FDA's Reproductive Health Drugs Committee evaluation of surrogate endpoints for preterm birth agents could create a favorable market environment for Columbia Laboratories' Prochieve 8% (progesterone gel).

During an assessment of Adeza's Gestiva (17-hydroxyprogesterone caproate) on Aug. 29, the panel concluded that a reduction of preterm birth at 32 weeks was the optimal surrogate for fetal and neonatal morbidity and mortality.

Columbia noted that its ongoing trial of Prochieve uses that timeframe as the primary endpoint.

The FDA panel voted for approval of Gestiva based on the totality of data, but was concerned that the primary endpoint in the pivotal study, preterm birth prior to 37 weeks, was not adequate (¹ Also see "Gestiva Passes Cmte. Review, But Further Study Of Miscarriage Risk Requested" - Pink Sheet, 28 August, 2006.).

The committee also urged further study of miscarriage risk with Gestiva. Columbia President Robert Mills told "The Pink Sheet" DAILY that the company has not seen any risk of miscarriage during the eight years the product has been on the market as part of an assisted reproductive technology regimen.

Columbia's Phase III trial for Prochieve is fully enrolled at 669 patients, and the firm expects to announce results in the first quarter of 2007. The company describes the study as the largest preterm birth prevention trial ever undertaken; Gestiva's pivotal trial enrolled 463 patients.

Columbia expects to submit an NDA for Prochieve for the prevention of recurrent preterm birth by mid-2007.

Although Gestiva would have a substantial head-start in the marketplace - the user fee date is Oct. 20 - Columbia expects to be able to differentiate Prochieve based on its safety track record as well as the fact that it is a natural progesterone and delivered vaginally as opposed to an injection.

-M. Nielsen Hobbs (n.hobbs@elsevier.com)

Columbia’s Prochieve Could Get Competitive Edge From Committee Review Of Rival Product

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