CorePharma Must Divest Generic Rights to Complete Impax Merger

CorePharma will divest generic rights to a dry mouth therapy and a liver drug to clear the way for Impax’s $700 million acquisition of the Middlesex, N.J., drugmaker.

Without the divestiture, the merger would likely squelch future generic competition of dry mouth therapy pilocarpine tablets and generic ursodiol tablets, which are prescribed for biliary cirrhosis, the FTC has charged. That, in turn, could push up prices.

To settle the complaint, CorePharma’s rights to the drugs will be shifted to Ireland-based Perrigo, according to an agreement reached by the companies and the FTC and released March 6. Impax and CorePharma must also provide transitional services and do whatever is needed to help Perrigo obtain FDA approval.

Impax is one of only four companies currently producing generic ursodiol tablets. CorePharma is currently developing its own version and is one of a small number of potential competitors that could enter the market in the near future, the FTC says. The two firms are also the only drugmakers likely to soon sell generic pilocarpine tablets in a market comprised of just two firms.

Impax and CorePharma both hold approved pilocarpine ANDAs, although neither currently markets the therapy, according to the FTC.  
Impax’s purchase of CorePharma parent Tower Holdings also comes with Amedra Pharmaceuticals and Lineage Therapeutics, expanding Impax’s brand and generics portfolios. The merger was announced in October and is expected to close soon.

The proposed agreement between the companies and the FTC is here: www.fdanews.com/03-09-15-Impax-CorePharmaConsentAgreement.pdf. For more information, go to www.fdanews.com/03-9-15-FTCComplaint.pdf. — Bryan Koenig