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Justine Degeuser Morgane Dufour Pauline Dulouard Olivier Héloir 23th February 2012.

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Presentation on theme: "Justine Degeuser Morgane Dufour Pauline Dulouard Olivier Héloir 23th February 2012."— Presentation transcript:

1 Justine Degeuser Morgane Dufour Pauline Dulouard Olivier Héloir 23th February 2012

2 2 Summary From Merck to Merck Serono Merck Serono nowadays Merck Serono’s future

3 3 Merck’s history

4 Merck is the world’s oldest pharmaceutical and chemical company morphine codéine morphine codéine Merck’s history 1668 Friedrich Jacob Merck: Engel-Apotheke (“Angel Pharmacy”) in Darmstadt 1827 Plant extracts and other chemicals by Heinrich E. Merck Alkaloïdes:Alkaloïdes:

5 Merck’s history A subsidiary in New York was created (Georg Merck, a grandson of Heinrich Emanuel Merck) Merck was represented on all continents Confiscation : World War I, Merck & Co. became an independent American company pharmaceutical company George Merck is giving direction to his son that turns the company of fine chemicals in pharmaceutical company The Merck Institute of Therapeutic Research is based

6 Merck’s history 1953 MSD After the Second World War merged with Sharp & Dohme = MSD 1953 Establishment of Merck KGaA EMD For USA: Merck = EMD

7 7 From Merck to Merck Serono Chemistry + Primary Care

8 8 Business sector in 2005

9 9 Sales in 2005 ProductsEUR million Concor®348.4 Glucophage®297.2 Duoneb®251.5 Erbitux®218.2 others573

10 10 Small molecules + Erbitux® Erbitux® – a first-in-class IgG1 monoclonal antibody targeting the EGFR. Treatment of metastatic colorectal cancer and squamous cell carcinoma of the head and neck – Eli Lilly Merck licensed the right to market Erbitux® outside the US and Canada Development of biological molecules

11 11 Looking for a biotech company Erbitux® is a recent success of Merck Group Development of not only new chemical but especially biological molecules Strategy to grow from a local, mid-sized pharmaceuticals and chemicals company into a leading global biopharmaceuticals player Focus on specialist and innovative drugs

12 Serono for sale 4 therapeutic areas: Fertility treatments : world leader (60%market share) Gonal-f® Growth and metabolic disorders Psoriasis Multiple sclerosis : blockbuster Rebif® is the globalmarket leader Led since 1996 by billionaire Ernesto Bertarelli 4th largest companies specializing in biotech

13 13 Advantages of Serono High-quality manufacturing Innovative and successful products A well-stocked and promising development pipeline Access to the important U.S. market Decision to acquire the pioneering biopharmaceutical company Serono

14 14 Acquisition of Serono – ,6 milliards CHF= 10,6 milliards d‘ € On February 5th, 2007, Merck held 97% of Serono’s capital and 98% of the voting rights.

15 15 Serono’s pipeline

16 Serono’s drugs Neurology Reproductive Health Growth & Metabolism Dermatology Serono’s drugs Serono : BIOTECH

17 Merck’s drugs Oncology Hypertension DANCOR® Growth and metabolism Diabetes Merck’s drugs Merck : CHEMISTRY

18 18 Merck Serono’s drugs Merck Serono : BIOTECH Merck Serono’s drugs Neurology Reproductive Health Growth & Metabolism Dermatology Hypertension Dancor® Oncology Diabetes

19 + Merck Serono Merck had integrated the name Serono and became Merck Serono

20 In medical biotechnology, Merck Serono is a leader in Europe. Merck Serono Merck Serono Vs EMD Serono Divisions for innovative prescription drugs of Merck In North America (U.S. and Canada), the activities of Merck Serono are conducted under the name EMD Serono. EMD: Emanuel Merck, Darmstadt

21 21 Merck relocated on the premises of Serono Headquarters in Geneva (Switzerland)

