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Senju gains Chinese rights to ophthalmic gatifloxacin

This article was originally published in Scrip

Kyorin Pharmaceutical has granted fellow Japanese company Senju the exclusive right to market an ophthalmic solution of gatifloxacin in China.

Senju already markets a 0.3% eye drop formulation of the broad spectrum fluoroquinolone antibacterial in Japan, where it was launched as Gatiflo in 2004 for a range of ocular infections. Allergan markets the product in the US as Zymar and also in other selected territories.

The financial terms of the deal were not disclosed, but Kyorin said it would receive an up-front payment plus royalties equal to a percentage of Senju's Chinese sales of the product. It will also supply bulk powder material to Senju, a specialist in prescription and over-the-counter eye care products.

Gatifloxacin has become virtually exclusively an ophthalmic product following the global withdrawals of oral and injection formulations over the past few years.

Licensee Bristol-Myers Squibb, which held rights in the US (marketed as Tequin) and other markets, halted sales in its territories for commercial reasons in 2006. The US FDA subsequently pointed to safety issues with the non-ophthalmic forms and said that it would not approve any generic versions of gatifloxacin.

Kyorin and local partner Dainippon Sumitomo Pharma voluntarily discontinued sales of a tablet formulation in Japan last year, following a suspected link with continued cases of hyper/hypoglycaemia. These came despite earlier warnings and a contraindication in diabetes patients (scripnews.com, October 1st, 2008).

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