Hospira, Stada and Bioceuticals sign biosimilar EPO deal

USA-based specialty pharmaceutical firm Hospira and German companies Stada Arzneimittel AG and Bioceuticals, say they have established a development, manufacturing and distribution agreement focusing on a biosimilar version of the hormone erythropoietin.

Under the terms of the deal, Hospira has exclusive rights to Bioceuticals' EPO product in the USA, Canada and European Union, with the exclusion of Germany where it is entitled to semi-exclusive rights. In return, Bioceuticals, which was originally established by Stada, will receive an upfront payment of $21.0 million and up to $34.0 million in milestones based on regulatory approvals and sales goals.

Currently, the drug is being reviewed by the European Medicines Agency (EMEA) under a biosimilar marketing application and, if approved, could be launched for use in the field of dialysis by the end of 2007. Hospira added, however, that the sale of the product in the USA is not expected for several years due to the later expiration of current patents. In addition, Bioceuticals is conducting trials of the agent in support of an oncology indication.