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Justine Degeuser Morgane Dufour Pauline Dulouard Olivier Héloir

Justine Degeuser Morgane Dufour Pauline Dulouard Olivier Héloir. 23th February 2012. Summary. From Merck to Merck Serono. Merck Serono nowadays. Merck Serono’s future. Merck’s history. Merck’s history. Merck is the world’s oldest pharmaceutical and chemical company

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Justine Degeuser Morgane Dufour Pauline Dulouard Olivier Héloir

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

  2. Summary FromMerck to MerckSerono MerckSerononowadays MerckSerono’s future

  3. Merck’s history

  4. Merck’s history Merck is the world’s oldest pharmaceutical and chemical company morphine codéine

  5. Merck’s history 1900 1887 1914 1925 1933 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 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 After the Second World War merged with Sharp & Dohme =MSD 1953 Establishment of Merck KGaA For USA: Merck = EMD 1953

  7. FromMerck to MerckSerono Chemistry + Primary Care

  8. Business sector in 2005

  9. Sales in 2005

  10. Small molecules + Erbitux® Development of biologicalmolecules 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. 1998 – Eli Lilly Merck licensed the right to market Erbitux® outside the US and Canada

  11. Looking for a biotech company Focus on specialist and innovative drugs 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

  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 4th largest companies specializing in biotech Led since 1996 by billionaire Ernesto Bertarelli http://www.annualreports.de/documents/Merck-ar2006en.pdf

  13. Advantages of Serono Decision to acquire the pioneering biopharmaceutical company Serono

  14. Acquisition of Serono – 2007 16,6 milliards CHF= 10,6 milliards d‘ € On February 5th, 2007, Merck held 97% of Serono’s capital and 98% of the voting rights.

  15. Serono’s pipeline

  16. Serono’s drugs Serono : BIOTECH

  17. Merck’s drugs Merck : CHEMISTRY

  18. Merck Serono’s drugs Merck Serono : BIOTECH

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

  20. Merck Serono Merck Serono Vs EMD Serono In medical biotechnology, Merck Serono is a leader in Europe. 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. Merck relocated on the premises of Serono Headquarters in Geneva (Switzerland)

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

  23. Merck generics for sale 13/05/07 4.9 billion € 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 http://news.merck.de/N/0/7BDAC02AD85D7D39C125730500286E43/$File/Generics_e.pdf

  24. Theramex for sale 10/28/2010 265 million€ Merck KGaA's European Based Women's Health Business revenues = 100 million € in 2009 Teva Pharmaceutical has acquired Merck's Theramex TevaPharma take over the distribution rights of Theramex's products sold in several countries. http://www.worldpharmanews.com/merckkgaa/1451-merck-kgaa-sells-theramex-to-teva-for-eur-265-million http://www.merckgroup.com/en/media/extNewsDetail.html?newsId=A52969A174686390C12577CA003EB758&newsType=1

  25. MerckSerononowadays

  26. What’s Merck group and Merck Serono now?

  27. Sales of MerckKGaA - 2011 Pharmaceuticals : 63% MerckSerono 92% Consumer Health Care 8%

  28. Merck Serono Regularincrease of the activityIncrease of sales +27% +29%

  29. MerckSerono – R&D expenses 2010 : 1167 millions € 2007-2010 : increase of 32%

  30. 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 http://www.merckgroup.com/company.merck.de/en/images/IR_2012_01_09_JPM_EN_tcm1612_85236.pdf?Version= http://www.ema.europa.eu/docs/fr_FR/document_library/EPAR_-_Summary_for_the_public/human/000071/WC500023742.pdf

