CDMOs partnering in Covid-19 initiatives
Several of the world’s major pharmaceutical CDMOS have recently made announcements relating to their participation in projects to develop treatment for the Covid-19 virus. Many involve chloroquines, in anticipation of their large-scale use.
Swedish-based Recipharm said that it has now secured supply of chloroquine phosphate, the API for its drug Klorokinfosfat RPH Pharma, and has commenced manufacture of the product. It has also begun the development of a new product with hydroxychloroquine sulfate (HCQ) as the API This followed reports that chloroquine phosphate may be part of the therapy for COVID-19 patients.
Although chloroquine and HCQ are not yet indicated for Covid-19, the company said, many clinical studies involving them are in progress and it has therefore “put substantial focus on having stock available in the event that demand increases upon positive clinical data and new guidelines”.
Meanwhile in the UK, Sterling Pharma Solutions has also begun producing HCQ and will manufacture the API for a finished product being manufactured and supplied by Accord Healthcare. This will re-establish UK production in the event of successful trials. Sterling has already bought over 50 tonnes of the key raw materials, equating to roughly 60 million finished tablets of HCQ.
Accord expects to supply about 50 million tablets/month from its facility in Barnstable. “It is vital to proactively establish a strong supply route ahead of time,” said Sterling CEO Kevin Cook.
Similarly in the US, AMRI is increasing HCQ production at its site in Rensselaer, New York state, in anticipation of increasing demand. The company said that its Type II DMF for HCQ is available to support increased need and noted that the FDA has authorised emergency use of HCQ to treat some hospitalized patients with Covid-19.
Earlier, in Japan, Kaneka 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 the US 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.