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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 - PowerPoint PPT Presentation
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Justine DegeuserMorgane DufourPauline DulouardOlivier Héloir23th February 2012
2
Summary
From Merck to Merck Serono
Merck Serono nowadays
Merck Serono’s future
3
Merck’s history
1668
19141953
Merck is the world’s oldest pharmaceutical and chemical company
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:
Merck’s history
1887
1900
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
Merck’s history
1953After the Second World War merged with Sharp & Dohme = MSD
1953Establishment of Merck KGaA For USA: Merck = EMD
7
From Merck to Merck Serono
Chemistry + Primary Care
8
34%
66%
Chemicals Pharmaceuticals
Business sector in 2005
9
Concor®21%
Glucophage®18%
Erbitux®13%
Duoneb®15%
Others34%
Sales in 2005 - EUR Million
Sales in 2005
Products EUR million
Concor® 348.4
Glucophage® 297.2
Duoneb® 251.5
Erbitux® 218.2
others 573
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.
1998 – Eli Lilly Merck licensed the right to market Erbitux® outside the US and Canada
Development of biological molecules
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
http://www.annualreports.de/documents/Merck-ar2006en.pdf
Serono for sale
4 therapeutic areas:Fertility treatments : world leader (60%market share) Gonal-f®Growth and metabolic disordersPsoriasisMultiple sclerosis : blockbuster Rebif® is the globalmarket leader
Led since 1996 by billionaire Ernesto Bertarelli
4th largest companies specializing in biotech
13
Advantages of SeronoHigh-quality manufacturing
Innovativeand successful products
A well-stockedand promising development pipeline
Access to the important U.S. market
Decision to acquire the pioneering biopharmaceutical company Serono
14
Acquisition of Serono – 200716,6 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
Serono’s drugs
Neurology
Reproductive Health
Growth & Metabolism Dermatology
Serono’s drugsSerono : BIOTECH
Merck’s drugs
Oncology
Hypertension
DANCOR®
Growth and metabolism Diabetes
Merck’s drugsMerck : CHEMISTRY
18
Merck Serono’s drugsMerck Serono : BIOTECH
Merck Serono’s drugs
Neurology
Reproductive Health
Growth & Metabolism Dermatology Hypertensio
n
Dancor®
Oncology Diabetes
+
Merck SeronoMerck had integrated the name Serono and became Merck Serono
In medical biotechnology, Merck Serono is a leader in Europe.
Merck Serono
Merck Serono Vs EMD SeronoDivisions for innovative prescription drugs of MerckIn 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
Strategy focused on delivering innovations to patientsTherapeutic areas: neurodegenerative diseases
oncology fertility endocrinology rheumatology
Bring cardiometabolic care products in emerging markets
Develop and scale biologics
Merck generics for sale
Mylan acquired Merck's genericsThe divested Generics business represents EUR 1,802 million of sales in 2006 and sells products in more than 90 countries
13/05/07 4.9 billion €
http://news.merck.de/N/0/7BDAC02AD85D7D39C125730500286E43/$File/Generics_e.pdf
Theramex for sale
10/28/2010 265 million€
Merck KGaA's European Based Women's Health Businessrevenues = 100 million € in 2009
Teva Pharmaceutical has acquired Merck's TheramexTeva Pharma 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-millionhttp://www.merckgroup.com/en/media/extNewsDetail.html?newsId=A52969A174686390C12577CA003EB758&newsType=1
25
Merck Serono nowadays
What’s Merck group and Merck Serono now?
27
Merck Serono92%
Consumer Health Care 8%
Sales of Merck KGaA - 2011Pharmaceuticals : 63%
282007 2008 2009 20100
1000
2000
3000
4000
5000
6000
Sales
2007 2008 2009 20100
500100015002000250030003500400045005000
Gross margin
Regular increase of the activity Increase of sales
+29% +27%
Merck Serono
29
2007 2008 2009 20100
200
400
600
800
1000
1200
R&D
2010 : 1167 millions €2007-2010 : increase of 32%
Merck Serono – R&D expenses
33
Patent cliff
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
Revenues lost due to patent expiries - a % of 2010 revenueKey products protected for next three years -patent expiries:Rebif ® : EU 2015, US 2022Erbitux ® : EU 2014, Japan 2016 Gonal-f ® : EU 2009, USA 2015
34
Pipeline & Products
35
Strategy of Merck Serono
Strategic focusEnhance 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
Strategy merck seronoAssessment of Therapeutique Areas
37
31%
15%
12%
6%
36%
Neurodegenerative diseases
Oncology
Fertility
Endocrinology
Cardiometabolic Care / Others
Sales - 2010 Products % Sales
Eur Million
Rebif® 31% 1 668
Erbitux® 15% 820
Gonal-f® 9% 504
Concor® franchise 7% 373
Glucophage® franchise 6% 316
Other products 32% 1 727
~60% of portfolio based on biologically manufactured products
Biologics
Small molecules
38
Phase I In RegistrationPhase IIIPhase II
Erbitux® (cetuximab)Anti-EGFR mAbNSCLC (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
CilengitideIntegrin inhibitor (CENTRIC)Glioblastoma
Stimuvax®Cancer immunotherapy (START, INSPIRE)NSCLCHypoxia-targeted drug (TH-302)Soft tissue sarcoma
Kuvan Sapropterin dihydrochloride (SPARK****)PKU in pediatric patients < 4year
ONO - 4641Oral S1P receptor modulatorMultiple sclerosis
CilengitideIntegrin inhibitorSCCHN
CilengitideIntegrin inhibitorNSCLC
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 18Cartilage injury repair
ARX 424 Long-acting interferonMultiple sclerosis
ATX-MS-1467Immune tolerizing agentMultiple sclerosisExtended-release formulation of interferon beta-1aMultiple sclerosisPI –2301Second-generation peptide copolymerMultiple sclerosisMEK inhibitor (AS703026/MSC1936369B)Solid tumors and hematological malignancies
Novel combinations of MEK inhibitor (AS703026/MSC1936369B) with one of two sanofi-aventis PI3K inhibitors**Solid tumor
