Atlanta biomedical company @CryoLife buying German company for $225M
Wednesday, October 11, 2017 12:00 AM

CryoLife has entered into a definitive agreement to acquire JOTEC AG (“JOTEC”).  JOTEC is a German-based, privately-held developer of technologically differentiated endovascular stent grafts, and cardiac and vascular surgical grafts, focused on aortic repair.  The combination of CryoLife and JOTEC will create a Company with a broad and highly competitive product portfolio focused on aortic surgery, and will position CryoLife to compete strongly in the important and growing endovascular surgical markets.

Pat Mackin, Chairman, President, and Chief Executive Officer of CryoLife, said, “We believe this acquisition will enable CryoLife to deliver sustained, high single-digit revenue growth, while also diversifying our revenues into a significantly larger addressable market.  JOTEC has a technologically differentiated product portfolio addressing the $2 billion global market for stent grafts used in endovascular and open repair of aortic diseases.  Their advanced product portfolio has allowed them to achieve a 17 percent revenue CAGR over the past five years, significantly outpacing the growth in the overall European market.  We expect the acquired portfolio to continue to post double-digit growth outside of the United States for at least the next five years.  In addition, the acquisition will leverage our global infrastructure and accelerate our ability to go direct in Europe, and will foster considerable cross-selling opportunities between the CryoLife and JOTEC product portfolios.  The transaction will also drive gross margin expansion and accelerate our trajectory towards 20 percent or higher operating margins.  We believe this will position CryoLife to deliver growth in non-GAAP EPS at a CAGR of at least 20 percent over the next five years.”

Mr. Mackin added, “We also expect the JOTEC new product pipeline and R&D capabilities to drive longer-term growth beyond the five year horizon, particularly as their most innovative products enter the U.S. market.  We plan to utilize CryoLife’s clinical and regulatory expertise to gain FDA approval for these products, which we believe will allow for entry into the U.S. market.”

Thomas Bogenschütz, Chief Executive Officer of JOTEC, commented, “CryoLife is ideally positioned to accelerate adoption of our products through its highly complementary and global cardiac and vascular surgery business.  We are looking forward to working with CryoLife’s team to drive growth of our existing business, expand into new geographies, and accelerate our R&D initiatives in key markets such as the U.S.”

JOTEC generated revenue of approximately €41 million in 2016, representing compound annual growth of approximately 17 percent over the preceding five years.  JOTEC generated revenues of €43 million, or approximately $51 million at current currency exchange rates, for the twelve months ended June 30, 2017.

Strategic Rationale for the Transaction

  • Provides CryoLife with:
    • Technologically advanced and highly competitive product portfolio that is taking market share
    • A strong new product pipeline and outstanding R&D capabilities
    • Near-term and longer-term revenue growth drivers through 2028; and
    • Access to the $1.2 billion U.S. stent graft market, which is expected to grow to approximately $1.5 billion by 2021
  • Increases CryoLife’s addressable market opportunity via access to the current $2.0 billion global stent graft market, which is expected to grow to approximately $2.5 billion by 2021
  • Accelerates CryoLife’s direct sales strategy in key European markets
  • Creates significant cross-selling opportunities by leveraging CryoLife’s and JOTEC’s existing direct sales organizations
  • Drives projected high single-digit revenue growth, expands gross margin, and yields 20 percent plus operating margin over a five-year period

Terms of the Agreement

Under terms of the definitive agreement, CryoLife will acquire JOTEC for an upfront payment of $225 million, subject to certain adjustments, consisting of 75 percent in cash and 25 percent in CryoLife common stock issued to JOTEC’s shareholders.  CryoLife expects to finance the transaction and related expenses, as well as refinance its existing $69 million term loan, with new $255 million senior secured credit facilities, consisting of a $225 million institutional term loan B and a $30 million undrawn revolving credit facility, $56.25 million in CryoLife common stock, and available cash on hand.  The senior secured credit facilities are fully underwritten by Deutsche Bank, Capital One and Fifth Third Bank, and are expected to be syndicated to investors prior to closing of the acquisition.

