Nuovi laboratori Controllo Qualit£  e Ricerca & Sviluppo ......

Click here to load reader

download Nuovi laboratori Controllo Qualit£  e Ricerca & Sviluppo ... ¢â‚¬¢ LATISSE ¢® Brow ¢â‚¬¢ ... UK Ukraine

of 43

  • date post

    24-Aug-2020
  • Category

    Documents

  • view

    0
  • download

    0

Embed Size (px)

Transcript of Nuovi laboratori Controllo Qualit£  e Ricerca & Sviluppo ......

  • Nuovi laboratori Controllo Qualità e Ricerca & Sviluppo

    Posa della prima pietra

    26 febbraio 2015

  • Bogdan Oghina

    Enrico Cozzi

    Carlos Villalobos

    Antonella Martignoni

    Vera Terragni

    Lorena Muggetti

    Claudio Zaninetti

    Managing Director, Injectables

    Major of Nerviano

    VP, Injectables and Biologics

    Executive Director, Quality – Injectables/Biosimilars

    Quality Operations Director

    Research & Development Director

    Engineering, Maintenance & Utilities Director

    I relatori

  • Actavis

    Actavis (NYSE:ACT) markets a broad portfolio of branded and generic pharmaceuticals and

    develops innovative medicines for patients suffering from diseases principally in the Central Nervous

    System, Gastroenterology, Women’s Health, Urology, Cardiovascular, Respiratory and Anti-infective

    therapeutic categories.

    The Company is an industry leader in R&D, with one of the broadest brand development pipelines in

    the pharmaceutical industry, and a leader in the submission of generic product applications. Actavis

    has commercial operations in 60+ countries and operates 30+ manufacturing and distribution

    facilities around the world.

    3

  • Actavis by the Numbers

    Commercial Operations in 60+ Countries

    Markets/Distributes

    nearly 1,000 products

    30+ manufacturing facilities

    20+ R&D centers

    ~44+ billion unit capacity

    25+ specialty brand products

    in near or mid-term stage of

    development

  • Our business

  • Evolution of Actavis 1984 - Today

    1984

    Expanding Global Generics

    2006 - 2012

    Emerging Brand and

    Specialty Global

    Company

    2013 - 2014

    November 17, 2014

    6

  • Announced November 17, 2014

  • An Exceptional Transaction Announced November 17, 2014

    • Creates a New Top 10 Global Growth Pharmaceutical

    Company

    - $23B of pro forma revenue in 2015

    • $66B cash and stock deal at $219 per share

    • Approved by both Boards; strongly supported by both

    management teams

    - Subject to shareholder approval of both companies; customary

    regulatory approvals

    - Anticipate the transaction to close in the second quarter of 2015

    • Industry-leading combined management team led by Brent

    Saunders, CEO and President and Paul Bisaro, Executive

    Chairman

    8

  • The Most Dynamic Company in “Growth Pharma” An Exceptional Company by the Numbers

    Double-

    Digit %

    Accretion

    10+%

    Revenue

    Growth

    Target

    >30,000 Employees

    $8B Free Cash

    Flow in 2016

    ~$23B Global

    Revenue

    ~$1.7B R&D Spend

    ~$147B Enterprise

    Value

    2017

    Aspiration

    $25 EPS

    9

  • Creating the Most Dynamic Company in

    “Growth Pharma”

    10

  • $15 Billion Global Brand Portfolio 6 Blockbuster Franchises & Strong Anti-Infectives/Established Brands Franchises

