Almirall grants Invida commercial rights for Aclidinium in Australia and New ZealandAlmirall????? (Invida)??????????? Aclidinium?????

Similar documents
vz Strategic Transaction with Almirall

Third Quarter Consolidated Financial Results

Summary of the risk management plan (RMP) for Duaklir Genuair (aclidinium / formoterol fumarate dihydrate)

ALMIRALL AND IRONWOOD ANNOUNCE POSITIVE RESULTS FROM A PHASE 3 TRIAL WITH LINACLOTIDE IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION

For personal use only

Boehringer Ingelheim and investment in R&D. Volker Barkmann

Verona Pharma Announces Positive Top-Line Data from Phase 2a Clinical Trial in COPD with RPL554 Dosed in Addition to Tiotropium (Spiriva )

Chronic respiratory disease: towards better treatments

aclidinium 322 micrograms inhalation powder (Eklira Genuair ) SMC No. (810/12) Almirall S.A.

COPD and Asthma Devices Market by Inhalers Type (Drug powder, Metered Dose, Soft Mist), Nebulizers (Compressor, Ultrasonic, Mesh) - Global

Package leaflet: Information for the patient. Eklira Genuair 322 micrograms inhalation powder Aclidinium (aclidinium bromide)

Summary of the risk management plan (RMP) for Laventair (umeclidinium bromide and vilanterol)

COPD Research at the University of Maryland School of Maryland

Health for Humanity 2020 Goals 2

Partnering for Growth

Summary A pharmaceutical company which develops therapeutic products for

Another Record Year for Bayer HealthCare Pharmaceuticals in Asia Pacific

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) TREATMENT GUIDELINES

BETTER DEFINING AIRWAYS DISEASE WITH TECHNEGAS

About BNM.

Therapeutic products for respiratory and autoimmune diseases. Annual General Meeting

First Indication: Pulmonary Hypertension (PH) Overview

Revefenacin (TD-4208) Phase 3 Efficacy Results

Dear Reader, What was the study about? Why was the research needed? BI NCT

COPD Device Workshop. Summary. Role of inhaler device in COPD. Why use inhaler device in COPD?

See Important Reminder at the end of this policy for important regulatory and legal information.

A world leader in allergy immunotherapy. Jefferies Global Healthcare Conference, London : 19 November 2014 : Flemming Pedersen, CFO & EVP

Innovative products for r espiratory rrespiratory d iseases diseases September 2012

NHS Dumfries & Galloway Triple therapy in COPD patients over 16 years

Aradigm Corporation. A respiratory specialty pharmaceutical company fulfilling unmet needs in pulmonary medicine (ARDM) February 2008

MEDICATION GUIDE ANORO ELLIPTA

Putting ALK on the right growth trajectory

American Thoracic Society (ATS) Perspective

Theravance Biopharma, Inc. (NASDAQ: TBPH)

Brimica Genuair 340/12 Powder for inhalation aclidinium (as bromide)/eformoterol fumarate dihydrate

After simple testing that only takes minutes people with elevated test results are then recommended to see their physicians for follow-up.

Forward Looking Statements

Developing & Commercializing Targeted Small Molecule Drugs in Cancer

AWMSG SECRETARIAT ASSESSMENT REPORT. Aclidinium bromide (Eklira Genuair ) 322 micrograms inhalation powder. Reference number: 938 FULL SUBMISSION

A world leader in allergy immunotherapy

Connecting Health & Housing: Asthma and the Home. Presented by: The California-Nevada Public Health Training Center

glycopyrronium 44 micrograms hard capsules of inhalation powder (Seebri Breezhaler ) SMC No. (829/12) Novartis Pharmaceuticals Ltd.