22 22 Merck Serono becomes Serono Strategy focused on delivering innovations to patients Therapeutic areas: neurodegenerative diseases oncology fertility endocrinology rheumatology Bring cardiometabolic care products in emerging markets Develop and scale biologics

23 Merck generics for sale Mylan acquired Merck's generics The divested Generics business represents EUR 1,802 million of sales in 2006 and sells products in more than 90 countries 13/05/ billion €

24 Theramex for sale 10/28/ million€ Merck KGaA's European Based Women's Health Business revenues = 100 million € in 2009 Teva Pharmaceutical has acquired Merck's Theramex Teva Pharma take over the distribution rights of Theramex's products sold in several countries.

25 25 Merck Serono nowadays

26 What’s Merck group and Merck Serono now?

27 Merck Serono 92% Consumer Health Care 8% Sales of Merck KGaA Pharmaceuticals : 63%

28 28 Regular increase of the activity Increase of sales +29% +27% Merck Serono

29 : 1167 millions € : increase of 32% Merck Serono – R&D expenses

30 Drug without prescription Women’s and children’s health Cough and cold treatments Products to support everyday health and agility. Leading brands = Bion®, Femibion®, Nasivin®, Flexagil®, Seven Seas®, Kidabion®, Cebion® and Diabion®. Consumer Health Care

31 = Liquid Crystals, Advanced Technologies, Pigments & cosmetics. Materials and solutions are being used by the consumer electronics, lighting, printing, plastics, and cosmetics industries. Merck is active in the growth markets around “clean energy” and develops innovative materials. Performance Materials

32 32 Merck Millipore BIO SCIENCELAB SOLUTIONPROCESS SOLUTION Acquisition de millipore pour millions d’ €

33 33 Patent cliff Revenues lost due to patent expiries - a % of 2010 revenue Key products protected for next three years -patent expiries: Rebif ® : EU 2015, US 2022 Erbitux ® : EU 2014, Japan 2016 Gonal-f ® : EU 2009, USA 2015

34 34 Pipeline & Products

35 35 Strategy of Merck Serono Strategic focus Enhance the productivity of our drug discovery activities with innovative and emerging technologies Expand upon our Multiple Sclerosis franchise to enter other neurodegenerative disease areas Expand our pipeline in Rheumatology with complementary product opportunities offering a broad indication potential

36 36 Strategy merck serono Assessment of Therapeutique Areas

37 37 Sales Products% Sales Eur Million Rebif®31%1 668 Erbitux®15%820 Gonal-f®9%504 Concor® franchise7%373 Glucophage® franchise6%316 Other products32%1 727 ~60% of portfolio based on biologically manufactured products Biologics Small molecules

38 38 Phase I In Registration Phase III Phase II Erbitux® (cetuximab) Anti-EGFR mAb NSCLC (1st line therapy) EMA: Application submitte Rebif® HSA-free formulation (interferon beta-1a) for patients with early signs of MS (REFLEX) EMA: Approved Erbitux® (cetuximab) Anti-EGFR mAb (PETACC-8*) Adj colon cancer Erbitux® (cetuximab) Anti-EGFR mAb (EXPAND) Gastric cancer Cilengitide Integrin inhibitor (CENTRIC) Glioblastoma Stimuvax® Cancer immunotherapy (START, INSPIRE) NSCLC Hypoxia-targeted drug (TH-302) Soft tissue sarcoma Kuvan Sapropterin dihydrochloride (SPARK****) PKU in pediatric patients < 4year ONO Oral S1P receptor modulator Multiple sclerosis Cilengitide Integrin inhibitor SCCHN Cilengitide Integrin inhibitor NSCLC Anti-integrin mAb (DI17E6) Metastatic colorectal cancer Anti-integrin mAb (DI17E6) Metastatic prostate cancer (mCRPC), setting prior to chemotherapy Hypoxia-targeted drug (TH-302) Pancreatic cancer Fibroblast Growth Factor 18 Cartilage injury repair ARX 424 Long-acting interferon Multiple sclerosis ATX-MS-1467 Immune tolerizing agent Multiple sclerosis Extended-release formulation of interferon beta-1a Multiple sclerosis PI –2301 Second-generation peptide copolymer Multiple sclerosis MEK inhibitor (AS703026/MSC B) Solid tumors and hematological malignancies Novel combinations of MEK inhibitor (AS703026/MSC B) with one of two sanofi-aventis PI3K inhibitors** Solid tumor MEK inhibitor (AS703988/MSC B) Solid tumors c-Met kinase inhibitor (EMD ) Solid tumors NHS-IL12*** Cancer immunotherapy Solid tumors Fibroblast Growth Factor 18 Osteoarthritis Atacicept anti-Blys/anti-APRIL fusion protein Lupus nephritis Endocrinology Rheumatology Neurodegenerative Diseases Oncology Atacicept anti-Blys/anti-APRIL fusion protein Systemic lupus erythematosus

