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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 h loir

Justine Degeuser

Morgane Dufour

Pauline Dulouard

Olivier Héloir

23th February 2012


Justine degeuser morgane dufour pauline dulouard olivier h loir

Summary

FromMerck to

MerckSerono

MerckSerononowadays

MerckSerono’s future


Justine degeuser morgane dufour pauline dulouard olivier h loir

Merck’s history


Justine degeuser morgane dufour pauline dulouard olivier h loir

Merck’s history

Merck is the world’s oldest pharmaceutical and chemical company

morphine codéine


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

Merck’s history

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

1953

Establishment of Merck KGaA

For USA: Merck = EMD

1953


Justine degeuser morgane dufour pauline dulouard olivier h loir

FromMerck to MerckSerono

Chemistry + Primary Care


Justine degeuser morgane dufour pauline dulouard olivier h loir

Business sector in 2005


Justine degeuser morgane dufour pauline dulouard olivier h loir

Sales in 2005


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

Advantages of Serono

Decision to acquire the pioneering biopharmaceutical company Serono


Justine degeuser morgane dufour pauline dulouard olivier h loir

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.


Justine degeuser morgane dufour pauline dulouard olivier h loir

Serono’s pipeline


Justine degeuser morgane dufour pauline dulouard olivier h loir

Serono’s drugs

Serono : BIOTECH


Justine degeuser morgane dufour pauline dulouard olivier h loir

Merck’s drugs

Merck : CHEMISTRY


Justine degeuser morgane dufour pauline dulouard olivier h loir

Merck Serono’s drugs

Merck Serono : BIOTECH


Justine degeuser morgane dufour pauline dulouard olivier h loir

Merck Serono

Merck had integrated the name Serono and became Merck Serono

+


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

Merck relocated on the premises of Serono

Headquarters in Geneva (Switzerland)


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

MerckSerononowadays


Justine degeuser morgane dufour pauline dulouard olivier h loir

What’s Merck group and Merck Serono now?


Justine degeuser morgane dufour pauline dulouard olivier h loir

Sales of MerckKGaA - 2011

Pharmaceuticals : 63%

MerckSerono

92%

Consumer Health Care

8%


Justine degeuser morgane dufour pauline dulouard olivier h loir

Merck Serono

Regularincrease of the activityIncrease of sales

+27%

+29%


Justine degeuser morgane dufour pauline dulouard olivier h loir

MerckSerono – R&D expenses

2010 : 1167 millions €

2007-2010 : increase of 32%


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

Pipeline & Products


Justine degeuser morgane dufour pauline dulouard olivier h loir

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 


Justine degeuser morgane dufour pauline dulouard olivier h loir

Strategymerckserono

Assessment of Therapeutique Areas


Justine degeuser morgane dufour pauline dulouard olivier h loir

Sales - 2010

Biologics

Small molecules

~60% of portfolio based on biologically manufactured products


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

Therapeutic areas


Justine degeuser morgane dufour pauline dulouard olivier h loir

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.


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

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.


Justine degeuser morgane dufour pauline dulouard olivier h loir

Therapeutic areas


Justine degeuser morgane dufour pauline dulouard olivier h loir

  • 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.


Justine degeuser morgane dufour pauline dulouard olivier h loir

  • 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


Justine degeuser morgane dufour pauline dulouard olivier h loir

  • NeurodegenerativeDiseases

Rebif ® Perfect Life Cycle Management Strategy

Life cycle management improves patient convenience and protects key franchises


Justine degeuser morgane dufour pauline dulouard olivier h loir

  • NeurodegenerativeDiseases

Rebif ® Ready-to-use syringes


Justine degeuser morgane dufour pauline dulouard olivier h loir

  • NeurodegenerativeDiseases

Rebiject II ® auto-injector


Justine degeuser morgane dufour pauline dulouard olivier h loir

  • NeurodegenerativeDiseases

RebiSmart® New Formulation


Justine degeuser morgane dufour pauline dulouard olivier h loir

  • 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)


Justine degeuser morgane dufour pauline dulouard olivier h loir

Therapeutic areas


Justine degeuser morgane dufour pauline dulouard olivier h loir

  • Fertility

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)


Justine degeuser morgane dufour pauline dulouard olivier h loir

  • Fertility

Luveris®lutropin alfa for injection

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

Cetrotide®cetrorelixacetate

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)


Justine degeuser morgane dufour pauline dulouard olivier h loir

Therapeutic areas


Justine degeuser morgane dufour pauline dulouard olivier h loir

  • Endocrinology

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.


Justine degeuser morgane dufour pauline dulouard olivier h loir

  • 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® sapropterindihydrochloride

First treatment indicated in Europe for the treatment of hyperphenylalaninemia


Justine degeuser morgane dufour pauline dulouard olivier h loir

Therapeutic areas


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

CardioMetabolic care and others

Rheumatology

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.


Justine degeuser morgane dufour pauline dulouard olivier h loir

MerckSerono’s future


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

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.

Oncology

  • 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)

Endocrinology

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

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.


Justine degeuser morgane dufour pauline dulouard olivier h loir

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

MerckSerono’s future

April 2012

To return all rights to Safinamide at Newron Pharmaceuticals SpA

But continue co develepment for Pruvanserine & Sarizotan

2012

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


Justine degeuser morgane dufour pauline dulouard olivier h loir

Strategy for the future

Future growth trends

They want to become the leader in oncology by 2015

69


Justine degeuser morgane dufour pauline dulouard olivier h loir

MerckSerono’s SWOT


Justine degeuser morgane dufour pauline dulouard olivier h loir

Thankyou for your attention


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