Questcor gains API manufacturing transfer approval
Administration (FDA) has approved its application to transfer the
manufacturing process of the Active Pharmaceutical Ingredient (API)
in the company's adrenocorticotropic hormone (ACTH) preparation.
H.P. Acthar Gel is a natural source, highly purified preparation of the adrenal corticotropin hormone (ACTH). Unlike synthetic ACTH, Acthar is formulated to provide prolonged release after intramuscular or subcutaneous injection.
It works by stimulating the adrenal cortex to secrete the natural endogenous corticosteroids, including cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances.
BioVectra of Canada will now manufacture Acthar API. Additionally, the FDA approved the transfer of two bioassays required for testing and release of Acthar API and H.P. Acthar Gel finished vials to Product Safety Laboratories of New Jersey in the US.
"FDA approval of the Acthar API manufacturing transfer accomplishes a goal that was established when this product was acquired," said Dave Medeiros, vice president of manufacturing at Questcor.
"The success of this transfer is attributable to strong partnerships between Questcor, BioVectra and ZLB Behring, plus the cooperation and dedication of the BioVectra and ZLB Behring personnel involved with this project," he added.
Questcor's move fits in with the company's overall strategy, announced in April of this year. Questcor said that it would initially focus its sales and marketing resources on promoting H.P. Acthar Gel (repository corticotropin injection) to neurologists. H.P. Acthar Gel is currently the company's largest product in terms of sales.
Questcor acquired Acthar from Aventis Pharmaceuticals, (now ZLB Behring) in 2001, and began the transition of the manufacturing of Acthar API and of Acthar finished vials from Aventis to new contract manufacturers in early 2003.
In July 2003, Questcor transferred the Acthar final fill and packaging process to Chesapeake Biological Laboratories. The FDA approved this transfer in January 2004. The approval the Acthar API manufacturing process and the two bioassay transfers has left the Acthar potency bioassay waiting for a transfer to a new contract laboratory, approved by the FDA.
