Lundbeck strengthens ownership of desmoteplase by acquiring Paion’s remaining rights

• Lundbeck acquires Paion’s remaining rights to desmoteplase for EUR 20.1 million thereby further strengthening the control over desmoteplase
• Desmoteplase may address a significant unmet medical need and has the potential to help more people who suffer from an ischaemic stroke
• Desmoteplase is being studied for the treatment of patients with acute ischaemic stroke 3-9 hours after onset of symptoms.
• No pharmacological treatment is available today that allows patients to reach hospital and be diagnosed and treated within this extended time window
• More than half the patients in the phase III programme have been enrolled in two studies and the first study, DIAS-3, is expected to be completed in the first half 2013
• Submission of MAA and NDA are expected in first half 2014

H. Lundbeck A/S (Lundbeck) and Paion AG (together with its subsidiary Paion Deutschland GmbH., “Paion”) today announced that the companies have entered into a definitive agreement under which Lundbeck acquires all of Paion’s remaining rights to desmoteplase currently under clinical phase III development for ischaemic stroke. The deal is an all-cash transaction valuing the assets at EUR 20.1 million or approximately DKK 150 million. The Board of directors at Lundbeck and the management and Supervisory Board of Paion AG have unanimously approved the transaction. The acquisition is a logical next step in the development of desmoteplase.

"Stroke patients today suffer from substantial unmet medical needs and existing clinical data suggest that patients with a detectable blood clot can benefit from desmoteplase," says Executive Vice President Anders Gersel Pedersen, Head of R&D at Lundbeck, and continues: "While desmoteplase is regarded as a high-risk project this transaction provides financial and operational benefits to Lundbeck."

Financial highlights
Under the terms of the transaction, Lundbeck will make an initial upfront payment of EUR 18.6 million (or approximately DKK 140 million) immediately upon and shortly after closing of the transaction. The remainder of the purchase price will be held in escrow for one year. The transaction will be financed using currently available cash resources.

The acquisition price of the assets will be booked as "Product rights" under intangible assets in Lundbeck's balance sheet.

Additional details of the financial terms of the agreement have not been disclosed, but Lundbeck is to pay single-digit royalties on sales as well as certain insignificant milestones to Bayer Pharma AG.

About desmoteplase
Desmoteplase, the most fibrin-specific plasminogen activator known today, is a genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus. It has received fast-track designation from the US Food and Drug Administration (FDA) for the indication of acute ischaemic stroke.

Lundbeck presented data at the International Stroke Conference (ISC) in San Antonio, Texas in February 2010, which showed very supportive data for desmoteplase. Post hoc analysis of data from the clinical phase III study, DIAS-2, showed that the subgroup of patients with visible arterial occlusion or high-grade stenosis on baseline angiographies had improved response for desmoteplase over placebo[1].

The data suggest that patients with a so-called Thrombolysis in Myocardial Infarction (TIMI) score of 0 or 1 revealed lower response rates in the placebo group (18%) and higher response rates in the desmoteplase groups (36% and 27% for desmoteplase 90 µg/kg and 125 µg/kg, respectively).

The findings from the post hoc analysis provided the basis for the design of the continued clinical phase III programme (DIAS-3 and 4). DIAS-3 and DIAS-4 are randomized, double-blind, placebo-controlled, multinational phase III twin trials, aiming to enroll 800 patients in total with acute ischaemic stroke.

Evidence of safety and efficacy was obtained in the Dose Escalation of Desmoteplase in Acute ischaemic Stroke (DEDAS, n=37) and Desmoteplase in Acute Ischaemic Stroke (DIAS, n=102) phase II trials. The DIAS-2 phase III trial (n=186) supported the safety profile of desmoteplase.

About stroke
Stroke is the third leading cause of death in the industrialised world and a leading cause of serious, long-term disability. In the US alone, approximately 800,000 people suffer an ischaemic stroke each year[2], and around 8-12% of them die within 30 days. In Europe it is estimated that more than 700,000 people will experience an acute ischaemic stroke annually. On average, every 40 seconds someone in the US has a stroke. Strokes can - and do - occur at any age. Nearly one quarter of strokes occur in people under the age of 65².

For the US, the American Heart Association estimates the financial burden of stroke due to in-hospital costs, long-term care programmes and productivity losses to be approximately USD 69 billion in 2009[3].

Financial guidance
The content of this release will have no influence on the Lundbeck Group's financial guidance for 2012 which was provided on 8 February 2012 in connection with the release of the financial results for 2011.

Lundbeck contacts

About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improving the quality of life for people suffering from brain disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at disorders such as depression and anxiety, psychotic disorders, epilepsy and Huntington’s, Alzheimer’s and Parkinson’s diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark. Today Lundbeck employs approximately 6,000 people worldwide. Lundbeck is one of the world’s leading pharmaceutical companies working with brain disorders. In 2011, the company's revenue was DKK 16.0 billion (approximately EUR 2.2 billion or USD 3.0 billion). For more information, please visit www.lundbeck.com.

[1] Gregory W. Albers, Rüdiger von Kummer, on behalf of the DIAS-3 and DIAS-4 Study Group: “Desmoteplase 3–9 Hours After Acute Ischaemic Stroke: An Update on the DIAS Clinical Trial Program”. International Stroke Conference 2010 • February 23–26, 2010 • San Antonio, TX, USA

[2] Decision Resources: ”Acute Ischaemic Stroke”, January 2012

[3] Y. Yoneda et al.: Hospital cost of ischaemic stroke and intracerebral hemorrhage in Japanese stroke centers / Health Policy 73 (2005) 202–211

http://www.strokecenter.org/patients/stats.htm