Lundbeck Launches Support Program for Parents of Children with Infantile Spasms

  Lundbeck Launches Support Program for Parents of Children with Infantile
  Spasms

Business Wire

DEERFIELD, Ill. -- October 16, 2013

UnderStanding Together was launched today for parents of children with
infantile spasms (IS), a difficult form of epilepsy that usually affects
children between the ages of four and eight months.^1 This Lundbeck program
connects parents coping with this diagnosis with others who have faced similar
challenges and have experience with Lundbeck’s treatment for IS, SABRIL®
(vigabatrin). By calling 855-417-7859, families can enroll in the program to
speak on the phone with another parent who has a child with infantile spasms.

A diagnosis of infantile spasms can be overwhelming, making treatment
decisions very difficult. Recommendations issued by the National Organization
for Rare Diseases (NORD),^2 the American Academy of Neurology (AAN)^3 and the
Tuberous Sclerosis (TS) Alliance^4 all agree that infantile spasms be
diagnosed as early as possible and managed with one of two approved
treatments.

SABRIL is approved by the U.S. Food and Drug Administration as monotherapy for
pediatric patients one month to two years of age with infantile spasms for
whom the potential benefits outweigh the potential risk of permanent vision
loss.^5,6 In evaluating whether to start SABRIL, doctors and parents work
together to assess the risk of vision loss versus the benefit of the
medication. There are other serious risks associated with SABRIL. Please see
the important safety information below for more details.

“When my daughter Addie first started experiencing infantile spasms, we were
desperate to find ways to help her. I spent hours researching online, and the
information I found was overwhelming,” says Karen, a mother who will speak
with other parents on the telephone via the UnderStanding Together program.
“It was extremely helpful to connect with other families who had already gone
through the initial shock and decision making associated with an infantile
spasms diagnosis. Now it’s come full circle, and I’m able to talk with others
in a similar situation.”

Participants in the UnderStanding Together program will be paired up with
parents whose children have IS and have used SABRIL. They can ask questions
and discuss experiences to learn how the parent worked with a healthcare team
through the decision-making process they faced. Following the call,
participants will receive additional information and resources in the mail.

“SABRIL has been prescribed to more than 2,500 infantile spasms patients,
according to our SABRIL patient registry, which collects information on all
patients who have taken SABRIL since its approval in 2009,”^7 said Amy Magro,
Director of Epilepsy Marketing at Lundbeck. “We know how tough treatment
decisions can be for parents of children with IS, and this program is part of
our ongoing commitment to support both families and health care professionals
in making informed decisions.”

For more information, please visit www.SABRIL.net. To enroll in the
UnderStanding Together program, call toll-free 855-417-7859.

About Infantile Spasms

Infantile spasms is a difficult-to-treat epilepsy syndrome that usually
strikes infants between four to eight months old.^1 Infants suffer spasms that
typically last for one to five seconds and occur in clusters of up to 100
spasms at a time.^8,9 Each year approximately 2,000 to 2,500 new cases of IS
are reported in the U.S.^9 SABRIL may not be appropriate for use in all
patients with IS.

Use

SABRIL for Oral Solution is a prescription medicine used to treat babies, 1
month to 2 years old who have infantile spasms (IS), if you and your doctor
decide that the possible benefits of SABRIL are more important than the
possible risk of vision loss.

Important Safety Information

                             WARNING: VISION LOSS

                See Medication Guide for complete information

In all people who take SABRIL:

  *You are at risk for vision loss with any amount of SABRIL
  *Your risk of vision loss may be higher the more SABRIL you take daily and
    the longer you take it
  *It is not possible for your doctor to know when vision loss will happen.
    It could happen soon after starting SABRIL or any time during treatment.
    It may even happen after treatment has stopped

SABRIL can permanently damage the vision of anyone who takes it. The most
noticeable loss is in the ability to see to the side when looking straight
ahead (peripheral vision). If this happens, it will not get better. People who
take SABRIL do not lose all of their vision, but some people can have severe
loss particularly to their peripheral vision. With severe vision loss you may
only be able to see things straight in front of you (sometimes called ‘tunnel
vision’). You may also have blurry vision.

