OPERATOR: Good day and welcome to the Novo Nordisk update on FDA Advisory Committee recommendation for liraglutide conference call. For your information, today's conference is being recorded.
At this time, I would like to turn the conference over to your host, Lars Rebien Sorensen. Please go ahead, sir.
LARS REBIEN SORENSEN, PRESIDENT & CEO, NOVO NORDISK A/S: Thank you and good morning to everyone. Welcome to this Novo Nordisk conference call regarding the outcome of the FDA Advisory Committee meeting last night on liraglutide.
I'm Lars Rebien Sorensen, the CEO of Novo Nordisk and with me, I have our Chief Science Officer, Mads Krogsgaard Thomsen and the Chief Financial Officer Jesper Brandgaard, and present are also our Investor Relations officers.
The conference call is scheduled to last approximately 30 minutes and we expect the Q&A session to begin in approximately 10 minutes.
Despite multiple drug classes and agents to treat Type 2 diabetes, there remains a need for Type 2 diabetes treatment that could better address the [multi-sectoral] aspect of the disease. The goal of therapy is to achieve and maintain glycemic control and improve other risk factors such as excess body weight and elevated blood pressure.
The liraglutide development program was designed with this in mind.
Based on the review of the data in our submission, the FDA asked the Advisory Committee to discuss the cardiovascular profile of liraglutide as well as thyroid safety. Mads Krogsgaard will elaborate on this in more detail in a moment.
From an overall point of view, Novo Nordisk recognizes the concerns expressed by the Advisory Committee members, primarily with regard to findings of C-cell tumors in rodents. However, we remain committed to bringing liraglutide to the market to the benefit of people with Type 2 diabetes.
The outcome of the Advisory Committee meeting does not significantly impact Novo Nordisk's expectations of the Company's financial results in 2009. We will update the expectations for the Company's financial results for 2009 on April 30 in connection with the release of the financial results in the fist quarter of 2009.
Before handing over to Mads, I'd like to note that the FDA Advisory Committee is obviously a very important element in the US regulatory process for liraglutide but the process is not finalized and Novo Nordisk will continue to work closely with the FDA over the next couple of months.
This may limit our ability to answer some of your questions but we will try to give as much information as possible at this point in time.
With this, I'd like to hand over to Mads.
MADS KROGSGAARD THOMSEN, EVP & CSO, NOVO NORDISK A/S: Thank you, Lars.
The focus of the Advisory Committee meeting was on the cardiovascular profile of liraglutide, the finding of C-cell thyroid tumors in rodents plus an assessment of papillary thyroid cancer safety in humans.
I will go through these areas starting by addressing the setting in which the cardiovascular data available on liraglutide should be considered. In December of 2008, the FDA issued new guidance to the industry asking sponsors to demonstrate pre-approval that new therapies for Type 2 diabetes do not result in an unacceptable increase in cardiovascular risk.
The new drug application for liraglutide was filed with the FDA on May 23, 2008. Therefore, the liraglutide program was not prospectively designed to assess cardiovascular risk. As a consequence of the timing of issuance of the new CV guidance, the FDA and Novo Nordisk decided to jointly perform post-drug evaluation of cardiovascular events based on so-called major adverse cardiovascular event, [MACE] analysis that were conducted in a number of different ways and different patient populations.
Based on the results of the MACE analysis, the FDA asked the Advisory Committee to vote on whether the data from the aggregated liraglutide development program had ruled out unacceptable CV risk relative to comparators.
The outcome of this vote was favorable with eight for and five against and none abstaining from voting. To address cardiovascular risk concerns expressed by the Advisory Committee, a post-approval study [however] to assist cardiovascular risk in a large high-risk population of type 2 diabetes patients over several years will be initiated following discussions with the FDA on the study protocol.
With regard to the thyroid discussion, it is important to distinguish between the preclinical findings of C-cell tumors in rodents which were the focus of the two first votes and the …