Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has tempered its enthusiasm about its oral multiple sclerosis treatment, Laquinimod. In the company's 20-F financial report for 2011 filing with the US Securities and Exchange Commission (SEC) on Friday, Teva states, "In October 2011, we held a meeting with the US Food and Drug Administration (FDA) to discuss the possibility of filing an NDA (New Drug Application) for Laquinimod. Following the meeting, we believe it would be premature to file an NDA at this time. Further clinical studies of Laquinimod as monotherapy and add-on therapy in patients with relapsing-remitting multiple sclerosis are currently under review."
Last year, Teva spoke much more optimistically about Laquinimod. Despite ambiguous results from the Phase III clinical trial, in which the drug failed to meet its primary endpoint, achieving it only after a statistical correction, Teva said that it could file an NDA and begin marketing of the drug in late 2012 or early 2013.
Teva added in the 20-F, "Laquinimod is currently in Phase II development for Crohn’s disease and in Phase I/II studies for lupus nephritis and lupus arthritis. Results of each of these studies are expected in 2012."
As for Teva's brand drug for the treatment of Parkinson's disease, Azilect, Teva says that, in December 2010, it filed a supplemental NDA with the FDA for the use of Azilect to slow the clinical progression of Parkinson’s disease. "In January 2012, we received a complete response letter from the FDA relating to the application. We are reviewing the details of the letter and evaluating next steps."
Teva launched Azilect in Israel in March 2005, followed by a rolling launch in various European markets, and in the US in 2006. It is now approved for marketing in 45 countries.
Teva spent $471 million in 2011 on legal settlements and reserves, up from $2 million in 2010 and $434 million in 2009. As a generics drug company, Teva faces frequent patent litigation. Litigation by Pfizer Inc. (NYSE: PFE; LSE: PFZ) unit Wyeth on Protonix is still ongoing. Teva says that it believes that has substantial grounds for appeal of the US District Court for the District of New Jersey's decision on the case, but that if Wyeth ultimately wins its case, Teva could be required to pay $1.1 billion in damages.
In recent years, Teva had production problems at its Jerusalem and Irvine, California facilities, as well as its Animal Health unit facility in Missouri. The Jerusalem and Animal Health facilities have resumed full operations, but the Irvine injectable products facility is still only partly operating. The company wrote an impairment cost of $117 million on the California facility and $201 million for the Animal Health facility.
Teva's workforce rose by 15% in 2011, partly through acquisitions, to 45,754 persons, including 7,110 persons in Israel, 5% more than a year earlier. Its major acquisitions in 2011 were $6.8 billion for Cephalon in the US, and $1.1 billion for Taiyo Pharmaceuticals in Japan.
Teva's share price fell 1.8% on the TASE today to NIS 167.10, despite rising 1.1% on Nasdaq on Friday to $44.65, giving a market cap of $39.5 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on February 19, 2012
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