CMO Moves: Regulatory Catalysts for Drug Manufacturing – August

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

In this ongoing series, Pharmaceutical Technology takes into account recent regulatory decisions that are likely to affect drug and biologic production volumes. Through this, we shed light on the role of contract manufacturing organizations (CMOs), an important stakeholder in the pharmaceutical landscape, and their relationship 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 CMOs likely to be affected by regulatory decisions from the US Food and Drug Administration (FDA), the 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 PharmSource reports.

Vaccines against Covid-19 continue to advance

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

Novavax’s Covid-19 vaccine has also been in development for a relatively long time, before receiving recent positive verdicts. On 6 July, the EC approved the extension of its conditional marketing authorization to include adolescents aged 12-17. This was quickly followed by an FDA emergency use authorization (EUA) for the use of Nuvaxovid in adults. Production 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 and obesity drugs hit their stride

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, Patheon of ThermoFisher Scientific and PCI Pharma Services are taking responsibility for the dosage and solid packaging.

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

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 the production of the biologic API for recombinant uricase therapy. In the oncology arena, checkpoint inhibitors from Merck & Co and AstraZeneca received NICE approvals for use in combination with chemotherapy for metastatic triple-negative breast cancer and as a maintenance therapy for the treatment of non-small cell lung cancer after chemoradiation platinum-based, resp. . With the former, Organon has been contracted for parenteral packaging for Keytruda, while parenteral production for the latter’s Imfinzi has been awarded to Vetter Pharma-Fertugung.

ripin the previous edition of this series, Click here AND here.