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Original Source: FD (FAIR DISCLOSURE) WIRE
ERIC ROWINSKY, CHIEF MEDICAL OFFICER, IMCLONE SYSTEMS, INC.: Good afternoon; I am Eric Rowinsky. I am the Chief Medical Officer for ImClone systems and I'm very happy to present the synopsis of the Company and where we are now. I will be making forward-looking statements and I refer you to our SEC filing for those statements.
So what is ImClone? ImClone really has accumulated the resources both scientific, developmental and I should also add commercial and infrastructurally to really take and enable compounds and theories to actual realistic therapeutics. ImClone truly is a comprehensive company and is getting more comprehensive. We discover, develop and commercialize novel therapeutic products in the field of oncology and I hope to show you that we are a lot more than ERBITUX, thanks to really good scientific abilities and scientists that are at the Company and have been for many years.
With regard to our value drivers in the past, and the present and the near-term it has certainly been ERBITUX, and I think this will continue to drive value over the next several years. And I will show you some evidence for that in the remaining minutes of the presentation. However I think in the long-term it will continue to be our pipeline which is very robust and very unique and I think marvels with any biotech and pharmaceutical company in the present time. We have also strength in discovery and research comprehensiveness, and a growing product developmental capabilities with the development of a very large and I think, very lean, nevertheless lean clinical and regulatory department over the last two years. Significant manufacturing capabilities and a focused experienced and even growing commercial organization.
Well, ERBITUX is the mainstay of the current action of the Company with a pipeline to follow. What we're doing with ERBITUX is basically giving forth new indications and I will show you some evidence that these new indications are [away], are incoming and really by virtue of high quality, pivotal trials. And expanding our commercial infrastructure as well.
2006 has been a very busy year for us at ImClone and a number of achievements and milestones and I would just like to enlighten you with those milestones. In 2007 and 2008 we will probably be just as busy or busier with respect to filing activities and new pivotal trials. In 2006 ImClone or ERBITUX surpassed $1 billion in annual global in market sales. In 2006 U.S. market sales of $652 million were obtained, an increase of 58% over 2005.
We defended and I think this is quite important, key strategic markets against panitumumab and other competitive threats. ERBITUX and irinotecan is the most frequently used regimen in third-line colorectal carcinoma that is in refractory disease. ERBITUX is also the most frequently used agent in the United States to treat head and neck cancer in the metastatic setting and I will talk to you about some new indications based on very high, very robust data.
We have received two FDA approvals for head and neck cancer in 2006 as well as a European Commission approval for head …