DOCSLIB.ORG

Annual Report 2006 2006 Highlights

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Annual Report 2006 2006 Highlights Annual Report 2006 2006 Highlights Safinamide confirms efficacy and safety in a Phase III trial for Parkinson’s disease Safinamide shows very promising effects on cognition, giving the drug potential as a treat- ment for Alzheimer’s disease and Mild Cognitive Impairment Global Development and Commercialisation agreement for safinamide signed with Merck Serono, worth up to $ 200 million – plus royalties – to Newron Start of a pivotal Phase III trial with safinamide in mid to late-stage Parkinson’s disease patients Ralfinamide set up to generate Phase II MTD data in neuropathic pain by mid-2007 and design of trial for use in inflammatory pain IPO completed on the SWX Swiss Exchange raises ¤ 74.3 million – one of the largest biotech IPOs of 2006 Corporate Profile Newron (SWX: NWRN) is a clinical-stage biopharmaceutical company based in Bresso, Milan. Our mission is to discover, develop and commercialise novel drugs to treat diseases of the Central Nervous System (CNS) and pain. The products that we are developing include safinamide, in late-stage trials for the treat- ment of patients with Parkinson’s disease, and ralfinamide to treat neuropathic pain and inflammatory pain. Newron’s clinical pipeline is supported by a portfolio of early-stage proprietary compounds generated by its ion channel drug discovery platform. Table of Contents Dear Shareholder .................................................................................................... 4 Company Information ............................................................................................. 6 A Focus on CNS ....................................................................................................... 8 Diseases and Markets .............................................................................................. 12 Drug Pipeline ......................................................................................................... 17 Strong Partnership .................................................................................................. 24 Newron’s Team ....................................................................................................... 26 Corporate Governance ............................................................................................ 28 Group Structure and Shareholders ............................................................................. 31 Capital Structure ..................................................................................................... 33 Board of Directors ................................................................................................... 36 Senior Management ................................................................................................ 44 Compensation, Shareholdings and Loans .................................................................... 47 Shareholders’ Participation ....................................................................................... 49 Change of Control and Defence Measures .................................................................... 51 Auditors ................................................................................................................ 52 Information Policy .................................................................................................. 53 IFRS Financial Statements ....................................................................................... 54 Income Statement ................................................................................................... 56 Balance Sheet ......................................................................................................... 57 Statement of Changes in Shareholders’ Equity .............................................................. 58 Cash Flow Statement ............................................................................................... 59 Notes to the Financial Statements .............................................................................. 60 Auditors’ Report ..................................................................................................... 74 Italian GAAP Financial Statements ........................................................................... 76 Directors’ Report ..................................................................................................... 78 Financial Statements ............................................................................................... 94 Notes to the Financial Statements .............................................................................. 99 Auditors’ Report ..................................................................................................... 