Lundbeck acquires European commercialization rights for Flurizan® from Myriad, USA - a new drug in final phase III development for the treatment of Alzheimer's disease.

 

Myriad and Lundbeck have entered into a European commercialization agreement under which Lundbeck will have rights to market and sell Flurizan® in the European Union and several associated non-EU countries and will manage the regulatory process. Lundbeck has agreed to pay Myriad an initial USD 100 million and will pay up to USD 250 million in connection with regulatory approvals. Furthermore, Lundbeck has agreed to pay attractive commercialization milestones and will purchase bulk pharmaceutical material from Myriad. Lundbeck has also agreed to pay escalating royalties of 20 - 39% on sales less the amount paid for the bulk drug.

 

"Lundbeck has an excellent track record in the field of Alzheimer's disease and is globally known for its reputation as a CNS speciality pharmaceutical company. I can't think of a better European partner for Flurizan®," said Peter Meldrum, President and CEO of Myriad Genetics, Inc. "The selection of Lundbeck as our European partner completes the first stage of our global commercialization strategy for Flurizan®."

 

"We are very excited to be entering this partnership with Myriad. Flurizan® has the potential to bring an important new Alzheimer's medicine to patients in Europe," said Executive Vice President Anders Gersel Pedersen, head of drug development at Lundbeck.  "Lundbeck is fully committed to the field of Alzheimer's disease and this partnership further demonstrates that commitment."

 

More than 200 patients have been treated in the clinical phase II trials with Flurizan®. Overall, the results support the hypothesis that Flurizan® may delay the disability of Alzheimer's disease. Flurizan® has an attractive therapeutic and safety profile in patients with mild Alzheimer's treated for 1 year. In addition to the reported significant benefit observed in patients with mild Alzheimer's in activities of daily living (p=0.033), global function (p=0.042) and a positive trend in cognition, the phase II data revealed a significant reduction (p=0.020) in the number of and a delay in time to psychiatric events (p=0.011)[1]. In a 24-month follow up study Flurizan® demonstrates an increasing response rate (absolute risk reduction) over time in subjects with mild Alzheimer's disease treated with Flurizan®. These long-term and increasing response rates have not been observed previously in clinical studies of drugs in Alzheimer's disease[2]. However, as with all clinical phase 2 results these data are preliminary and needs to be confirmed in larger clinical phase 3 trials.

 

Flurizan® is now being studied in two final phase 3 clinical trials. The US phase 3 trial enrolled 1,684 patients with mild Alzheimer's disease at 131 investigator sites in the US. This trial has completed and preparation of the database for analysis is in process. Announcement of the results of this trial is planned for June 2008. The global phase 3 trial enrolled 840 patients with mild Alzheimer's disease at 90 investigator sites globally. The trial is scheduled for completion during the fall of 2008 and data are planned to be available towards the end of the year.

 

Regulatory submissions are anticipated during first half of 2009.

 

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 between 5-6 million people with dementia/Alzheimer's in Europe. The total costs to society is estimated to amount to EUR 55 billion making dementia the most expensive brain disorder from a medical perspective.[3] 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 announcement of the acquisition of the European rights for Flurizan® Lundbeck has decided to terminate its ongoing share buy back programme. At 21 May 2008, a total of 30,319,784 shares had been bought back, corresponding to a transaction value of DKK 4,047,608,042 and an average purchase price of DKK 133.4973, equal to about 67% of the total programme. Last day of potential trading will be today, Thursday 22 May 2008.

 

Since the initiation of the share buy back programme Lundbeck has publicly announced that it has been entitled to terminate the share buy back programme at any time as a consequence of changes to the company's financial position or changes in the market for instance acquisitions or in-licensing opportunities. Besides the acquisition of European rights for Flurizan® Lundbeck will continue to actively pursue further in-licensing or acquisition opportunities. 

 

The content of this release will have no influence on the Lundbeck Group's revenue and profit from operations (EBIT) for 2008. Lundbeck expects an investment level of approximately DKK 500 million excluding in-licensing and milestone payments and approximately DKK 1,075 million including in-licensing and milestone payments.

 

Myriad Contact

 

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 343 - 22 May 2008

 

 

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 Web site at www.myriad.com.

 

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.