I there will be an article very soon. I contacted to New Jersey papers by phone, the COURRIER and THE STAR LEDGER. I used to live in North Plainfield NJ but Now I'm in Tampa, FL.
I think Pandey request an interview himself, since XKEM is in New Jersey.
U.S. Company Pays Nigeria for Rights to Sickle Cell Anemia Drug
BY REBECCA GOLDSMITH c.2003 Newhouse News Service
The plastic pots hold humble ingredients collected in rural Nigeria. Three are cooking spices: cloves, piper guineensis seeds and a type of sorghum known as guinea corn. A fourth is a white powder made from the native Pterocarpus osun tree.
When blended and boiled, however, the plant products take on healing powers, according to Nigerian folk doctors who use them to alleviate the tormenting symptoms of sickle cell anemia.
One American pharmaceutical entrepreneur hopes the concoction aids his struggling company, too. Ramesh Pandey is trying to prove the treatment is a viable drug for use in the United States and the rest of the world.
Pandey, a native of India, had never heard of sickle cell anemia until he met a contingent of Nigerian researchers through a Rutgers University symposium in 2001. The blood disorder, which can bring an early death, primarily afflicts people of African descent, including 72,000 in the United States.
A rare agreement now binds the futures of Pandey's company, Xechem International Inc. of New Brunswick, N.J., and a Nigerian government agency, the National Institute of Pharmaceutical Research and Development. Xechem paid the institute for the right to bring the traditional remedy to the world market. The institute will collect royalties if the campaign succeeds.
Drug makers have long turned to plant sources and folk medicine in their search for modern therapies. But this may be the first time a developing country kept a stake in the future of its native formula, industry observers say.
Charles Wambebe, who led the Nigerian institute for 12 years during the drug's development, said he thinks this is the first such deal linking an African country and a foreign pharmaceutical firm.
"It's like a model for others to follow," Wambebe said from his home in the Republic of Congo, where he works for the World Health Organization's regional office for Africa.
Such agreements may become more common as regions formerly on the geographic fringe find links to the rest of the world through the Internet, international networks and other outgrowths of globalization, said Joseph E. Eid, co-director of the sickle cell program at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School.
"I think it's something that we will see more of, being that the world has become one big town," Eid said. "People are exchanging information at a higher speed, and everything is more accessible now."
The drug, called Nicosan, was developed over eight years starting in 1993 with $5 million in research grants from the U.N. Development Program and the Japanese government.
When it came time to manufacture the medicine, Nigeria turned to foreign investors after an unsuccessful search for a local company, Wambebe said.
"Unfortunately, in developing countries we do not recognize the importance of research," he said. "They see it as an investment that they cannot get a return on immediately."
Pandey says he urged the Nigerian scientists to stick to basics.
"Look into what you have," he told them. "You have biodiversity. It is like gold. Americans are getting crazy for herbal products. You are sitting on the pot of gold. First look at your strengths."
The message found a receptive audience. The next day, the delegation toured his laboratories on the third floor of a former Mack truck factory, Pandey said.
The drug is now in the earliest stages of the approval process. Doctors at four hospitals plan to conduct clinical trials.
Xechem applied to the U.S. Food and Drug Administration for "orphan" status, which is designed to speed up approvals for certain drugs. The company still must file an investigational new drug application, a precursor to beginning clinical studies, Pandey said.
Explaining why the Nigerians teamed up with him, he said: "I can get the FDA approval. They can't."
Investing in a new drug is a gamble Pandey has lost before. His company created a generic to compete with Bristol-Myers Squibb Co.'s blockbuster Taxol cancer drug. But Bristol-Myers Squibb won a patent extension in the United States, dashing Xechem's hopes.
Pandey estimates the sickle cell market is worth $500 million.
More than 2.5 million Nigerians suffer from the disease while another 30 million are genetic carriers. In the United States, about 1 in 500 black newborns is diagnosed with sickle cell. About 10 percent of black Americans carry the gene.
Patients inherit from both parents a gene that makes an altered form of hemoglobin, the protein that carries oxygen throughout the body.
The problem makes red blood cells take the crescent shape of a sickle. Misshapen cells block proper blood flow, a process called "sickling." The illness causes extreme pain and organ damage, especially to the brain and lungs.
The disease has no known cure. The only approved treatments are bone marrow transplants and a chemotherapy drug called hydroxyurea. Both cause severe side effects, and there are no approved medications for children.
In Nigeria, no affordable treatments are available. Finding one was among the Nigerian institute's primary goals during Wambebe's tenure there, he said.
"We just hope the president of Xechem will give a special discount to Africa" if the company starts mass-producing the drug, Wambebe said.
In the United States, doctors struggle to treat children with powerful drugs while protecting them from side effects.
"More kids are living longer, and the mortality is better than it was, but we're seeing more chronic problems," such as lung damage, heart failure and bone damage, said Richard Drachtman, a specialist in pediatric hematology and oncology.
Eid and Drachtman care for 400 children with the disease at the Bristol-Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital. Their program is one of four slated to conduct clinical trials to test Nicosan's effectiveness. The others are at the State University of New York in Brooklyn, Howard University in Washington and Children's Hospital in Philadelphia.
"It's a bad disease to have, and it doesn't get a lot of funding and recognition," Eid said. "That's why we're eager to participate in a trial that may help get those patients back on track."
June 12, 2003
(Rebecca Goldsmith covers global economics for The Star-Ledger of Newark. She can be reached at rgoldsmith@starledger.com.)
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