Pharmaceutical and biotech companies live and die by regulatory decisions on their treatments. These decisions affect not only the company developing the particular therapy, but also the people responsible for its manufacture.
Continued in this series. Pharmaceutical technology Takes a look at recent regulatory rules impacting the production volume of pharmaceuticals and biologics. Through this, we shed light on contract manufacturing organizations (CMOs), an important stakeholder in the pharma landscape, and their relationship with pharma companies.
This analysis covers the period from mid-June to the end of July and is based on a list of CMOs affected by regulatory decisions by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and reimbursement authorities. such as the UK’s National Institute for Health and Care Excellence (Nice).
These outsourcing contracts include parenteral manufacturing, packaging, bioactive pharmaceutical ingredient (API) manufacturing, and more. This analysis is based on the GlobalData Pharma Intelligence Center’s Deal Database and PharmaSource reports.
Covid-19 vaccines continue to advance
Over the past few months, Valneva has seen its share of mixed regulatory decisions for its Covid-19 vaccine VLA2001. The company had a EUR 1.37 billion supply contract with the UK government, and was going to set up a manufacturing facility in Livingston, West Lothian, Scotland. But in late 2021, the government canceled the deal. In April, the EMA requested more data from the company, and the European Commission (EC) also announced plans to cancel the advance purchase agreement if the vaccine is not authorized by the EMA before April 30. However, on June 23 the vaccine received a marketing authorization, and last month, the EC approved a revised purchase agreement for the vaccine. IDT Biologika is charged with developing a biological API for it.
Novavax’s Covid-19 vaccine has been in development for a relatively long time before recently receiving positive decisions. On July 6, the EC approved the extension of the conditional marketing authorization to cover adolescents aged 12-17 years. This was soon followed by an FDA Emergency Use Authorization (EUA) for the use of Nuvaxovid in adults. Biologic API manufacturing of the vaccine has been outsourced to Biofabri, FUJIFILM Diosynth Biotechnologies USA, Mabion, SK Bioscience, and Emergent Biosolutions. Additionally, parenteral manufacturing has been contracted with Baxter Biopharma and Emergent.
Cardiovascular and obesity drugs hit their stride
In mid-June, Nice recommended the use of Amarin’s VEGF to prevent cardiovascular events such as heart attacks and strokes. Small molecule manufacturing has been outsourced to many CMOs; BASF SE, Nisshin Pharma, Chemport and Novasep are producing small molecule APIs, while MIA Pharma, Patheon by ThermoFisher Scientific, and PCI Pharma Services are handling solid dosage and packaging.
In the metabolic disorder space, the expanded label from the FDA means that Rhythm Pharmaceuticals’ Imcivree can now be prescribed for long-term weight management in adult and pediatric patients six years of age and older with obesity due to Bardet-Biddle syndrome (BBS). Corden Pharma International, PolyPeptide Group, and Recipharmare have agreed to participate in various phases of its development.
Horizon Therapeutics’ label for Crystexa was expanded to include its use as an adjunctive treatment with methotrexate for patients with uncontrolled gout. Bio-Technology General (Israel), Fujifilm Diasynth, and NOF Corporation are responsible for manufacturing the biological API for recombinant uricase therapy. In the oncology arena, checkpoint inhibitors by Merck & Co and AstraZeneca received favorable approvals for use in combination with chemotherapy for metastatic triple-negative breast cancer, and as maintenance therapy for the treatment of non-small cell lung cancer after platinum-based chemotherapy, respectively. . With the former, Organon is contracted for parenteral packaging for Keytruda, while parenteral manufacturing for Imfinzi of the latter is outsourced to Vetter Pharma-Fertugung.
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