Columbia Labs, Watson submit NDA for Prochieve
LIVINGSTON and PARSIPPANY, N.J. — A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.
Columbia Labs and Watson Pharmaceuticals announced the submission of a new drug application for Prochieve (progesterone gel), which seeks to reduce the risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. The NDA submission included data from two phase-3 clinical trials evaluating the use of Prochieve in reducing the risk of preterm birth in women, as well as supportive pharmacokinetic studies.
Columbia Labs said that it has requested priority review from the FDA, which would shorten the review process to six months, versus 10 months for standard review.
"Premature cervical shortening is a powerful predictor of risk for preterm delivery. At present, there are no widely accepted interventions to address this medical need," said Frank Condella, Columbia Labs president and CEO. "The recently published ‘PREGNANT’ study has demonstrated that the use of Prochieve can significantly reduce the incidence of early preterm birth in women with a short cervix at mid-pregnancy, and the study also provided evidence of improvement in infant outcome."
Watson acquired the rights of progesterone products from Columbia Labs last year.
Crossmark, MPG form MPG Drug
NEW YORK — Crossmark and Market Performance Group are looking to optimize their role in the drug industry through a new venture.
The companies announced that they have merged their respective chain drug sales businesses to form MPG Drug, which will be a division of Crossmark. With this merger, MPG Drug now will be the largest provider of headquarter sales and retail services in the U.S. drug industry, the companies said, by providing growth solutions in a timely manner.
"The integration of our capabilities, expertise and strong relationships in this channel allows us to become an industry-leading chain drug specialist," Crossmark’s COO Ben Fischer said. "This new division of Crossmark positively transforms the collective capabilities of both companies, enabling us to lead the way as the sales agency of preference in this channel."
Hospira reports Q1
LAKE FOREST, Ill. — Hospira had net sales of $1 billion during first quarter 2011, the generic drug maker said Tuesday.
Sales for the quarter, which ended March 31, declined by 0.5%, compared with first quarter 2010, while profits were $149.9 million, a 5.8% increase over last year.
“Hospira started out the year with a stronger-than-expected first quarter, aided by strong U.S. sales of docetaxel and gemcitabine, two major oncolytic pharmaceuticals,” executive chairman and former CEO Christopher Begley said, referring to generic versions of two chemotherapy drugs. “During the quarter, we gained momentum on several of our existing and newly launched specialty pharmaceuticals and made good progress in decreasing our level of backorders to better serve our customers. We remain focused on driving quality enhancements throughout the organization and on improving shareholder value through strong execution and sustainable growth.”
Begley also welcomed new CEO F. Michael Ball, who joined the company on March 28.