Living well with COPD

DS-8201 Strategic Collaboration

Patient Education at the Point of Dispensing Improves Adherence and Increases Sales

Defining COPD. Georgina Grantham Community Respiratory Team Leader/ Respiratory Nurse Specialist

DRUG DISCOVERY INSIGHTS EVOTEC AND BAYER ALLIANCE TO FIGHT CHRONIC COUGH

PPD S EXPERT HEMATOLOGY AND ONCOLOGY TEAM

PATIENT INFORMATION INCRUSE ELLIPTA

27 September Interim results for the six months ended 30 June 2018

Towards tailored and targeted asthma self-management using mobile technologies

Boehringer Ingelheim BioXcellence. Producing Value. Global Contract Manufacturing Excellence

MOVICOL Launched in Japan -The First Polyethylene Glycol Preparation for Chronic Constipation in Japan-

MOVICOL Launched in Japan -The First Polyethylene Glycol Preparation for Chronic Constipation in Japan-

2017 GOLD Report. Is it worth its weight in GOLD??? CSHP-NB Fall Education Day September 30, 2017

ONO PHARMACEUTICAL CO., LTD. and Bristol-Myers Squibb Announce Strategic Immuno-Oncology Collaboration in Japan, South Korea and Taiwan

Wirral COPD Prescribing Guidelines

Instructions for Use TUDORZA PRESSAIR (TU-door-za PRESS-air) (aclidinium bromide inhalation powder)

More information at

Executive Summary. for. Tobacco Use at Camosun College, 2009

Wednesday 26 th November 2008 The ASX Company Announcements office: Chairman s AGM Address

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE

Committed to the research, development and commercialisation of human therapeutic products for chronic respiratory and autoimmune diseases

Diabetic Retinopathy Treatment - Global Market Outlook ( )

SUGAR, OBESITY AND DIABETES THE OTHER GLOBAL FOOD CRISIS

Dealdoc. Licensing, development and marketing agreement for Relenza. Glaxo Wellcome GlaxoSmithKline Biota. Sep

Intercell and Novartis form world leading strategic partnership to drive vaccines innovation

Using the Mozambique National Quality Policy to Encourage Biomedical Research, Innovation, & Infrastructure Investment

Dainippon Sumitomo Pharma

Clinical Policy: Roflumilast (Daliresp) Reference Number: CP.PMN.46 Effective Date: Last Review Date: 08.18

Merrill Lynch Pharmaceutical, Biotechnology & Medical Device Conference New York, February 4, 2004

New Delhi Declaration

Chronic Obstructive Pulmonary Disease (COPD) Clinical Guideline

A multitude of devices

COPD RESOURCE PACK Section 5. Drug Treatment & Inhalers in Stable COPD

For personal use only

For personal use only

Rising to the Challenge of Satisfying Unmet Medical Needs. Back-of-the-eye. Main Back-of-the-Eye Diseases. Uveitis. Behcet s disease.

Medical Developments International

Peak inspiratory flow through the Genuair â inhaler in patients with moderate or severe COPD

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION

IMPORTANT: PLEASE READ

Shareholder Presentation Annual Meeting 2018

REVIEW OF PRODUCTS AND OPERATIONS

Chronic obstructive pulmonary disease

040716_ANDI_VENTIS WEBSITE(new) Printout 1. HOME PAGE. Welcome to our world of Dry Powder Inhalers!

Healthy Lungs. Presented by: Brandi Bishop, RN and Patty Decker, RRT, RCP

Financial Presentation

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE

A world-class specialty pharma business focused on respiratory disease

Lead team presentation: Roflumilast for treating chronic obstructive pulmonary disease [ID984]

Combatting noncommunicable diseases global burden and best practices

OPENING UP A NEW WORLD

Bayer Pharma AG Berlin Germany Tel News Release. Not intended for U.S. and UK Media

Global Hearing Aids Market (by Devices, Implant Types, OTC Amplifiers, Diagnostic Instruments), Sales Volume, Company Analysis and Forecast to 2022

JTI Switzerland. JTI Schweiz 3

Landmark Phase III Study of Bayer s Xarelto (Rivaroxaban) Initiated for the Secondary Prevention of Myo

Alertness and Sleep Health Management Research & Technology. Strategic Opportunity Overview

Transcription:

