Watson submits ANDA for generic cancer drug

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Watson submits ANDA for generic cancer drug

Genéricos/Novedades | Posted 18/01/2013 0 Post your comment

Watson Pharmaceuticals confirmed on 28 December 2012 that Actavis, which was acquired by Watson in October 2012, has filed an Abbreviated New Drug Application (ANDA) with FDA seeking approval to market generic bortezomib. Actavis’ ANDA product is a generic version of Millennium Pharmaceuticals’ (Millennium) cancer drug Velcade (bortezomib).

Millennium filed a patent infringement lawsuit against Actavis on 21 December 2012, in the US District Court of Delaware seeking to prevent Actavis from marketing its generic bortezomib product prior to the expiration of certain US patents. The lawsuit could prevent FDA approval of Actavis’ ANDA for up to 30 months from the date Millennium received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Velcade is a proteasome inhibitor for intravenous or subcutaneous administration. Proteasomes are enzymes found in cells, and play a role in regulating cell function and growth. Velcade blocks the activity of proteasomes, which can lead to the death of cancer cells. Velcade was approved by FDA in May 2003 and by EMA in April 2004 for the treatment of patients with multiple myeloma. It is also indicated in the US for patients with mantle cell lymphoma, an aggressive subtype of non-Hodgkin’s Lymphoma.

According to IMS Health data, US sales of Velcade for the 12 months ending 31 October 2012 were US$740 million.

The drug’s patent has been extended for composition of matter to May 2017 from October 2014, according to the US Patent and Trademark Office. Patents in the rest of the world will expire in 2015 with extensions obtained in several EU countries through 2019 and pending in other countries. Millennium is also studying Velcade in three late-stage trials in patients with different types of lymphoma, another blood cancer. If Velcade is approved to treat these additional cancers, the company may be able to further extend the life of the patent and further delay generics entry.

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Source: EMA, FDA, Watson