MEK inhibitor (AS703988/MSC2015103B)Solid tumors
c-Met kinase inhibitor (EMD 1214063)Solid tumors
NHS-IL12***Cancer immunotherapySolid tumors
Fibroblast Growth Factor 18OsteoarthritisAtaciceptanti-Blys/anti-APRIL fusion protein Lupus nephritis
Endocrinology
Rheumatology
Neurodegenerative Diseases
Oncology
Ataciceptanti-Blys/anti-APRIL fusion protein Systemic lupus erythematosus
39
OncologyNeurodegenerative DiseasesFertilityEndocrinology
CardioMetabolic care and others
Therapeutic areas
40
Colorectal cancer CRC
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 cancerFlat "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
Oncology
IgG1 monoclonal antibody targeting EGFR.Approved in many countries all over the world for KRAS wild-type mCRC with chemotherapyApproved 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 CanadaIn 2010, sales of Erbitux® rose by 18% to 820 million €.Strenghts : Strong position in niche markets in Europe
High market share in metastatic colorectal cancerStandard of care in head & neck cancer
42
Oncology
Erbitux competitors - CRC
Avastin® – Bevacizumab Roche / Genentech, USA + EUApproved for mCRC, Advanced nonsquamous NSCLC,Metastatic kidney cancer when used with interferon alfa, Glioblastoma.
Vectibix® – Panitumumab Amgen, USA + UEApproved for mCRC with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens
Xeloda® – Capecitabine Roche / Genentech, USA + UEApproved for mCRC, cancer of colon after surgery , breast cancer
43http://www.medscape.com/viewarticle/725271_5http://www.ncbi.nlm.nih.gov/pubmed/20068568
Application submitted to EMAFirst 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 – EXPANDErbitux + 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
Cilengitide : the integrin inhibitorsControl tumor growth. Action : attacking the tumor cells directly in a targeted manner and stopping angiogenesis that feed the tumor.
Phase III : Cilengitide in glioblastoma CENTRICEstimated 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. 2015
Stimuvax ®
http://www.oncothyreon.com/pipeline/vaccines/stimuvax/collaboration.html
Oncology
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/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.
Phase I
Oncology
46
Therapeutic areas
Oncology
Neurodegenerative
Diseases
Fertility
Endocrinology
CardioMetabolic care and
others
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
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
Rebif ® Perfect Life Cycle Management Strategy
Neuro degenerative Diseases
Life cycle management improves patient convenience and protects key franchises
50
Rebif ® Ready-to-use syringes
Neuro degenerative Diseases
51
Rebiject II ® auto-injector
Neuro degenerative Diseases
52
RebiSmart® New Formulation
Neuro degenerative Diseases
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
Therapeutic areas
Oncology
Neurodegenerative
Diseases
Fertility
Endocrinology
CardioMetabolic care and
others
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/ StrengthsPioneer and market leaderComprehensive portfolio of complementary products
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
Therapeutic areas
Oncology
Neurodegenerative
Diseases
Fertility
Endocrinology
CardioMetabolic care and
others
Saizen® somatropin for injection
Endocrinology
Recombinant human growth hormone made by DNA technology.
Market position/ StrengthsAmong Top 5 in growth hormones“only in class”products for selected niche indications
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
Therapeutic areas
Oncology
Neurodegenerative
Diseases
Fertility
Endocrinology
CardioMetabolic care and
others
61
246 million people with type 2 diabetes around the worldGlucophage : 1st first-line treatment for type 2 diabetesGlucovanceMetformine : was the Molecule of Merck
DiabetesLeading market positions with gold standard products that have high brand equityExcellent track record in life cycle management (i. e. formulations)Strong position in Emerging Markets
Market position/ Strengths
CardioMetabolic CareCardioMetabolic 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 hypothyroidism20% of this population is currently receiving treatmentLevothyroxine sodium
Thyroid disease
62
RheumatologyCardioMetabolic 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
Merck Serono’s future
64
Merck Serono’s future
Expand their fast growing presence in China and other Emerging MarketsGrow their U.S. business with specialist-focused therapiesExpand their ongoing presence in the Japanese market
Strategy focus
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
Redefining the R&D organization
One executive for separated R and D functionsLeaner organization with clear responsibilities on individuals rather than on committees.
New R&D Organization
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
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 SpABut continue co develepment for Pruvanserine & Sarizotan
April 2012
2012
69
Future growth trends
69
2006-2011 Future growth trend
Neurodegenerative Disease 7.9%
Oncology 24.2%
Fertility 5.9%
Endocrinology 8.9%
CardiometabolicCare/Others
5.5%
Strategy for the future
They want to become the leader in oncology by 2015
Merck Serono’s SWOTSTRENGTHS
Erbitux ® standard of care
Rebif® performance benefiting from
volume growth and price/Life cycle management
New R&D hub in Beijing
Efficient patent cliffLeader in fertilityGreat reputation
WEAKNESSES
50% of sales held by Rebif® et Erbitux®
Failure in gaining regulatory approvals
forcladribine 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
THREATSIncreasing
competition from biosimilar
Increasing competition in
multiple sclerosis-oncology market
Competitors=Avastin® for Erbitux® and
Avonex®-Tysabri® for Rebif®
Generics²
71
Thank you for your attention