    A c ta

    v is

    A

    ll e rg

    a n

    Women’s Health

    & Urology Ophthalmology CNS

    Cardiovascular &

    Respiratory

    GI &

    Cystic Fibrosis

    Dermatology &

    Aesthetics

    ~$3 Billion+ ~$3 Billion+ ~$3 Billion+ $1 Billion+ $1 Billion+ $1 Billion+

    Anti-infectives &

    Est. Brands

    http://www.google.com/url?url=http://www.frx.com/Products&rct=j&frm=1&q=&esrc=s&sa=U&ei=awJbVKLQM4iVyQTskYLYDA&ved=0CBgQ9QEwAQ&usg=AFQjCNGbappa2IUvamsCDaV-Qsi42WeV0w http://www.google.com/url?url=http://www.practiceofmadness.com/2013/11/medical-advertising-images/&rct=j&frm=1&q=&esrc=s&sa=U&ei=xgNbVOijMderyAST_IK4CQ&ved=0CBYQ9QEwAA&usg=AFQjCNH9im1Bjg148vYxO_O7_toMpul1Aw http://www.google.com/url?url=http://medcitynews.com/2009/10/schering-plough-launches-schizophrenia-bi-polar-disorder-drug-after-buying-maker/saphris-logo/&rct=j&frm=1&q=&esrc=s&sa=U&ei=S_ZgVOzqLoi5yQTehoGwCg&ved=0CBYQ9QEwAA&usg=AFQjCNGjGX--prdebKOrX7ztB_9-DHTTqw http://www.google.com/url?url=http://www.frx.com/Products&rct=j&frm=1&q=&esrc=s&sa=U&ei=OgNbVOTzKpS0yATr9oLQDQ&ved=0CBoQ9QEwAg&usg=AFQjCNG5uN2Fw1rzkQqY3a_1_MCnrht7Gw http://www.google.com/url?url=http://www.tudorzahcp.com/&rct=j&frm=1&q=&esrc=s&sa=U&ei=ufdgVIfoGZOVyATd34D4DA&ved=0CBYQ9QEwAA&usg=AFQjCNHSgwjCHlXnpstCYLiGmtmkmsj2PQ http://www.google.com/url?url=http://www.daliresp.com/&rct=j&frm=1&q=&esrc=s&sa=U&ei=1_dgVN_wIcueyAS-voKABw&ved=0CBgQ9QEwAA&usg=AFQjCNH69-cEr0ZPJLLIJDUi8x5dOtdrhQ http://www.google.com/url?url=http://thuocthang.vn/tin-tuc/thong-tin-duoc/linzess-thuoc-moi-dieu-tri-hoi-chung-ruot-kich-thich-va-tao-bon/269.aspx&rct=j&frm=1&q=&esrc=s&sa=U&ei=DgNbVMelOZKjyAShk4LgDg&ved=0CBoQ9QEwAg&usg=AFQjCNEIod1CmfmJRTNt4SVOBlBtAqbEWA https://www.google.com/url?url=https://www.zenpep.com/&rct=j&frm=1&q=&esrc=s&sa=U&ei=9flgVJOrE8GjyATgvoHADg&ved=0CBYQ9QEwAA&usg=AFQjCNFht523454lGbGePCv_wFHg646UlA https://www.google.com/url?url=https://coupondoc.com/coupons/127-lumigan&rct=j&frm=1&q=&esrc=s&sa=U&ei=Icm0U5GTIdSmyATd74HoDA&ved=0CBoQ9QEwAg&usg=AFQjCNFm-_VFBGYIP--ZMhODcTDYxvBSSw

  • Unparalleled Commercial Reach

    • Presence in 100 Countries

    with Greater Market and

    Product Reach – A leader in growing

    markets including Europe,

    Southeast Asia, China, India

    and Latin America

    • World-class commercial sales and marketing organization

    competing across multiple market segments – Brands, generics, branded-generics, OTC

    12

  • • BOTOX CFL Asia

    • BOTOX Forehead Lines

    • BOTOX Spasticity Adult LL, Adult UL, Ped LL,

    Ped UL

    • RESTASIS® EU

    • Bimatoprost SR

    • DARPin® AMD

    • “SEMPRANA®” Headache

    • LATISSE® Brow

    • Oxymetazoline Rosacea

    • ACZONE® X

    • SER-120

    • OZURDEX® RVO China

    • LASTACAFT® Japan

    • Bystolic + valsartan

    • Namenda + donepezil

    • Levonorgestrel-releasing intrauterine system

    (LNG20)

    • CAZ-AVI

    • Viibryd Low- Dose

    • Eluxadoline

    • Cariprazine

    • Esmya

    • Sarecylcline

    Industry-leading Generics Pipeline

    • 60+ First to Files, 228 pending ANDAs

    • 1,200+ Pending MAAs Internationally

    Actavis Brands Allergan

    ~$1.7 Billion Commitment to R&D

    Strong Late Stage Pipeline

    Actavis Generics

  • Committed to ~$1.7 Billion Combined R&D Investment

  • Industry-leading Global Supply Chain

  • Actavis‘ Injectable Business

  • Global Injectables Business is Supplied

    from two European Facilities

    Bucharest (Sindan), Romania:

    • Role

    – The origin of the Actavis oncology

    business

    – Small, flexible, niche

    • Production capabilities:

    – Cytotoxic freeze-dried and solution

    products in vials; SOD (tablets and

    capsules)

    • Annual production volume: ~3M vials & 30M

    tab/cps

    • Approximately 250 employees

    Nerviano, Italy:

    • Role

    – Delivering scale and capacity

    – Long history of global supply (formerly a

    Pfizer facility)

    • Production Capabilities:

    – Containment, Cytotoxic and non-

    Cytotoxic freeze-dried and Solution

    products in Vials, Amps and Pre-Filled

    Syringes

    • Annual production volume: >25-35 million

    vials depending on product mix

    • Approximately about 450 employees

  • Diversifying US Generic Portfolio into Alternate Dosage Forms

    Other

    Hormones

    Buccal Transdermal

    Oral Liquid

    Ophthalmic & Optic

    Injectable

    Topical

    MR Oral Solid

    IR Oral Solid

    Inhalation

    In Market Filed at FDA

    In Development

    Chart: % of development projects based on # of products in each dosage form

    18

  • • Firm believe in excellence and commitment to quality

    • Increased R&D capabilities

    • Vital to be competitive in price and supply of our medicines

    • Engagement and cooperation with our employees, unions, suppliers and

    business partners

    • Video

    19

    Why invest in Italy, when our competitors invest elsewhere?

  • 20

    Actavis Nerviano

  • 21

    Actavis Italy SpA

    Via L. Pasteur, 10 – 20014 – Nerviano (MI) - Italy

    About Nerviano

  • Nerviano – La storia

    1969: Farmitalia costruisce lo stabilimento di Nerviano, dedicato all’uso veterinario

    1975: Far