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H. Lundbeck Myriad Genetics, Inc. has today announced the outcome of a clinical phase III trial of Flurizan® (tarenflurbil) in 1,684 patients with mild Alzheimer's disease. The clinical phase III data do not correspond to the data observed in clinical phase II in patients with mild Alzheimer's disease. Lundbeck and Myriad will now investigate the data further to understand the outcome of the trial in which the compound did not meet the two primary endpoints.
"The clinical phase II data for Flurizan® in patients with mild Alzheimer's disease supported further development of Flurizan®. The first headline results from this trial are discouraging for patients and relatives affected by Alzheimer's disease and make it less likely that these initial observations could lead to an approval. We will now look further into the details of the study to evaluate whether patients in fact could benefit from the compound," says Executive Vice President Anders Gersel Pedersen, head of Drug Development at Lundbeck, and continues:
"Alzheimer's disease is perhaps the area where advances in treatments are most needed. Lundbeck is a leading player in brain disorders and despite the inherent risk we will continue to develop new pharmaceuticals for the treatment of the disease either in-house or through in-licensing."
In general, the reported adverse events reflect the expected profile of an elderly population with Alzheimer's disease and most symptoms were well balanced between Flurizan® and placebo. In the Flurizan® treatment group there were a few signs of increased frequencies of adverse events including anemia, pneumonia, renal failure, and gastrointestinal ulcers. The analysis of all currently available data reveals no other meaningful safety differences between the treatment groups.
About Alzheimer's disease Alzheimer's disease is a neurodegenerative disease characterised by progressive cognitive impairment such as memory loss, reduced perception ability and language disruptions, eventually preventing the patient from taking care of himself. Anxiety, confusion and anger may occur in the late stages of the disease.
Alzheimer's disease affects 5% of the population over the age of 65 and more than 30% of the over-85 age group. Today, about 60% of Alzheimer patients are correctly diagnosed, and of these patients about 80% are diagnosed with either moderate or severe Alzheimer's disease. It is estimated that there are 5-6 million people with dementia/Alzheimer's in Europe. The total cost to society is estimated to amount to EUR 55 billion making dementia the most expensive brain disorder from a medical perspective.[1] The aging population in Europe will make dementia an even bigger burden to society in the years to come. Studies have shown that even relatively small delays in disease progression will have huge impact on medical costs.
In connection with the acquisition of European rights for Flurizan® Lundbeck made an upfront payment of USD 100 million equal to DKK 481 million. Since it is less likely that Flurizan® will become a product Lundbeck has decided to write down that amount, which will be expensed as a one-off item in Lundbeck's Profit & Loss statement in the second quarter of 2008.
Teleconference Lundbeck will host a conference call today at 9:30 AM (CET, Copenhagen time) for analysts and investors. To participate in the conference call, please call one of the following call-in numbers:
UK: +44 (0) 20 7162 0025 US: +1 334 323 6201
Conference ID 802010
A replay will be available one hour after the teleconference and will be accessible for seven days. Please call one of the following call-in numbers and quote the access code:
William A. Hockett EVP, Corporate Communications +1 (801) 584-3600 email: bhockett@myriad.com
Lundbeck contacts
Investors: Media:
Jacob Tolstrup Jens Harder Højbjerg Director Media Relations Manager +45 36 43 30 79 +45 36 43 28 33
Palle Holm Olesen Head of Investor Relations +45 36 43 24 26
Stock Exchange Release No 349 - 30 June 2008
About Myriad Genetics Myriad Genetics, Inc. is a biopharmaceutical company focused on the development of novel healthcare products. The company develops and markets predictive medicine products, and is developing and intends to market therapeutic products. Myriad's news and other information are available on the company's website at www.myriad.com.
About Lundbeck H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of pharmaceuticals for the treatment of psychiatric and neurological disorders. In 2007, the company's revenue was DKK 11 billion (approximately EUR 1.6 billion or USD 2.0 billion). The number of employees is approx. 5,300 globally. For more information, please visit www.lundbeck.com.
1. Costs of Disorders of the Brain in Europe; European Journal of Neurology; Volume 12, Supplement 1, June 2005
