US Food and Drug Administration (FDA) approved the first ‘redosable’ gene therapy Friday, in the form of Krystal’s Vyjuvek. Vyjuvek is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, which when administered topically to DEB wounds delivers two copies of the…

Thermo Fisher eyes up to $50bn M&A in coming years

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Not shy of multi-billion-dollar acquisitions, Thermo Fisher says it expects to spend another $40-50 billion on “disciplined” M&A when the time is right. Since the formation of Thermo Fisher through the merger of Thermo Electron and Fisher Scientific in 2006, the company has made 44 acquisitions across all aspects of the life sciences services space, representing more than $69 billion. Some of the biggest include the $13.6 billion Life Technologies buy in 2013, the $7.2 billion acquisition of contract manufacturer Patheon…

Bavarian Nordic: Boosting inhouse manufacturing drives vaccine ambition

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The takeover of a Swiss plant from contract manufacturer Emergent will bring Bavarian Nordic greater control of its vaccine production, the firm says. In February, Danish drugmaker Bavarian Nordic inked a $270 million agreement to buy numerous vaccine assets and a manufacturing facility in Bern, Switzerland from contract development and manufacturing organization (CDMO) Emergent Biosolutions. Yesterday, the deal closed. Speaking on the firm’s Q1 results, CEO Paul Chaplin said the acquisition is key in helping Bavarian Nordic become “one of…

Lilly working to resolve mirikizumab manufacturing issues following CRL

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Eli Lilly expects mirikizumab to become the first interleukin-23 subunit alpha (IL-23p19) to treat ulcerative colitis once manufacturing issues highlighted by the US FDA are resolved. Last month, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Eli Lilly for mirikizumab, its monoclonal antibody candidate for the treatment of ulcerative colitis (UC). Patrik Jonsson, president of Lilly Immunology, discussed his company’s approach to resolving the issue at the Bank of America Securities 2023 Healthcare Conference…