116 Information for Investors ........................................................................................ 118 Glossary ............................................................................................................... 119 Dear Shareholder Rolf Stahel Luca Benatti The importance of finding effective new treatments for diseases of the Central Nervous System is well understood. Conditions such as Parkinson’s disease carry an enormous burden for the patients, their families and carers, and the healthcare systems that provide drug treatments and rehabilitation care. Europe and the US both have approximately 53,000 new cases of Parkinson’s disease each year. According to a recent report, between now and 2030, the number of patients could more than double. Current treatments, some of which have been around since the 1960’s, carry significant long-term side effects. The team at Newron have proven research and development expertise within the CNS field. Many of them have been involved previously in the development and commercialisation of major CNS drugs. We are confident that, as a team, we will build on these successes within Newron. Since 1999 we have had many achievements in the development of our clinical pipe- line. We are a young company, however, and there is more to do, but we are fully committed to successfully achieving our goal of bringing important new treatments to patients whose lives are blighted by disease. 2006 was a landmark year for Newron. Safinamide’s development was highlighted with excellent data from the first Phase III trial. Not only did we confirm the safety and efficacy data seen previously in our Phase II study, but we were also able to show very promising effects on cognition compared to patients on dopamine agonist therapy. This could mean that safinamide is a potential treatment for cognitive decline in Parkinson’s disease as well as the larger indica- tions of Alzheimer’s disease and Mild Cognitive Impairment. With such positive results, we renewed our discussions with potential pharmaceutical part- ners and concluded a deal with Serono, now Merck Serono, in September. Merck Serono is the right partner both for Newron and for safinamide. The collaboration is extremely positive and our teams share a joint dedication to progress safinamide in PD towards regulatory filing in 2009. One of the additional benefits of our agreement with Merck Serono is the option for us to consider co-marketing safinamide in certain European countries. This could potentially accel- erate our objective to build a small, focused, CNS specialty sales force whereby we can retain the value of our future marketed products. In the meantime, we look forward to reporting data from existing trials with both safinamide and ralfinamide and the commencement of new trials. Newron Annual Report 2006 In 2006, our drug discovery programmes were focused on the ion channel target class. The main objective of these programmes was to provide leads and product candidates to fuel the Company’s pipeline. Chemistry optimization work has resulted in the synthesis of lead molecules which showed significant activity in several CNS disease models. The most advanced of these compounds could enter preclinical development in 2007. As a result of our good data, the opportunities that we have with both our lead drugs, and the global agreement with Merck Serono, we felt the time was right for us to seek new funds through an IPO on the SWX Swiss Exchange. We were delighted with the response to our road show and the fact that international investors across Europe and the US have shared our vision for Newron’s future. The IPO raised ¤ 74.3 million and was amongst the largest biotech fund- raising initiatives during 2006. Our intentions are to use these funds by supporting the ongoing and new clinical development programmes, licensing or acquiring new products to expand our Central Nervous System (CNS) pipeline, and begin the development of a specialty sales and marketing force once we have the appropriate products ready for launch. Based on the achievements of 2006, Newron is well positioned to build further on its CNS expertise and focus. This is only possible through the expertise and commitment of our team and we thank them for their ongoing support. As a public company, Newron has entered an exciting new phase and we believe that we are well positioned for continued growth. Rolf Stahel Luca Benatti Chairman Chief Executive Officer Newron Annual Report 2006 6 Newron Annual Report 2006 Company Information Newron Annual Report 2006 A Focus on CNS Newron’s goal is to become a fully integrated biopharmaceutical company focused on the discovery, development and commer- cialisation of drugs for the treatment of CNS-related diseases
Load more

Recommended publications