The definitive agreement has been approved by both companies’ boards of directors.  The transaction is expected to close later this year, subject to customary closing conditions.

Financial Commentary

Third quarter revenues were adversely affected due to the impact of the recent hurricanes on our business in Florida and Texas, which we estimate to be approximately $1.0 million, and additionally due to the continued delay in obtaining the re-certification of our AAP.  Including the impact of these factors, third quarter revenue was approximately $45.1 million, compared to our third quarter revenue guidance of between $46.5 and $47.5 million.  In addition, in connection with the transaction, CryoLife notified certain of its distributors that it had elected to terminate its relationship with those distributors based on a decision to distribute product through the to be combined Company’s direct sales channel.  As a result of this decision, at the end of the respective contract terms, CryoLife will be buying back a portion of the inventory that was previously sold to these distributors, which will result in a $1.1 million third quarter reversal of previously recorded revenues.  Considering all of these factors, preliminary third quarter revenues were approximately $44.0 million.  Additional revenue reversals and revisions to the third quarter estimates are possible in subsequent quarters.

Management expects to update its 2017 financial guidance in its third quarter financial conference call and to issue initial financial guidance for the combined Company in its year-end conference call.

Moving forward, the Company expects pro forma compound annual revenue growth in the high single-digits on a percentage basis over the next five years.  Non-GAAP earnings per share is expected to be dilutive in 2018 and accretive in 2019.  Over the next five year period, the Company expects 20 plus percent compound growth in non-GAAP earnings per share.

Advisors

In connection with the transaction, Vinson and Elkins is acting as lead legal counsel to CryoLife.  Walder Wyss Ltd is acting as lead legal counsel to JOTEC.

Webcast and Conference Call Information

CryoLife will hold a teleconference call and live webcast tomorrow at 8:30 a.m. Eastern Time to discuss the proposed transaction, followed by a question and answer session hosted by Mr. Mackin.

To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 8:30 a.m.  A replay of the teleconference will be available October 11 through October 18 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The conference number for the replay is 13671595.

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations.

 

About CryoLife

Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of medical devices and implantable living tissues used in cardiac and vascular surgical procedures.  CryoLife markets and sells products in more than 80 countries worldwide.  For additional information about CryoLife, visit our website, www.cryolife.com.

About JOTEC

Headquartered in Hechingen, Germany, JOTEC develops, produces, and markets medical devices for aortic and peripheral vascular disease.  JOTEC’s product portfolio encompasses conventional vascular grafts and interventional implants for vascular and cardiac surgery and radiology and cardiology.  JOTEC was founded in 2000.  For additional information about JOTEC, visit the website, www.jotec.com/en/.

 
Recro Pharma Announces PDUFA Date for IV Meloxicam 30mg
Thursday, October 05, 2017 12:00 AM

PDUFA Date Set For May 26, 2018

MALVERN, Pa., Oct. 05, 2017 (GLOBE NEWSWIRE) -- Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for hospital and other acute care settings, today announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA date of May 26, 2018 for its decision on the New Drug Application (NDA) for for intravenous (IV) meloxicam 30mg for the management of moderate to severe pain.

About IV/IM Meloxicam 30mg

Meloxicam is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase (COX) and subsequent reduction in prostaglandin biosynthesis. IV meloxicam 30mg was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Recro Pharma, Inc.

