Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.BioAlliance Pharma has successfully completed patient enrolment in the pivotal Phase III clinical trial performed with a view to registering Loramyc in the US, for the treatment of oropharyngeal candidiasis.
Subscribe to our email newsletter
With 540 patients enrolled by 40 specialist clinical centers in the US, Canada and South Africa, the company has achieved its target ahead of schedule. The trial results are expected in the first half of 2008. The company plans to file a market authorization application in the second half of next year, subject to the FDA’s regulatory requirements.
Costantini, president and CEO of BioAlliance Pharma, said: “Our development team has proved its effectiveness in successfully completing the enrolment process. This milestone is a significant one in our alliance with Par Pharmaceutical, which will commercialize our product in the US.”