  • Mechanisms and Clinical Significance of Pharmacokinetic-Based Drug-Drug Interactions With
    DMD Fast Forward. Published on November 15, 2018 as DOI: 10.1124/dmd.118.084905 This article has not been copyedited and formatted. The final version may differ from this version. DMD # 84905 Title Mechanisms and Clinical Significance of Pharmacokinetic-based Drug-drug Interactions with Drugs Approved by the U.S. Food and Drug Administration in 2017 Jingjing Yu, Ichiko D. Petrie, René H. Levy, and Isabelle Ragueneau-Majlessi Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, WA, USA (J.Y., I.P., R.H.L. I.R-M.) Downloaded from dmd.aspetjournals.org at ASPET Journals on October 3, 2021 1 DMD Fast Forward. Published on November 15, 2018 as DOI: 10.1124/dmd.118.084905 This article has not been copyedited and formatted. The final version may differ from this version. DMD # 84905 Running Title Page a) Running title: A review of clinical DDIs in 2017 NDAs b) Corresponding author: Jingjing Yu, Drug Interaction Database (DIDB) Program, Department of Pharmaceutics, School of Pharmacy, University of Washington, Box 357610, Seattle, WA 98195, Phone: 206.221.2856, Fax: 206.543.3204, E-mail: [email protected] c) Number of text pages: 18 Number of tables: 2 Downloaded from Number of figures: 2 Number of references: 38 Number of words in the Abstract: 242 dmd.aspetjournals.org Number of words in the Introduction: 227 Number of words in the Discussion: 619 d) Abbreviations: at ASPET Journals on October 3, 2021 AUC, area under the time-plasma concentration curve; BCRP, breast cancer resistance protein; Cmax, maximum plasma
    [Show full text]
  • Could Mycolactone Inspire New Potent Analgesics? Perspectives and Pitfalls
    toxins Review Could Mycolactone Inspire New Potent Analgesics? Perspectives and Pitfalls 1 2 3, 4, , Marie-Line Reynaert , Denis Dupoiron , Edouard Yeramian y, Laurent Marsollier * y and 1, , Priscille Brodin * y 1 France Univ. Lille, CNRS, Inserm, CHU Lille, Institut Pasteur de Lille, U1019-UMR8204-CIIL-Center for Infection and Immunity of Lille, F-59000 Lille, France 2 Institut de Cancérologie de l’Ouest Paul Papin, 15 rue André Boquel-49055 Angers, France 3 Unité de Microbiologie Structurale, Institut Pasteur, CNRS, Univ. Paris, F-75015 Paris, France 4 Equipe ATIP AVENIR, CRCINA, INSERM, Univ. Nantes, Univ. Angers, 4 rue Larrey, F-49933 Angers, France * Correspondence: [email protected] (L.M.); [email protected] (P.B.) These three authors contribute equally to this work. y Received: 29 June 2019; Accepted: 3 September 2019; Published: 4 September 2019 Abstract: Pain currently represents the most common symptom for which medical attention is sought by patients. The available treatments have limited effectiveness and significant side-effects. In addition, most often, the duration of analgesia is short. Today, the handling of pain remains a major challenge. One promising alternative for the discovery of novel potent analgesics is to take inspiration from Mother Nature; in this context, the detailed investigation of the intriguing analgesia implemented in Buruli ulcer, an infectious disease caused by the bacterium Mycobacterium ulcerans and characterized by painless ulcerative lesions, seems particularly promising. More precisely, in this disease, the painless skin ulcers are caused by mycolactone, a polyketide lactone exotoxin. In fact, mycolactone exerts a wide range of effects on the host, besides being responsible for analgesia, as it has been shown notably to modulate the immune response or to provoke apoptosis.
    [Show full text]
  • Inbrija, INN-Levodopa
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Inbrija 33 mg inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 42 mg levodopa. Each delivered dose contains 33 mg levodopa. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule. White opaque capsules containing white powder, with “A42” printed in black on the cap of the capsule and two black bands printed on the body of the capsule. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. 4.2 Posology and method of administration Posology Patients should be on a stable levodopa/dopa-decarboxylase inhibitor (e.g. carbidopa or benserazide) regimen before starting Inbrija. Patients selected for treatment with Inbrija should be able to recognize the onset of their 'OFF' symptoms and be capable of preparing the inhaler or else have a responsible care giver able to prepare the inhaler for them when required. Inbrija should be inhaled when symptoms, motor or non-motor, of an OFF period start to return. The recommended dose of Inbrija is 2 hard capsules up to 5 times per day each delivering 33 mg levodopa. The maximum daily dose of Inbrija should not exceed 10 capsules (330 mg). It is not recommended to take more than 2 capsules per OFF period. Exceeding the recommended dose may lead to increased levodopa associated adverse reactions.
