Ducere Pharma to Relaunch Ex-Novartis AG Cruex Antifungal

Ducere Pharma to Relaunch Ex-Novartis Cruex Antifungal
March 31, 2015
By Mark Terry, BioSpace.com Breaking News Staff

In May 2013, Novartis AG dumped the rights to six of its over-the-counter (OTC) drugs, five of which were manufactured at a plant in Nebraska with reoccurring cGMP violations. All of the drugs were bought by Hope, Penn.-based Ducere Pharma, which announced yesterday it is relaunching one of the drugs, Cruex, for the treatment of toenail fungus.

Of the drugs, Cruex was the one not manufactured at the facility in Nebraska. The products Novartis sold were Comtrex cold reliever, Doan’s pain pills, Myflex anti-pain cream, Nupercainal hemorrhoid cream, and Cruex. The primary concerns with the Nebraska facility were filed under Form FDA 483, which is a little less formal and lists “observations made by the FDA representative(s) during the inspection” of the facility. They are not final agency determinations.

The sell-off was an early swing of the ax to Basel, Switzerland-based Novartis AG’s major ongoing restructuring. In addition to layoffs in the U.S. and Puerto Rico, Novartis sold off its Novartis Animal Health division to Indianapolis-based Eli Lilly and Company for about $5.4 billion.

Novartis also signed a deal with U.K.-based GlaxoSmithKline to create a new consumer health business. Novartis bought GSK’s oncology products lines for $14.5 billion. GSK bought Novartis’s vaccines business for $7.1 billion, except the influenza component of the vaccines division.

Ducere’s goal is to breath new life into established brands abandoned by their previous owners. “One of the things we do when we acquire these brands is figure out if we can use it in some other way,” said Chris Dominello, Ducere’s chief executive officer in a statement. “When Cruex was with Novartis, its sales had declined. We wanted to see if we could bring it back into a category where it could have a bigger impact.”

As a result, it is reformulating Cruex using a new active ingredient called Bonicel, a probiotic, and marketing Cruex as a toenail fungus treatment gel. The product launch is expected to start in April at Walmart stores.

The toenail fungus market is worth about $80 million annually. “We think we found a category where we can make a name for our product,” said Dominello in a statement. “The category doesn’t have a well-known name product.”

At the moment, one of the big competitors with a prescription treatment is Jublia, marketed by Canadian firm Valeant Pharmaceuticals International, Inc. . Valeant recently acquired Seattle-based Dendreon Corporation for about $400 million. As part of that deal, Valeant acquired the rights to Dendreon’s Provenge (sipuleucel-T), a treatment for advanced prostate cancer.

Back to news