Tuesday, September 3, 2013

Competition for Amgen's Neulasta - Teva receives Market Authorization for Lonquex (lipegfilgrastim)

Lonquex is a medicine that contains the active substance lipegfilgrastim. Lipegfilgrastim is similar to filgrastim, which has been available in the European Union (EU) for a number of years. In Lonquex, the filgrastim has been ‘pegylated’ (attached to a chemical called polyethylene glycol). This decreases the rate at which filgrastim is removed from the body and allows the medicine to be given less often. It is used to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving cytotoxic chemotherapy.

This would be the second pegylated version of filgrastim in the EU market. Amgen sells pegylated filgrastim under the brand name Neulasta, and sells about $4billion globally ( about $900m Ex-US).

Teva already has a presence in the filgrastim space, as it is selling biosimilar version of filgrastim. There are six players inlcuding Teva which sells biosmilar filgrastim in the EU market. 
Lipegfilgrastim acts in the same way as naturally produced G‑CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and to prevent febrile neutropenia (a sign of infection) in patients undergoing chemotherapy.

Clinical data on Lonquex

In a main study in 202 breast cancer patients Lonquex compared well with another pegylated filgrastim: the average duration of severe neutropenia during chemotherapy was 0.7 days (around 17 hours) with Lonquex compared with 0.8 days (around 19 hours) with the other medicine. Lonquex also compared well with the other medicine in the number of febrile neutropenia cases: 1 in the Lonquex-treated group versus 3 in the comparator group.
In another main study in 376 patients with lung cancer, treatment with Lonquex was superior to placebo (a dummy treatment) in reducing the time it took to recover from neutropenia as well as the occurrence and duration of severe neutropenia.

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