News I UCB (cid:9)
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`10/8/16, 12:47 PM
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`r=Is Insoirec oy patients.
`L J Driven oy science.
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`BRIVIACT® now available in U.S. pharmacies for epilepsy patients living
`with partial-onset seizures
`
`• BRIVIACT® (brivaracetam) CV recently approved by U.S. FDA as adjunctive therapy in the treatment of partial-
`
`onset seizures in patients 16 years of age and older with epilepsy, and now available'
`
`• With BRIVIACT® patients can start with a therapeutic dose on day one
`
`• People with epilepsy are living with unmet needs, as approximately 30% remain uncontrolled on existing
`
`therapies and still experience seizures2
`
`• UCB has a longstanding heritage in developing differentiated treatment solutions for people living with
`epilepsy; regulatory filings in countries worldwide are underway
`
`Brussels, Belgium — 31 May, 7:30 AM CET — Today UCB announced that BRIVIACT® (brivaracetam) CV,
`approved as adjunctive therapy for the treatment of partial-onset seizures in patients 16 years of age and older
`
`with epilepsy, is now available in U.S. pharmacies across the country. BRIVIACT® is available in three
`formulations: film-coated tablets, oral solution and injection. Injection may be used when oral administration is
`temporarily not feasible. Injection (single-dose vials) will be available in pharmacies in June.
`
`BRIVIACT® is a new molecular entity that was approved by the U.S. Food and Drug Administration (FDA) on
`February 18, 2016, providing an important new treatment option for those living with epilepsy. On May 12, 2016,
`the Drug Enforcement Administration (DEA) listed BRIVIACT® as a Schedule V controlled substance.
`
`Gradual dose escalation is not required when initiating treatment with BRIVIACT®. The recommended starting
`dosage is 50 mg twice daily (100 mg per day). Based on individual patient tolerability and therapeutic response,
`the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per
`day).
`
`"What It is important to note that with BRIVIACT is that titration is not required to achieve a therapeutic dose.
`
`Patients can start their very first BRIVIACT® treatment with a therapeutic dose. This makes it a useful addition to
`the current antiepileptic medication armamentarium," said Dr. Pavel Klein, MD, Director, Mid-Atlantic Epilepsy and
`Sleep Center, Bethesda, Maryland.
`
`BRIVIACT® is associated with important warnings and precautions including suicidal behavior and ideation,
`somnolence, fatigue, dizziness, disturbance in gait and coordination, psychiatric adverse reactions including
`non-psychotic and psychotic symptoms, and hypersensitivity reactions (bronchospasm and angioedema).
`BRIVIACT® is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the
`
`inactive ingredients. The most common adverse reactions (at least 5% for BRIVIACT® and at least 2% more
`frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.1
`
`Patients with epilepsy are living with significant unmet needs. Approximately 30% of people with epilepsy
`uncontrolled on existing therapies and still experience seizures, which can lead to devastating physical a
`
`http://www.ucb.com/presscenter/News/article/BRIVIACT-now-available in ...S pharmacies-for-epilepsy-patients-living-with-partial-onset-seizures
`ARGENTUM Exhibit 1076
` Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`IPR2016-00204
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`emotional consequences.2• 3 Epilepsy can develop in anyone at any age, and approximately one in 26 people will
`develop epilepsy in their lifetime.4
`
`"At UCB, we are constantly inspired to improve patients' lives, which is why we are excited that BRIVIACT® is now
`available in U.S. pharmacies. This is an important addition to our existing epilepsy portfolio," said Jeff Wren, Head
`of Neurology and Executive Vice President at UCB. "We remain steadfast in our commitment to addressing
`unmet needs for people with epilepsy, and will continue our efforts to bring this important treatment to even
`more patients worldwide."
`
`In January 2016, the European Commission granted the marketing authorization for BRIVIACT® as an adjunctive
`therapy in the treatment of partial-onset seizures with or without secondary generalization in adult and
`adolescent patients from 16 years of age with epilepsy. In the EU, BRIVIACT® is already available to patients in the
`UK, Germany, and Denmark. In Canada, brivaracetam is approved as the trade name BRIVLERA®. UCB has
`submitted additional regulatory applications for brivaracetam in other countries including Australia, Brazil, Russia,
`Switzerland and Turkey.
`
`About BRIVIACT®
`BRIVIACT® is a new molecular entity that was rationally designed and developed by UCB. Brivaracetam displays a
`high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the
`anticonvulsant effect. However, the precise mechanism of action by which BRIVIACT® exerts its anticonvulsant
`activity is not known. BRIVIACT® is available in three formulations (film-coated tablets, oral solution, and
`
`injection).1-5
`
`IMPORTANT SAFETY INFORMATION
`
`arnings and Precautions
`
`• Suicidal Behavior andideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal
`behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression;
`unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their
`caregivers, and/or families to be alert for these behavioral changes and report them immediately to a
`healthcare provider.
`
`• Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in
`coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of patients taking at
`least 50 mg per day of BRIVIACT compared to 14% of patients taking placebo. Dizziness and disturbance in gait
`and coordination were reported in 16% of patients taking at least 50 mg per day of BRIVIACT compared to 10%
`of patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for
`these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient
`experience on BRIVIACT.
`
`• Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic
`and psychotic symptoms. These events were reported in approximately 13% of patients taking at least 50 mg
`per day of BRIVIACT compared to 8% of patients taking placebo. A total of 1.7% of adult patients taking
`BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo.
`Advise patients to report these symptoms immediately to a healthcare provider.
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`Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been
`reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is
`contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive
`ingredients.
`
`ithdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be
`withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.
`
`Adverse Reactions
`
`The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are
`somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.
