BioAlliance Gets Swiss Regulatory Okay for Oral Candidasis Drug
This clearance follows FDA’s recent acceptance of Loramyc NDA submission.!--h2>
BioAlliance Pharma’s share price opened today 8.5% up on the announcement that the Swiss regulatory authorities had sanctioned Loramyc®, its mucoadhesive buccal tablet for the treatment of oropharyngeal candidiasis in immunocompromised patients.
Swiss approval comes less than a week after FDA confirmed its acceptance of the NDA submission for the drug. If sanction in the U.S., Loramyc will be marketed in the country by Strativa Pharmaceuticals.
Loramyc was first given the go-ahead in France in 2007, and roll-out in additional European countries continues. The drug made sales of €1 million, or roughly $1.43 million, in 2008. In February 2009 BioAlliance terminated its licensing agreement with SpeBio (a joint venture with SpePharm), originally signed in 2007, covering the distribution of Loramyc in EU countries excluding France. BioAlliance also initiated legal proceedings against SpeBio, citing the latter’s violation of its contractual obligations.