39 39 Oncology Neuro degenerative Diseases Fertility Endocrinology CardioMetabolic care and others Therapeutic areas

40 Colorectal cancer CRC 40 Oncology The third most deadly cancer among women and the fourth in men. Worldwide, it is responsible for around 529,000 deaths per year. Metastatic bowel or mCRC : start in colon or rectum but has spread to another part of the body - metastasizes. About a quarter of people diagnosed with CRC already have metastatic CRC. Head and Neck cancer Flat "squamous" cells that line the surfaces in the head and neck area, such as the mouth, nose and throat, and are thus termed "squamous cell carcinomas of the head and neck" (SCCHN). Significant increase in the worldwide incidence of SCCHN over the past decade, particularly among women. Globally, there are almost 650,000 new cases of head and neck cancer each year, and over 350,000 deaths.

41 Erbitux® Cetuximab 41 Oncology IgG1 monoclonal antibody targeting EGFR. Approved in many countries all over the world for KRAS wild-type mCRC with chemotherapy Approved in squamous cell carcinoma cancer of the head and neck – SCCHN in combination with radiation therapy or chemotherapy. Erbitux® - Product of Eli Lilly, rights to commercialize Erbitux outside US and Canada In 2010, sales of Erbitux® rose by 18% to 820 million €. Strenghts : Strong position in niche markets in Europe High market share in metastatic colorectal cancer Standard of care in head & neck cancer

42 42 Oncology Erbitux competitors - CRC Avastin® – Bevacizumab Roche / Genentech, USA + EU Approved for mCRC, Advanced nonsquamous NSCLC, Metastatic kidney cancer when used with interferon alfa, Glioblastoma. Vectibix® – Panitumumab Amgen, USA + UE Approved for mCRC with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens Xeloda® – Capecitabine Roche / Genentech, USA + UE Approved for mCRC, cancer of colon after surgery, breast cancer

43 43 Application submitted to EMA First line therapy in NSCLC in combination with chemotherapy NSCLC accounts for 80%–85% of all lung cancer cases. Erbitux ® - in registration Gastric cancer in combinaition with chemotherapy – EXPAND Erbitux + FUFOX : high response rate in metastatic gastric cancer. Adjuvant treatment in stage III colon cancer - PETACC-8 The final report with the official results of this trial is Dec.2014 Erbitux ® - Phase III Oncology Strong product in an expanding market

44 44 Cilengitide : the integrin inhibitors Control tumor growth. Action : attacking the tumor cells directly in a targeted manner and stopping angiogenesis that feed the tumor. Phase III : Cilengitide in glioblastoma CENTRIC Estimated Primary Completion Date : Sept.2012 Phase II : SCCHN & NSCLC Cilengitide Cancer immunotherapy that is designed to stimulate the body’s immune system to identify and target cells expressing MUC1. Phase III : unresectable stage III NSCLC - START & INSPIRE Estimated Primary Completion Date : Sept Stimuvax ® Oncology

