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Ranbaxy to gain royalty from Bayer for Cipro

Our Bureau

NEW DELHI, Dec. 16

EVEN as German pharma major Bayer AG receives the green signal from the US regulatory authority for its antibiotic Cipro XR (500 mg), home-grown drug company Ranbaxy has announced that it would receive royalty on sales of the drug.

Ranbaxy Laboratories Ltd (RLL) on Monday said the US Food and Drug Administration (FDA) had approved Bayer's antibiotic product Cipro{lcub}logicalnot{rcub}shy XR or Ciprofloxacin Extended-Release tablets. The new formulation is given once a day over three days and is prescribed for the treatment of uncomplicated urinary tract infections.

Bayer is expected to ship the product to the US, starting January 2003. Bayer had submitted an application to FDA in October 2002 to market Cipro XR tablets in 1,000 mg dosage strength for once-a-day therapy of complicated urinary tract infections, according to an RLL communiqué here.

Industry sources pointed out that Ranbaxy had inked a deal with Bayer in 1999 and as per this agreement, Bayer was to make milestone payments to Ranbaxy at different stages of development of Ranbaxy's Cipro OD (once-a-day) formulation. The initial amount agreed upon was $65 million though this was scaled down later, the source said.

Ranbaxy officials were not willing to put a figure to the royalty that was expected from Bayer on the sales of Cipro XR. However, RLL has already received up to $22 million by way of milestone payments on the development of the drug licensed out by it to Bayer.

Cipro XR releases the active ingredient from two layers — while the first releases ciprofloxacin into the blood within hours, it is followed up by a second extended release of the active ingredient to sustain the impact over 24 hours.

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