Almirall grants Invida commercial rights for Aclidinium in Australia and New ZealandAlmirall????? (Invida)??????????? Aclidinium????? Almirall licenses Aclidinium to Invida in Australia and New Zealand This is the fifth territorial licensing agreement for Aclidinium. Previous partnerships have been established in the US, Japan, Korea and Europe Aclidinium, a new therapeutic option for Chronic Obstructive Pulmonary Disease (COPD), was recently approved in the US and Europe where it is already on the market in Denmark and Germany It is estimated that around 2 million people in Australia suffer from COPD, where it is the sixth most common cause of death among men and seventh among women1-2 Barcelona and Singapore, 10th October 2012.- Almirall (ALM:MC) and Invida Holdings Private Limited, a member of the Menarini Group, are pleased to announce that Almirall has granted Invida commercial rights for Aclidinium in Australia and New Zealand for the treatment of COPD. Financial details of the agreement have not been disclosed. The agreement includes both Aclidinium monotherapy and its combination with Formoterol. Invida, as a leading pharmaceutical commercialization company in Asia-Pacific, is committed to bringing innovative drugs and pharmaceutical research to doctors and patients in the region. Invida will be responsible for marketing the novel compound in Australia and New Zealand, both to primary and specialty care physicians. This agreement further strengthens Almirall and Invida s existing partnership in the area of dermatology within the Australian market. Eduardo Sanchiz, Chief Executive Officer of Almirall, stated "In partnership with Invida, we will be able to offer this novel therapy in Australia and New Zealand for COPD, a disease increasing in prevalence that causes mortality and poor quality of life. With this new agreement Aclidinium, via partners or Almirall s own salesforce, now has access to over 80% of the COPD world market including the US, Japan, Korea and Europe. John A. Graham, Chief Executive Officer of Invida, comments that This deal strengthens Invida s partnership with Almirall as well as its position as a leading pharmaceutical company in Asia-Pacific. Aclidinium expands Invida s current product offerings into the respiratory field, which taps into our already established expertise in dermatology, consumer products and primary and speciality care. Aclidinium, a new therapeutic option from Almirall s respiratory R&D, was recently approved in the US and Europe where it is already available in Denmark and Germany. This paves the way for the subsequent introduction of Almirall s combination products for COPD, currently in late stage development. 1 / 5

About Aclidinium and the Genuair inhaler Aclidinium bromide is a novel, long-acting inhaled muscarinic antagonist -sometimes referred to as an anticholinergic-, which has a long residence time at M3 receptors and a shorter residence time at M2 receptors, and which is designed to be rapidly broken down in plasma, leading to high topical efficacy but low propensity for systemic anticholinergic effects. When given by inhalation, Aclidinium leads to bronchodilation by inhibiting airway smooth muscle contraction. Aclidinium bromide is rapidly hydrolyzed in human plasma to two major inactive metabolites. Aclidinium bromide was administered to patients in clinical trials using a novel, state-of-the-art, user-friendly multidose dry powder inhaler (MDPI), Genuair. This inhaler was designed with a click and colour feedback system which, through a 'coloured control window' and an audible click, indicates that the patient has inhaled the dose correctly. It also incorporates significant safety features such as a visible dose indicator, an anti-double-dosing mechanism and an endof-dose lock-out system to prevent use of an empty inhaler. Aclidinium is being developed worldwide and has been recently approved in the USA by the FDA where it will be marketed by Forest Laboratories and marketed under the name of Tudorza Pressair. In Europe, it will be marketed by Almirall under the trade name Eklira Genuair and by Menarini under the name Bretaris Genuair. In Japan the product is in development in partnership with Kyorin and with Daewoong in Korea. Almirall holds the rights for the rest of the world. Eklira Genuair and Bretaris Genuair are trademarks owned by Almirall, S.A. About COPD The World Health Organization (WHO) has described COPD as a global epidemic; an estimated 64 million people have COPD worldwide3. More than 3 million people died of the condition in 2005, which is equal to 5% of all deaths globally that year. Total deaths from COPD are projected to increase by more than 30% in the next 10 years without interventions to cut risks, particularly exposure to tobacco smoke. The most common symptoms of COPD are breathlessness (an increased effort to breathe), heaviness or a need for air, excessive mucus, and a chronic cough. Some people feel they are gasping for breath. These symptoms get worse when exercising, in case of a respiratory infection or during an exacerbation periods of time when there is a sudden increase in symptoms and the disease is worse. COPD affects the ability to breathe and is a progressive disease, which means that COPD gets worse over time. Daily activities may become more difficult as the disease worsens. There are significant unmet needs in the treatment of COPD and new therapies may be of value. COPD is the sixth most common cause of death among men and seventh among women in Australia; even though it is less prevalent than asthma, COPD accounts for many more deaths. Commonly associated with other diseases such as heart disease, lung cancer, stroke, pneumonia and depression, COPD affects over two million Australians. The financial burden of COPD to the Australian community is estimated at AUD8.8 billion annually, including health and 2 / 5

