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Merck Reports Organic Growth in all Four Businesses in Second Quarter

  • Sales rise in the second quarter by 1.9%, AZ acquisition compensates for negative foreign exchange effects
  • EBITDA pre one-time items up 2.3% to € 846 million despite lower royalty, license and commission income; EBITDA pre margin improves to 30.3%
  • All businesses contribute to double-digit organic sales growth in Emerging Markets
  • Net income down -4.1% due to one-time effects of AZ inventory revaluation
  • Full-year forecast confirmed – despite negative foreign exchange effects and lower royalty, license and commission income

Darmstadt, Germany, August 13, 2014 – Merck, a leading company for top-quality high-tech products in the pharmaceutical and chemical sectors, generated organic sales growth of 3.4% in the second quarter of 2014. In addition, the company reported an acquisition-related sales increase of 3.0%, which was countered by negative foreign exchange effects of -4.5%. Overall, sales thus increased moderately by € 52 million or 1.9% to € 2.8 billion in the second quarter (Q2 2013: € 2.7 billion). Despite considerably lower royalty, license and commission income, EBITDA pre one-time items grew to € 846 million, equivalent to an EBITDA margin pre one-time items of 30.3% (Q2 2013: 30.1%).

“We had a solid second quarter,” said Karl-Ludwig Kley, Chairman of the Executive Board of Merck. “This was primarily due to our healthy operating business. Especially in Emerging Markets, all our divisions performed well. Merck’s stronger focus on this attractive region is visibly paying off. The completed acquisition of AZ is also having a positive effect on Group sales and EBITDA pre one-time items.”

Merck_4698Royalty, license and commission income fell sharply by -30.4% to € 68 million in the second quarter (Q2 2013: € 97 million). This was mainly due to the decline in royalty and license income in the Merck Serono division. Total revenues, in other words sales plus royalty, license and commission income, nevertheless increased by 0.8% to € 2.9 billion (Q2 2013: € 2.8 billion), reflecting the strength of the operating business.

The operating result (EBIT) of the Merck Group declined by € -24 million to € 441 million in the second quarter. This was largely attributable to the higher level of one-time items, especially from acquisitions, lower royalty, license and commission income, as well as negative foreign exchange effects in comparison with the year-ago period. The operating business and the efficiency improvement measures implemented within the scope of the “Fit for 2018″ transformation and growth program had a positive effect.

After adjusting for depreciation, amortization and one-time items, EBITDA pre one-time items, the key financial indicator used to steer operating business, grew by 2.3% to € 846 million (Q2 2013: € 826 million), resulting in an EBITDA margin pre one-time items relative to sales of 30.3% (Q2 2013: 30.1%). Taking into account the 1:2 share split, earnings per share pre one-time items amounted to € 1.16 in the second quarter of 2014 (Q2 2013: € 1.13).

Emerging Markets are a key driver of organic growth
From a regional perspective, dynamic business in Emerging Markets contributed first and foremost to the organic sales growth of the Merck Group. Very strong growth of 11.1% was mainly driven by the Merck Serono and Merck Millipore divisions. Including negative foreign exchange effects of -8.5% and increases of 5.9% from the AZ acquisition, Merck generated sales of € 1.0 billion in the Emerging Markets region (Q2 2013: € 967 million), equivalent to an increase of 8.5%. The Emerging Market region’s share of Group sales thus grew to 37% in the second quarter (Q2 2013: 35%), exceeding Europe (36%) despite stronger foreign exchange effects.

All four divisions of the Merck Group delivered organic sales growth in the second quarter. In particular, Consumer Health generated a good organic sales increase of € 15 million, equivalent to a growth rate of 8.5%. Delivering an absolute increase of € 44 million (3.0%), Merck Serono made the largest contribution to organic sales growth.

“At Merck Serono, we want to further expand our business with existing medicines this year. To this end, we are focusing on Emerging Markets with a high number of underserved patients. The past quarters have already confirmed the success of this approach,” said Kley.

