H. Lundbeck A — Earnings Release 2013

Oct 25, 2013

H. Lundbeck A/S

DK-2500 Valby , Copenhagen Fax +45 36 43 82 62 www.lundbeck.com CVR number: 56759913

Ottiliav ej 9 Tel +45 36 30 13 11 E-mail inv estor@lundbeck.com

Corporate Release

Lundbeck receives positive opinion for approval of Brintellix (vortioxetine) in the European Union

• The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of BrintellixTM for the treatment of adult patients with Major Depressive Episodes
• Major depression is a leading cause of disability and lost work productivity affecting more than 30 million people in Europeⁱ
• Brintellix has a unique multimodal activity profile that may translate into therapeutic benefits in depression that current therapies do not sufficiently address
• The recommended dose range is 5-20 mg per day

Valby, Denmark, 25 October 2013 - H. Lundbeck A/S (Lundbeck) today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion and recommended marketing authorisation of Brintellix (vortioxetine) for the treatment of adults w ith Major Depressive Episodes, commonly referred to as depression.

"Depression is a complex and heterogeneous disease with emotional, physical and cognitive symptoms that make it challenging for many patients to fully regain their ability to function in their personal and professional lives," said Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck. "The approval of this novel pharmacological therapy continues our long history of innovation in the research and treatment of brain diseases and underscores our commitment to advance the treatment of depression."

Brintellix has been studied in a comprehensive global clinical development program that included more than 7,000 patients. Close to 4,000 patients w ere treated w ith Brintellix in 12 short-term (6 to 8 w eeks), placebo-controlled studies of major depressive disorder. In 9 of the 12 studies, Brintellix show ed statistically significant and clinically relevant effects on depression relative to placebo; one of these studies w as a dedicated study in the elderly. The symptoms of depression w ere assessed using the Montgomery and Åsberg Depression Scale (MADRS) or Hamilton Depression Rating Scale (HAM-D24). In addition, significant effect w as observed in the proportions of responders and remitters and in the improvement in the Clinical Global Impression – Global Improvement (CGI-I) score. The efficacy of Brintellix increased w ith higher doses.

Furthermore, the efficacy of Brintellix w as demonstrated in patients w ith major depression in a 12-w eek head-to-head study versus the most recently approved antidepressant in the EU, agomelatine. Brintellix w as significantly superior to agomelatine as measured by improvement in the MADRS total score and by the proportion of remitters and improvement in the CGI-I.

The long-term effect of Brintellix w as demonstrated in a 24-64 w eek, relapse-prevention study. Brintellix treatment resulted in a statistically significant longer time to relapse of depression compared to placebo. Treatment w ith Brintellix reduced the risk of relapse by 50% compared to placebo.

The most common adverse reaction in patients treated w ith Brintellix w as nausea. Adverse reactions w ere usually mild or moderate and occurred w ithin the first tw o w eeks of treatment. The reactions w ere usually transient and did not generally lead to discontinuation of therapy.

In short- and long-term clinical studies, Brintellix had no significant effect on body w eight. The incidence of self-reported adverse sexual reactions w as low and similar to placebo in the short- and long-term studies. In studies using the ASEX scale, no clinically relevant difference to placebo in symptoms of sexual dysfunction w as seen at the 5 to 15 mg/day doses of Brintellix. For the 20 mg/day dose, an increase in TESD w as seen compared to placebo. Brintellix has not been associated w ith any clinically significant effects on vital signs, including systolic and diastolic blood pressure and heart rate.

The recommended starting dose of Brintellix is 10 mg once daily in adults less than 65 years of age. The dose may be increased to a maximum of 20 mg once daily or decreased to a minimum of 5 mg once daily depending on individual patient response.

The European Commission usually delivers its final decision w ithin 2-3 months of the CHMPpositive opinion. The decision w ill be applicable to all 28 European Union member states plus Iceland Liechtenstein and Norw ay. Subject to the Commission's final approval and completion of pricing and reimbursement discussions, it is expected that Brintellix w ill be available to patients in the first markets during the first half of 2014.

About Brintellix (vortioxetine)

The mechanism of action of vortioxetine is thought to be related to its direct modulation of serotonergic receptor activity and inhibition of the serotonin (5-HT) transporter. Nonclinical data indicate that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter, leading to modulation of neurotransmission in several systems, including predominantly the serotonin but probably also the norepinephrine, dopamine, histamine, acetylcholine, GABA and glutamate systems. This multimodal activity is considered responsible for the antidepressant and anxiolytic-like effects and the improvement of cognitive function, learning and memory observed w ith vortioxetine in animal studies. How ever, the precise contribution of the individual targets to the observed pharmacodynamic profile remains unclear and caution should be applied w hen extrapolating animal data directly to man.

The World Health Organization has issued a new Anatomical Therapeutic Chemical (ATC) code for Brintellix to be implemented in 2014.

Brintellix w as discovered by Lundbeck researchers in Copenhagen, Denmark. Brintellix received FDA approval for the treatment of major depressive disorder on 30 September 2013.

The Science of Major Depression

The monoamine-deficiency theory posits that the underlying pathophysiological basis of depression is a depletion of serotonin, norepinephrine or dopamine in the central nervous system. And w hile the exact cause of depression is unknow n, research suggests that there are multiple serotonin receptors that may be important in major depression and may influence many biologic and neurologic processes. The release of bio-chemicals, such as serotonin, dopamine and norepinephrine enables impulses to be passed from one cell to another in the nervous system.

Lundbeck contacts

Investors: Media:

Palle Holm Olesen Mads Kronborg Chief Specialist, Head of Investor Relations Media Relations Manager PALO@lundbeck.com MAVK@lundbeck.com +45 36 43 24 26 +45 36 43 30 00

Jens Høyer Investor Relations Officer JSHR@lundbeck.com +45 36 43 33 86

About Lundbeck

H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 50 years, w e have been at the forefront of research w ithin neuroscience. Our development and distribution of pioneering treatments continues to make a difference to people living w ith brain diseases. Our key areas of focus are alcohol dependence, Alzheimer's disease, depression/anxiety, epilepsy, Huntington's disease, Parkinson's disease, schizophrenia and stroke.

Our 5,800 employees in 57 countries are engaged in the entire value chain throughout research, development, production, marketing and sales, and are committed to improving the quality of life of people living w ith brain diseases. Our pipeline consists of several late-stage development programs and our products are available in more 100 countries. We have research centers in China, Denmark and the United States, and production facilities in China, Denmark, France, Italy and Mexico. Lundbeck generated revenue of approximately DKK 15 billion in 2012 (EUR 2 billion; USD 2.6 billion).

Lundbeck's shares are listed on the stock exchange in Copenhagen under the symbol "LUN". Lundbeck has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol "HLUYY". For additional information, w e encourage you to visit our corporate site w ww.lundbeck.com.

Safe Harbor/Forward-Looking Statements

The abov e information contains forward-looking statements that prov ide our expectations or forecasts of future ev ents such as new product introductions, product approv als and financial performance.

Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of dev elopment projects, production problems ,

unexpected contract breaches or terminations, gov ernment-mandated or market-driv en price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and gov ernmental laws and related interpretation thereof, and unexpected growth in costs and expenses.

Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapprov ed uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approv ed drugs for any use they deem appropriate, including unapprov ed uses, at Lundbeck, promotion of unapprov ed uses is strictly prohibited.

i J.Olesen, et al. Eur J Neurology. 2012; 19:155-162