Isis Pharmaceuticals, Inc. (ISIS)
KYNAMRO Data Presented at the ESC 2012
August 29, 2012 10:00 AM ET
Dr. Stanley Crooke - Chairman and CEO
Dr. Klaus Parhofer - Professor, Metabolism and Endocrinology, Ludwig-Maximilians University, Munich
Lynne Parshall - Chief Operating Officer
Rich Geary - Senior Vice President, Development
Walter Singleton - Vice President, Development and CMO
Wade Walke - Executive Director, Corporate Communications and IR
Nicholas Bishop - Cowen & Company
Stephen Willey - Stifel Nicolaus
Carol Werther - Summer Street
Chad Messer - Needham & Company
Sam Colin - First Manhattan Company
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Good day, ladies and gentlemen. And welcome to Isis Pharmaceuticals' Conference Call to Review KYNAMRO Data that was recently presented at the ESC 2012 Meeting. As a reminder, this call is being recorded for replay purposes.
I would now like to turn the conference over to Dr. Stanley Crooke, Chairman and CEO. Please proceed.
Dr. Stanley Crooke
Good morning, everyone. And thanks for joining us today. As [Donato] indicated the purpose of this call is to have Dr. Parhofer to review the additional results or some additional results on KYNAMRO that were presented at the European Society of Cardiology Meeting this morning in Munich.
Joining us on today’s call are Dr. Klaus Parhofer, Professor of Metabolism and Endocrinology at Ludwig-Maximilians University in Munich; Lynne Parshall, Chief Operating Officer; Rich Geary, Senior Vice President of Development; Walter Singleton, Vice President, Development and Chief Medical Officer; and Wade Walke, Executive Director, Corporate Communications and Investor Relations.
Wade, would you please read the forward-looking statement.
Thanks Stan. A reminder to everyone this webcast includes forward-looking statements regarding the development activity in therapeutic and commercial potential and safety of KYNAMRO. Any statement describing Isis's goals, expectations, financial or other projections, intentions or beliefs including the planned commercialization of KYNAMRO is a forward-looking statement and should be considered an at-risk statement.
Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use of human therapeutics and in the endeavor of building a business around such drugs.
Isis's forward-looking statements also involve assumptions that if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.
Although, Isis's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements.
These and other risks concerning Isis programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, 2011 and on its most recent quarterly report on Form 10-Q which are on file with the SEC. Copies of these and other documents are available from the company.
Now, I'll turn the call back over to Stan.
Dr. Stanley Crooke
Thanks Wade. Let me begin by saying how pleased we are with the progress being made by the Genzyme sanofi Isis team. We are well along in preparations for the FDA Advisory Committee panel in October and the review of the European application is progressing. We look forward to KYNAMRO being approved in Europe this year and in the United States early next year.
Earlier today, Dr. Parhofer presented a poster at the ESC Meeting in Munich. In our call, Dr. Parhofer will review these data with you. Dr. Parhofer is as I mentioned Professor of Professor of Endocrinology and Metabolism at the University of Munich in Germany and he has a major focus on metabolism of apolipoprotein.
Dr. Parhofer has made significant contributions to the cardiovascular community with more than 130 published papers. Dr. Parhofer is currently conducting an investigator-sponsored study evaluating the use of KYNAMRO in patients who are undergoing apheresis.
Apheresis is a dialysis like procedure in which blood is filtered through a machine to remove excess cholesterol. Although, apheresis is the only option available to patients with severally elevated LDL-cholesterol levels, many eligible patients are not treated with apheresis because of the lack of availability, the high cost and the negative impact on their quality of life.
Analysis presented today focuses on the potential of KYNAMRO to reduce the need for apheresis by lowering LDL-cholesterol levels below the thresholds for apheresis eligibility in patients with severe heterozygous FH.
So, with that, I’m going to turn the call over to Dr. Parhofer. Dr. Parhofer, please.
Dr. Klaus Parhofer
Thanks Stan. Thanks also for giving me the opportunity to discuss this data today just presented earlier here in my hometown at the ESC Meeting. Well, what we evaluated in this study was basically the potential of mipomersen to reduce the need for apheresis in severe heterozygous FH, thus the hypothesis was mipomersen may delay, elongate interval or eliminate the need for apheresis by reducing LDL-cholesterol level below the threshold for apheresis eligibility even when employing eligibility criteria more stringent than in the U.S. guideline.
On the next slide, you can see my disclosures and I work as a Consultant for Mipomersen especially for that study.
Let me now turn to the introduction. Next slide please, and you probably know that LDL-apheresis is weekly or biweekly applied and it’s actually the only non-transplant treatment option for patients with severe heterozygous FH if maximum lipid-lowering therapy fails to lower LDL-cholesterol to target levels.
And also it’s quite expensive and with limited access in the United States, especially LDL-apheresis is appropriate for heterozygous FH patients if they despite maximum lipid-lowering therapy do not achieve an LDL-cholesterol below 22 milligram per deciliter in persons with coronary heart disease or below 300 milligram per deciliter in the absence of CHD.