Columbia Laboratories Enters Collaborative Agreement With the National Institutes of Health (NIH)
Columbia Laboratories, Inc. (Nasdaq: CBRX) has signed an agreement with the Perinatology Research Branch (PRB) of the Eunice Kennedy Shriver National Institutes of Child Health and Human Development (NICHD) for collaboration in Columbia Laboratories’ ongoing PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) Study of PROCHIEVE(R) 8% (progesterone gel) to reduce the risk of preterm birth in women with a short cervix at mid-pregnancy. The PRB is headed by Roberto Romero, MD.
“The NICHD recognizes the importance of partnerships in the clinical development of products for the prevention of preterm birth and collaborates with pharmaceutical companies when trials have scientific merit and are consistent with the overall goals of the NICHD,” stated Dr. Romero. “Because the PRB was planning its own trial to evaluate vaginal progesterone in short cervix patients, joining forces in a single trial creates enormous efficiencies. Combining the two trials increases the statistical power of the PREGNANT Study and completes the overall program sooner than conducting two independent trials. This collaboration demonstrates the commitment of the NICHD to the research goals set by the Surgeon General to reduce prematurity in the United States.”
The protocol for the PREGNANT Study will be amended to reflect the addition of nine NICHD sponsored sites and an increase in the number of patients from 300 to 450. All clinical data, whether generated by NICHD sites or Columbia sites, will be collected centrally and, assuming success in the study, the results will be available to Columbia for regulatory filings.
Robert S. Mills, Columbia Laboratories’ president and chief executive officer, commented, “We are extremely pleased that the NICHD and Dr. Romero will participate in this important clinical study. While our PREGNANT study is well powered with 300 patients, by increasing the size of the cohort to 450 patients, the power of this study to show improvements in both the obstetrical endpoints and infant outcomes becomes even stronger.”
The PREGNANT Study is a randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the effect of PROCHIEVE 8% on reducing the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. The primary endpoint of the study is a reduction in the incidence of preterm birth at less than or equal to 32 weeks gestation vs. placebo.
Eighteen Columbia sites have received Institutional Review Board (IRB) approvals, and patient enrollment is underway; the NICHD sites are expected to begin enrolling patients by year-end 2008. Columbia believes that, if the study is successful, the participation of the NICHD will have a positive impact on physicians’ adoption of
PROCHIEVE 8% to reduce the risk of preterm birth in women with a short cervix at mid-pregnancy as measured by transvaginal ultrasound, which will lead to improved patient care and a more rapid reduction in the incidence of preterm birth.
About Short Cervix
Women who have a cervical length of 3.0 centimeters or less when measured by transvaginal ultrasound at mid-pregnancy are at increased risk for preterm birth. It is estimated that 10% and 30% of pregnant women have a cervical length of less than 2.5 and 3.0 centimeters, respectively, when measured at mid-pregnancy.
About PROCHIEVE 8%
PROCHIEVE(R) 8% (progesterone gel) is FDA-approved for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency and for the treatment of secondary amenorrhea. Many clinical studies demonstrating a strong efficacy profile in ART have been published. PROCHIEVE 8% is safe for use during pregnancy, and has been safely used by tens of thousands of women globally to help sustain pregnancy at the early stages for eleven years.
The most common side effects of PROCHIEVE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. PROCHIEVE 8% is contraindicated in patients with active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs. For more information, please visit www.prochieve8.com.
About the Perinatology Research Branch of the National Institutes of Health
The mission of the Perinatology Research Branch (PRB) of the National Institutes of Health, as a part of the Intramural Division of the Eunice Kennedy Shriver National Institutes of Child Health and Human Development, is to conduct clinical and laboratory research in maternal, fetal and neonatal diseases responsible for perinatal morbidity and mortality. The PRB emphasizes a multi-disciplinary approach to improve the etiologic understanding, diagnosis, treatment and prevention of disorders related to infant mortality.
About Columbia Laboratories
Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the women’s healthcare and endocrinology markets that use its novel bioadhesive drug delivery technology. Columbia markets CRINONE(R) 8% (progesterone gel) and PROCHIEVE(R) 8% (progesterone gel) in the United States for progesterone supplementation as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency. The Company also markets STRIANT(R) (testosterone buccal system) to treat hypogonadism in men. The Company’s partners market CRINONE 8%, STRIANT and three other products to additional U.S. and foreign markets. The Company’s research and development programs include the PREGNANT Study and a vaginal lidocaine product to prevent and treat dysmenorrhea (a condition marked by painful menstruation). For more information, please visit www.columbialabs.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements about Columbia Laboratories, Inc.’s expectations regarding the Company’s strategic direction, prospects and future results, and clinical research programs, which statements are indicated by the words “will,”"plan,”"expect,”"estimate,”"should” and similar expressions. Such forward-looking statements involve certain risks and uncertainties; actual results may differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of CRINONE(R) 8% (progesterone gel), PROCHIEVE(R) 8% (progesterone gel) and STRIANT(R) (testosterone buccal system) in the U.S.; the timely and successful development of new products, including vaginal lidocaine to prevent and treat dysmenorrhea, and new indications for current products, including PROCHIEVE(R) 8% to reduce the risk of preterm birth in women with a short cervix in mid-pregnancy; the timely and successful completion of clinical studies, including the ongoing Phase III PREGNANT Study of PROCHIEVE 8% in short cervix patients; success in obtaining acceptance and approval of new products and new indications for current products by the FDA and international regulatory agencies; the impact of competitive products and pricing; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia’s reports filed with the Securities and Exchange Commission. Columbia Laboratories undertakes no obligation to publicly update any forward-looking statements.
PROCHIEVE(R), CRINONE(R) and STRIANT(R) are registered trademarks of Columbia Laboratories, Inc.