Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Marketing strategy?

You have to believe JT and TR will put 100% effort into this. Right now I believe it's the belief that JT and TR, based on their experiences of working w Neulasta at Amgen, will be able to carve out a market for Rolontis. Based on the mishaps so far on their watch they know their jobs depend on a successful marketing strategy for Rolontis. It may not go on the label but the statistically significant DSN and Incidence of Severe Neutropenia (Slides 13 and 14 of the current Presentation) will surely be discussed on sales calls, perhaps calling it a 'biobetter'. I haven't followed how Lonquex (lipegfilgrastim) is working out for Teva in the EU but they were going to market it as a biobetter even though they only had a non-inferiority trial to support it. Here's an excerpt from an article on their strategy

Teva gets EU nod for Neulasta 'biobetter'
12th August 2013

by

PharmaTimes reporter

Teva has chalked up a milestone in its branded products business after winning EU approval for Lonquex, a white blood cell stimulator that will compete with Amgen's blockbuster Neulasta brand.

The Israeli drugmaker said the European Medicines Agency (EMA) approved Lonquex (lipegfilgrastim) to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients undergoing chemotherapy for cancer.

Lonquex will compete in the marketplace with Neulasta (pegfilgrastim) and like its rival is dosed as a single subcutaneous injection once per chemotherapy cycle.

Teva's drug is glycopegylated form of granulocyte colony stimulating factor (G-CSF), a cytokine that regulates the production and release of functional neutrophils from the bone marrow.

Glycopegylation differs from traditional pegylation in that it adds polymer chains to the active protein that are distant from the active site, which should in theory prevent variations in the activity of the drug molecule and increase its structural homogeneity.

Teva refers to Lonquex as a 'biobetter', although in trials Lonquex was shown only to be non-inferior to Neulasta, with no evidence as yet that it has any advantages over Amgen's drug.

http://www.pharmatimes.com/news/teva_gets_eu_nod_for_neulasta_biobetter_1005530