Recro Pharma is a specialty pharmaceutical company that operates through two business divisions, an Acute Care, hospital product division and a revenue-generating contract development and manufacturing, or CDMO division, located at the Company’s Gainesville facility. The Acute Care division is primarily focused on developing innovative products for hospital and other acute care settings. The Company’s lead product candidate is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor.  IV meloxicam 30mg has successfully completed two pivotal Phase III clinical efficacy trials in patients following bunionectomy and abdominoplasty surgeries, a large double blind Phase III safety trial, four Phase II clinical trials for the management of moderate to severe post-operative pain, as well as other safety studies.  As injectable meloxicam is in the non-opioid class of drugs, the Company believes it will overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential while maintaining meaningful analgesic effects for relief of pain. The Company’s CDMO division leverages its formulation expertise to develop and manufacture pharmaceutical products using its proprietary delivery technologies and other manufacturing services for commercial partners who commercialize or plan to commercialize these products. These collaborations can result in revenue streams including royalties, profit sharing, research and development and manufacturing fees, which support continued operations for its CDMO division and it contributes non-dilutive funding for the development and pre-commercialization activities of its Acute Care division.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward looking statements reflect Recro's expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words "anticipate," "believe," "estimate," "upcoming," "plan," "target", "intend" and "expect" and similar expressions, as they relate to Recro or its management, are intended to identify such forward-looking statements. These forward looking statements are based on information available to Recro as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause Recro’s performance to differ materially from those expressed in, or implied by, these forward looking statements. Recro assumes no obligation to update any such forward-looking statements. Factors that could cause Recro’s actual performance to materially differ from those expressed in the forward-looking statements set forth in this press release include, without limitation: the ability to obtain and maintain regulatory approval of injectable meloxicam and the labeling under any such approval; regulatory developments in the United States and foreign countries; results and timing of the clinical trials of injectable meloxicam, the Company’s ability to achieve its financial goals, including financial guidance; the Company’s ability to raise future financing for continued development and the payment of milestones; the Company’s ability to pay its debt; customer product performance and ordering patterns, the performance of third-party suppliers and manufacturers; the Company’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection; and the successful commercialization of injectable meloxicam. In particular, there can be no assurance that the FDA will complete its review by the PDUFA goal date, that the FDA will not require changes or additional data, or that the FDA will approve the NDA.  The forward looking statements in this press release should be considered together with the risks and uncertainties that may affect Recro’s business and future results included in Recro’s filings with the Securities and Exchange Commission at www.sec.gov. Recro assumes no obligation to update any such forward looking statements.

CONTACT:    

Investor Relations Contact:
Argot Partners
Susan Kim/Natalie Wildenradt
(212) 600-1902
[email protected]
[email protected]

Recro Pharma, Inc.
Michael Celano
(484) 395-2413
[email protected]

Media Contact:
Argot Partners
Eliza Schleifstein
(973) 361-1546 
[email protected]

 
Emory University research funding breaks new record, $628M for FY 2017
Tuesday, September 26, 2017 12:00 AM

Emory University reported Monday that it pocketed $628 million in external research funding in fiscal year 2017, an increase from $574.6 million the year before and a new record high.

Emory attributed the big increase to "groundbreaking results and the promise of future discoveries with the potential to change the face of science and medicine."

Researchers in Emory's Woodruff Health Sciences Center (WHSC) received more than $584.8 million in FY17, or more than 93 percent of the university total. The WHSC includes schools of medicine, public health, nursing, Yerkes National Primate Research Center, Winship Cancer Institute and Emory Healthcare.

Of the 2017 total, more than 61 percent, or $384 million, came from federal agencies. Read the full story here.

 
Georgia Clinical & Translational Science Alliance receives $51 million NIH state-wide grant
Tuesday, September 26, 2017 12:00 AM

After a decade of research collaboration, the Atlanta Clinical & Translational Science Institute (ACTSI) will welcome a new partner and change its name, reflecting a new statewide focus. The University of Georgia will officially become the fourth academic partner and ACTSI will now be known as the Georgia Clinical & Translational Science Alliance (Georgia CTSA)

This alliance is celebrating 10 years of research advancement by expanding across the state through a five-year, $51 million Clinical and Translational Science Award (CTSA) from the National Institutes of Health (NIH). The Emory-led Georgia CTSA will focus on transforming the quality and value of clinical research and translating research results into better outcomes for patients.

