Leading the octreotide scale-up
A generics case study
Bachem develops a cost-effective, large-batch process for octreotide acetate synthesis
Octreotide acetate is a therapeutic octapeptide analog of the naturally occurring hormone somatostatin. First approved for use in the United States in 1988, this longer-acting synthetic peptide agonist is used for the reduction of growth hormone and insulin-like growth factor 1 primarily used in adults with acromegaly. 95% of acromegaly cases are caused by tumors of the pituitary gland where surgical resection is often not possible, requiring life-long use of growth hormone (GH)-lowering therapy.
Challenges with pharmacological treatments include persistence of symptoms and failure of biochemical control, as well as therapy regimens requiring daily injections. GH-lowing therapy is associated with reduced quality of life (QOL) and higher economic burdens for patients. New therapies such as oral formulations promise better disease control and quality of life for patients but require 30-60 times higher octreotide acetate concentrations, thus putting demand on complex API manufacturers such as Bachem to cost-effectively scale production.
Our client, a large pharmaceutical company who once manufactured octreotide in-house, decided in 2016 to partner with Bachem to take over large-scale API production. A win-win collaboration.
Read more about the collaboration in our generics case study.
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