Sun Pharma resolves US unit's regulatory concerns

It was a day of mixed announcements (on rulings in the United States) for Mumbai-based drug-maker Sun Pharma.

Even as the company said that it had resolved regulatory issues raised by the US Food and Drug Administration on its Cranbury plant — in a separate development, Sun lost a patent dispute on colon cancer drug Eloxatin, owned by French drug-maker Sanofi.

The US District Court for the District of New Jersey ruled against Sun Pharmaceuticals in favour of Sanofi with respect to a contractual dispute arising from the resolution of the Eloxatin (oxaliplatin) patent litigation, a Sanofi note said.

The District Court's latest ruling maintains Eloxatin's US market exclusivity through August 9, 2012 – keeping at bay the launch of generically similar versions of Eloxatin. A Sun Pharma spokesperson told Business Line that they would go through the judgement and look at the options available. Media reports peg Eloxatin sales at 248 million euros ($349 million) in the second quarter.

Earlier rulings

Sun had appealed the District Court's April 2010 ruling directing Sun to stop selling its generic version of oxaliplatin products as of June 30, 2010. Sun had launched “at risk” its generic versions of the drug in the US.

In December 2010, the US Court of Appeals for the Federal Circuit vacated the District Court's ruling and remanded the case to the District Court of New Jersey for further consideration, Sanofi said.

Cranbury clearance

Earlier on Monday, Sun Pharmaceutical said it had resolved regulatory issues regarding its Cranbury plant. The US FDA informed Sun Pharmaceutical Industries Inc, its wholly-owned subsidiary, that after a June 2011 re-inspection of its Cranbury (New Jersey) manufacturing facility, the site has an acceptable regulatory status, the company said.

“Therefore, the issues noted in the August 25, 2010 warning letter are considered to be resolved,” it added. The regulatory sword, however, continues to hang over the Detroit plant under Caraco, Sun's wholly-owned subsidiary. Caraco continues to work with consultants to resolve the issues raised by the US FDA at its Detroit plant, the company said.

The plant was under the regulatory scanner, as a US FDA inspection had identified violations of Good Manufacturing Practice regulations, the company had said, when the warning letter was issued. However, it had maintained its 2010-11 consolidated sales growth guidance, adding that SPI Inc had undertaken immediate corrective actions. Sun Pharma shares closed down almost three per cent on the BSE at Rs 474 on Monday.

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