BioAlliance To Regain Full US Rights For Oravig
BioAlliance Pharma has decided to regain full US commercialisation rights for Oravig (a miconazole mucoadhesive tablet for the treatment of oropharyngeal candidiasis), as well as the NDA. After one year of marketing by American partner Vestiq Pharmaceutical, the sales performance of Oravig was not meeting expectations. BioAlliance is already in advanced discussions with potential partners for the acquisition or for a licensing agreement of the product.
BioAlliance also provided details on Loramyc (the tradename for Oravig outside of the US)'s development in Japan. In Japan, as usually required by Japanese authorities, a complementary development plan is driven by Sosei to complete the registration file. After a first successful Phase I trial, the pivotal Phase III trial, initiated in March 2013, should be completed by the end of 2014. Upon Loramyc registration, BioAlliance should receive a significant milestone payment from Sosei. Moreover, Sosei has implemented a commercialisation agreement with Fujifilm Pharma for the promotion and distribution of Loramyc in Japan once its marketing authorisation is obtained.
|Companies Involved||BioAlliance Pharma, Vestiq Pharmaceutical|
|Date Last Reported||24/09/2012|
|Estimated Total Value||US$44mn|
|Therapeutic Area||General Anti-infectives Systemic|
|Related Agreement||BioAlliance/Vestiq enter commercialisation agreement for Oravig in US|