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Executive Summary

PROTROPIN II EXPORT: GENENTECH HAS BEEN "DULY DILIGENT" in pursuing U.S. approval of the recombinant human growth hormone product and therefore should not be prevented from exporting the product to Canada, Genentech maintained in Nov. 9 comments to FDA. Noting that the export amendments require a sponsor to be actively pursuing approval in the U.S. to allow export outside the country, Genentech said that it has "been duly diligent in pursuing approval [in the U.S.] for a number of indications." The firm's letter responds to Lilly's Oct. 5 comments to FDA objecting to Genentech's Aug. 26 request to export Protropin II (recombinant somatropin). Lilly argued that Genentech should not be allowed to export the recombinant product because the company is not actively pursuing approval. Lilly contends that its own seven-year orphan drug exclusivity from FDA for Humatrope inherently means that other sponsors of recombinant somatropin are not actively pursuing approval. Genentech responded that it is actively pursuing approval of Protropin II for a number of indications and that Lilly's exclusivity applies only to the growth hormone deficiency indication. "Lilly's comment misleadingly suggests that FDA is not free to approve the recombinant somatropin of another manufacturer for the treatment of any indication," Genentech said. "This overlooks the fact that Lilly only has a designation as an orphan drug and approval of its recombinant somatropin for treatment of a single indication: growth hormone deficiency." The company noted that it "is 'actively pursuing' the clinical investigation and approval of our recombinant human growth hormone . . . for a number of indications, including treatment of growth hormone deficiency, Turner's Syndrome and idiopathic short stature." Genentech also argued that exclusivity under the Orphan Drug Act should not affect export requests. "There is simply no evidence that Congress intended to extend the reach of the Orphan Drug Act beyond the boundaries of this country," Genentech maintained. "Just as the provisions for five years of exclusivity under Waxman-Hatch related to new chemical entities do not have a world-wide effect through the Export Amendments, neither should the exclusivity period under the Orphan Drug Act create such a global barrier to competition."

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