`
`BRIIVIIACT is a Schedule V controlled substanc
`
`Please refer to full Prescribing Information at http://www.briviact.com/briviact-Pl.pdf
`
`For more information on BRIVIACT®, contact 844-599-CARE (2273).
`
`BRIVIACT® is a registered trademark of the UCB Group of Companies.
`
`About EpRepsy4-6-1'8-9
`Epilepsy is a chronic neurological disorder affecting approximately 65 million people worldwide and more than 2
`million people in the U.S. It is the fourth most common neurological disorder in the U.S. Although epilepsy may
`be linked to factors such as health conditions, race and age, it can develop in anyone at any age. Approximately
`one in 26 people will develop epilepsy in their lifetime.
`
`There are many different types of epilepsy, but the main characteristic of the condition is recurrent seizures.
`Seizures are classified by the pattern of onset—partial seizures start in one part of the brain and generalized
`seizures are characterized by widespread involvement of the whole brain.
`
`Epilepsy is considered to be a disease of the brain defined by any of the following conditions: (1) at least two
`unprovoked (or reflex) seizures occurring >24 hours apart; (2) one unprovoked (or reflex) seizure and a probability
`of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring
`over the next 10 years; (3) diagnosis of an epilepsy syndrome.
`
`About UCB in Epilepsy
`UCB has a rich heritage in epilepsy with more than 20 years of experience in the research and development of
`anti-epileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address
`unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its
`treatment. We partner and create super-networks with world-leading scientists and clinicians in academic
`institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by
`patients and driven by science in our commitment to support patients with epilepsy.
`
`For further information
`
`Corporate Communications
`
`France Nivelle,
`Global Communications,
`T +32 2 559 9178, france.nivelle@ucb.com [mailto:france.nivelle@ucb.com]
`
`http://www.ucb.com/presscenter/News/article/BRIVIACT-now-available-in...S-pharmacies-for-epilepsy-patients-living-with-partial-onset-seizures (cid:9)
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`News I UCB (cid:9)
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`Jim Baxter,
`Media Relations, UCB
`T +32 473 78 85 01, jim.baxter@ucb.com [mailto:jim.baxter@ucb.com]
`
`UCB Investor Relations
`
`Antje Witte,
`Investor Relations, UCB
`T +32 2 559 94 14, antje.wittecaucb.com [mailto:antje.witte@ucb.com]
`
`Isabelle Ghellynck,
`Investor Relations, UCB
`T +32 2 559 9588, isabelle.ghellynck@ucb.com [mailto:isabelle.ghellynck@ucb.com]
`
`References
`
`BRMACTO US Prescribing information_ Brussels, Belgium: UCB, 2016.
`
`Kwan, P. et al. Early identification of Refractory Epilepsy. New England Journal of Medicine,
`2000, 342(5). 314-319_
`
`Sperling MR. The consequences of uncontrolled epilepsy. CNS Spectr. 2004.
`
`The Epilepsy Foundation of America. Who gets epilepsy? Accessed May 2016 from
`http://www.epilepsy.comilearn/epilepsy-101/who-gets-epilepsy
`ihttp://vvww_epilepsy.com/learn/epilepsy-101/who-gets-epilepsy]
`
`Klein, P et al. Brivaracetam for the treatment of epilepsy_ Expert Opin Pharmacother, 2016.
`
`European Federation of Pharmaceutical Industries and Associations. Epilepsy. Accessed May 2016
`from http://www_efpia_euidiseases/89/59/Epilepsylhttp://www_efpia.eu/diseases/89/59/Epilepsyl
`
`institute of Medicine_ Epilepsy Across the Spectrum. Promoting Health and Understanding.
`Washington. DC: The National Academic Press, 2012 brief report.
`
`rodie MJ et al. Fast Facts: Epilepsy. Health Press. 5th edition, 2012.
`
`Fisher, R.S_, et al., ILAE Official Report: A practical clinical definition of epilepsy. Epilepsia, 2014.
`55(4): 475-482.
`
`About UCB
`UCB, Brussels, Belgium (www.ucb.com [http://www.ucb.com] ) is a global biopharmaceutical company focused
`on the discovery and development of innovative medicines and solutions to transform the lives of people living
`with severe diseases in immunology and neurology. With more than 7500 people in approximately 40 countries,
`the company generated revenue of €3.9 billion in 2015. UCB is listed on Euronext Brussels (symbol: UCB). Follow
`us on Twitter: @UCB_news
`
`Forward looking statements
`This press release contains forward-looking statements based on current plans, estimates and beliefs of
`management. All statements, other than statements of historical fact, are statements that could be deemed
`forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash,
`other financial information, expected legal, political, regulatory or clinical results and other such estimates and
`results. By their nature, such forward-looking statements are not guarantees of future performance and are
`
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`subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those
`that may be implied by such forward-looking statements contained in this press release. Important factors that
`could result in such differences include: changes in general economic, business and competitive conditions, the
`inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with
`research and development, changes in the prospects for products in the pipeline or under development by UCB,
`effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent
`protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations,
`changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees.
`Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an
`offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which
`such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws
`of such jurisdiction. UCB is providing this information as of the date of this document and expressly disclaims any
`duty to update any information contained in this press release, either to confirm the actual results or to report a
`change in its expectations.
`There is no guarantee that new product candidates in the pipeline will progress to product approval or that new
`indications for existing products will be developed and approved. Products or potential products which are the
`subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the
`partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products
`after they are marketed.
`Moreover, sales may be impacted by international and domestic trends toward managed care and health care
`cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting
`biopharmaceutical pricing and reimbursement.
`
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