SRI children's cancer drug clears hurdle

Southern Research Institute once had difficulty finding a development partner for its drug to treat pediatric leukemia, but Clofarabine is now one step away from sales in Europe.

Sold as Clolar in the United States to treat acute lymphblastic leukemia in children, clofarabine received approval this week from the European Medicines Agency for similar use under the brand name Evoltra. London-based drug maker Bioenvision, which licensed the compound from Southern Research in 1997, said it now needs final marketing authorization by the European Commission to launch Evoltra throughout the European Union.

That process could take three months. Meanwhile, Bioenvision has is preparing to roll out Evoltra by appointing general managers in certain major European markets. Sales and marketing teams across Europe also will be expanded, the company said.

Clofarabine is the sixth anti-cancer drug discovered by Southern Research to win FDA approval. It now has been approved for treating ALL, a cancer of the blood and bone marrow in pediatric patients on two continents.

At Southern Research, the opinion means the drug will become available to more patients around the world who could really use it, said Jack Secrist, Southern Research vice president of drug discovery. At one point, the institute couldn't get pharmaceutical companies to take a chance on the drug it discovered in the 1980s.

"Back in the 1990s, we had a very difficult time entering into a licensing agreement with anyone to develop this drug, said Secrist. The institute spent five to seven years looking for a partner for the drug, he said.

"Bioenvision recognized its potential value and really did a great job of getting it moving both in Europe and in this country through its sublease agreement with ... Genzyme," he said.

Genzyme, which has marketing rights to clofarabine in North America, sells it as Clolar.

Orphan drug designation granted by the FDA and in Europe provides Bioenvision and Genzyme exclusive marketing for 10 years. Southern Research still holds the patent and receives royalties based on sales.

"The drug is showing considerable promise in adult leukemia as well," Secrist said, "and I know both Genzyme and Bioenvision have plans to seek approvals for a particular type of adult leukemia ... as soon as the clinical data allows it."

Bioenvision said it has completed enrolling subjects for its Phase II clinical trial on adult acute myeloid leukemia in elderly patients and expects to apply for marketing approval by midyear.

Bioenvision said it also plans to test the drug on other diseases.

E-mail: cmccauley@bhamnews.com