The German manufacturer has received US Food and Drug Administration (FDA) approval to make the enzyme Retavase at its facility in Halle/Saale about 20km northwest of Leipzig on behalf of Italian drugmaker Chiesi which owns the rights to the product in a number of markets.
According to Ilona Koebsch, business development manager at Wacker Biotech, the approval came after the firm successfully transferred the production process for reteplase, previously manufactured by its original marketing holder Roche, to the facility.
At the Halle/Saale plant “we manufacture the drug substance based on E.coli fermentation in our 1,500-liter fermentation line using stainless steel bioreactors. After fermentation, we perform the refolding of the inclusion bodies followed by purification to obtain the active ingredient,” she told Biopharma-Reporter.
While she added Wacker will produce the drug substance for Chiesi’s market supply, the total amounts depend on market demand and so actual volumes were not given. However, Koebsch said the production site in Halle is “big enough to cover the project, so we are using our existing capabilities to manufacture reteplase.”
Developed by Roche, Retavase was first approved to treat acute myocardial infarction in 1996.
The enzyme reteplase, a tissue plasminogen activator with twelve disulfide bridges that is folded in a complex manner, causes blood clots to dissolve when administered to patients with the condition.
In 1998, the Swiss drugmaker sold the US rights to Retavase to Centocor for $335m, which in 2005 sold the product to ESP Pharma later acquired by PDL Biopharma. In 2008 the drug was sold to EKR Therapeutics which became part of Cornerstone Therapeutics four years later.
The product was taken off the market due to Cornerstone Therapeutics seeking FDA approval of a new supplier of the active pharmaceutical ingredient.
Chiesi acquired the rights to Retavase in 2014 through its acquisition of Cornerstone, and has since been working with Wacker to put the product back on the market.
The FDA’s approval of Wacker’s manufacturing site “represents a significant milestone in Chiesi’s work to bring Retavase back to the US market,” said Alan Roberts, SVP of Scientific Affairs for Chiesi USA.