CMO Movement: Regulatory Catalyst for Pharmaceutical Manufacturing - August

Pharmaceutical and biotech companies live or die on regulatory decisions about therapeutics. These verdicts affect not only the company that developed a particular treatment, but also the company responsible for manufacturing it.

In this ongoing series, pharmaceutical technology We highlight recent regulatory decisions that are likely to impact pharmaceutical and biologics manufacturing volumes. Through it, we highlight the role of contract manufacturing organizations (CMOs), a key stakeholder in the pharmaceutical industry, and their relationship with pharmaceutical companies.

This analysis covers the period from mid-June to late July, and CMOs likely to be affected by regulatory decisions by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and reimbursement authorities based on the list of It’s like the National Institutes of Health (NICE) in the UK.

These outsourcing agreements include parenteral manufacturing, packaging, and active biological (API) manufacturing. This analysis is based on the GlobalData Pharma Intelligence Center’s transaction database and his PharmSource reports.

Covid-19 vaccine continues to advance

In the past few months, Valneva has seen its share of different regulatory decisions regarding its Covid-19 vaccine VLA2001. The company had a €1.37 billion supply contract with the British government and he planned to build a manufacturing facility in Livingston, Lothian, West of Scotland. However, in late 2021, the government has terminated the deal. In April, the EMA requested additional data from the company, and the European Commission (EC) also announced plans to terminate the pre-purchase agreement if the vaccine was not approved by his EMA by April 30. . However, on June 23, the vaccine received marketing authorization, and last month the EC approved a modified purchase agreement for the vaccine. IDT Biologika is responsible for manufacturing its biological APIs.

Novavax’s Covid-19 vaccine has also been in development for a relatively long time before receiving a recent positive verdict. On 6 July, the EC approved the extension of the conditional marketing authorization to adolescents aged 12-17. This was quickly followed by the FDA’s Emergency Use Authorization (EUA) for the adult use of Nuvaxovid. Manufacturing of the biological API for the vaccine is outsourced to Biofabri, Fujifilm Diosynth Biotechnologies USA, Mabion, SK Bioscience and Emergent Biosolutions. Additionally, manufacturing of the injectable is outsourced to Baxter BioPharma and Emergent.

Cardiovascular and obesity drugs gain momentum

In mid-June, NICE recommended the use of Amarin’s vasquepa to prevent cardiovascular events such as heart attack and stroke. Small molecule manufacturing is outsourced to several of her CMOs. BASF SE, Nisshin Pharma, Chemport, and Novasep manufacture small molecule APIs, while MIA Pharma, ThermoFisher Scientific’s Patheon, and PCI Pharma Services are responsible for solid dosage and packaging.

In the metabolic disorders area, FDA’s expanded labeling allows Rhythm Pharmaceuticals’ Imcivree to be prescribed for chronic weight management in obese adult and pediatric patients age 6 and older with Bardet-Biedl syndrome (BBS). became. Corden Pharma International, Polypeptide Group and Recipharmare have contracts to participate in various stages of manufacturing.

Horizon Therapeutics’ labeling of Krystexxa has been expanded to include its use as a treatment for patients with uncontrolled gout, given with methotrexate. Bio-Technology General Israel, Fujifilm Diosynth, and NOF Corp are responsible for manufacturing the biological API for recombinant uricase therapy. In oncology, Merck & Co.’s and AstraZeneca’s checkpoint inhibitors have been demonstrated in combination with chemotherapy for metastatic triple-negative breast cancer and as maintenance therapy for non-small cell lung cancer after platinum-based chemoradiation, respectively. Got NICE approval. In the former, Organon is contracted for the parenteral packaging of his Keytruda and in the latter his Imfinzi parenteral manufacturing is outsourced to Vetter Pharma-Fertugung.

repeatThe previous edition of this series, click here When here.