Another Copaxone rival nears FDA nod

The US Food and Drug Administration (FDA) has accepted for priority review an application by Germany's Merck KGaA (DAX: MRK) for its Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis. Cladribine is an oral treatment that would compete against Teva Pharmaceutical Industries Ltd's (Nasdaq: TEVA; TASE: TEVA) Copaxone.

The goal for completing a priority review is six months instead of the standard ten months. Priority Review is applied to drugs that the FDA feels have the potential to provide significant advances in treatment.

The announcement means that Merck KGaA has joined the race for an oral treatment for multiple sclerosis. Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ) is currently in the lead, with its drug Gilenia already undergoing an FDA review.

Merck expects a decision by the FDA in the fourth quarter of 2010. Novartis believes that it will obtain FDA marketing approval for Gilenia in the third quarter. If the drugs are approved they are like to win market share from Copaxone, which is delivered intravenously. Teva is developing an oral version of Copaxone.

Merck KGaA's first filing of an New Drug Application (NDA) for Cladribine in November 2009 was rejected on the grounds that the application was incomplete. The company refiled in June, and the FDA today accepted it. The Russian regulator approved Cladribine two weeks ago, and Merck hopes to launch sales there in early 2011.

Yesterday, Teva president and CEO Shlomo Yanai said, "Copaxone sales continue to grow. It is the leading treatment worldwide for multiple sclerosis, with a 40% market share in the US. We see Copaxone sales continuing to grow in the coming years, and peaking in 2013."

Teva's shares remain under pressure as investors worry over the impact on the company. The share price fell 0.1% on Nasdaq yesterday to $50.11, and fell 2.3% by midday on the TASE today to NIS 191.80.

Published by Globes [online], Israel business news - www.globes-online.com - on July 28, 2010