The New Jersey drugmaker confirmed this week that BioLife – a subsidiary of Baxalta –will no longer be supplying it with the leukocyte blood cells needed to produce Alferon, explaining that the company “was departing that particular area of its business.”
The announcement follows just weeks after Hemispherx reported in an US Securities and Exchange Commission (SEC) filing that supply problems were likely to delay the relaunch of Alferon on the US market by six months.
“We had anticipated that it would take approximately until at least the 2nd half of 2015 before we would have Alferon approved for commercial sales; however, during the final stage of the manufacturing process we encountered issues regarding a change in both the contract supplier of leukocytes and regarding a reagent used in the formulation of Alferon.
Hemispherx added that: “We are currently resolving these issues and hope consequent delays will only extend our estimated time line by at least six months.”
Replacement suppliers include Gulf Coast Regional Blood Centre in Houston, which begin shipping blood cells to Hemispherx’ revamped facility last Friday.
Hemispherx CFO Thomas Equels said: “BioLife's decision to shut down its Penn Plasma business arm before meeting BioLife's contract obligations to Hemispherx put us at risk.
“We had to move quickly to ameliorate long term damages and redirect resources, seeking to avoid a prolonged delay in the production of Alferon.”
The news comes just months after Hemispherx completed upgrades at its manufacturing facility in New Brunswick, New Jersey.
It spent $8m (€7.1m) to replace six 100 litre reactors with a single 600 litre unit, which it said had allowed to cut the manpower needed to make Alferon by 80%.