    [Show full text]
  • 207145Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207145Orig1s000 OTHER REVIEW(S) CSS Consult: NDA 207,145 Safinamide M E M O R A N D U M Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research * Date: March 8, 2017 To: Billy Dunn, M.D., Director Division of Neurology Products Through: Martin Rusinowitz, M.D., Medical Officer Silvia Calderon, Ph.D., Pharmacologist Controlled Substance Staff From: Alicja Lerner, M.D., Ph.D., Medical Officer Controlled Substance Staff Subject: Erratum-CSS Review of NDA 207,145 dated December 29, 2016 (Author: Lerner, Alicja) AMENDMENT This memorandum corrects an error and changes the title of Table 4, page 14, in the previously submitted CSS review dated Dec 29, 2016. In our prior review, we erroneously listed the subject population reporting the tabulated adverse events as comprising only healthy volunteers (HV). However, as indicated in the revised Table Title, the data derived from Phase 2 and Phase 3 controlled trials. This erratum does not change the conclusions or recommendations in the previous CSS review. Table 4 should read: Table 4. Summary of Selected Abuse Potential Adverse Events from all Completed Safinamide Phase 2 and Phase 3 Controlled Trials for PD – All Pooled Studies (based on the table 11, page 27, 8 factor-analysis). 1 of 2 Reference ID: 4066812 CSS Consult: NDA 207,145 Safinamide Body System Or Organ Class All Safinamide Placebo pool pool N=919 N=1516 (n, %) (n, %) Patients with at least one abuse potential event 230 (15.2)
    [Show full text]
  • Ketamine: an Update for Its Use in Complex Regional Pain Syndrome
    xperim & E en l ta a l ic P in h Bentley et al., Clin Exp Pharmacol 2015, 5:2 l a C r m f Journal of DOI: 10.4172/2161-1459.1000169 o a l c a o n l o r g u y o J ISSN: 2161-1459 Clinical and Experimental Pharmacology Commentry Open Access Ketamine: An Update for Its Use in Complex Regional Pain Syndrome and Major Depressive Disorder William E Bentley*, Michael Sabia, Michael E Goldberg and Irving W Wainer Cooper University Hospital, Camden, New Jersey, United States of America Abstract In recent years, there has been significant research in regard to the efficacy of ketamine in regards to treating Complex Regional Pain Syndrome (CRPS) and Major Depressive Disorder (MDD). Many patients have had substantial symptomatic relief; however, not all patients have had positive results. This has prompted current research with evidence to suggest certain biomarkers exist that would infer which patients will/will not respond to ketamine treatment. Current biomarkers of interest include D-Serine (D-Ser) and magnesium, which will be discussed. Whether or not D-Ser and/or magnesium levels should be checked and possibly dictate therapy is an area of future research. It is also possible that downstream metabolites of ketamine are the key to successful therapy. Keywords: Complex regional pain syndrome; Major Depressive thoughts; and slowing of speech and action. These changes must last a Disorder(MDD); Ketamine minimum of 2 weeks and interfere considerably with work and family relations” [6]. Treatment options include antidepressant medications, Complex Regional Pain Syndrome (CRPS) and Major Depressive cognitive behavioral therapy, and interpersonal therapy.
    [Show full text]
  • ACPA Guide to Pain Management
    [Document title] [Document subtitle] Abstract [Draw your reader in with an engaging abstract. It is typically a short summary of the document. When you’re ready to add your content, just click here and start typing.] ACPA [Email address] 1 ACPA Resource Guide To Chronic Pain Management An Integrated Guide to Medical, Interventional, Behavioral, Pharmacologic and Rehabilitation Therapies 2019 Edition American Chronic Pain Association P.O. Box 850 Rocklin, CA 95677 Tel 800-533-3231 Fax 916-652-8190 E-mail [email protected] Web Site http://www.theacpa.org Copyright 2019 American Chronic Pain Association, Inc. All rights reserved. No portion of this book may be reproduced without permission of the American Chronic Pain Association, Inc. 2 Table of Contents A STATEMENT FROM THE ACPA BOARD OF DIRECTORS ...........................................................................................................................5 INTRODUCTION ........................................................................................................................................................................................................6 OVERVIEW OF CHRONIC PAIN TREATMENT ..................................................................................................................................................8 WHAT DOES SUCCESSFUL PAIN TREATMENT LOOK LIKE? .......................................................................................................................8 PAIN TYPES, SOURCES & CLASSIFICATION .....................................................................................................................................................9
