More CDMOs in COVID-19 deals

The ongoing race to develop the first effective vaccines for the treatment of COVID-19 continues to generate manufacturing and development agreements between pharmaceutical giants, biotechs and CDMOs.

Most recently, Sterling Pharma Solutions agreed to carry out final purification of drug product for Moleculin Biotech’s WP1122 drug candidate from its site in Cary, North Carolina. Moleculin is about to submit an IND for this to the FDA and wanted a reliable source of supply in the US.

Also within July, late-stage biotech Novavax reached separate agreements with Fujifilm Diosynth Biotechnologies (FDB) and AGC Biologics to manufacture the drug bulk substance and the saponin-based Matrix-M adjuvant respectively for its COVID-19 vaccine candidate, NVX-CoV2373, which it created via recombinant nanoparticle technology. FDB’s site in Morrisville, North Carolina has begun production of the first batch for a Phase III trial due to begin later this year.

Matrix-M was developed in-house at Novaxax and AGC will deliver large-scale production for trials. This is all part of the $1.6 billion award made to Novavax under the federal government’s Operation Warp Speed programme to develop millions of doses of vaccine.

Earlier, Novasep signed a partnership with AstraZeneca to produce the active substance for Oxford University’s COVID-19 vaccine from dedicate specific production areas at its site at Seneffe, Belgium. The project is also supported by the Inclusive Alliance for Vaccines, comprising France, Germany, Italy and the Netherlands.

AMRI has been named as the second US API supplier for ViralClear Pharmaceuticals, which is investigating the potential of merimepodib to fight SARS-CoV-2 either as a stand-alone treatment or in combination with other antiviral agents or immune modulators. Merimepodib was previously developed for chronic hepatitis C and psoriasis by Vertex.

In May, Lonza signed a ten-year strategic collaboration agreement with messenger RNA therapeutics and vaccines firm Moderna, under which they it will carry out large-scale manufacture of Moderna’s mRNA vaccine for SARS-CoV-2, mRNA-1273. Production has begun in the US and they aim to manufacture up to 1 billion doses in time.

The project is partly funded by Moderna’s contract with Biomedical Advanced R&D Authority (BARDA). This is part of the Office of the Assistant Secretary for Preparedness & Response within the Department of Health and Human Services, which was announced on 16 April. Moderna submitted an IND application for Phase II and later stage studies 11 days later.

Separately, CordenPharma has expanded an ongoing strategic manufacturing services agreement with Moderna to include the supply of lipid excipients for mRNA-1273. These will be produced at the company’s site in Switzerland for the Phase II trial.

In Japan, Kaneka has agreed to supply API for the anti-influenza drug, Avigan Tablet (favipiravir) to Fujifilm. This is expected to be effective against COVID-19 and the Japanese government is increasing its stockpiles in order to supply it to up to 2 million people. Fujifilm is therefore ramping up tablet production.

Finally in April, Alcami formed a partnership to supply API for clinical trials of Eagle Pharmaceuticals’ Ryanodex (dantrolene sodium) for injectable suspension, which inhibited the growth of the virus in in vitro tests. Eagle has applied to the FDA for an IND for a Phase II clinical trial and has requested an expedited review. The drug is already approved for the treatment of malignant hyperthermia.