Will the third licensee of a buccal tablet for mouth fungus succeed where others have failed?

Orally dissolving buccal Oravig--Courtesy of CVS

Dara BioSciences ($DARA) is the new marketer of the only orally dissolving buccal tablet approved for oral thrush, which occurs when the Candida albicans fungus grows in the lining of the mouth.

The medication, dubbed Oravig, has proven to be a hot potato. It was first approved under the helm of Strativa Pharmaceuticals in 2010. But the company reorganized and sent the drug back to its original developer, BioPharma Alliance, in 2011. BioPharma then licensed Oravig to Vestiq Pharmaceuticals for $44 million. That company went bankrupt and did not meet the med's sales expectations.

Now Dara will try to avoid the strikeout by becoming the third company to try to sell Oravig. Adding to the confusion, the outlicenser is now French pharma company Onxeo due to industry M&A activity.

The maze of tangled and so-far-unsuccessful alliances demonstrates the true nature of pharma partnerships, but Dara's willingness to try where others have failed shows the allure of novel drug delivery assets.

Other forms of therapy for oral thrush, like topical agents, aren't very effective, explained Dr. Rajesh Lalla of the University of Connecticut Health Center. "Topical localized therapies for oropharyngeal candidiasis (the fungus) are available," he said in Dara's statement. "Unfortunately these therapies are not optimal due to the need for dosing several times a day, short contact time of the active agent with the oral mucosa, sugar content which can promote yeast growth, unpleasant taste, and difficulty of use in patients with a dry mouth or oral ulceration."

David Drutz, DARA's chief medical officer, told Xconomy that Oravig solves many of those problems: "This delivers the drug only where it is needed." The medicine contains a reformulated version of the common antifungal agent miconozole designed to dissolve in the upper lip over 6 to 8 hours.

Onxeo specializes in orphan drugs to treat cancer, while Oravig adds to Dara's portfolio of medicines for mouth conditions. Dara did not make any upfront payments and owes Onxeo only milestone payments.

Dara says 3 million prescriptions are written per year for oral thrush in the U.S. The company hopes to expand the indication for Oravig by conducting a pediatric study.

- read the release
- here's Xconomy's take