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Simcere Pharmaceutical Group (NYSE: SCR) reported it has received SFDA approval to manufacture and market Relenza (zanamivir), the flu treatment developed by GlaxoSmithKline (NYSE: GSK). Relenza, an inhaled neuraminidase inhibitor, is one of only two approved drugs for treating H1N1 flu. Simcere holds an exclusive license for Relenza in China.

Simcere declares itself a maker of branded generic drugs, though it also makes the innovative cancer treatment Endu, a recombinant human endostatin and the stroke treatment edaravone. One year ago, Simcere formed a mAb-based partnership with Epitomics of San Francisco to develop treatments for cancer. The company also branched into vaccines with a new partnership in a further attempt to broaden its business.

Revenues from Endu have been much lower recently because Simcere is carrying out a Phase IV test of the drug in patients with non-small cell lung cancer, its only approved indication. Simcere is distributing the product to these patients free of charge.

Simcere’s Q3 revenues came in below analysts’ expectations, and costs for carrying out its business (including R&D) rose significantly, resulting in lower earnings. In December, the company had to close down a production line in a newly acquired vaccine subsidiary after Simcere found quality problems in a human rabies vaccine.

Despite the problems, Simcere is currently priced at $9.39. Its 12-month range is $4.76 to $10.03. At this price, Simcere has a market capitalization of $528 million.

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Source: Simcere Wins OK for Flu Drug Relenza