CubaNews / July 2004
By Larry Luxner
On the edge of Havana, out past the suburbs of Miramar along rural Calle 216, sits one of Cuba’s most advanced centers for biotechnology research: the Centro de Inmunología Molecular (CIM).
CIM, housed in a 15,000-sq-meter facility, em-ploys 420 people including biologists, chemical engineers, physicists, doctors and others. Its stated objective is to develop new products for the diagnosis and treatment of cancer and other diseases related to the immune system.
And that could help generate hundreds of millions of dollars for the cash-strapped island.
Normando Iznaga is head of business and development at CIMAB S.A., which licenses the rights of all products developed by CIM. He said CIMAB’s sales are “under $10 million,” but declined to elaborate further.
“We are not yet in the First World, but we’ve been very successful,” he told CubaNews in an exclusive interview in Havana. “Today we have more than 15 products originally developed by the biotech industry that are used in Cuba’s national health-care system.”
CIMAB — a quasi-state entity established in 1992 — is currently engaged in four joint-venture licensing agreements. The largest is with Toronto-based YM BioSciences Inc. A second venture, known as Recombio, involves pharmaceutical firms in Spain and Switzerland. The third is a Chinese venture with Beijing-based Biotech Pharmaceuticals, and the fourth is a J-V with Biocon India Ltd.
CIMAB also has a licensing contract with a German company, Oncoscience AG of Hamburg, as well as patent agreements with British firm Biovation and Canada’s Arius Research.
So far, CIMAB has already registered several products. These include an anti-CD3 monoclonal antibody for the treatment of patients with organ transplant rejection; human recombinant Erythropoietin for the treatment of anemia due to chronic renal failure; granulocyte colony stimulating factor for neutropenia treatment in cancer patients, and “humanized” anti-epidermal growth factor receptor monoclonal antibody for cancer treatment.
CIMAB also has other monoclonal antibodies for tumor imaging, chemotherapy drugs for neoplastic diseases and a range of products for the in vitro study of malignant tumors, AIDS and other immune system disorders.
Iznaga, 39, said Cuba has invested over $1 billion in its biotech sector, and $50 million specifically in CIM.
“Sometimes you have a lot of money but not enough ideas,” he said. “In Cuba, it’s the other way around. We don’t have money, but we have a lot of ideas.”
Iznaga insisted that “we do not infringe on patents. We follow the rules of the WTO and the World Office of Patent Protection.” He added that “all production here is done under the supervision of our quality control department. We follow production specifications, our national regulatory agency also follows specifications, and several of our clients also control that.”
In February 2003, CIMAB announced that it and Biocon India Ltd. had formed a new venture, Biocon Pharmaceuticals Ltd., that will manufacture a range of biotech products for the Indian market. The venture is 49% owned by CIMAB and 51% owned by Biocon, one of India’s largest health-care companies.
The facility, in which Biocon is investing around $27 million, is expected to begin commercial production of two monoclonal antibodies and three cancer vaccines in 2006, mainly for the treatment of head and neck cancer. The plant is being constructed in the Bommasandra suburb of Bangalore.
“Products from this joint venture will be marketed under the Biocon brand,” said Kiran Mazumder-Shaw, chairman and managing director of Biocon. “After marketing the products in India for two or three years, we will target the U.S. and European markets, provided we get all the necessary approvals.”
In one of the most potentially lucrative deals, San Diego-based CancerVax Corp. has asked the U.S. government for permission to acquire from CIMAB a license to produce three specific cancer vaccines that target the epidermal growth factor receptor.
These vaccines will be used to treat lung cancer and potentially other forms of cancer. CancerVax plans to license the first of the three, EGF, directly from CIMAB, and the other two jointly from CIMAB and YM, which holds the current rights to the vaccines.
Hazel Aker, corporate counsel at CancerVax, told CubaNews that “we submitted a license application seeking approval to enter into licensing agreements with CIMAB for specific active immunotherapeutic products.” She said the application was submitted to the U.S. Treasury Department’s Office of Foreign Assets Control (OFAC) last fall, and is still being reviewed.
“We will be conducting our own clinical research on these vaccines to test them and hopefully obtain regulatory approval,” said Aker. “We’re also hoping to get approval from OFAC, but there’s no guarantee we’ll get it.”
Treasury spokeswoman Molly Millerwise refused to say if or when OFAC might approve the CancerVax application, stating that OFAC does not comment on individual cases.
In 1998, another company, SmithKline Beecham, was awarded a similar license, and the following year signed a deal with Cuba’s Finlay Institute to license the rights to a meningitis-B vaccine.
“The only way to have negotiations with U.S. companies is through OFAC, and the only company that has succeeded in getting a license to talk about business in Cuba is CancerVax,” said Iznaga.
“Our problem is not with American companies, but with the U.S. government,” he said.
“We’re talking about cancer — a disease that doesn’t care about race, gender or political orientation. Anybody can suffer from cancer, and I wonder why the U.S. government would not allow Americans to benefit from a drug that could treat such a prevalent disease.”
Iznaga told CubaNews that if CancerVax wins OFAC approval, “this will tell the world that it’s possible to do business with Cuba — and that there are good biotech products in Cuba which can treat diseases that today don’t have cures. If there were no embargo, we could be a billion-dollar company.”
He noted that in Cuba, the most common cancers are lung, breast and colon cancers, which is why at CIMAB, “we focus only on cancer and auto-immune diseases.”
David Allan, chairman and CEO of YM Bio-Sciences, said the license for its monoclonal antibody — similar to ImClone’s Erbitux, which inhibits cancer cell growth by blocking the epidermal growth factor receptor — is held through a venture owned “more than two-thirds” by YM. He declined to give further specific financial details of the venture.
“Our business is the development of drugs discovered at universities, and one of our drugs comes from the University of Havana,” Allen told us. “To the degree that we have received regulatory approval from numerous health agencies worldwide to put the drug into humans, it’s been successful.”
Yet Allan suggested that perhaps too much has been made of Cuba’s biotech industry.
“Pick at random any U.S. biotech company of reasonable success. ImClone has a $6 billion market cap, and recently raised $500 million in half an hour. That’s probably more than has been invested in Cuban biosciences in the last 10 years. And ImClone is one of thousands of such companies.”
Allan said that “to us, I could care less that it’s Cuba. I only care that it’s good research.”