    [Show full text]
  • Drug Name Plate Number Well Location % Inhibition, Screen Axitinib 1 1 20 Gefitinib (ZD1839) 1 2 70 Sorafenib Tosylate 1 3 21 Cr
    Drug Name Plate Number Well Location % Inhibition, Screen Axitinib 1 1 20 Gefitinib (ZD1839) 1 2 70 Sorafenib Tosylate 1 3 21 Crizotinib (PF-02341066) 1 4 55 Docetaxel 1 5 98 Anastrozole 1 6 25 Cladribine 1 7 23 Methotrexate 1 8 -187 Letrozole 1 9 65 Entecavir Hydrate 1 10 48 Roxadustat (FG-4592) 1 11 19 Imatinib Mesylate (STI571) 1 12 0 Sunitinib Malate 1 13 34 Vismodegib (GDC-0449) 1 14 64 Paclitaxel 1 15 89 Aprepitant 1 16 94 Decitabine 1 17 -79 Bendamustine HCl 1 18 19 Temozolomide 1 19 -111 Nepafenac 1 20 24 Nintedanib (BIBF 1120) 1 21 -43 Lapatinib (GW-572016) Ditosylate 1 22 88 Temsirolimus (CCI-779, NSC 683864) 1 23 96 Belinostat (PXD101) 1 24 46 Capecitabine 1 25 19 Bicalutamide 1 26 83 Dutasteride 1 27 68 Epirubicin HCl 1 28 -59 Tamoxifen 1 29 30 Rufinamide 1 30 96 Afatinib (BIBW2992) 1 31 -54 Lenalidomide (CC-5013) 1 32 19 Vorinostat (SAHA, MK0683) 1 33 38 Rucaparib (AG-014699,PF-01367338) phosphate1 34 14 Lenvatinib (E7080) 1 35 80 Fulvestrant 1 36 76 Melatonin 1 37 15 Etoposide 1 38 -69 Vincristine sulfate 1 39 61 Posaconazole 1 40 97 Bortezomib (PS-341) 1 41 71 Panobinostat (LBH589) 1 42 41 Entinostat (MS-275) 1 43 26 Cabozantinib (XL184, BMS-907351) 1 44 79 Valproic acid sodium salt (Sodium valproate) 1 45 7 Raltitrexed 1 46 39 Bisoprolol fumarate 1 47 -23 Raloxifene HCl 1 48 97 Agomelatine 1 49 35 Prasugrel 1 50 -24 Bosutinib (SKI-606) 1 51 85 Nilotinib (AMN-107) 1 52 99 Enzastaurin (LY317615) 1 53 -12 Everolimus (RAD001) 1 54 94 Regorafenib (BAY 73-4506) 1 55 24 Thalidomide 1 56 40 Tivozanib (AV-951) 1 57 86 Fludarabine
    [Show full text]
  • Membrane Stabilizer Medications in the Treatment of Chronic Neuropathic Pain: a Comprehensive Review
    Current Pain and Headache Reports (2019) 23: 37 https://doi.org/10.1007/s11916-019-0774-0 OTHER PAIN (A KAYE AND N VADIVELU, SECTION EDITORS) Membrane Stabilizer Medications in the Treatment of Chronic Neuropathic Pain: a Comprehensive Review Omar Viswanath1,2,3 & Ivan Urits4 & Mark R. Jones4 & Jacqueline M. Peck5 & Justin Kochanski6 & Morgan Hasegawa6 & Best Anyama7 & Alan D. Kaye7 Published online: 1 May 2019 # Springer Science+Business Media, LLC, part of Springer Nature 2019 Abstract Purpose of Review Neuropathic pain is often debilitating, severely limiting the daily lives of patients who are affected. Typically, neuropathic pain is difficult to manage and, as a result, leads to progression into a chronic condition that is, in many instances, refractory to medical management. Recent Findings Gabapentinoids, belonging to the calcium channel blocking class of drugs, have shown good efficacy in the management of chronic pain and are thus commonly utilized as first-line therapy. Various sodium channel blocking drugs, belonging to the categories of anticonvulsants and local anesthetics, have demonstrated varying degrees of efficacy in the in the treatment of neurogenic pain. Summary Though there is limited medical literature as to efficacy of any one drug, individualized multimodal therapy can provide significant analgesia to patients with chronic neuropathic pain. Keywords Neuropathic pain . Chronic pain . Ion Channel blockers . Anticonvulsants . Membrane stabilizers Introduction Neuropathic pain, which is a result of nervous system injury or lives of patients who are affected. Frequently, it is difficult to dysfunction, is often debilitating, severely limiting the daily manage and as a result leads to the progression of a chronic condition that is, in many instances, refractory to medical This article is part of the Topical Collection on Other Pain management.