The Georgia CTSA unites the strengths of its academic partners, Emory University, Morehouse School of Medicine, the Georgia Institute of Technology and the University of Georgia (UGA). Emory is a national leader in health care and biomedical research as well as an outstanding leader in clinical and translational research training and education. Morehouse School of Medicine is a nationally recognized historically black institution that brings ethnic diversity to biomedical research, addresses health disparities through successful community engagement research, and serves as a pipeline for training minority researchers. Georgia Tech is a national leader in biomedical engineering, bioinformatics, and the application of innovative systems engineering to health care solutions. UGA has a proven track record in outstanding basic and translational research and, as the state's land-grant institution, offers a robust statewide network that enhances community outreach, service and research.

"Continuing such an alliance and involving these leading state institutions is extremely important and in-line with Georgia's goals for the promotion of clinical and translational research, innovation and development," says Nathan Deal, Governor, State of Georgia. "Having an active Clinical & Translational Science Awardee in Georgia has brought our citizens cutting-edge cures and the latest in clinical and translational research."

Georgia CTSA is one of 64 Clinical and Translational Science Awards (CTSA) at major academic medical centers across the country, funded by the National Institutes of Health's National Center for Advancing Translational Science, and is the only CTSA in Georgia. The award will fund cores focused on improving quality, efficiency and collaboration of the research process, provide consultative support and new tools in bioinformatics and biostatistics, pilot funding for new research projects, training and workforce development, while integrating special populations and focusing on participant interactions, and creating local centers tackling clinical trial inefficiencies.

The Georgia CTSA welcomes contact principal investigator (PI) at Emory, W. Robert Taylor, MD, PhD, and a new multi-PI leadership structure:

W. Robert Taylor, MD, PhD
Contact Principal Investigator, Georgia CTSA
Interim Chair, Department of Medicine
Director, Division of Cardiology
Marcus Chair in Vascular Medicine
Professor of Medicine and Biomedical Engineering
Emory University School of Medicine

Elizabeth O. Ofili, MD, MPH
Principal Investigator, Morehouse School of Medicine, Georgia CTSA
Professor of Medicine, Cardiology
Senior Associate Dean of Clinical and Translational Research
Director, Clinical Research Center
Morehouse School of Medicine

Andrés J. García, PhD
Principal Investigator, Georgia Institute of Technology, Georgia CTSA
Rae S. and Frank H. Neely Endowed Chair and Regents' Professor, Woodruff School of Mechanical Engineering and Petit Institute for Bioengineering and Bioscience
Director, Interdisciplinary Bioengineering Graduate Program
Georgia Institute of Technology

Bradley G. Phillips, PharmD, BCPS, FCCP
Principal Investigator, University of Georgia, Georgia CTSA
Millikan-Reeve Professor and Head, Clinical & Administrative Pharmacy, College of Pharmacy
Director, Clinical and Translational Research Unit (CTRU), Office of Research
University of Georgia

Henry M. Blumberg, MD
Principal Investigator, KL2 and TL1, Georgia CTSA
Professor of Medicine and Epidemiology, Division of Infectious Diseases
Emory University School of Medicine

"The Georgia CTSA creates a unique opportunity for synergy among historic partners in health care, education and cutting-edge research, and has emerged as an innovative and integrated environment where clinical and translational researchers can flourish," says Taylor. "The Georgia CTSA is a catalyst and incubator for clinical and translational research across the state, with impacts throughout the Southeast and nation."

Georgia CTSA has improved health care and research for Georgia citizens through collaboration with the Grady Health System, Children's Healthcare of Atlanta, Atlanta VA Medical Center, Georgia Research Alliance, Georgia Bio, and multiple community medical groups throughout the state.

"Georgia CTSA continues established, strong clinical and research partnerships by leveraging the infrastructure support of the NIH-funded Research Centers at Minority Institutions (RCMI) at Morehouse School of Medicine. We will continue to implement innovative patient centered and participatory care delivery models, toward the elimination of health disparities," says Ofili.

"Georgia CTSA's innovative support of discovery and collaborative partnerships help to rapidly translate scientific discoveries and new technology, which positively impacts patient care in Georgia. This is an exciting story for the state," says Garcia. The new alliance is improving health care and clinical research for the citizens of Georgia and continues to create synergies that foster and accelerate new and emerging technologies and discoveries.