  31. Pipeline & Products

  32. Strategy of MerckSerono 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 

  33. Strategymerckserono Assessment of Therapeutique Areas

  34. Sales - 2010 Biologics Small molecules ~60% of portfolio based on biologically manufactured products

  35. Phase I Phase II Phase III In Registration ARX 424 Long-acting interferon Multiple sclerosis ONO - 4641 Oral S1P receptor modulator Multiple sclerosis Erbitux® (cetuximab) Anti-EGFR mAb (PETACC-8*) Adj colon cancer Rebif® HSA-free formulation (interferon beta-1a) for patients with early signs of MS (REFLEX) EMA: Approved ATX-MS-1467 Immune tolerizing agent Multiple sclerosis Extended-release formulation of interferon beta-1a Multiple sclerosis Cilengitide Integrin inhibitor SCCHN Erbitux® (cetuximab) Anti-EGFR mAb (EXPAND) Gastric cancer Erbitux® (cetuximab) Anti-EGFR mAb NSCLC (1st line therapy) EMA: Application submitte Cilengitide Integrin inhibitor NSCLC Cilengitide Integrin inhibitor (CENTRIC) Glioblastoma PI –2301 Second-generation peptide copolymer Multiple sclerosis Anti-integrin mAb (DI17E6) Metastatic colorectal cancer Stimuvax® Cancer immunotherapy (START, INSPIRE) NSCLC Hypoxia-targeted drug (TH-302) Soft tissue sarcoma MEK inhibitor (AS703026/MSC1936369B) Solid tumors and hematological malignancies Anti-integrinmAb (DI17E6) Metastatic prostate cancer (mCRPC), setting prior to chemotherapy Novel combinations of MEK inhibitor (AS703026/MSC1936369B) with one of two sanofi-aventis PI3K inhibitors** Solid tumor Hypoxia-targeted drug (TH-302) Pancreatic cancer Kuvan Sapropterindihydrochloride (SPARK****) PKU in pediatric patients < 4year Fibroblast Growth Factor 18 Cartilage injury repair MEK inhibitor (AS703988/MSC2015103B) Solid tumors Atacicept anti-Blys/anti-APRIL fusion protein Systemic lupus erythematosus c-Met kinase inhibitor (EMD 1214063) Solid tumors Oncology NHS-IL12*** Cancer immunotherapy Solid tumors NeurodegenerativeDiseases Fibroblast Growth Factor 18 Osteoarthritis Rheumatology Atacicept anti-Blys/anti-APRIL fusion protein Lupus nephritis Endocrinology

  36. Therapeutic areas

  37. Oncology Colorectal cancer CRC 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.

  38. Oncology Erbitux®Cetuximab • IgG1 monoclonal antibody targeting EGFR. • Approved in many countries all over the world for KRAS wild-type mCRCwith 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

  39. Oncology Erbituxcompetitors - CRC Avastin® – BevacizumabRoche / Genentech, USA + EU Approved for mCRC, Advanced nonsquamous NSCLC, Metastatic kidney cancer when used with interferon alfa, Glioblastoma. Vectibix® – PanitumumabAmgen, 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

  40. Oncology Erbitux ® - in registration Application submitted to EMA First line therapy in NSCLC in combination with chemotherapy NSCLC accounts for 80%–85% of all lung cancer cases. Erbitux ® - Phase III Gastric cancer in combinaition with chemotherapy – EXPAND Erbitux + FUFOX : highresponse rate in metastaticgastric cancer. Adjuvant treatment in stage III colon cancer - PETACC-8  The final report with the official results of this trial isDec.2014 Strong product in an expanding market http://www.medscape.com/viewarticle/725271_5 http://www.ncbi.nlm.nih.gov/pubmed/20068568

  41. Oncology Cilengitide 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 Stimuvax ® 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. 2015 http://www.oncothyreon.com/pipeline/vaccines/stimuvax/collaboration.html

  42. Oncology Phase I 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/MSC1936369B with one of two compounds of sanofi-aventis. PI3K/mTOR inhibitor SAR245409 (also known as XL765), is under the responsibility of Merck Serono Class I PI3K inhibitor SAR245408 (also known as XL147), is under the responsibility of Sanofi-Aventis.

  43. Therapeutic areas

  44. NeurodegenerativeDiseases Multiple sclerosis • 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.

  45. NeurodegenerativeDiseases Rebif ® Interferon beta-1a 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. Rebifdecreases 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

  46. NeurodegenerativeDiseases Rebif ® Perfect Life Cycle Management Strategy Life cycle management improves patient convenience and protects key franchises

  47. NeurodegenerativeDiseases Rebif ® Ready-to-use syringes

  48. NeurodegenerativeDiseases Rebiject II ® auto-injector

  49. NeurodegenerativeDiseases RebiSmart® New Formulation

  50. NeurodegenerativeDiseases Rebif ® Major Competitors 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) Tysabriis 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)

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