For the Merck Serono division, slight organic sales growth over the previous year is assumed. It can be expected that the well-balanced product portfolio as well as organic growth in the Emerging Markets region will offset the declines in sales of Rebif resulting from the competitive situation in the United States and Europe. EBITDA pre one-time items of Merck Serono should decrease slightly in 2014 as forecast, particularly as a result of the expected decline in royalty, license and commission income, which will have a net effect of approximately € -100 million versus 2013. For the Consumer Health division, Merck forecasts moderate organic sales growth in 2014. Merck expects that all regions and especially the core strategic brands will contribute to sales growth. EBITDA pre one-time items should likewise increase moderately in 2014 as a result of positive sales developments. Merck assumes that the Performance Materials division will achieve slight organic sales growth in 2014. Overall, the acquisition of AZ Electronic Materials will lead to a substantial increase in the sales of the Performance Materials division despite negative foreign exchange effects. EBITDA pre one-time items of the division should therefore also increase considerably in 2014. The integration costs resulting from the acquisition of AZ Electronic Materials are estimated to amount to around € 50 million, approximately € 10 million of which will be incurred in 2014. For Merck Millipore, moderate organic sales growth is expected in 2014, which will however be partly offset by foreign exchange effects. Based on forecast sales growth, EBITDA pre one-time items should increase slightly in 2014.

For more detail report, please visit  http://www.merckgroup.com/company.merck.de/en/images/Q2_2014_Quarterly%20Report_final_EN_tcm1612_126074.pdf?Version=

 
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Posted by on August 14, 2014 in Industry

 

Merck Serono India Wins Five Awards at the ‘CMO Asia Awards 2014′

At the recently held ‘The CMO Asia Awards’ in Singapore, Merck Serono India has been honoured with FIVE AWARDS for our outstanding work in Healthcare Communications, Social and Digital Media Marketing domains.

CMOAsia-800pxThese Asia Pacific level awards witnessed a total of 415 entries from more than 12 countries in the region, spanning across various industries and sectors – from leading Corporate Houses, MNCs and Media Giants. Dr. Reddy’s Laboratories Ltd, YES Bank Ltd, India Today Group, Viacom18 Media, Bajaj Allianz General Insurance Company Ltd, Max Life Insurance Co. Ltd, Sony DADC, Mother Dairy Fruits & Vegetables Pvt Ltd, Tata Chemicals Ltd, Godrej, Infosys Ltd, Tata Consultancy Services, SAP India, Bennett, Coleman & Company Limited (BCCL), Reliance Life Insurance Company Ltd, were some of the entries from India.

The Chief Marketing Officers’ (CMO) Council is dedicated to high level knowledge exchange through leadership and networking amongst senior CMOs and decision makers across industry segments. ‘The CMO Asia – Healthcare Excellence Awards 2014 and Social Media & Digital Marketing Excellence Awards 2014’ were judged by an independent jury comprising senior and accomplished professionals from Marketing, Public Relations, Brand Strategy, and Corporate Communications sphere.

Winning five awards in the midst of such mainstream entities is indeed an achievement. This phenomenal success has made Merck Serono India, the most awarded Pharmaceutical Company in the Digital and Social Media space in India. This recognition is a testament to our Business Innovation, creative use of New Media: Social Media in Pharma Marketing through the revolutionary Content-Conversation tactics using the Multi-Channel Marketing Approach.

These awards validate Merck Serono India’s multi-pronged strategies to create and reinforce our branding as a market leader in the Indian Pharmaceutical Industry and encourage us to move forward and accelerate on our innovative communications journey.

