Complex Sandostatin Manufacturing Holding Off Competition, Novartis

The complexity to manufacture the growth hormone inhibiting peptide Sandostatin will ensure protection from competition, says Novartis.

2017 sales of the acromegaly peptide Sandostatin (octreotide) were down slightly on the previous year, but still brought in US$1.6 billion (€1.3 billion) for Swiss biopharma Novartis.

During the firm’s recent first quarter financial call, board member Elizabeth Doherty told stakeholders that while the firm is always looking at potential risks from competition, “we know ourselves with our own experience how difficult it is to make and I think the quality of the manufacturing is going to be a deciding factor on anybody’s ability to get in.”

Manufacturing Difficulties

Sandostatin, first approved by the US Food and Drug Administration (FDA) for the reduction of growth hormone IGF-1 in acromegaly in 1998, is manufactured from Novartis’ production plant in Schaftenau, Austria.

Novartis oncology spokesperson Michael Meo told BioProcess Insider increased competition for Sandostatin LAR comes after significant investment by competitors in both commercial and clinical areas, in a disease area with limited numbers of diagnosed and treated patients.

However, as Doherty said, production complexities will keep competition at bay until at least 2019 and perhaps beyond.

“The long-acting formulation of Sandostatin is based on small microparticles made of a special polymer that contain the active ingredient (octreotide), which is steadily released in the bloodstream over a period of four weeks,”  Meo explained.

“The manufacture of the long-acting formulation is highly complex and requires strict adherence to specifications to ensure that the delivery of the medicine continues throughout the four weeks.”

He added there are multiple steps in the manufacture of Sandostatin critical for product quality. These include: “the synthesis and purification of the active ingredient to remove by-products, the microsphere formulation, the control of microsphere size, shape and drug dissolution, batch-to-batch consistency, and protective packaging to prevent degradation.”

For the first quarter 2018, Novartis reported net sales of $12.7 billion, up 10% on the same period last year due in part to the increased worldwide uptake of heart failure drug Entresto (sacubitril/valsartan) and psoriasis-treating monoclonal antibody Cosentyx (secukinumab).