Gilead antiviral API supplier expanding plant after US FDA OKs Descovy
The expansion of the Freeport facility began on March 31. The project will cost $120m, take two years and increase active pharmaceutical ingredient (API) manufacturing capacity and capability according to an announcement on the Bahamas Government website.
Pharmachem has made tenofovir disoproxil - the active pharmaceutical ingredient (API) in Viread and one of the active pharmaceutical ingredients in Atripla and Truvada – for Gilead for more than a decade.
A Gilead spokesman told us: "The new API facility is for the exclusive production of Gilead product.The facility will be built next to the existing manufacturing plant on Grand Bahama, with the additional capacity and operational capability enabling the manufacturing of more structurally complex APIs."
The new facility – which is expected to be operational in 2019 – will supply APIs for Gilead’s new HIV treatment Descovy, which was approved by the US Food and Drug Administration (FDA) on Monday.
The drug combines emtricitabine and a new tenofovir prodrug - tenofovir alafenamide – which has demonstrated equivalent antiviral efficacy to Viread at a tenth of the dosage.
Facility history
The Freeport facility was set up by Mexican drug firm Laboratorios Syntex SA in the 1960s to make the API for Naproxen, a non-steroidal anti-inflammatory drug (NSAID). In 1994, Roche bought the facility along with Syntex.
Two years later the plant was acquired by Pietro Stefanutti, then president of Italian API firm Pharmaceutical Fine Chemicals. In 1998 it was sold to manufacturing conglomerate Allied Signal, however, it was later mothballed when that firm merged with Honeywell.
Stefanutti reacquired the Freeport facility in 2003 in partnership with the Bahamian Port Authority, bringing with him a supply contract from Gilead.
Under Pharmachem, the facility has supplied Gilead with tenofovir disoproxil since 2004, including during the seven year period the firm was owned by France-based contract manufacturing organisation (CMO) Novasep.
