SABRIL® (vigabatrin) Vision Data Presented in Two Late-Breaking Posters at American Epilepsy Society Annual Meeting

  SABRIL® (vigabatrin) Vision Data Presented in Two Late-Breaking Posters at
  American Epilepsy Society Annual Meeting

Business Wire

WASHINGTON -- December 9, 2013

Two late-breaking presentations focused on SABRIL vision data were presented
today at the annual meeting of the American Epilepsy Society (AES). One
presentation includes interim results from a prospective, open-label trial of
retinal structure and function in adult patients with refractory complex
partial seizures (CPS), and the other presents four-year data from Lundbeck’s
SABRIL patient registry.^1,2 Because of the risk of permanent vision loss, the
U.S. Food and Drug Administration (FDA) requires a Risk Evaluation and
Mitigation Strategy (REMS) for SABRIL which includes the ongoing registry.

SABRIL is indicated as adjunctive therapy for patients 10 years of age and
older with refractory CPS who have inadequately responded to several
alternative treatments and for whom the potential benefits outweigh the risk
of vision loss. SABRIL is not indicated as a first line agent for CPS. SABRIL
is indicated as monotherapy for pediatric patients 1 month to 2 years of age
with infantile spasms (IS) for whom the potential benefits outweigh the
potential risk of vision loss.^3

Initial results of the SABRIL^® Vision Study (Poster 3.302, Hall D, Level 2)

Currently, much of the published SABRIL vision data are derived from
cross-sectional studies without baseline values. This study includes baseline
values and aims to longitudinally measure changes in optic nerve and retinal
structure and function using static perimetry and spectral optical coherence
tomography (OCT). It is an ongoing, one-year, open-label clinical study, and
the first prospective, long-term study evaluating SABRIL vision effects.
Interim results presented at AES cover the first 30 patients who reached their
first post-reference vision assessments, which occurred at Month 3.^1

Four-Year Results from the SABRIL^® Registry (Poster 3.303, Hall D, Level 2)

Of the 5,487 patients enrolled in the registry through August 27, 2013, 3,436
had IS and 1,696 had refractory CPS. Median duration of treatment in the
registry was 9.9 months. A small data subset of patients with detailed vision
results reviewed by independent, expert neuro-ophthalmologists is included in
the poster presentation. This subset included results from all physicians who
voluntarily submitted vision results for expert analysis. Because of the
nature of the registry and vision testing variability, clear comparisons
cannot be drawn between registry data and clinical trial data.^2

“Sabril is an important therapeutic option for people living with refractory
complex partial seizures or infantile spasms, and it’s essential that we
continue studying its potential benefits and risks,” said Robert C. Sergott,
MD, an author on both late-breaking poster presentations, director of
neuro-ophthalmology at the Wills Eye Institute, and professor of
ophthalmology, neurology and neurosurgery at Thomas Jefferson University
Medical College. “It’s encouraging to see the Sabril Vision Study enroll
patients and begin to yield results. Prospective studies with baseline
measures, consistent evaluation methods, and longitudinal analyses are
critical to evaluating this therapy. Meanwhile, the registry continues to
collect information on Sabril use since it became available in the United
States in 2009.”

About the SABRIL Registry

All patients using Sabril are enrolled in a registry. The registry collects
prescriber specialty, patient demographics, diagnosis, prior and concurrent
anti-seizure medications, periodic ophthalmologic assessment data (i.e., the
results of mandatory monitoring every three months, unless otherwise
exempted), and the proportion of patients with refractory CPS and IS who
continue/discontinue receiving Sabril after the treatment initiation phase.

About SABRIL® (vigabatrin)

SABRIL is a prescription oral antiepileptic drug developed in the United
States by Lundbeck. SABRIL is available in 500-mg tablets or 500-mg packets of
powder for oral suspension. Because of the risk of permanent vision loss,
SABRIL is available only through a restricted distribution program under a
REMS called the SHARE Program (1-888-45-SHARE). For more information, please
visit www.SABRIL.net.

Important Safety Information

                             WARNING: VISION LOSS

         See full Prescribing Information for complete boxed warning

  *SABRIL causes progressive and permanent bilateral concentric visual field
    constriction in a high percentage of patients. In some cases, SABRIL may
    also reduce visual acuity.
  *Risk increases with total dose and duration of use, but no exposure to
    SABRIL is known that is free of risk of vision loss
  *Risk of new and worsening vision loss continues as long as SABRIL is used,
    and possibly after discontinuing SABRIL
  *Unless a patient is formally exempted, periodic vision assessment is
    required for patients on SABRIL. However, this assessment cannot always
    prevent vision damage.
  *SABRIL can cause permanent vision loss. SABRIL is available only through a
    restricted program called the SHARE Program.