45 45 In 2010, Merck KGaA signed a worldwide research and development agreement with Sanofi-Aventis U.S. Inc. Two novel experimental combinations of the MEK inhibitor AS703026/MSC B with one of two compounds of sanofi-aventis. PI3K/mTOR inhibitor SAR (also known as XL765), is under the responsibility of Merck Serono Class I PI3K inhibitor SAR (also known as XL147), is under the responsibility of Sanofi-Aventis. Phase I Oncology

46 46 Therapeutic areas Oncology Neuro degenerative Diseases Fertility Endocrinology CardioMetabolic care and others

47 47 Multiple sclerosis Neuro degenerative Diseases MS is a complex, multifaceted disease of the central nervous system (CNS) with multiple pathways. Approximately 400,000 people in the U.S. have MS. (2.5 million worldwide) MS interferes with the brain’s ability to control such functions as seeing, walking & talking. It is unpredictable and every person with MS will have his or her unique set of symptoms.

48 48 Rebif ® Interferon beta-1a Neuro degenerative Diseases Rebif is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Rebif is a purified glycoprotein, which is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta-1a gene has been introduced. Rebif decreases the frequency of clinical exacerbations and delays the accumulation of physical disability. Rebif was approved by the U.S. FDA on March 7, 2002 is available in over 80 countries worldwide. Blockbuster with €1.7bn sales in 2010

49 49 Rebif ® Perfect Life Cycle Management Strategy Neuro degenerative Diseases Life cycle management improves patient convenience and protects key franchises

50 50 Rebif ® Ready-to-use syringes Neuro degenerative Diseases

51 51 Rebiject II ® auto-injector Neuro degenerative Diseases

52 52 RebiSmart® New Formulation Neuro degenerative Diseases

53 53 Rebif ® Major Competitors Neuro degenerative Diseases Tysabri is approved as monotherapy treatment for relapsing forms of multiple sclerosis. Administered by infusion (intravenous) (Biogen Idec and Elan ) Copaxone (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis. (Teva Pharmaceuticals) Avonex (interferon beta-1a) is approved by the FDA to treat relapsing forms of MS. (Biogen Idec) It is the leading MS therapy in the US, with around 40% of the overall market, and in Europe, with around 30% of the overall market. Betaferon/Betaseron is approved as monotherapy treatment for relapsing-forms of multiple sclerosis. (Bayer)

54 54 Therapeutic areas Oncology Neuro degenerative Diseases Fertility Endocrinology CardioMetabolic care and others

55 55 Gonal-F® Follitropin alpha for Injection Fertility The Gonal-f® RFF Pen is a gonadotropin hormone produced by recombinant DNA technology (rDNA). It is used in ovulation induction (OI) and in vitro fertilization (IVF) Market position/ Strengths Pioneer and market leader Comprehensive portfolio of complementary products

56 56 Luveris® lutropin alfa for injection Fertility The first and only recombinant human luteinizing hormone (r-hLH) approved in the world Cetrotide® cetrorelix acetate Gonadotropin releasing hormone antagonist Crinone® progesterone gel Indicated for progesterone supplementation as part of an Assisted Reproductive Technology (ART) Ovidrel® hCG The first and only recombinant human chorionic gonadotropin (r-hCG)

57 57 Therapeutic areas Oncology Neuro degenerative Diseases Fertility Endocrinology CardioMetabolic care and others

58 58 Saizen® somatropin for injection Endocrinology Recombinant human growth hormone made by DNA technology. Market position/ Strengths Among Top 5 in growth hormones “only in class”products for selected niche indications

59 59 Endocrinology Serostim® somatropin for injection Indicated for the treatment of HIV wasting in patients receiving antiretroviral therapy Egrifta® tesamorelin for injection First treatment indicated to reduce excess abdominal fast in HIV-infected patients with lipodystrophy Kuvan® sapropterin dihydrochloride First treatment indicated in Europe for the treatment of hyperphenylalaninemia

