BTG Wins Approval From U.S. FDA for Drug to Mitigate Toxic Cancer Medicine

BTG Plc (BGC), a London-based specialty pharmaceutical company, won U.S. approval for its drug to combat the toxic effects of a cancer treatment.

The Food and Drug Administration cleared the medicine to reduce toxic methotrexate levels due to kidney failure, the agency said today in a statement. Methotrexate is a common chemotherapy used against recurring types of certain cancers, including leukemia and lymphoma.

The drug, known as Voraxaze, is expected to produce peak sales of $15 million, Louise Makin, BTG’s chief executive officer, said Nov. 17 during an earnings call. Methotrexate can cause death, liver and lung damage and may leave patients susceptible to serious infections, according to the National Institutes of Health.

“Voraxaze is an important new treatment option for cancer patients aimed at preventing these toxicities associated with sustained high levels of methotrexate,” Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said in the statement.

Protherics Plc, acquired by BTG in 2008, withdrew its European application for Voraxaze in 2007 after the European Medicines Agency raised concerns that the purity of the product may have been affected by a plan to manufacture the drug at a factory that hadn’t been used to make the medicine for clinical trials. Potential European approval is contingent on future conversations with government and regulatory bodies, Ashley Tapp, a spokeswoman for BTG, said by e-mail.

Orphan-Drug Status

Voraxaze was granted an orphan-drug status because it will treat a condition that affects fewer than 200,000 Americans. Orphan drugs are awarded seven additional years to market their products free from generic competition.

Voraxaze is available in the U.S. as part of a compassionate-use program under which the FDA allows patients with immediately life-threatening diseases access to alternative treatments on a case-by-case basis. The medicine brought in sales of $5.1 million for the year ending March 31, 2011, according to data compiled by Bloomberg.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net.

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.