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SERONO WILL CONTINUE HUMAN GROWTH HORMONE COLLECTION EFFORTS

Executive Summary

SERONO WILL CONTINUE HUMAN GROWTH HORMONE COLLECTION EFFORTS to facilitate a return to the market with the product. The firm stated in a May 9 press release announcing a halt to distribution of its product that it would "continue its carefully controlled pituitary collection efforts, further refine its purification technology, and undertake scientific studies related to Creutzfeldt-Jakob disease" in support of its commitment to "returning the natural product to the market." Serono halted distribution of its human growth hormone (hGH) in response to a request from FDA. The company explained it "reluctantly decided to interrupt distribution of its human growth hormone product, Asellacrin, in the U.S., despite the fact that there is no evidence of any problems with the Serono product anywhere in the world." With the market withdrawal of Serono's Asellacrin, human growth hormone is currently commercially unavailable in the U.S. KabiVitrum and the Natl. Institutes of Health (NIH) both halted distribution of hGH in April after NIH received reports of three men who died from Creutzfeldt-Jakob disease at five, 10, and 16 years after cessation of NIH's hGH therapy. FDA met with KabiVitrum and Serono on April 22, after which KabiVitrum said it would withdraw its hGH product. Serono said at that time that it would continue to market the drug. Serono maintained in its release that its hGH "is manufactured by purification procedures significantly improved over those used by the [NIH's Natl. Hormone and Pituitary Program] and the British government during the time [the patients who died] were treated in the 1970's, and also different from that used by KabiVitrum." Serono added that it "is confident that its current purification methods result in a product that is free from viral contamination and that the benefits of Asellacrin therapy far outweigh any risks." However, the firm said it had "no choice but to comply with the FDA's request by interrupting distribution. Versions of rDNA-derived human growth hormone are being developed by Serono, KabiVitrum and Genentech. The Genentech rDNA product is in the NDA pending stage, while Serono and KabiVitrum are still doing tests.

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