"Lovenox sales were €489 million in the second quarter, down 11.0%, reflecting generic pressure in the U.S. where sales declined 52.5% to €87 million. Sanofi commercializes an Authorized Generic of Lovenox in the U.S. (sales are booked in the Generics business).
Outside the U.S., Lovenox recorded another quarter of growth with sales of €402 million (+6.6%). In Emerging Markets, sales increased 12.0% to €158 million. In Western Europe sales of the product reached €219 million, up 2.8%. First-half sales of Lovenox were €1,015 million (-10.7%),
79.4% of which (€806 million) was generated outside the U.S. (+ 9.2%).
"In neurology, earlier this year, lower courts ruled against us in the U.S. and U.K., respectively on Copaxone, and we intend to appeal those decisions. We remain confident in our application and expect to receive FDA approval before we have the ability to launch our product, given the anticipated length of the appeals process."
Just first one, can you give us any details on your confidence in the comments you made earlier about the timing for the Copaxone FDA approval?
Yes, we remain absolutely confident on our regulatory pathway and our ability to receive an approval. As you know, the -- how Hatch-Waxman works, our ability to get an approval prior to the appeals process is not possible. So we are very focused on still receiving our regulatory approval and absolutely, as I mentioned in my comments, believe that we'll get that prior to the appeals process ending.
Copaxone is "definitely coming after that 2015 timeframe"
if you could just provide some update on how you see things progressing in the LOVENOX market right now?
So the LOVENOX market, so we have grown from about 2% market share in the beginning of the quarter to about 10% market share now. As you know, we are only operating in the retail space. We now have a good supply and steady supplies from Amphastar. And then -- so the market has been growing. The price erosion has been significantly more than we expected. There has been a very hectic competition in that market with the AG and also from Sandoz. But overall, we are pleased. We have seen a good growth in the quarter, and we will continue to compete in this space going forward.
So biosimilars, we want to build on Pfizer experience now in biologic development and manufacturing and of course commercialization. Second, the biosimilar market is expanding and is expected to grow from something around $1.5 billion today to $22 billion in 2020. So we want to build on that and we have successfully obtained IND for rituximab Pfizer product as well as Trastuzumab a biosimilar for Herceptin and we have started clinical trials already.
"In the past quarter, there were 3 substantial Copaxone events that were considered by many to be pivotal for the company. In June, we announced positive top line data from the GALA Phase III clinical trial assessing the efficacy, safety and tolerability of 40 mg/1 ml glatiramer acetate injection, administered subcutaneously 3x a week compared to placebo in relapsing, remitting multiple sclerosis patients. Study results showed that the dosage of glatiramer acetate significantly reduced disease activity while maintaining a favorable safety and tolerability profile.
A further analysis of the GALA data are ongoing and as we continue to work with the health authorities to determine the next steps, we are guiding on the submission of the GALA data to the U.S. FDA in the first quarter of 2013 with a possible launch date in the first quarter of 2014.
We are also extremely pleased with the favorable court ruling in the Copaxone patent infringement litigation where the U.S. District Court of the Southern District of New York found in favor of Teva.
The court has also enjoined the FDA from approving the defendant's reported generic versions of Copaxone until the Orange Book patents expire on May 24, 2014, and the defendants from selling their products until the process patent expires on September 1, 2015, assuming, of course, they achieve the necessary regulatory approval."