Biotech Values

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Comments from Bill Marth re: meeting with FDA

News story posted today on an Israeli news website.
http://english.themarker.com/teva-sued-over-process-for-generic-lovenox-1.329082?localLinksEnabled=false

Teva sued over process for generic Lovenox

Court battles between Teva Pharmaceuticals and the partnership between Momenta Pharmaceuticals and Sandoz, of the Novartis International group, have now extended past competing treatments for multiple sclerosis and into the field of anticoagulants. Late last week the two companies, who manufacture a generic version of Lovenox, sued Teva over patent infringement for copying the patented production method and chemical structure analysis of the active ingredient of the knockoff.

Teva said the charges were baseless. The lawsuit won't keep Teva from taking a risk and proceeding with the marketing of its generic version of Lovenox, an anti-clotting drug, once it gets long-awaited Food and Drug Administration approval, pending since 2003. Momenta and Sandoz had their version approved by the FDA in July, creating concern that the companies could use the same method to circumvent Teva patents on Copaxone, its first proprietary drug, which accounts for an estimated 30% of its profits.

Bill Marth, CEO of Teva North America, said the company held a meeting with the FDA over its generic Lovenox product and proved that Teva's version is identical to the original developed by Sanofi-Avenis and does not copy the Momenta method. He added that it will be disappointing if Teva doesn't receive approval for the drug before the end of the year.

Sandoz reported sales of $292 million for its Lovenox knockoff in the last nine weeks of the third quarter, equivalent to 222 million euros, while Sanofi-Avenis reported sales for its original version were down 47% to 284 million euros, indicating that the launching of the generic had little impact on market prices.

Teva sued Momenta and Sandoz in August 2008 over patent infringements for Copaxone, which has market protection until 2014, after the two filed for FDA approval of their generic version of the drug in July 2008. With the lawsuit pending, the two companies can't launch their product until at least February 2011 or upon winning the case.

Teva won the first round of the legal battle when the District Court of New York rejected an application by Momenta and Sandoz for a summary judgment invalidating the patents.

Novartis has another product competing with Copaxone - Gilenya - launched in September as the first orally-administered MS treatment.

Competition with Gilenya and concern over the launch of a generic version of Copaxone are apparently the major reasons for Teva's weak share price in the last few months. Its shares finished last week trading at $49.30, lower than their average over the last 50 days ($52 ) and in the last 200 days ($55 ).