H. Lundbeck A — Earnings Release 2014

Nov 3, 2014

-- The head-to-head QUALIFY study compared the effectiveness of aripiprazole
once-monthly to paliperidone palmitate once-monthly in adult patients with
schizophrenia
-- Patients treated with
aripiprazole once-monthly
demonstrated a statistically significant improvement on the primary
endpoint, quality-of-life measure, compared to those treated with
paliperidone palmitate
-- Discontinuations due to adverse events occurred in 10.8% of patients in the
aripiprazole once-monthly group compared to 18.4% of patients in the
paliperidone once-monthly group

Valby, Denmark and Princeton, N.J., U.S., 3 November 2014 - H. Lundbeck A/S
(Lundbeck) and Otsuka America Pharmaceutical Inc. (Otsuka) today announced
results from the QUALIFY study[i]; the first study of its kind comparing two
atypical long-acting injectable anti-psychotic therapies in a close-to-real
life setting. The effectiveness of aripiprazole (aripiprazole extended-release
injectable suspension, for intramuscular use, Abilify Maintena®) and
paliperidone palmitate once-monthly (paliperidone palmitate extended-release
injectable suspension, for intramuscular use) in adult patients with
schizophrenia was measured by the Heinrichs-Carpenter Quality of Life Scale
(QLS; primary endpoint). QLS is clinician-rated scale designed to evaluate
social functioning and behaviour in patients with schizophrenia.

The QLS is one of the most commonly used quality-of-life scales in
schizophrenia clinical trials. The four domains of the QLS evaluate the
patient’s intrapsychic foundations (sense of purpose, motivation, emotional
interaction, etc.); interpersonal relations (social activity, social network,
etc.) instrumental role (work functioning, work satisfaction, etc.); and common
objects and activities. Higher scores indicate better quality of life[ii].
Additional secondary assessments include the Clinical Global Impressions scales
(CGI, which measures symptom severity and treatment response), the
Investigator’s Assessment Questionnaire (IAQ, designed to evaluate response to
antipsychotics) and the Subjective Well-being under Neuroleptic Scale – short
version (SWN-S, a self-rating scale for patients on antipsychotic drugs).

In a 28 week trial, patients treated with aripiprazole once-monthly
demonstrated a statistically significant improvement in the QLS total score
compared to patients treated with paliperidone palmitate once-monthly. The mean
difference between treatments of the change from baseline to week 28 in QLS
total score was 4.4 (p=0.031) with a respective change of 7.5 for the
aripiprazole once-monthly group and 3.1 for the paliperidone once-monthly
group.

A difference between treatments was also confirmed by a change in the Clinical
Global Impression-Severity Scale (CGI-S, used by clinicians to evaluate the
severity of a patient’s illness) from baseline to 28 weeks of treatment
(p=0.004). Both treatments were generally well-tolerated, however
discontinuation rates due to adverse events were 10.8% (n=16/148) vs. 18.4%
(n=27/147), for aripiprazole once-monthly group vs paliperidone once monthly
group, respectively[iii].

About the QUALIFY study

QUALIFY is a randomized, open-label rater-blinded, head-to-head comparison of
intramuscular aripiprazole once-monthly (400 or 300 mg/month) and intramuscular
paliperidone palmitate injection (50 to 150 mg/month (EU) or 78 to 234 mg/month
(US and Canada)) over 28 weeks. The study was designed as a non-inferiority
study, allowing for subsequent superiority testing, if non-inferiority
criterion was met. After a minimum of 3-week oral conversion period where
patients received either oral aripiprazole or oral paliperidone, the
intramuscular formulations were administered according to the prescribing
information for five weeks and continued for 20 weeks. The primary endpoint was
the QLS total score change from baseline to week 28. The study randomized 295
patients in Europe and North America of which 281 received study treatment.

The study design was presented at the New Clinical Drug Evaluation Unit (NCDEU)
53rd Annual Meeting in May 2013[iv]. Data from the QUALIFY study will be
presented at upcoming medical congresses and in scientific publications.

About Abilify Maintena (aripiprazole once-monthly)

Abilify Maintena (aripiprazole once-monthly) is the first and only once-monthly
injection of a dopamine D2 partial agonist. It is available in a number of
European countries for maintenance treatment of schizophrenia in adult patients
stabilised with oral aripiprazole. Furthermore, it is available in the US for
the treatment of schizophrenia. In Canada it is available for the maintenance
treatment of schizophrenia in stabilised adult patients and in Australia for
maintenance of clinical improvement in the treatment of schizophrenia.

About schizophrenia

Schizophrenia is a disease characterized by a distortion in the process of
thinking and of emotional responsiveness. It most commonly manifests as
hallucinations, paranoid or bizarre delusions, or disorganized speech and
thinking, and is accompanied by significant social or occupational dysfunction.
Onset of symptoms typically occurs in young adulthood and the condition is
chronic, often requiring life-long treatment to mitigate symptoms. It has been
estimated that schizophrenia affects approximately 1% of the adult population
in the US, and approximately 24 million people worldwide[v], [vi]. In the US,
there are approximately 2.4 million adults with schizophrenia, prevalent
equally in both genders[vii],[viii]. While there is no cure for the disease,
symptoms and risk of relapse—the re-emergence or worsening of psychotic
symptoms[ix] — can be managed in most patients with appropriate antipsychotic
treatment.

