Greg Madison, the CEO of Keryx Biopharmaceuticals (NASDAQ:KERX), reported that as it is evident by press release, the company posted strong 2Q2016. Unfortunately, the great performance of field sales team will be disturbed due to a looming supply interruption.
Keryx stated that they are contemplating about the dialysis community and the patients taking Auryxia. These people will be impacted by unplanned supply interruption. The management understand the advantages that patients and healthcare providers can get from Auryxia. For the same reason, they are going to work meticulously to revoke this interruption as soon as possible. They anticipate having ample supply of Auryxia during the fourth quarter.
Madison stated that it is vital to note that this interruption is due to a production linked problem. It doesn’t impact the safety profile of presently available product. As they work through this disruption, the medical organizations and field sales will stay connected with the kidney dialysis community. This step will permit them to emerge from unexpected supply disruption in the best possible position.
Keryx CEO further added that for now they have a single source CMO, which turns API or active ingredients of Auryxia into tablets. This firm have been successfully manufacturing commercial batches for almost two years. Earlier in this year, the company started experiencing issues converting API to complete manufacturing process, which in turn led in variable yields.
The company had managed supply levels efficiently even in a scenario of increased demand in 2Q2016. Recently, the CMO informed that a production problem has reoccurred in latest production run and they have stopped production to know the cause. Due to halting production and increased demand, they have exhausted reserves of Auryxia. Currently, inventories held by direct customers and wholesalers will not be adequate for patients.
Keryx management intends to work with current CMO to resolve this problem and get back the normal supply as soon as possible.