60 60 Therapeutic areas Oncology Neuro degenerative Diseases Fertility Endocrinology CardioMetabolic care and others

61 246 million people with type 2 diabetes around the world Glucophage : 1st first-line treatment for type 2 diabetes Glucovance Metformine : was the Molecule of Merck Diabetes Leading market positions with gold standard products that have high brand equity Excellent track record in life cycle management (i. e. formulations) Strong position in Emerging Markets Market position/ Strengths CardioMetabolic Care 61 CardioMetabolic care and others CV diseases are responsible for one in every three deaths which translates into 17 million people worldwide each year Bisoprolol : 1st-line treatment of hypertension Cardiovascular diseases 200 million people worldwide suffer from hypothyroidism 20% of this population is currently receiving treatment Levothyroxine sodium Thyroid disease

62 Rheumatology 62 CardioMetabolic care and others Phase II : Systemic lupus erythematosus (SLE) Phase I : Lupus nephritis Atacicept - anti-BLyS/anti-APRIL fusion protein Phase II : Cartilage injury Phase I : Osteoarthritis Fibroblast growth factor 18 Exclusive worldwide license to Merck Serono to develop and commercialize Fibroblast Growth Factor 18, and the genetic fusion molecule Atacicept. Partnership with BMS

63 63 Merck Serono’s future

64 64 Merck Serono’s future Expand their fast growing presence in China and other Emerging Markets Grow their U.S. business with specialist-focused therapies Expand their ongoing presence in the Japanese market Strategy focus

65 65 Development programs discontinued Cladribine tablets for use in Multiple Sclerosis (Phase III) Safinamide for treatment of Parkinson indications (Phase III) New Formulation of Rebif in the U.S. Neuro- degenerative Diseases Erbitux for use in metastatic triple-negative breast cancer (Phase II) Clinical development for IMO-2055, currently in development for squamous cell carcinoma of the head and neck (Phase II) Oncology ARX-201 for use in growth hormone deficiencies (Phase II) Endocrinology

66 66 Redefining the R&D organization One executive for separated R and D functions Leaner organization with clear responsibilities on individuals rather than on committees. New R&D Organization

67 67 Merck Serono’s future Mendor signed a distribution agreement with Merck Serono for the meter Mendor Discreet ™ Merck Serono + Threshold = global agreement to co-develop and commercialize phase III Hypoxia-Targeted Drug TH-302 February 2012

68 68 Merck Serono’s future Merck Serono will increase tenfold its annual donation of praziquantel tablets which will increase from 25 to 250 million units - schistosomia To return all rights to Safinamide at Newron Pharmaceuticals SpA But continue co develepment for Pruvanserine & Sarizotan April

69 Future growth trends Future growth trend Neurodegenerative Disease7.9% Oncology24.2% Fertility5.9% Endocrinology8.9% Cardiometabolic Care/Others 5.5% Strategy for the future They want to become the leader in oncology by 2015

70 Merck Serono’s SWOT STRENGTHS Erbitux ® standard of care Rebif® performance benefiting from volume growth and price/Life cycle management New R&D hub in Beijing Efficient patent cliff Leader in fertility Great reputation WEAKNESSES 50% of sales held by Rebif® et Erbitux® Failure in gaining regulatory approvals for cladribine tablets Lack of new products in the portfolio Licence for Erbitux® OPPORTUNITIES Expand Merck Serono’s oncology pipeline and product portfolio Several patenerships (BMS-Sanofi) Possible expansion in Asia THREATS Increasing competition from biosimilar Increasing competition in multiple sclerosis- oncology market Competitors=Avastin® for Erbitux® and Avonex®-Tysabri® for Rebif® Generics²

71 71 Thank you for your attention

72 72 Rebif ® Interferon beta-1a Neuro degenerative Diseases Interferon Beta


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