"The addition of UGA provides the Georgia CTSA a state-wide footprint to connect with every county in the state to address health and wellness needs, particularly in rural and underserved populations; opportunities for continued excellence in research by strengthening existing and expanding new research collaborations; and the ability to enrich interprofessional education to include students and trainees from pharmacy and other disciplines so that they can learn how to work together as a team to discover new approaches and treatments that improve health and patient care," says Phillips.  "As a new member of the Georgia CTSA, faculty and students across our campus will have unique support and infrastructure that builds upon current capabilities and increases our trajectory in fostering clinical and translational science in the state and beyond."

 
UCB’s anti-epileptic drug VIMPAT® (lacosamide) receives EU approval for paediatric use
Tuesday, September 26, 2017 12:00 AM

UCB’s anti-epileptic drug VIMPAT® (lacosamide) receives EU approval for paediatric use

 
  • VIMPAT® is approved for monotherapy and adjunctive therapy of partial-onset (focal) seizures in children aged 4 years and older and now provides a new treatment choice for physicians and their paediatric patients with epilepsy.1
  • Epilepsy is the most common serious neurological disorder among children and young adults with the prevalence of paediatric epilepsy in Europe ranging from 3.2 – 5.1 per 1,000.2
  • Despite its high prevalence, approximately 10 – 29% of paediatric epilepsy patients experience inadequate seizure control with currently available anti-epileptic drugs.3,4

Brussels (Belgium), 21 September 2017 – 18:00 (CEST): UCB today announced that the European Commission (EC) approved expanding the use of its anti-epileptic drug (AED) VIMPAT® (lacosamide) as monotherapy and adjunctive therapy in the treatment of partial-onset seizures (also known as focal-onset seizures (FOS) according to ILAE terminology 5,6) with or without secondary generalisation in adults, adolescents and children from 4 years of age.1

The approval follows a positive opinion adopted in July by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and provides a new treatment option to aid the management of childhood epilepsy.7

Today’s approval of VIMPAT® for children aged 4 to 16 is an important step forward for the management of paediatric epilepsy, a condition which can present significant challenges to children and their families,” said Jeff Wren, Executive Vice-President, Head of UCB’s Neurology Patient Value Unit. “One of our key commitments at UCB is to improve the lives of people with epilepsy, and we are proud to be providing a proven treatment option for this highly impacted patient population.”

Epilepsy is a common, chronic neurological disorder, affecting approximately 65 million people worldwide,8 with almost half of incident cases diagnosed during childhood.9 There are a number of comorbidities in childhood that may be associated with epilepsy, including cognitive impairment and neuropsychiatric conditions, mood disorders, and physical comorbidities.10 The stigma associated with epilepsy, especially during adolescence, has been related to low self-esteem, worry, and negative feelings about life,11 with 12 – 26% of children with epilepsy reporting depression and anxiety.12  Paediatric patients may suffer from adverse events with currently available AEDs.13 As such, there is a need for additional treatment options that may provide seizure control with a low side effect profile.

Paediatric patients with focal seizures can still experience poor seizure control with currently available treatment options, along with a reduced quality of life,” said Professor Alexis  Arzimanoglou,  Coordinator of the Epilepsy Program of the Epilepsy Unit at San Juan de Deu Barcelona Children's University Hospital and Director of the Paediatric Clinical Epileptology, Sleep disorders and Functional Neurology Department at the University Hospitals of Lyon, France.  “With the approval of lacosamide, healthcare professionals and paediatric patients in the EU now have an additional treatment option for focal onset seizures, either as monotherapy or adjunctive therapy, representing a great advance to further help children aged 4 years and older suffering from epilepsy.”

