Fresenius Kabi withdraws petitions against Pfizer cancer patents

IPAB dismisses revocation applications by Fresenius Kabi against Pfizer's crizotinib and axitinib

Cancer drug major Fresenius Kabi Oncology Ltd, the Indian arm of Germany-based Fresenius Kabi, has withdrew revocation petitions against cancer drug patents owned by Pfizer and its subsidiaries as the former has "lost business interest" in the molecules.

The dispute was mainly on two products - Crizotinib, branded as Xalkori and Axitinib, named as Inlyta - for which Pfizer has patent rights under its arms Agouron Pharmaceuticals Inc and Sugen Inc. Both the companies has received favourable order from the Intellectual Property Appellate Board (IPAB) on their plea to withdraw from litigation.

Fresenius Kabi has informed its decision to withdraw four petitions against patent of Crizotinib and one against Axitinib, with the IPAB. The counsel representing Pfizer informed that the company has no objection for the withdrawal. IPAB Chairman Justice K N Basha and Technical Member (Patents) DPS Parmar took up each matter and dismissed the revocation applications, "as they are not pressed".

Fresenius Kabi also gave an undertaking with the Board that it will withdraw a post grant opposition pending with the Controller of Patents, Delhi, related to the matter. All the miscalleneous petitions were also cancelled, with this.

According to information available, while it has filed revocation petition against these drugs earlier, Fresenius Kabi has lost business interest on the drug later, leading to the withdrawal of the petition.

Xalkori is a kinase inhibitor used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and was caused by a defect in a gene, called anaplastic lymphoma kinase (ALK). It was launched in late 2011. Pfizer, in March this year, said that a Phase 3 study of the drug has met its primary objective of prolonging progression-free survival of ALK-positive advanced non-squamous NSCLC among previously untreated patients when compared to standard platinum-based chemotherapy regimens.

According to a Reuters report in March, this year, sales of the drug was at around $350 million a year, which according to Cowen and Co estimates would grow to $1 billion by 2020. MNCs Roche and Novartis also has products addressing the disease in the market.

Axitinib, sold by Pfizer under the brand Inlyta, is used to treat advanced kidney cancer (advanced renal cell carcinoma) when one prior drug treatment for this disease has not worked or has stopped working.

Ian Read, Chairman and CEO of Pfizer Inc, in an earnings call by the end of July, 2014, said that the company saw the continued uptake of Xalkori and Inlyta globally. The company officials said that Xalkori has seen revenues of $109 million for the second quarter of 2014, with an increase of 59 per cent over the previous year and Inlyta also has seen an uptake in key new regions with $101 million sales with an increase of 44 per cent operationally from last year.