 
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Posted by on August 12, 2014 in Merck Serono

 

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Merck Serono Initiates Phase II Study of Anti-PD-L1 Antibody MSB0010718C in Metastatic Merkel Cell Carcinoma

  •  First patient begins treatment in an international Phase II study investigating the efficacy and safety of MSB0010718C in patients with metastatic Merkel cell carcinoma (mMCC)
  • mMCC is a rare and aggressive skin cancer lacking effective treatments
  • MSB0010718C is also currently being explored in a seven cohort Phase I clinical trial for the treatment of solid tumors that aims to recruit 590 patients

Darmstadt, Germany, July 29, 2014 – Merck Serono, the biopharmaceutical division of Merck, today announced the initiation of an international Phase II study designed to assess the efficacy and safety of MSB0010718C, an investigational fully human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1). This multicenter, single-arm, open-label study is being conducted in patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive type of skin tumor,1,2 who have previously received one line of chemotherapy. It is expected to recruit 84 patients across Asia Pacific, Australia, Europe and North America. The primary endpoint of the study is overall response.

Me-Ms-Stacked-VerticalThe PD-L1/PD-1 pathway is implicated as a major mechanism by which tumors evade elimination by the immune system.3 The PD-L1 molecule is expressed in many cancer types, including mMCC.3,4 MSB0010718C, which blocks the interaction of PD-L1 with its receptor PD-1, may have the potential to restore effective anti-tumor T-cell responses and thereby to inhibit tumor growth.

Immune mechanisms are implicated in the pathogenesis of MCC, with an increased risk observed in immunosuppressed individuals.5 MCC also is associated with the presence of the Merkel cell polyomavirus, which may have a role in tumor formation.6 Globally, the incidence of MCC is increasing, and outcomes for patients with this disease are poor.1,2 Therefore, new treatment approaches are required to improve the outcome of patients with this type of cancer.

“We believe that modulating the immune system by targeting PD-L1 represents a promising new approach in the treatment of this aggressive cancer, especially considering that many of the predisposing factors for mMCC seem to be related to functional disruptions of the immune system,” said Helen Sabzevari, Senior Vice President of Immuno-Oncology at Merck Serono. “Our anti-PD-L1 compound may present a potential new approach for the treatment of mMCC patients. The initiation of this Phase II study is an important milestone, as we endeavor to help those suffering from mMCC, a devastating disease with significant unmet need.”

In addition to this new study in mMCC, MSB0010718C is currently being explored in a Phase I clinical trial for the treatment of solid tumors. The study aims to recruit 590 patients and has enrolled 422 patients to date. On June 1, 2014, Merck Serono presented initial data from this dose escalation study in solid tumors at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago.7 This study is currently recruiting patients into expansion cohorts in seven cancer types: castrate-resistant prostate cancer, colorectal cancer, gastric/gastroesophageal cancer, melanoma, metastatic breast cancer, non-small cell lung cancer and ovarian cancer.

References
1. Hughes MP, et al. Curr Dermatol Rep 2014;3:46–53.
2. Kaae J, et al. J Natl Cancer Inst 2010;102(11):793–801.
3. Lipson EJ, et al. Cancer Immunol Res 2013;1(1):54-63.
4. McDermott DF and Atkins MB. Cancer Med 2013; 2(5):662–73.
5. Bhatia S, et al. Curr Oncol Rep 2011;13(6):488-97.
6. Feng H, et al. Science 2008;319(5866):1096–100.
7. Heery CR, et al. J Clin Oncol 2014;32:5(Suppl.) Abstract No. 3064.

About MSB0010718C
MSB0010718C is an investigational fully human IgG1 monoclonal antibody that binds to the PD-L1 (programmed death-ligand 1) protein, which is present at high levels in many cancer types. By competitively blocking the interaction with PD-1 receptors, it is believed that MSB0010718C thereby restores anti-tumor T-cell responses.

About Merkel cell carcinoma (MCC)
MCC is a rare and aggressive disease in which cancer cells form in the top layer of the skin, close to nerve endings. MCC, which is also known as neuroendocrine carcinoma of the skin or trabecular cancer, often starts in those areas of skin that are most often exposed to the sun, including the head and neck, arms, legs, and trunk. Risk factors for MCC include sun exposure and having a weak immune system (i.e., solid-organ transplant recipients, people with HIV/AIDS and people with other cancers, such as chronic lymphocytic leukemia, are at higher risk). Caucasian males over age 50 are at increased risk.
MCC tends to metastasize at an early stage, spreading initially to nearby lymph nodes, and then potentially to more distant areas in the body, including other lymph nodes or areas of skin, lungs, brain, bones, or other organs.
Current treatment options for MCC include surgery, radiation and chemotherapy. Treatment for metastatic or Stage IV MCC is generally palliative.