The approval of VIMPAT is based on the principle of extrapolation of its efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children. The EMA has established that focal epilepsies in children older than 4 years old have a similar clinical expression to that in adolescents and adults.14 The Food and Drug Administration (FDA) and EMA allow extension of indication to paediatric populations using extrapolated data provided the dose is established and the safety is demonstrated. The EMA states that, from the safety viewpoint, a minimum of 100 children treated by the study drug should be followed for at least one year.14

VIMPAT has over 1,056,500 patient-years of exposure.15 Its established efficacy, safety and tolerability of adjunctive therapy in adults with focal seizures has been demonstrated by three double-blind and three open-label extension studies.16,17,18,19,20,21 The efficacy, safety and tolerability profile of first-line VIMPAT monotherapy has been demonstrated in a phase 3, double-blind study and a related open-label extension study.22

VIMPAT is approved in 72 countries worldwide. In the EU, it is also approved as monotherapy and adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondary generalisation in adults and adolescents (16 – 18 years) with epilepsy.23 In the US, VIMPAT is approved as monotherapy or adjunctive therapy for the treatment of POS in adults with epilepsy (ages ≥ 17 years).24

About VIMPAT®

VIMPAT® (lacosamide) was first launched in the European Union in September 2008, as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent (16-18 years) patients with epilepsy. In countries of the EU, VIMPAT® is available as film-coated tablets, syrup and solution for infusion. VIMPAT® solution for infusion is an alternative for patients when oral administration is temporarily not feasible. VIMPAT® tablets and injection were launched in the U.S. in May 2009 as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are aged 17 years and older. VIMPAT® injection is a short-term replacement when oral administration is not feasible in these patients. VIMPAT® oral solution was launched in the US in June 2010. The availability of the oral tablets, oral solution, and intravenous (IV) injection allows for consistent patient treatment. In Asia, VIMPAT® is available in Korea, Hong Kong, Malaysia, Philippines and Thailand, and was approved for use in Japan in 2016, where the product will be jointly commercialised by Daiichi Sankyo. VIMPAT® is not approved in China.

Important safety information about VIMPAT® is available below.

About Epilepsy 8,25

Epilepsy is a disease of the brain affecting approximately 65 million people worldwide. It is defined as either the occurrence of two or more unprovoked seizures >24 hours apart or one unprovoked (or reflex) seizure and a probability of further seizures occurring over the next 10 years that is similar to the general recurrence risk (at least 60%) after two unprovoked seizures or diagnosis of an epilepsy syndrome. Although epilepsy may be linked to factors such as health conditions, race and age, it can develop in anyone at any age, and approximately 1 in 26 people will develop epilepsy in their lifetime.

About UCB in Epilepsy

UCB has a longstanding commitment to improving the lives of people with epilepsy around the world. With over 20 years of experience in the research and development of antiepileptic drugs, our goal is to become a preferred partner for the global epilepsy community, improving knowledge about and access to effective solutions to help patients better manage their individual epilepsy journeys. We strive to 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 people with epilepsy.

About UCB

UCB, Brussels, Belgium (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 of the immune system or of the central nervous system. With more than 7500 people in approximately 40 countries, the company generated revenue of €4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Important Safety Information about VIMPAT® in the EU and EEA