    [Show full text]
  • Intrathecal Drug Infusions
    INTRATHECAL DRUG INFUSIONS RATIONAL USE OF POLYANALGESIA TIMOTHY R. DEER, MD • PRESIDENT AND CEO, THE CENTER FOR PAIN RELIEF, CHARLESTON, WEST VIRGINIA • CLINICAL PROFESSOR OF ANESTHESIOLOGY, WEST VIRGINIA UNIVERSITY • BOARD OF DIRECTORS, INTERNATIONAL NEUROMODULATION SOCIETY • IMMEDIATE PAST CHAIR, AMERICAN SOCIETY OF ANESTHESIOLOGISTS, COMMITTEE ON PAIN MEDICINE • BOARD OF DIRECTORS; AMERICAN ACADEMY OF PAIN MEDICINE AND AMERICAN SOCIETY OF INTERVENTIONAL PAIN PHYSICIANS 2 INS 2009 • SYMPOSIUM ON INTRATHECAL DRUG DELIVERY • DISCLOSURES IN INTRATHECAL DRUG DELIVERY • CONSULTANT: INSET, JOHNSON AND JOHNSON. Intrathecal Pump for Pain ! 1 mg intrathecal morphine = 300 mg oral morphine CONFIDENTIAL Krames ES. J Pain Symptom Manage. 1996 Jun;11(6):333-52 4 Objectives • Review current options for pump infusions • Build on the talks of Dr. Levy and Dr. Abejon • Use a case based approach to discuss the issues • Make conclusions regarding the algorithm of Intrathecal analgesia Clinical Decision Making • Regulatory Approval in your country • Case reports • Lectures and anecdotal information • Retrospective analysis • Double-blind, randomized, prospective studies • Physician innovation with no available evidence • Consensus Statements 2000 Guidelines for Intraspinal Infusion 2007 Polyanalgesic Consensus Guidelines for Management of Pain by Intraspinal Drug Delivery Line 1 Morphine or Hydromorphone or Ziconotide Fentanyl or Clonodine alone OR one of the following 2-drug Line 2 combinations: • Morphine (or Hydromorphone) + Ziconotide • Morphine (or
    [Show full text]
  • Treatment Options for Motor and Non-Motor Symptoms of Parkinson’S Disease
    biomolecules Review Treatment Options for Motor and Non-Motor Symptoms of Parkinson’s Disease Frank C. Church Department of Pathology and Laboratory Medicine, The University of North Carolina School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] Abstract: Parkinson’s disease (PD) usually presents in older adults and typically has both motor and non-motor dysfunctions. PD is a progressive neurodegenerative disorder resulting from dopamin- ergic neuronal cell loss in the mid-brain substantia nigra pars compacta region. Outlined here is an integrative medicine and health strategy that highlights five treatment options for people with Parkinson’s (PwP): rehabilitate, therapy, restorative, maintenance, and surgery. Rehabilitating begins following the diagnosis and throughout any additional treatment processes, especially vis-à-vis consulting with physical, occupational, and/or speech pathology therapist(s). Therapy uses daily administration of either the dopamine precursor levodopa (with carbidopa) or a dopamine ago- nist, compounds that preserve residual dopamine, and other specific motor/non-motor-related compounds. Restorative uses strenuous aerobic exercise programs that can be neuroprotective. Maintenance uses complementary and alternative medicine substances that potentially support and protect the brain microenvironment. Finally, surgery, including deep brain stimulation, is pursued when PwP fail to respond positively to other treatment options. There is currently no cure for PD. In conclusion, the best strategy for treating PD is to hope to slow disorder progression and strive to achieve stability with neuroprotection. The ultimate goal of any management program is to improve the quality-of-life for a person with Parkinson’s disease.
