CMO Moves: Regulatory Catalysts for Drug Manufacturing: August

Pharmaceutical and biotech companies live and die by regulatory decisions about their therapies. These verdicts affect not only the company that developed the particular therapy, but also those responsible for manufacturing it.

In this ongoing series, Pharmaceutical Technology takes a look at recent regulatory decisions likely to affect drug and biologics manufacturing volumes. With this, we shed light on the role of contract manufacturing organizations (CMOs), a major player in the pharmaceutical landscape, and their relationships with pharmaceutical companies.

This analysis covers the period from the end of mid-June to the end of July and is based on a list of OCMs that are likely to be affected by the regulatory decisions of the Food and Drug Administration (FDA), the European Medicines Agency ( EMA) and reimbursement authorities. such as the UK’s National Institute of Health and Care Excellence (NICE).

These outsourcing contracts involve parenteral manufacturing, packaging, bioactive pharmaceutical ingredient (API) manufacturing, and more. This analysis is based on the GlobalData Pharma Intelligence Center’s offer database and PharmSource reports.

NICE decisions from mid-June to the end of July for biopharmaceutical drugs and the CMOs contracted to make them.
Source: GlobalData Pharmaceutical Intelligence Center

Vaccines against Covid-19 continue to advance

In recent months, Valneva has seen its share of mixed regulatory decisions for its VLA2001 Covid-19 vaccine. The company had a €1.37 billion supply deal with the UK government and a manufacturing facility would be established in Livingston, West Lothian, Scotland. But at the end of 2021 the government terminated the agreement. In April, the EMA asked the company for additional data, and the European Commission (EC) also announced that it planned to terminate an early purchase agreement if the vaccine was not authorized by the EMA by 30 ‘April. On June 23, however, the vaccine received marketing authorization and last month, the EC approved an amended purchase agreement for the vaccine. IDT Biologika has been responsible for manufacturing the biological API.

Novavax’s Covid-19 vaccine has also been in development for a relatively long time, before receiving recent positive verdicts. On July 6, the EC approved the extension of its conditional marketing authorization to include adolescents between 12 and 17 years of age. An emergency use authorization (US) from the FDA for the use of Nuvaxovid in adults soon followed. Manufacturing of the vaccine biologic API has been outsourced to Biofabri, Fujifilm Diosynth Biotechnologies USA, Mabion, SK Bioscience, and Emergent Biosolutions. In addition, parenteral manufacturing is contracted to Baxter Biopharma and Emergent.

Cardiovascular drugs and obesity have taken their toll

In mid-June, NICE recommended the use of Amarin’s Vazkepa to prevent cardiovascular events such as heart attacks and strokes. Small molecule manufacturing has been outsourced to several CMOs; BASF SE, Nisshin Pharma, Chemport and Novasep are producing the small molecule API, while MIA Pharma, ThermoFisher Scientific’s Patheon and PCI Pharma Services are handling the solid dosage and packaging.

US FDA and EMA decisions from mid-June to late July for biopharmaceutical drugs and CMOs contracted to manufacture them. The color key for the manufacturing contract type is the same as above.
Source: GlobalData Pharmaceutical Intelligence Center

In the metabolic disorders space, an expanded FDA label now means that Rhythm Pharmaceuticals’ Imcivree can be prescribed for chronic weight control in adult and pediatric patients six years of age and older with obesity due to Bardet-Biedl (BBS). Corden Pharma International, Polypeptide Group and Recipharmare were contracted to participate in the various stages of its manufacture.

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

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