UCB Heralds Successor to Keppra as EU Approves Vimpat for Epilepsy (cid:9)
`
`10/12/16, 2:45 PM
`
`Otniseralds Successor to Keppra
`as EU Approves Vimpat for Epilepsy
`
`Published: 9/3/2008
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`The approval marks an important step on the road to rebuilding
`UCB's fortunes, but a regulatory nod from the United States will
`prove to be even more critical.
`
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`Significance
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`Implications
`
`The European Commission
`has approved UCB's drug
`Vimpat (lacosamide) as an
`adjunctive treatment for
`partial-onset seizures with or
`without secondary
`generalisation in epilepsy
`patients aged 16 or over.
`
`The approval is the first
`regulatory green light for
`Vimpat, which UCB has
`developed as a follow-on to
`current blockbuster Keppra
`(levetiracetam). UCB is still
`awaiting a decision on
`marketing from the FDA in the
`United States.
`
`ARGENTUM Exhibit 1080
` Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`IPR2016-00204
`
`Outlook Keppra's U.S. patent will
`
`https://www.ihs.com/country-industry-forecasting.html?1D=106596415
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`I147-1-714410
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`UCB Heralds Successor to Keppra as EU Approves Vimpat for Epilepsy (cid:9)
`
`10/12/16, 2:45/PM
`
`expire next year, and Vimpat's
`success in both the United
`States and Europe will be
`crucial to UCB's fortunes in
`years to come. The drug faces
`stiff competition, however,
`from the likes of Lamictal,
`Lyrica and Topamax, and UCB
`will need to invest in proving
`Vimpat's therapeutic
`advantages over these rivals.
`
`EU Green Light for Vimpat
`
`The European Commission has granted marketing approval to
`Vimpat (lacosamide), produced by Belgian drug-maker UCB, as an
`adjunctive treatment for partial-onset seizures with or without
`secondary generalisation in patients aged 16 and above. The
`approval comes just over two months after a committee from the
`European Medicines Agency (EMEA) gave its support for the drug,
`and therefore has not come as a surprise. Vimpat will now be
`available across the European Union (EU) in several doses and
`formulations, which UCB says will offer patients a broader range of
`dosage options:
`
`• Oral tablets (50, 100, 150 or 200 mg)
`• Oral syrup (15 mg/mL)
`• Solution for infusion (10 mg/mL)
`
`Vimpat's imminent European launch will see the drug prescribed in
`tandem with at least one other epilepsy treatment, as its approval
`was based on clinical trials which examined Vimpat's use in patients
`whose partial-onset seizures were not adequately controlled with
`between one and three other epilepsy medicines. UCB's existing
`epilepsy blockbuster Keppra (levetiracetam) is also approved for
`adjunctive treatment, and saw blockbuster sales of just over 1 billion
`euro (US$1.5 billion)—up 43% year-on-year in comparable terms—
`in 2007. Keppra is due to lose patent protection in the United States
`next year, and UCB has already filed regulatory applications with the
`U.S. FDA, seeking marketing approval for Vimpat as an adjunctive
`epilepsy therapy as well as a treatment for diabetic neuropathic
`pain. The Belgian pharma giant also sought European marketing
`approval for Vimpat in this second indication back in August 2007,
`and is currently awaiting a verdict from the EMEA.
`
`Outlook and Implications
`
`https://www.ihs.com/country-industry-forecasting.html?ID=106596415 (cid:9)
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`UCI3 Heralds Successor to Keppra as EU Approves Vimpat for Epilepsy (cid:9)
`
`10/12/16, 2:45 PM
`
`European marketing approval for Vimpat in the most potentially
`lucrative of its two developed indications is a much-needed sign of
`encouragement for UCB, which recently revealed plans to axe 17%
`of its staff in order to optimise costs at a time of financial uncertainty
`(see Belgium: 28 August 2008: UCB Unveils SHAPE
`Restructuring Programme, Prepares to Downsize 17% of Staff).
`What the company needs now is for the U.S. FDA to follow suit and
`approve Vimpat for epilepsy in the United States, where UCB stands
`to lose revenue most heavily once Keppra's patent protection
`expires.
`
`In the past, UCB has said that between 20-30% of epileptic patients,
`equivalent to 10-15 million people globally, are inadequately treated
`by existing epilepsy treatments, offering a potentially large patient
`population that could benefit from Vimpat. However, the treatment
`will be competing against other well-established adjunctive epilepsy
`drugs, including Lamictal (lamotigrine; GlaxoSmithKline, U.K.),
`Topamax (topamirate; Johnson & Johnson, U.S.), and Neurontin
`(gabapentin; Pfizer, U.S.). On the U.S. market, Vimpat will also be
`competing against Pfizer's formidable blockbuster Lyrica
`(pregabalin), which has been approved as an adjunctive treatment
`for partial-onset seizures in adult epilepsy patients since 2005.
`
`In order to make Vimpat stand out from rival products, UCB will
`need to employ aggressive marketing tactics, but will also need to
`invest in further studies examining the drug's unique mode of action.
`UCB claims that Vimpat has shown to modulate the activity of
`sodium channels—which help regulate activity in the nervous
`system—differently to other epilepsy drugs, and that it is the only
`epilepsy treatment known to bind to the collapsing response
`mediator protein-2 (CRMP-2). How this distinguishes Vimpat in
`terms of therapeutic effect is not yet fully understood, but
`demonstrating this through further clinical trials could help improve
`the drug's fortunes in years to come.
`
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