FDA Overrides Committee And Approves Serono's Zorbtive

15 December 2003 00:00  [Source: ICB Americas]

Earlier this month, the US Food and Drug Administration (FDA) approved Zorbtive (somatropin (rDNA origin) for injection), a new treatment for short bowel syndrome (SBS) by Geneva, Switzerland-based Serono SA, one of Europe's biggest biotechnology companies. The approval comes as a surprise because it meant overriding the June decision of the FDA's advisory committee, which voted against approving the drug for this indication.

Already sold under the trade name Serostim in the US, Serono's product is the only growth hormone approved by the FDA for the treatment of AIDS wasting, or cachexia. Serostim is marketed in 12 countries, including the US, for this indication.

Some analysts report that the additional SBS indication under the Zorbtive name is a strategic move on Serono's part to revitalize a flagging franchise, but that market potential remains limited with an estimated 10,000 to 20,000 SBS patients in the US.

"Sales of the product were disappointing in 2002 due to issues of alleged fraud at the pharmacy level," says Michael King, an analyst with WestLB AG. Sales for Serostim in the AIDS wasting indication dropped to $95 million in 2002 from $125 million in 2001. Sales have continued to fall this year to $65.9 million for the first nine months ending September 30.

The FDA's recent approval of the drug in the SBS indication is a positive surprise for Serono, as some analysts had projected an early 2005 approval following the negative review by the FDA advisory committee. However, analysts caution that the new indication may not necessarily rejuvenate the company's matured growth hormone franchise.

"Although the approval in the indication SBS is a potential upside for our sales forecast, it will have no major impact on our top and bottom lines, as we currently forecast that Serostim sales would only represent 4.5 percent of estimated 2003 sales," says Daniel Wendorff, another analyst with WestLB. Even though no classical competitors to Zorbtive currently exist in the market, the standard treatment for SBS is and will most likely remain parenteral nutrition, he notes. "The biggest problem patients are suffering from is the lack of a large enough reabsorptive surface in the bowel to get sufficient amounts of nutrients in the body."

Other medical treatments for SBS address either symptoms, like secretory diarrhea or abnormal bacterial growth, or improvement in nutritional reabsorption. In a Phase III clinical study, Zorbtive was shown to significantly reduce patient dependence on total parenteral nutrition when administered with specialized nutritional support, reports Serono.

The FDA advisory committee had voted against approval of the drug based partly on the fact that the majority of the patients in the study were from one treatment center and that the positive results might not be replicable in a wider patient population. The committee also cited concerns over the 18-week trial period, which it claimed was too short to fully evaluate the drug.

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