  *SABRIL causes permanent bilateral concentric visual field constriction.
    Because assessing vision may be difficult in infants and children, the
    frequency and extent of vision loss in pediatric patients are poorly
    characterized. In adults, 30% or more of patients can be affected, ranging
    in severity from mild to severe, including tunnel vision to within 10° of
    visual fixation, and can result in disability. SABRIL can also damage the
    central retina and may decrease visual acuity.
  *The onset of vision loss is unpredictable and can occur soon after
    starting treatment, at any time during treatment, even after months or
    years, or possibly after discontinuation. Symptoms of vision loss from
    SABRIL are unlikely to be recognized by patients or caregivers before it
    is severe. Vision loss of milder severity may still adversely affect
    function.
  *Unless a patient is formally exempted from periodic ophthalmologic
    assessment as documented in the SHARE Program, vision should be assessed
    at baseline (no later than 4 weeks after starting SABRIL), every 3 months
    during therapy, and at 3 to 6 months after discontinuing therapy. Once
    detected, vision loss is not reversible. Even with frequent monitoring,
    some patients will develop severe vision loss. Consider drug
    discontinuation, balancing benefit and risk, if vision loss is documented.
  *Because of the risk of permanent vision loss, withdraw SABRIL from
    patients with refractory complex partial seizures who fail to show
    substantial clinical benefit within 3 months of initiation, and from
    patients with infantile spasms who fail to show substantial clinical
    benefit within 2 to 4 weeks of initiation, or sooner, if treatment failure
    becomes obvious. Periodically reassess patient response and continued need
    for SABRIL.
  *Do not use SABRIL in patients with, or at high risk of, other types of
    irreversible vision loss, or, with other drugs associated with serious
    adverse ophthalmic effects, unless the benefits clearly outweigh the
    risks. The interaction in these situations has not been well
    characterized, but is likely adverse.
  *Use the lowest dose and shortest exposure to SABRIL that is consistent
    with clinical objectives. Adjust the dose in patients with renal
    impairment.
  *Abnormal magnetic resonance imaging (MRI) signal changes have been
    observed in some infants treated for IS with SABRIL. These changes
    generally resolved with discontinuation of treatment, and resolved in a
    few patients despite continued use.
  *Antiepileptic drugs (AEDs), including SABRIL, increase the risk of
    suicidal thoughts and behavior. Monitor appropriate patients for the
    emergence or worsening of depression, suicidal thoughts or behavior,
    and/or any unusual changes in mood or behavior.
  *As with all AEDs, discontinue SABRIL gradually to avoid withdrawal
    seizures.
  *SABRIL can cause anemia, peripheral neuropathy, weight gain, and edema.
    SABRIL can cause somnolence and fatigue. Advise patients not to drive or
    operate machinery until they know how it will affect them.
  *Vigabatrin is excreted in human milk and may cause serious adverse events
    in nursing infants. Do not use SABRIL during pregnancy unless the
    potential benefit justifies the potential risk to the fetus. Pregnancy
    Registry: To provide information regarding the effects of in utero
    exposure to SABRIL, physicians should recommend that pregnant patients
    taking SABRIL enroll in the North American Antiepileptic Drug (NAAED)
    Pregnancy Registry. Patients must call the toll-free number 1-888-233-2334
    to enroll. Registry information can be found at
    http://www.aedpregnancyregistry.org/.
  *The most common adverse reactions in controlled studies (≥5% over placebo)
    include:

       *Adults >16 years of age: fatigue, somnolence, nystagmus, tremor,
         blurred vision, memory impairment, weight gain, arthralgia, abnormal
         coordination, and confusional state
       *Pediatrics 10 to 16 years of age: increased weight, upper respiratory
         tract infection, tremor, fatigue, aggression, and diplopia

  *In infants, the most common adverse reactions in a controlled clinical
    study (incidence >5%) were somnolence, bronchitis, ear infection, and
    acute otitis media.

Please see accompanying SABRIL full Prescribing Information including Boxed
Warning, and Medication Guide; go to www.sabril.net, or call toll-free
1-888-45-SHARE (1-888-457-4273).

About Lundbeck in the U.S.

A wholly owned subsidiary of H. Lundbeck A/S of Denmark, Lundbeck in the
United States is headquartered in Deerfield, Illinois, and is committed to
providing innovative specialty therapies that fulfill unmet medical needs of
people with central nervous system (CNS) disorders, including several
therapies for people with challenging seizure disorders.

With a special commitment to the epilepsy community, Lundbeck actively
supports and participates in hundreds of community-based initiatives. Learn
more about our epilepsy community programs at
http://www.lundbeck.com/us/our-commitment/community-involvement.

About H. Lundbeck A/S

Lundbeck is a global pharmaceutical company highly committed to improving the
quality of life of people living with brain diseases. For this purpose,
Lundbeck is engaged in the entire value chain throughout research,
development, production, marketing and sales of pharmaceuticals across the
world. The company’s products are targeted at disorders such as depression and
anxiety, psychotic disorders, epilepsy, Huntington’s, Alzheimer’s and
Parkinson’s diseases. Lundbeck’s pipeline consists of several mid- to
late-stage development programs.

Lundbeck employs more than 5,800 people worldwide, 2,000 of whom are based in
Denmark. We have employees in 57 countries and our products are registered in
more than 100 countries. We have research centers in Denmark, China and the
United States and production facilities in Italy, France, Mexico, China and
Denmark. Lundbeck generated revenue of approximately DKK 15 billion in 2012.
Lundbeck’s shares are listed on the stock exchange in Copenhagen under the
symbol “LUN.” Lundbeck has a sponsored Level 1 ADR programme listed in the US
(OTC) under the symbol “HLUYY.” For additional information, we encourage you
to visit our corporate site www.lundbeck.com.

Sources

1.Johnson CA, Sergott RC, Laxer KD, et al. Late-Breaking Abstract 3.302.
    Presented at the 67th Annual Meeting of the American Epilepsy Society,
    Dec. 9, 2013, Washington, DC.
2.Sergott RC, Foroozan R, Pellock J, et al. Late-Breaking Abstract 3.303.
    Presented at the 67th Annual Meeting of the American Epilepsy Society,
    Dec. 9, 2013, Washington, DC.
3.SABRIL® (vigabatrin) full Prescribing Information, Deerfield, IL.
    Lundbeck. 2013.

SABRIL and SHARE are registered trademarks of Lundbeck.

VGB-B-00062

Contact:

for Lundbeck
Matt Flesch, 847-282-1154
 
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