MonosolRx finds new licensee for oral film delivered ondansetron

MonosolRx has found a new US licensee for its oral film ondansetron product, Zuplenz, signing up Galena BioPharma nearly four years after previous partner Strativa handed the drug back.

The license – which will see Galena pay $5m upfront – gives the Portland, Oregon biopharma exclusive rights to sell Galena Zuplenz to US cancer patients looking to avoid nausea and vomiting after chemotherapy, radiotherapy or surgery.

Zuplenz is based on MonoSol Rx’s oral dosage film technology - PharmFilm - that is designed to dissolve rapidly when place on the tongue and deliver drug actives in a way that is better tolerated that ills or injections.

MonosolRx previously licensed the product to Strativa division. However, Strativa handed the drug back in 2011 after its parent company Par Pharmaceuticals decided to restructure its sales operations.

Sales royalties

In addition to the upfront fee, MonosolRx, which developed the licensed drug in collaboration with Swiss partner Applied Pharma Research (APR) said it is due to be paid “double digit” sales royalties by Galena

However, quite how much the delivery tech firm is likely to earn in Zuplenz royalties is point of debate.

Roth Capital analyst Joseph Pantginis raised his rating of Galena after the license was announced, suggesting the drug represents and opportunity.

We are currently projecting $20 million in peak sales for the drug for Galena and have made incremental changes to our model. The overall market for 5-HT3 inhibitors (such as Zuplenz) is $1bn in the US so we believe our $20m peak sales estimate represents low hanging fruit.”

TheStreet columnist Adam Feuerstein disagreed, citing the low revenues MonosolRx has seen from Zuplenz since it was launched in 2010 and the large number of ondansetron pill products on the market as the basis for his concerns.

He said Galena “stands little chance of delivering higher sales of Zuplenz than its previous marketer. The drug competes against a host of low-priced generic formulations of ondansetron, including an easily dissolving tablet.”