Lundbeck and Takeda Finalize Plans to Initiate Phase III Pivotal Clinical Trials with Lu AA21004 and Lu AA24530

OSAKA, March 3, 2010--H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited (Takeda) today jointly announced the plans for the additional clinical phase III studies on Lu AA21004 and phase III studies on Lu AA24530 in patients with major depressive disorder (MDD).

The new programme on Lu AA21004 will consist of four clinical phase III studies including approximately 2,000 patients with moderate to severe depression in addition to a long-term extension study. The planned doses are 10 mg, 15 mg and 20 mg. The pivotal programme is planned to commence in the first half of 2010.

Following the communication of initial top-line MDD results from previous phase III studies with Lu AA21004 in June 2009, additional data from the full programme was received and analysed. These data showed encouraging results for the potential efficacy and the tolerability profile of Lu AA21004. Data received towards the end of 2009 from the clinical phase III programme, with 560 patients in a MDD trial, showed statistical significance on the primary efficacy endpoint across all tested doses of Lu AA21004 compared to placebo in a primarily European-based trial. Also, encouraging results from an MDD relapse prevention study involving 639 patients showed statistically significant results on maintenance of efficacy in long-term treatment of MDD.

"With the full review of all data and dosages available we have strong data to continue development of Lu AA21004 including exploring the potential at higher dosages than previously studied”, says Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck. "We are pleased that with our partner Takeda we are ready to move forward."

In the completed clinical phase II dose finding study, Lu AA24530 produced consistent statistically significant improvements on the primary efficacy endpoint and on key secondary endpoints for the treatment of MDD. Based on the observed efficacy and tolerability in patients following treatment with Lu AA24530, the clinical phase III program will be initiated. The clinical phase III program will begin with four individual phase III studies of Lu AA24530, including a long-term study and a relapse prevention study. Approximately 2,000 patients are planned to be included investigating doses at 10 mg and 20 mg. Selected trials will include an active reference compound. The pivotal program is planned to commence by the end of 2010 and may also include future planned phase III studies to further investigate the compound’s benefit and risk profile.

“Central nervous system conditions represent a core therapeutic area of interest for Takeda,” said Nancy Joseph-Ridge, M.D., general manager for Takeda’s pharmaceutical development division. “Together with Lundbeck, we are pleased to continue our development activities for Lu AA21004 and Lu AA24530, further evaluating their potential as a future treatment option for the millions of patients suffering from depression.”

About Lu AA21004
Lu AA21004 is a 5-HT3, 5-HT7 and 5-HT1B receptor antagonist, 5 HT1A receptor agonist and 5-HT transporter inhibitor. A number of investigations in vivo have demonstrated that Lu AA21004 increases extracellular monoamine (5-HT, noradrenaline and dopamine) and acetylcholine levels in specific areas of the brain. All of these activities are considered to be of clinical relevance and involved in the mechanism of action of Lu AA21004.
Lu AA21004 has demonstrated a low drug-drug interaction potential. It is extensively metabolized in the liver and the absorption of Lu AA21004 is independent of food intake.

About Lu AA24530
In pre-clinical studies, Lu AA24530 has demonstrated activities as a multi-modal enhancer with reuptake inhibition at monoamine transporters, and antagonist activity at 5-HT3 and 5-HT2c receptors. In vivo rat studies have demonstrated that treatment with Lu AA24530 leads to increases in acetylcholine, noradrenaline, dopamine and 5-HT levels in brain regions that play a key role in the regulation of mood.

About depression
Depression is a very common, debilitating illness affecting around 121 million people worldwide according to WHO. Depression is the leading cause of disability as measured by YLDs (Years of Life lived with Disability) and the 4th leading contributor to the global burden of disease as measured by DALYs (Disability adjusted life years) in 2000. By the year 2020, depression is projected to reach 2nd place of the ranking of DALYs calculated for all ages, both sexes.
Depression and its impact on peoples’ lives are frequently not considered to be serious. The symptoms of depression can be chronic or recurrent, and impact patients both mentally and physically, yet it is still under-recognized and undertreated with less than 25 percent of those affected having access to adequate treatment for their condition[i].

Symptoms can include feelings of sadness, anxiety, loss of interest in activities, decreased energy, impaired sleep, impaired concentration, hopelessness, guilt, persistent physical symptoms such as pain and digestive disorders, and in more severe cases, suicidal thoughts and suicide attempts.


Takeda and Lundbeck alliance
In September 2007, H. Lundbeck A/S and Takeda Pharmaceutical Company Limited formed a strategic alliance for the exclusive co-development and co-commercialization in the United States and Japan of several compounds in Lundbeck's pipeline for the treatment of mood and anxiety disorders. The partnership initially focuses on co-development and co-commercialization of the two most advanced compounds in Lundbeck's pipeline for mood and anxiety disorders, Lu AA21004 and Lu AA24530. Once approved, the companies will co-promote the products in the United States and Japan.

Financial guidance
Lundbeck will present its financial result for 2009 on 4 March 2010. On the same occasion Lundbeck will present the expectations for the financial result for 2010.

Lundbeck contacts
Investors:
Jacob Tolstrup
Director, IR & Communication
45 36 43 30 79

Palle Holm Olesen
Head of Investor Relations
45 36 43 24 26

Magnus Thorstholm Jensen
Investor Relations Officer
45 36 43 38 16

Media:
Mads Kronborg
Media Relations
45 36 43 28 51

Takeda contact
Seizo Masuda, Takeda Pharmaceutical Company, Ltd.
Senior Manager, Corporate Communications Dept.
81 3 3278 2037

About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an international pharmaceutical company highly committed to improve the quality of life for people suffering from central nervous system (CNS) disorders. For this purpose Lundbeck is engaged in the research and development, production, marketing and sale of pharmaceuticals across the world, targeted at disorders like depression and anxiety, schizophrenia, insomnia, Huntington’s, Alzheimer’s and Parkinson’s diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and employs today over 5,500 people worldwide. Lundbeck is one of the world’s leading pharmaceutical companies working with CNS disorders. In 2008, the company's revenue was DKK 11.3 billion (approximately EUR 1.5 billion or USD 2.2 billion). For more information, please visit www.lundbeck.com.

About Takeda
Located in Osaka, Japan, Takeda (TSE:4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine.

Posted: March 2010


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