VIMPAT® is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. VIMPAT® therapy can be initiated with either oral or IV administration.  For the paediatric population, the physician should prescribe the most appropriate formulation and strength according to weight and dose.  A single loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of CNS adverse reactions. Administration of a loading dose has not been studied in acute conditions such as status epilepticus. Use of a loading dose is not recommended in adolescents and children weighing less than 50 kg. A maximum dose of 300 mg/day is recommended for paediatric patients weighing 50 kg or more and for adult patients with mild to moderate hepatic impairment.  Based on data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic impairment, a reduction of 25 % of the maximum dose should be applied. Lacosamide should be administered to adult and paediatric patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient. In adolescents and adults weighing 50 kg or more with mild to moderate hepatic impairment a loading dose of 200mg may be considered, but further dose titration (>200 mg daily) should be performed with caution. In paediatric patients weighing 50 kg or more and in adult patients with mild or moderate renal impairment a loading dose of 200 mg may be considered, but further dose titration (> 200 mg daily) should be performed with caution. In paediatric patients weighing 50 kg or more and in adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed with caution. In paediatric patients weighing less than 50 kg with severe renal impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of the maximum dose is recommended. Contraindications: Hypersensitivity to the active substance or any of the excipients; known second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Treatment with VIMPAT® has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine. Dose-related prolongations in PR interval with VIMPAT® have been observed in clinical studies. Cases with second- and third-degree AV block associated with VIMPAT® treatment have been reported in post-marketing experience. VIMPAT® should be used with caution in patients with known conduction problems, severe cardiac disease (e.g. history of myocardial infarction or heart failure), in elderly patients, or when VIMPAT® is used in combination with products known to be associated with PR prolongation.  In these patients it should be considered to perform an ECG before a VIMPAT® dose increase above 400mg/day and after VIMPAT® is titrated to steady-state. In the placebo-controlled trials of VIMPAT® in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy trials and in post-marketing experience. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheaded and fainting) and of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath). Patients should be counseled to seek medical advice should any of these symptoms occur. Suicidal ideation and behaviour have been reported in patients treated with antiepileptic medicinal products in several indications. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal and generalised seizures may coexist have not been determined. VIMPAT® syrup contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed). It contains 3.7 g sorbitol (E420) per dose (200 mg lacosamide), corresponding to a calorific value of 9.7 kcal. Patients with rare hereditary problems of fructose intolerance should not take this medicine. The syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. VIMPAT® syrup and the solution for infusion contain sodium, which should be taken into consideration for patients on a controlled sodium diet. Effects on ability to drive and use machines: VIMPAT® may have minor to moderate influence on the ability to drive and use machines. VIMPAT® treatment has been associated with dizziness or blurred vision. Accordingly patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of VIMPAT® on their ability to perform such activities. Undesirable effects: The most common adverse reactions (≥10%) are dizziness, headache, diplopia, and nausea. They were usually mild to moderate in intensity. Some were dose-related and could be alleviated by reducing the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time. Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. Other common adverse reactions (≥1% - <10%) are depression, confusional state, insomnia, balance disorder, coordination abnormal, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, paraesthesia, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, diarrhoea, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, feeling drunk, injection site pain or discomfort (local adverse events associated with intravenous administration), irritation (local adverse events associated with intravenous administration), fall, and skin laceration, contusion. The use of VIMPAT® is associated with dose-related increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur. The safety profile of lacosamide in open-label studies in adjunctive therapy in children from 4 years to less than 16 years was consistent with the safety profile observed in adults. In the paediatric population the most frequently reported adverse reactions were vomiting (17.1 %), dizziness (16.7 %), somnolence (12.1 %), headache (11.7 %) and convulsion (10.1 %). Additional adverse reactions reported in children were decreased appetite (6.6 %), lethargy (4.3 %) and abnormal behaviour (1.9 %). Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with VIMPAT® in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic medicinal products. Elevations of ALT to ≥3XULN occurred in 0.7% (7/935) of VIMPAT® patients and 0% (0/356) of placebo patients. Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported in patients treated with some antiepileptic medicinal products. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. If multiorgan hypersensitivity reaction is suspected, VIMPAT® should be discontinued.

Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 14th September 2017  http://www.ema.europa.eu/.

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 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. UCB is providing this information as of the date of this press release 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.

For further information:

Corporate Communications

France Nivelle, Global Communications, UCB

T+32.2.559.9178, [email protected]

Jim Baxter, Neurology Communications, UCB

T+32.2.473.78.85.01, [email protected]

Investor Relations

Antje Witte, Investor Relations, UCB

T+32.2.559.94.14, antje.wi[email protected]

Isabelle Ghellynck,

Investor Relations, UCB

T +32.2.559.9588, [email protected]

