CollaGenex Seeks UK Approval for Oracea
Posted on: Tuesday, 28 February 2006, 15:00 CST
CollaGenex Pharmaceuticals has filed a marketing authorization application with the UK's Medicines & Healthcare Products Regulatory Agency for its rosacea treatment candidate Oracea.
The marketing authorization application (MAA) was based primarily upon safety and efficacy results from two phase III clinical trials for Oracea. In the two studies, patients receiving Oracea experienced a 61% and 46% mean reduction in inflammatory lesions compared to 29% and 20%, respectively, in patients receiving placebo. The differences were clinically and statistically highly significant, and side effects of the drug were found to be similar to placebo.
"This is an important step towards maximizing the worldwide opportunity for Oracea," said Colin Stewart, president and CEO of CollaGenex. "If approved by the MHRA, we intend to seek registration for Oracea in other countries of the European Union."
A new drug application for Oracea has also been filed with the FDA, and this submission has been given a Prescription Drug User Fee Act (PDUFA) date of May 31, 2006. If approved, Oracea will be the first orally administered, systemically delivered drug developed to treat rosacea.
CollaGenex clearly needs to hear some good news about this drug as the company has posted significantly lower 2005 revenues.
Net revenues for Q4 2005 were just $3 million, compared to $13.2 million in the fourth quarter of 2004. This loss was driven by significantly reduced sales of Periostat following the introduction of generic competition in May 2005. Net loss for the quarter was $6.4 million, compared to net income of $3.4 million for the fourth quarter of 2004.
For the year ended December 31, 2005, meanwhile, net revenues were $26.4 million, compared to $52.1 million for the previous year. Net loss was $18.8 million for the year, compared to net income of $6.5 million for the year ended December 31, 2004.
Source: Datamonitor
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