Genmab Surges After FDA Clears Cancer Drug Shared With Glaxo
bloomberg.com
By Catherine Larkin
Oct. 27 (Bloomberg) -- Genmab A/S gained the most since June 2 in Copenhagen trading after winning U.S. approval for the Arzerra leukemia treatment, the Danish biotechnology company’s first product to reach the market.
Genmab gained 11 kroner, or 8 percent, to 148 kroner as of 9:04 a.m. The Food and Drug Administration yesterday cleared sales of Arzerra for patients who don’t get better on drugs such as Genzyme Corp.’s Campath. GlaxoSmithKline Plc, of London, owns rights to sell the drug and will pay royalties to the Copenhagen-based company.
Genmab shares slid 30 percent on Aug. 18 after the drug developer eliminated a potential milestone payment from Glaxo from its full-year sales and earnings forecast because data on Arzerra increased doubts the medicine would win approval without additional tests. While the drug was awarded an expedited review by the FDA, the agency said in June that it needed additional time to review new chemistry and manufacturing data submitted by the companies.
“The approval of Arzerra illustrates FDA’s commitment to using the accelerated approval process to approve drugs for patients who have limited therapeutic options,” Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.
Chronic lymphocytic leukemia is the most common form of leukemia in adults, with about 15,490 new diagnoses expected in the U.S. this year, according to the American Cancer Society. When bone marrow makes too many abnormal white blood cells called lymphocytes, the cancerous cells crowd healthy cells needed to fight infection and other normal blood components.
Accelerated Approval
The disease typically occurs in middle age and slowly progresses, killing more than 4,000 people annually, according to the Cancer Society. Glaxo and Genmab say new options are needed for patients with so-called refractory forms of chronic lymphocytic leukemia that don’t respond to current treatments.
The FDA agreed to consider their application for Arzerra under an accelerated approval program that allows drugs for serious illnesses to get on the market sooner based on preliminary evidence suggesting benefit. Outside advisers to the agency voted 10-3 in May that the companies’ data are “reasonably likely” to support the use of Arzerra in patients who aren’t helped by either Campath or generic fludarabine.
The treatment needs further study as part of the accelerated approval process, according to the FDA’s statement. Glaxo is conducting a clinical trial to confirm the addition of Arzerra to standard chemotherapy delays the progression of the blood cancer, the agency said.
Arzerra sales may reach 282 million pounds ($462 million) a year by 2012, according to the average estimate of four analysts surveyed by Bloomberg. The drug may compete with Cephalon Inc.’s Treanda and Roche Holding AG’s Rituxan. Glaxo filed a lawsuit Oct. 8 to protect itself and Genmab from patent claims by Basel, Switzerland-based Roche. |
