The drug - Zagallo (dutasteride) – was approved as a treatment for androgenic alopecia by Japanese regulators on September 28 after demonstrating positive results in a clinical trial.
GSK originally planned to launch the product on November 24, however, according to a statement issued by its Tokyo-headquartered subsidiary – GlaxoSmithKline K.K. – this been delayed until an unspecified date.
Claire Brough, GSK’s head of global pharmaceutical communications, told us the delay was prompted by the suspension of manufacturing at a capsule facility in Beinheim, France by its contractor Catalent last month.
She said the Zagallo launch would be postponed until GSK can secure supplies, explaining that this will likely involve sites in its own manufacturing network – including its facility in Poznan, Poland – and those operated by external suppliers.
CMO suspension
Catalent suspended production in mid-November after discovering “out-of-place softgel capsules in several product batches that were detected during quality control procedures and removed prior to distribution to patients.”
A spokesman told us the CMO is still investigating the incident, explaining that: "The ANSM ordered the suspension of production at Beinheim on 13th November, following the discovery of out-of-place capsules by Catalent’s quality control systems at the site, and one report of a capsule detected by one of its customer’s QC systems. As of today, Catalent is not aware of any instance of an out-of-place capsule being placed on the market.
He added that: "The company’s investigations indicate that the out-of-place capsules are highly unlikely to have been misplaced through unintentional human error or from the failure of a control process, and that the incidents could potentially be related to a deliberate action by one or more individuals."
Catalent notified the appropriate law enforcement authorities at the time according to the spokesman, who told us the company is cooperating fully with their ongoing investigations.
He declined to comment when asked if the manufacturing halt had impacted any other pharmaceutical firms.
"Catalent cannot comment on the particular actions of any of its customers. The company is working diligently with its customers and with all relevant authorities in order to resolve the situation as quickly as possible."