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

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.

Whether Chemo Group will be successful depends on politics. Just to
obtain the necessary U.S. licenses will likely take months, let alone
what will probably be years of clinical testing. The first hurdle Chemo
Group and its lobbyists and lawyers must clear is gaining a license from
the Office of Foreign Assets Control (OFAC). Second, the Cuban drug must
receive approval from the U.S. Food and Drug Administration (FDA) for
clinical testing.

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."

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 clinical trials 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.

If Chemo Group obtained OFAC and FDA approval, 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 an agreement over a meningitis drug.
In 1999, the State Department recommended approval of a deal between
SmithKline Beecham Plc and Cuba's Finaly 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.

Source: "Company seeks approval to bring Cuban drug to U.S. « Cuba
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