Lundbeck Inc. Receives 2010 Corporate Award from National Organization for Rare Disorders

DEERFIELD, Ill., May 19, 2010 – The National Organization for Rare Disorders (NORD) honored Lundbeck Inc. last night with its 2010 Corporate Award for the development of Sabril^Âź (vigabatrin) Powder for Oral Solution. Presented at NORD’s Partners in Progress Gala in Washington, D.C., the award recognizes efforts put forth by Lundbeck to make Sabril available in the U.S. for the treatment of infantile spasms (IS), a rare and difficult-to-treat epilepsy syndrome that usually strikes infants between four to eight months old.¹

Sabril is the first therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of IS. It is approved as monotherapy for pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of permanent vision loss.

"We are very proud to receive this award since the development of Sabril embodies our commitment to bringing innovative and high-need treatment options to patients diagnosed with rare diseases,” said Sean Nolan, president of Lundbeck Inc. “The Sabril approval in the U.S. was a complicated and lengthy process. Its availability is the result of extensive efforts over many years by multiple stakeholders including the advocacy community, physicians, Lundbeck and the FDA."

"Having a child with a rare condition like infantile spasms is overwhelming for parents, as proper diagnosis can be delayed and treatment options are limited," said Peter L. Saltonstall, NORD president and CEO. "With this award, we honor Lundbeck for making this important treatment option available to the physicians and patients coping with this serious condition."

Sabril causes permanent vision loss in infants, children and adults. Because assessing vision loss is difficult in children, the frequency and extent of vision loss in infants and children is poorly characterized. In adults, Sabril causes progressive and permanent bilateral concentric visual field constriction in 30 percent or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation and can result in disability. In some cases, Sabril also can damage the central retina and may decrease visual acuity. The lowest dose and shortest exposure to Sabril should be used that is consistent with clinical objectives.

Development of Sabril was sidetracked more than a decade ago due in large part to potential risks that limited the number of patients who could potentially benefit from treatment, including the risk of Sabril-induced permanent vision loss. After acquiring Sabril in 2004, Lundbeck (formerly Ovation Pharmaceuticals) committed to completing the development of Sabril and characterizing the potential benefits and risks of therapy. Multiple challenges delayed the approval process, including the need for an extensive Risk Evaluation and Mitigation Strategy (REMS). Following unanimous endorsement by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee, Sabril was approved for use in the U.S. in August 2009.

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.1 An estimated 8,500 infants in the U.S. have been diagnosed with IS,² and each year approximately 2,500 new cases of IS are reported in the U.S. Sabril may not be appropriate for use in all patients with IS.

About Sabril^Âź (vigabatrin)
Sabril is an oral antiepileptic drug developed in the United States by Lundbeck Inc. Sabril is available in 500 mg packets of powder for oral solution in babies one month to two years old who have IS if the parent or caregiver and the doctor decide that the possible benefits of Sabril are more important than the possible risk of vision loss. The precise mechanism of Sabril’s antiseizure effect is unknown, but is believed to be the result of its action as an irreversible inhibitor of gamma-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous system. No direct correlation between plasma concentration and efficacy has been established. The duration of drug effect is presumed to be dependent on the rate of enzyme re-synthesis rather than on the rate of elimination of the drug from the systemic circulation.³

About Sabril-Induced Abnormal MRI Signal Changes
In a retrospective epidemiologic study in infants treated for IS with Sabril, increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem and cerebellum have been observed. The prevalence of these changes was 21.5 percent in Sabril-treated patients versus 4.1 percent in patients treated with other therapies. These changes generally resolved with discontinuation, and in a few patients the lesion resolved despite continued Sabril use reported in the study above, in postmarketing experience and in published literature. Some infants exhibited coincident motor abnormalities; however, no causal relationship has been established. The long-term sequelae of the Sabril-induced MRI changes are unknown and have not been studied. The pattern of signal changes observed in IS patients was not observed in older children and adult patients treated for refractory CPS. Intramyelinic edema (IME) has been reported in a vigabatrin-treated infant on postmortem examination. The infant had hypoxic ischemic brain injury and abnormalities of myelin prior to treatment with vigabatrin.

About NORD
The National Organization for Rare Disorders (NORD) was established in 1983.  It is a nonprofit organization representing all Americans affected by rare diseases.  NORD’s services include advocacy on public policy issues; education and information for patients, families, medical professionals, and the public; patient assistance programs to help patients obtain certain medications they could not otherwise afford; mentoring for other patient organizations; and research grants and fellowships.  NORD’s website is at www.rarediseases.org.

About Lundbeck Inc.
Lundbeck Inc. was established in March 2009 following the acquisition of Ovation Pharmaceuticals, Inc. by Lundbeck and has proven success in developing and commercializing high-need treatments. The company is committed to providing innovative therapies that fulfill unmet medical needs of people with CNS disorders and rare diseases for which few, if any, effective treatments are available. For more information, please visit www.lundbeckinc.com.

About H. Lundbeck A/S
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, epilepsy, Huntington’s, Alzheimer’s and Parkinson’s diseases.

Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark, and employs today approximately 5,900 people worldwide. Lundbeck is one of the world’s leading pharmaceutical companies working with CNS disorders. In 2009, the company's revenue was DKK 13.7 billion (approximately EUR 1.8 billion or USD 2.6 billion). For more information, please visit www.lundbeck.com.

Important Safety Information

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 (1 month to 2 years of age) with IS only when you and your doctor decide that the possible benefits of SABRIL are more important than the possible 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 a vision test before starting SABRIL or within 4 weeks after starting SABRIL, and every 3 months after that until SABRIL is stopped. You should have a vision test for your baby after SABRIL is stopped. 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. Call a doctor right away if you have any symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings, and especially if they are new, worse, or worry you. 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 causes sleepiness and tiredness. 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 or 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 you or 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.

Oral Solution: For more information, please see the full Prescribing Information, including Boxed Warning, Medication Guide and Dosing Instructions.

ÂźTrademark of Lundbeck Inc.

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Sources:

• National Institute of Neurological Disorders and Stroke. NINDS Infantile Spasms Information Page. Available at: http://www.ninds.nih.gov/disorders/infantilespasms/infantilespasms.htm?css=print. Last accessed on May 5, 2010.
• Hurst D. The epidemiology of infantile spasms. In: Dulac O, Chugani H. Dalla Bernardina B., eds. Infantile Spasms and West Syndrome. Philadelphia, PA: Saunders; 1994.
• SabrilÂź (vigabatrin) for Oral Solution full Prescribing Information, including Boxed Warning.

Media Contact
Sally Benjamin Young
847-282-5770
syou@lundbeck.com