Kegler Brown Attorneys Lead the Way for U.S.-Cuba Pharmaceutical Agreements

Mercurio Biotec, LLC, an emerging American Biotech company closely allied with the Arizona Center for Accelerated Biomedical Innovation at the University of Arizona, has signed agreements with the Cuban company Heber Biotec S.A. The agreements encompass aspects necessary for (eventual) commercialization of the diabetic foot ulcer medication Heberprot-P in the United States, subject to approval by the Federal Drug Administration.

Kegler Brown attorneys Luis M. Alcalde and Steve Barsotti served as counsel to Mercurio throughout the negotiation process. Along with numerous meetings in Washington, D.C., with U.S. regulators and officials, Alcalde and Barsotti made a combined nine visits to Havana to help lead negotiations and conclude various agreements between Mercurio and Heber Biotec.

Kegler Brown is only the second U.S. law firm to have successfully completed signed agreements with Cuba to bring Cuban-origin pharmaceuticals to the U.S.

Kegler Brown has had a practice focused on Cuba for a number of years led by Cuban-American attorney Luis M. Alcalde. Steve Barsotti leads the firm’s practice focus on start-up and growth enterprise, and co-chair’s the firms IP and technology practice groups. Both Alcalde and Barsotti have substantial experience negotiating cross-border transactions as part of the firm’s Global Business practice group.

Heberprot-P must be approved by the Food and Drug Administration before being commercially available in the U.S.