Otsuka contacts

Investors: Media:

Yoko Ishii Rose Weldon
Otsuka Holdings Co., Ltd. Otsuka America Pharmaceuticals, Inc.
Ishiiyo@Otsuka.jp rose.weldon@otsuka-us.com
+81 3 6361 7411 +1 609 524 6879

Lundbeck contacts

Investors: Media:

Palle Holm Olesen Mads Kronborg
Vice President, Investor Relations Director, Media Relations
PALO@lundbeck.com MAVK@lundbeck.com
+45 36 43 24 26 +45 36 43 30 00

Jens Høyer Ashleigh Nicole Duchene
Specialist, Investor Relations Senior Manager, Communication
JSHR@lundbeck.com ADUC@lundbeck.com
+45 36 43 33 86 +1 847 282 1164

About Otsuka America Pharmaceuticals, Inc.

Otsuka America Pharmaceutical, Inc. (OAPI) is an innovative, fast-growing
healthcare company that commercializes Otsuka-discovered and in-licensed
products in the U.S., with a strong focus on neuroscience, oncology,
cardio-renal and medical devices. For more information, visit
http://www.otsuka-us.com.

OAPI is a subsidiary of Otsuka America, Inc. (OAI), a holding company
established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical
Co., Ltd, based in Japan. The Otsuka Group employs approximately 42,000 people
globally and its products are available in more than 80 countries worldwide.
Otsuka welcomes you to visit its global website at
https://www.otsuka.co.jp/en/.

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, we have been at the
forefront of research within neuroscience. Our key areas of focus are alcohol
dependence, Alzheimer’s disease, bipolar disorder, depression/anxiety,
epilepsy, Huntington’s disease, Parkinson’s disease, schizophrenia, stroke and
symptomatic neurogenic orthostatic hypotension (NOH).

An estimated 700 million people worldwide are living with brain disease and far
too many suffer due to inadequate treatment, discrimination, a reduced number
of working days, early retirement and other unnecessary consequences. Every
day, we strive for improved treatment and a better life for people living with
brain disease – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.

Our approximately 6,000 employees in 57 countries are engaged in the entire
value chain throughout research, development, production, marketing and sales.
Our pipeline consists of several late-stage development programmes and our
products are available in more 100 countries. We have research centres in
China, Denmark and the United States and production facilities in China,
Denmark, France and Italy. Lundbeck generated revenue of approximately DKK15.3
billion in 2013 (EUR2.1 billion; USD2.7 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, we encourage you to
visit our corporate site www.lundbeck.com.

Safe Harbor/Forward-Looking Statements

The above information contains forward-looking statements that provide our
expectations or forecasts of future events such as new product introductions,
product approvals 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 development projects, production problems, unexpected contract breaches or
terminations, government-mandated or market-driven 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 governmental
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
unapproved 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 approved drugs for any use they deem appropriate,
including unapproved uses, at Lundbeck, promotion of unapproved uses is
strictly prohibited.

[i]Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients
with Schizophrenia. ClinicalTrials.gov. 2014. Available at:
https://clinicaltrials.gov/ct2/show/NCT01795547?term=NCT01795547&rank=1.
Accessed on Oct. 28, 2014.

[ii] Heinrichs, D., et al. The Quality of Life Scale: An Instrument for Rating
the Schizophrenic Deficit Syndrome. Schizophrenia Bulletin. 1984; 10: 388-396.

[iii]Data on File: 14724A – the QUALIFY study.

[iv] Hansen, K., Baker R., Peters-Strickland T., Forray C., Nylander AG., Eramo
A.: “Assessing the Effectiveness of Aripiprazole Once-monthly vs. Paliperidone
Palmitate for the Long-term Treatment of Schizophrenia”. Poster from NCDEU2013.

[v]National Institute of Mental Health (NIMH). Health Topics: Statistics.
Available at http://www.nimh.nih.gov/statistics/1SCHIZ.shtml. Accessed May 14,
2013.

[vi]World Health Organization (WHO). Schizophrenia Fact Sheet. 2010. Available
at http://www.who.int/mental_health/management/schizophrenia/en/. Accessed May
14, 2013.

[vii]National Institutes of Mental Health (NIMH). The Numbers Count: Mental
Disorders in America. Available at
http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-i
n-america/index.shtml.
Accessed May 14, 2013.

[viii] Regier, Darrel et al. The de Facto US Mental and Addictive Disorder
Service System. Archives of General Psychiatry. 1993; 50: 85-94.

[ix] Almond, S et al. Relapse in schizophrenia: costs, clinical outcomes and
quality of life. British Journal of Psychiatry, 2004; 184: 346-351.