Watson Pharmaceuticals Inc.
(
WPI
) along with partner
Columbia Laboratories Inc.
(
CBRX
) recently announced that the US Food and Drug Administration (FDA)
has issued a complete response letter (
CRL
) to the companies' new drug application (NDA) for progesterone
vaginal gel 8%. The gel was under review for use in the reduction
of risk of preterm birth in women with a singleton gestation and a
short uterine cervical length in the mid-trimester of
pregnancy.
In the letter, the regulatory body has stated that the candidate
did not meet the level of statistical significance required from a
single trial to gain US approval. The FDA also had concerns about
the robustness in efficacy in the US sub-cohort as compared to the
overall efficacy of the trial. The regulatory body also stated that
an additional clinical trial will be required to get the gel
approved.
Watson Pharma and Columbia Labs had filed for the US approval of
the gel in June 2011.
We note that the news of the CRL did not come as a surprise
since in January the FDA's advisory committee had recommended
against the approval of the candidate. The committee had said that
the gel is safe but added that it needed more information in order
to recommend the candidate for approval.
Earlier, in February, Columbia Labs had transferred the NDA for
the gel to Watson Pharma. The transfer did not involve any
additional payment and following the transfer Watson Pharma gained
full rights and regulatory responsibilities for all activities
relating to the application.
According to the original agreement entered into by the
companies last year, Watson Pharma had acquired the US rights to
progesterone vaginal gel 8% and Crinone from Columbia Labs. Crinone
is available for the treatment of infertility in women. According
to the agreement, Columbia Labs receives royalties on net sales
made by Watson Pharma. Outside the US, Crinone is marketed by
Merck KGaA
(
MKGAF
).
COLUMBIA LABS (
CBRX
): Free Stock Analysis Report
WATSON PHARMA (
WPI
): Free Stock Analysis Report
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