    [Show full text]
  • Eisai and Meiji Enter Into Licensing Agreement Concerning Parkinson’S Disease Drug Safinamide in Japan and Asia
    FOR IMMEDIATE RELEASE April 5, 2017 Eisai Co., Ltd. Meiji Seika Pharma Co., Ltd. EISAI AND MEIJI ENTER INTO LICENSING AGREEMENT CONCERNING PARKINSON’S DISEASE DRUG SAFINAMIDE IN JAPAN AND ASIA Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo; CEO: Daikichiro Kobayashi, “Meiji”) announced today that they have entered into a license agreement for the commercialization of safinamide (development code: ME2125) for the treatment of Parkinson’s disease in Japan and Asia. Safinamide is currently under clinical development by Meiji in Japan. Under the agreement, Eisai will obtain exclusive rights to safinamide to market in Japan and to develop and market in Asia (seven countries*). Meiji will continue the clinical trials that it is currently conducting and submit a manufacturing and marketing authorization application for the drug in Japan. Meanwhile, Eisai will conduct clinical trials for seeking regulatory approval, and make the applications in Asia. Meiji will manufacture and supply the product of safinamide to Eisai for Japan and Asia. Furthermore, Meiji will receive an upfront payment from Eisai, as well as developmental milestone and sales royalty payments under the agreement. Parkinson's disease is a neurodegenerative disease which causes motor impairment, including shaking in the limbs, muscular rigidity and brachybasia. It is caused by degeneration of the dopamine nervous system, which leads to a shortage of dopamine, a neurotransmitter in the brain. According to a survey by the Ministry of Health, Labour and Welfare, the number of patients suffering from Parkinson’s disease in Japan numbered 163,000 in 20141, with the number of patients increasing due to the aging of the population.
    [Show full text]
  • MSM Chapter 1200 3/1/21
    MEDICAID SERVICES MANUAL TRANSMITTAL LETTER February 23, 2021 TO: CUSTODIANS OF MEDICAID SERVICES MANUAL FROM: JESSICA KEMMERER, HIPAA PRIVACY AND CIVIL RIGHTS OFFICER /Jessica Kemmerer/ BACKGROUND AND EXPLANATION The DHCFP is proposing revisions to Medicaid Services Manual (MSM), Chapter 1200 – Prescribed Drugs, Appendix A, to reflect recommendations approved on October 22, 2020, by the Drug Use Review (DUR) Board. The proposed changes include the addition of new prior authorization criteria for Doxepine Topical, the addition of new prior authorization criteria for Zeposia® (ozanimod), addition of new prior authorization for Evenity® (romosozumab-aqqg), Prolia® (denosumab), Forteo® (teriparatide) and Tymlos® (abaloparatide) within a new combined osteoporosis agents section, and addition of new prior authorization criteria for Orilissa® (elagolix) and Oriahnn® (elagolix, estradiol, and norethindrone) within a new Gonadorpin Hormone Receptor (GnRH) Antagonist and Combinations section. Additionally, the DHCFP is proposing revisions to the existing prior authorization criteria for psychotropic medications for children and adolescents, and revision to the existing clinical criteria for Epidiolex® (cannabidiol). Throughout the chapter, grammar, punctuation and capitalization changes were made, duplications removed, acronyms used and standardized, and language reworded for clarity. Renumbering and re- arranging of sections was necessary. These changes are effective March 1, 2021. MATERIAL TRANSMITTED MATERIAL SUPERSEDED MTL N/A MTL N/A MSM Ch 1200 – Prescribed Drugs MSM Ch 1200 – Prescribed Drugs Background and Explanation of Policy Changes, Manual Section Section Title Clarifications and Updates Appendix A Psychotropic Added new policy language criteria on which specific Section N Medications for drug classes may bypass polypharmacy clinical criteria. Children and Adolescents Appendix A Reserved for Future Created a new section titled “Doxepin Topical.” Added Section W Use new prior authorization criteria for doxepin topical.
    [Show full text]