References

  1. Data on File (European Commission, dated 19 September 2017). 
  2. Pugliatti, M., Beghi, E., Forsgren, L., Ekman, M., Sobocki, P. Estimating the cost of epilepsy in Europe: A review with economic modelling. Epilepsia. 2007;48(12):2224–2233.
  3. Ohtsuka, Y., Yoshinaga, H., Kobayashi, K. Refractory childhood epilepsy and factors related to refractoriness. Epilepsia. 2000;41(Suppl 9):14-17.
  4. Berg, A., Shinnar, S., Levy, S., Testa, F., Smith-Rapaport, S., Beckerman, B. Early development of intractable epilepsy in children: a prospective study. Neurology. 2001;56(11):1445-1452.
  5. Fisher, R.S., Cross, H.J., French, J.A., et al. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017;58(4):522-530.
  6. Berg, A.T., et al. Revised terminology and concepts for organization of seizures and epilepsies: Report of the ILAE Commission on Classification and Terminology, 2005–2009. Epilepsia. 2010;51:676-85.
  7. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP), 20th July 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000863/WC500231716.pdf. Accessed 20 September 2017.
  8. The Epilepsy Foundation of America. Who gets epilepsy? Available at: http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy. Accessed 20 September 2017.
  9. Shinnar, S., Pellock, J.M. Update on the epidemiology and prognosis of pediatric epilepsy. J Child Neurol. 2002;17(1):S4-17.
  10. Wei, S., Lee, W-T. Comorbidity of childhood epilepsy. J Form Med Assoc. 2015;114:1031-1038.
  11. MacLeod, J.S., Austin, J.K. Stigma in the lives of adolescents with epilepsy: a review of the literature. Epilepsy Behav. 2003;4(2):112-117.
  12. Caplan, R., Siddarth, P., Gurbani, S., Hanson, R., Sankar, R., Shields, W.D. Depression and anxiety disorders in pediatric epilepsy. Epilepsia. 2005;46(5):720-730.
  13. Guerrini, R., Zaccara, G., la Marca, G., Rosati, A. Safety and Tolerability of Antiepileptic Drug Treatment in Children with Epilepsy. Drug Saf. 2012;35(7):519-533.
  14. European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders. 2010. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070043.pdf. Accessed 20 September 2017.
  15. Periodic Safety Update Report data lock point Dec 15th 2016.
  16. Ben-Menachem, E., Biton, V., Jatuzis, D., Abou-Khalil, B., Doty, P., Rudd, G.D. Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia. 2007;48(7):1308-1317.
  17. Chung, S., Sperling, M.R., Biton, V., Krauss, G., Hebert, D., Rudd, G.D., Doty, P. Lacosamide as adjunctive therapy for partial-onset seizures: A randomied controlled trial. Epilepsia. 2010;51(6):958-967.
  18. Halász, P., Kälviäinen, R., Mazurkiewicz-Beldzinska, M., Rosenow, F., Doty, P., Hebert, D., Sullivan, T. Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial. Epilepsia. 2009;50(3):443-453. 
  19. Rosenfeld, W., Fountain, N.B., Kaubrys, G., et al. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy Behav. 2014;41:164-170.
  20. Husain, A., Chung, S., Faught, E., Isojarvi, J., McShea, C., Doty, P. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012;53(3):521-528.
  21. Rosenow, F., Kelemen, A., Ben-Menachem, E., et al. Long-term adjunctive lacosamide treatment in patients with partial-onset seizures. Acta Neurol Scand. 2016;133(2):136-144.
  22. Baulac, M., Rosenow, F., Toledo, M., Terada, K., Li, T., de Backer, M., Werhahn, K.J., Borck, M. Efficacy, safety, and tolerability of lacosamide monotherapy versus controlled-release carbamazepine in patients with newly diagnosed epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurology. 2017;16(1):43-54.
  23. European Medicines Agency. VIMPAT® (lacosamide). Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000863/human_med_001139.jsp&mid=WC0b01ac058001d124. Accessed 20 September 2017.
  24. U.S. Food and Drug Administration. VIMPAT® (lacosamide) Prescribing Information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf. Accessed 20 September 2017.
  25. Fisher, R.S., et al., ILAE Official Report: A practical clinical definition of epilepsy. Epilepsia. 2014;55(4):475-482.
 
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