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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

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Justine Degeuser

Morgane Dufour

Pauline Dulouard

Olivier Héloir

23th February 2012


FromMerck to



MerckSerono’s future

Merck’s history

Merck is the world’s oldest pharmaceutical and chemical company

morphine codéine

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

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

After the Second World War merged with Sharp & Dohme =MSD


Establishment of Merck KGaA

For USA: Merck = EMD


FromMerck to MerckSerono

Chemistry + Primary Care

Business sector in 2005

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

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

Serono for sale

4 therapeutic areas:

Fertility treatments : world leader (60%market share) Gonal-f®

Growth and metabolic disorders


Multiple sclerosis : blockbuster Rebif® is the globalmarket leader

4th largest companies specializing in biotech

Led since 1996 by billionaire Ernesto Bertarelli


Advantages of Serono

Decision to acquire the pioneering biopharmaceutical company Serono

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.

Serono’s drugs

Serono : BIOTECH

Merck’s drugs


Merck Serono’s drugs

Merck Serono : BIOTECH

Merck Serono

Merck had integrated the name Serono and became Merck Serono


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

Merck relocated on the premises of Serono

Headquarters in Geneva (Switzerland)

Merck Serono becomes Serono

Develop and scalebiologics

Strategy focused on delivering innovations to patients

Therapeutic areas: neurodegenerative diseases





Bring cardiometabolic care products in emerging markets

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


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.




What’s Merck group and Merck Serono now?

Sales of MerckKGaA - 2011

Pharmaceuticals : 63%



Consumer Health Care


Merck Serono

Regularincrease of the activityIncrease of sales



MerckSerono – R&D expenses

2010 : 1167 millions €

2007-2010 : increase of 32%

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



Pipeline & Products

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 


Assessment of Therapeutique Areas

Sales - 2010


Small molecules

~60% of portfolio based on biologically manufactured products

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


Immune tolerizing agent

Multiple sclerosis

Extended-release formulation of

interferon beta-1a

Multiple sclerosis


Integrin inhibitor


Erbitux® (cetuximab)


Gastric cancer

Erbitux® (cetuximab)

Anti-EGFR mAb

NSCLC (1st line therapy)

EMA: Application submitte


Integrin inhibitor



Integrin inhibitor (CENTRIC)


PI –2301

Second-generation peptide copolymer

Multiple sclerosis

Anti-integrin mAb (DI17E6)

Metastatic colorectal cancer


Cancer immunotherapy



Hypoxia-targeted drug (TH-302)

Soft tissue sarcoma

MEK inhibitor


Solid tumors and hematological


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




PKU in pediatric patients < 4year

Fibroblast Growth Factor 18

Cartilage injury repair

MEK inhibitor


Solid tumors


anti-Blys/anti-APRIL fusion protein

Systemic lupus erythematosus

c-Met kinase inhibitor

(EMD 1214063)

Solid tumors



Cancer immunotherapy

Solid tumors


Fibroblast Growth Factor 18




anti-Blys/anti-APRIL fusion protein

Lupus nephritis



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.



  • 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


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


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





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 


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



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.

  • 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.

  • 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

  • NeurodegenerativeDiseases

Rebif ® Perfect Life Cycle Management Strategy

Life cycle management improves patient convenience and protects key franchises

  • NeurodegenerativeDiseases

Rebif ® Ready-to-use syringes

  • NeurodegenerativeDiseases

Rebiject II ® auto-injector

  • NeurodegenerativeDiseases

RebiSmart® New Formulation

  • 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)

Market position/ Strengths

Pioneer and market leader

Comprehensive portfolio of complementary products

Gonal-F®Follitropin alpha for Injection

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)

Luveris®lutropin alfa for injection

The first and only recombinant human luteinizing hormone (r-hLH) approved in the world


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)

Market position/ Strengths

Among Top 5 in growth hormones

“only in class”products for selected niche indications

Saizen®somatropin for injection

Recombinant human growth hormone made by DNA technology.

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® sapropterindihydrochloride

First treatment indicated in Europe for the treatment of hyperphenylalaninemia

CardioMetabolic care and others

CardioMetabolic Care

  • Diabetes

Market position/ Strengths

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

  • 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

Cardiovascular diseases

  • 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

  • Thyroid disease

  • 200 million people worldwide suffer from hypothyroidism

  • 20% of this population is currently receiving treatment

  • Levothyroxine sodium

CardioMetabolic care and others


Atacicept - anti-BLyS/anti-APRIL fusion protein

Phase II : Systemic lupus erythematosus (SLE)

Phase I : Lupus nephritis

Fibroblastgrowth factor 18

Phase II : Cartilage injury

Phase I : Osteoarthritis

Partnershipwith BMS

Exclusive worldwide license to Merck Serono to develop and commercialize Fibroblast Growth Factor 18, and the genetic fusion molecule Atacicept.

MerckSerono’s future

MerckSerono’s future

Strategy focus

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

Development programs discontinued

Neuro- degenerative Diseases

  • Cladribine tablets for use in Multiple Sclerosis (Phase III)

  • Safinamide for treatment of Parkinson indications (Phase III)

  • New Formulation of Rebifin the U.S.


  • 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)


  • ARX-201 for use in growth hormone deficiencies (Phase II)

Redefining the R&D organization

New R&D Organization

One executive for separated R and D functions

Leaner organization with clear responsibilities on individuals rather than on committees.

MerckSerono’s future

February 2012

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

MerckSerono’s future

April 2012

To return all rights to Safinamide at Newron Pharmaceuticals SpA

But continue co develepment for Pruvanserine & Sarizotan


Merck Serono will increase tenfold its annual donation of praziquanteltablets which will increase from 25 to 250 million units - schistosomia

Strategy for the future

Future growth trends

They want to become the leader in oncology by 2015


MerckSerono’s SWOT

Thankyou for your attention