Because of the risk of vision loss, SABRIL is used in babies with IS only when
you and your doctor decide that the possible benefits of SABRIL are more
important than the risks. Parents or caregivers are not likely to recognize
the symptoms of vision loss in babies until it is severe. Doctors may not find
vision loss in babies until it is severe. It is difficult to test vision in
babies, but all babies should have their vision tested before starting SABRIL
or within 4 weeks after starting SABRIL, and every 3 months after that until
SABRIL is stopped. Your baby should have a vision test after SABRIL is
stopped. Your baby may not be able to be tested in certain situations. Your
doctor will determine if your baby can be tested.

Tell your doctor right away if you think that your baby is not seeing as well
as before taking SABRIL or is acting differently than normal. Even if your
baby’s vision seems fine, it is important to get regular vision tests because
damage can happen before your baby acts differently. Even these regular vision
tests may not show the damage to your baby’s vision before it is serious and
permanent. If your baby does not have these vision tests regularly, your
doctor may stop prescribing SABRIL for your baby. If your baby is not able to
complete vision testing, your doctor may continue prescribing SABRIL for your
baby. But, your doctor will not be able to watch for vision loss in your baby.

Brain pictures taken by magnetic resonance imaging (MRI) show changes in some
babies after they are given SABRIL. It is not known if these changes are
harmful.

Like other antiepileptic drugs, SABRIL may cause suicidal thoughts or actions
in a very small number of people, about 1 in 500 people taking it.

Do not stop SABRIL without first talking to a healthcare provider. Stopping
SABRIL suddenly can cause serious problems. Stopping a seizure medicine
suddenly can cause seizures that will not stop (status epilepticus) in people
who are being treated for seizures.

Before giving SABRIL to your baby, tell the doctor about all of your baby’s
medical conditions including if your baby has or ever had an allergic reaction
to SABRIL, or any vision or kidney problems.

Tell your doctor about all the medicines your baby takes.

SABRIL can cause serious side effects in adults such as low red blood cell
counts, sleepiness and tiredness, nerve problems, weight gain that happens
without swelling, and swelling. It is not known if these side effects also
happen in babies who take SABRIL. SABRIL may make certain types of seizures
worse. You should tell your baby’s doctor right away if the seizures get
worse.

The most common side effects of SABRIL in babies and young children include:
sleepiness—some babies may have a harder time suckling and feeding or may be
irritable, ear infection, and irritability. Tell your doctor if your baby has
any side effect that bothers you or that does not go away. These are not all
of the possible side effects of SABRIL. For more information, ask your doctor
or pharmacist.

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

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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

H. Lundbeck A/S 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. National Institute of Neurological Disorders and Stroke. NINDS Infantile
Spasms Information Page.
http://www.ninds.nih.gov/disorders/infantilespasms/infantilespasms.htm.
Accessed 9/30/13.

2. Go, CY et al. NORD Physician Guide to Infantile Spasms. 2013.

3. Go, CY et al. Evidence-based guideline update: Medical treatment of
infantile spasms: Report of the Guideline Development Subcommittee of the
American Academy of Neurology and the Practice Committee of the Child
Neurology Society. Neurology 2012; 78:1974.

4. Krueger, DA et al. Tuberous sclerosis complex surveillance and management:
recommendations of the 2012 international tuberous sclerosis complex consensus
conference. Pediatric Neurology 2013; 49:255.

5. SABRIL® (vigabatrin) for Oral Solution full Prescribing Information,
Deerfield, IL. Lundbeck 2012.

6. SABRIL® (vigabatrin) Tablets full Prescribing Information, Deerfield, IL.
Lundbeck 2012.

7. Sergott, RC et al. Three-year results from the Sabril® registry continue to
yield low rate of visual field defects [poster]. American Epilepsy Society
66th Annual Meeting; 2012 November 30 – December 4; San Diego, CA. Poster Nr.
1.369.

8. Infantile Spasms. Epilepsy.com.
http://www.epilepsy.com/epilepsy/epilepsy_infantilespasms. Accessed 9/23/13.

9. Wheless, JW et al. Infantile spasms (West syndrome): update and resources
for pediatricians and providers to share with parents. BMC Pediatrics 2012;
12:108.

SABRIL is a registered trademark of Lundbeck.

VGB-B-00016

Contact:

Lundbeck
Matt Flesch, 847-282-1154
 
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