hospital costs, lost productivity, premature death and lower employment. This is of growing concern as, along with an aging population, the burden of COPD is likely to increase1-2. About Almirall Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, it researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people s health and wellbeing. Almirall focuses its research resources on respiratory, gastrointestinal, dermatology and pain. Almirall s medicines are currently present in over 70 countries while it has direct presence in Europe, Mexico and Canada through 13 affiliates. For further information please visit: www.almirall.com. About Invida Invida, a fully owned member of the Menarini Group, improves the lives of patients in Asia- Pacific by commercializing differentiated pharmaceutical and OTC brands. This is done through proven brand marketing and sales know-how, strong expertise across a number of key therapeutic categories and deep experience in all major Asia-Pacific markets. Comprehensive functional capabilities provide rapid market access delivered by a passionate team of sales and marketing professionals. With over 3,300 employees in 13 markets in Asia-Pacific, Invida operates across the commercial value chain from regulatory approval and product launch to lifecycle management. Partnering is an integral component of Invida s business model. We collaborate closely through long-term relationships with selected partners in developing effective strategies and putting our extensive experience behind maximizing the potential of the assets entrusted to us.almirall?????(invida)??????????aclidinium?????? Aclidinium?????????????????????????????????????????? Aclidinium?????????? (COPD)?????????????????????????????????????????? 200???? COPD??????????????????????????????????????2012? 10? 10? - Almirall (ALM:MC)??????????????????????????(Invida Holdings Private Limited)?????? Almirall???????????????? Aclidinium?????,???????? COPD????????????????????? Aclidinium?????????? (Formoterol)???????????????????????????????????????????????????????????????????????????????????????????? Almirall??????????????????? Almirall????? Eduardo Sanchiz?? COPD??????????????????????COPD??????????????????????????????? COPD???????????????????????????????Aclidinium?????????????????COPD??????????80%????????John A. Graham??????????????Almirall???????????????????????????????Aclidini 3 / 5

um?????????????????????????????????????????????????????????? Aclidinium?Almirall???????????????????????????????????????????????? Almirall?????COPD?????????????????????? Aclidinium? Genuair?????????????????????????????????????? M3?????????? M2??????????????????????????????????????????????????Aclidinium??????????????????????????????????????????????????????????????????????????????? (MDPI) Genuair?????????????? click and colour???????????????????????????????????????????????????????????????????????????????????????? Aclidinium????????????????????????????? (FDA)????????? Forest Laboratories? Tudorza Pressair???????????????????????Almirall?Eklira Genuair???????????? Bretaris Genuair????????????????????? Kyorin??????Daewoong?Almirall?????????????????? Eklira Genuair? Bretaris Genuair????? Almirall, S.A.??? COPD?????? (WHO)? COPD??????????????????? 6400????COPD 3?2005??? 300???? COPD????????????? 5%?????????????????????????????? 10???? COPD???????30%??? COPD??????????????????????????????????????????????????????????????????????????????COPD????????????????? COPD??????????????????????????????????COPD???????????????????? COPD?????????????????????????????? COPD???????????? COPD?????????COPD??????????????????????????????COPD????????????????COPD????????????? 88?????????????????????????????????????????????COPD???????????COPD????????????? 1-2???? Almirall Almirall????????????????????????????????????????????????????????????????????????????????Almirall?????????????????????????????Almirall??????? 70????????????????????? 13????????????????????www.almirall.com????? (Invida)??????????????????????????? OTC?????????????????????????????????????????????????? 4 / 5

Powered by TCPDF (www.tcpdf.org) Menarini???????????????????????????????????????????????????????????????????????? 13???? 3,300??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? FAES?????????????FAES FARMA?????????????????????????????????????????????????????????????FAES?????????????????????????????? FAES???????????????????????? 60???????????????????????????FAES????? 1933?????????? www.faes.es????????????? (INVIDA HOLDINGS PTE LTD)??????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? 13???? 3,500???????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? 5 / 5