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Glaxo Expands In China With $70 Million Buy, but US Delays Lupus Drug Approval

From Guardian Web (December 7, 2010)

GlaxoSmithKline is expanding its presence in China with the $70m cash purchase of a pharmaceutical business specialising in urology and allergy products.

It is buying Nanjing MeiRui Pharma, giving it access to the company’s product portfolio, sales and marketing team and a manufacturing facility. The deal is expected to be completed by the end of the year.

However overnight there was a slight setback for Glaxo when US regulators delayed approval of Benlysta, the experimental lupus treatment it is developing in partnership with Human Genome. If it gets the green light - and the delay from December 9 to next March is to give the Food and Drug Administration more time to study extra data - then it would be the first new lupus treatment in the US for 50 years. Panmure Gordon’s US biotech analyst Brian Skorney said:

The FDA decision to delay the Benlysta [approval] by 90-days is not surprising to us given agency’s request for additional information following the advisory committee meeting last month. We believe that the agency’s decision to extend the review time...indicates that any outstanding issues the FDA has with the filing are readily addressable. The majority of recent examples of...dates that were extended by 30 days have resulted in approval around the new, giving us confidence that Benlysta will receive commercial clearance in the U.S. at the end of the first quarter of 2011.

Glaxo’s shares are currently 8p higher at £12.45.

Posted: December 2010