Company seeks approval to bring Cuban drug to U.S.

CUBA STANDARD — A U.S. subsidiary of Chemo Group, a Vienna, Austria-based pharmaceutical company with roots in Spain, contracted a duo of former power players in Washington to pave the way for the sale of a Cuban diabetes drug in the United States.

Chemo Group, which does business in the United States from offices in New Jersey under the Everett Laboratories brand name, has contracted the lobbying services of former New Hampshire Gov. and Havana native John Sununu, and of Bill Delahunt, a former Congressman for Massachussets who built a long track record seeking normalization with Cuba while in the House of Representatives. Chemo Group also hired Michael Krinsky, principal of New York law firm RBSKL, and Frank J. Sasinowski, a drug approval expert in the Washington offices of Hyman, Phelps & McNamara.

Delahunt and Sununu have already made inroads in Congress. In their quest to obtain U.S. licenses for Heberprot-P, a diabetic-foot drug developed by the Havana-based Center for Biological and Genetic Engineering (CIGB) and marketed by Havana-based Heber Biotec, Delahunt and Sununu gained, among others, the support of Miami Rep. Joe Garcia, the Miami Herald first reported. With his endorsement, Garcia, a Democrat and former executive director of the anti-Castro Cuban American National Foundation, is breaking ranks with the remainder of South Florida’s Congressional delegation.

“There’s a desperate need for a drug like this,” Delahunt said in an interview with Cuba Standard.  “There’s nothing in the pipeline, and very little research in a diabetic-foot ulcer treatment. We have 70,000 amputations annually in the United States, at a cost of $40 billion.”

“This is a tragedy confronting many, many people; Congress should be made aware of these issues,” he said. “This is a disease that affects every constituency, particularly African Americans and Hispanics.”

Whether Chemo Group will be successful depends mostly on the politics surrounding the Treasury Department’s Office of Foreign Assets Control (OFAC). If everything goes smoothly, Heberprot-P may be on the U.S. market by 2016 or 2017. However, the politics surrounding the OFAC license to import the drug for clinical testing make it difficult not only to predict a time frame, but whether the U.S. government will allow testing of the Cuban drug at all. The OFAC license aside, the process could include three years of clinical testing, plus up to 12 months for the Food and Drug Administration (FDA) to grant final approval, said Bill Koustas, an attorney with Hyman, Phelps & McNamara.

Once the OFAC hurdle is cleared, Chemo Group will apply for an investigational new drug application (IND) with the FDA. Chemo may begin testing while the FDA weighs the application; however it’s likely it will be approved, according to Koustas. For the final approval, once testing is completed, the FDA may take up to 12 months.

Congress aside, to obtain OFAC approval support in the State Department and White House could be crucial as well, Delahunt said. He wouldn’t say whether he had met anyone from either institution.

“This is a decision made by an executive agency,” he said about OFAC. “They may or may not seek guidance from the State Department.”

As to the likelihood of Heberprot being approved by the FDA, Heberprot-P is undergoing clinical trials in China, Russia and Canada, as well as the European Union. The drug has been approved by Cuba, Ecuador, the Dominican Republic, Vietnam, the Philippines and Algeria. In 2011, Cuba signed an agreement with Brazil to sell Heberprot-P in Brazil as well as in third countries.

To be sure, this would not be the first time a Cuban drug is tested in the United States.

In 2004, now-defunct CancerVax Corp., a California-based drug research company, obtained an OFAC license to test and sell three Cuban-made lung cancer vaccines, in an agreement with Cuba’s CIMAB S.A. The agreement came after two years of complex negotiations between CancerVax and Cuba. At the time the State Department emphasized it recommended approval of the licenses “strictly for humanitarian reasons.” To be able to effect $6 million in licensing payments to Cuba over three years, CancerVax set up complex three-way deals that involved payment in the shape of soybeans through a U.S. agricultural commodities firm, as well as with U.S. medical companies to provide Cuba with medicine and medical goods. If the drugs had received approval from U.S. regulators, the company would have made additional payments of up to $35 million.

CancerVax eventually folded for reasons unrelated to the Cuban deal, returning the licenses to CIMAB and YM BioSciences, a Canadian company.

The CancerVax deal was preceded by a U.S. agreement over a Cuban meningitis drug. In 1999, the State Department recommended approval of a deal between SmithKline Beecham Plc and Cuba’s Finlay Institute to develop and market a local vaccine against meningitis B. Although the development and testing was done for the European market, SmithKline did most of the work in a Belgian lab that was owned by a U.S. subsidiary.

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