About Merck Serono
Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.
For more information, please visit http://www.merckserono.com

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of € 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of our customers and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.

 
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Posted by on August 7, 2014 in Merck Serono

 

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Merck Serono Announces Collaboration with San Raffaele University & Research Hospital for Research in Neurodegenerative Diseases

  • Agreement for research in neurodegenerative diseases continues collaboration to develop pre-clinical and clinical research projects with a translational approach
  • Research to focus on developing innovative therapies against serious and disabling neurological diseases affecting young adults in particular

Darmstadt, Germany, July 23, 2014 – Merck Serono, the biopharmaceutical division of Merck, and the Institute of Experimental Neurology (INSPE), part of San Raffaele University and Research Hospital in Milan, Italy, announced today the continuation of a strategic alliance to develop pre-clinical and clinical research projects in the field of neurodegenerative diseases.

Me-Ms-Stacked-VerticalThe research will focus on developing innovative therapies against serious and disabling neurological diseases affecting young adults in particular, such as multiple sclerosis. Established in 2004, the renewal of the partnership extends the agreement between the parties for two additional years.

“Merck Serono is pleased to continue the collaborative alliance with the San Raffaele Scientific Institute,” said Harsukh Parmar, Senior Vice President, Global Head of Research & Early Development, Immunology & Neurology at Merck Serono. “Our translational approach to these disease states and combined commitment to expediting the discovery of new therapies aims to improve health outcomes for patients living with unmet medical needs.”

“The co-operation between pharmaceutical companies and both private and public research institutes is a fundamental instrument to finance the research, a delicate and critical issue,” said Professor Giancarlo Comi, director of INSPE and of the department of neurology at San Raffaele Hospital. “In compliance with the respective prerogatives and role of research institutions and companies in the pharmaceutical market, these forms of collaboration allow research institutes to actively participate as real drivers at the development of new therapies and at the definition of biomarkers, as essential tools for the drugs optimization.”

San Raffaele University and Research Hospital will provide its know-how and its laboratories to develop new therapies and to evaluate the effectiveness of the molecules developed by Merck Serono.

About Merck Serono
Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.
For more information, please visit http://www.merckserono.com

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of € 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.

 
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Posted by on August 7, 2014 in Industry, Merck Serono

 

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Merck Serono Commits € 2 million to the Grant for Fertility Innovation (GFI) for 2014/15

  • Investment reflects company’s ongoing commitment to innovation in Fertility research
  • Globally, nine projects receive funding from this grant cycle

Darmstadt, Germany, July 1, 2014 – Merck Serono, the biopharmaceutical division of Merck, Germany, today announced its strong support of the Grant for Fertility Innovation (GFI) fund with grants totaling up to € 2 million for the years 2014 / 2015. The announcement was made during the 30th annual meeting of the European Society of Human Reproduction and Embryology (ESHRE) currently taking place in Munich.

Dr. Steven Hildemann Global Chief Medical Officer Merck Serono

Dr. Steven Hildemann
Global Chief Medical Officer
Merck Serono

Launched in 2009, the GFI is dedicated to transforming innovative translational fertility research projects into concrete health solutions to improve the outcomes of assisted reproductive technologies (ART). In the last five years, approximately 640 applications to GFI were received from over 50 countries around the world; of these applications, nine projects from eight countries were awarded a grant for a total of € 2 million.

“The Grant for Fertility Innovation is reflective of our broad, ongoing commitment to advancing scientific knowledge that can be translated into meaningful solutions for patients in need,” said Dr. Steven Hildemann, Global Chief Medical Officer and Head of Global Medical and Safety at Merck Serono. “The GFI enables the novel ideas that exist among forward-thinking fertility researchers from around the world, accelerating our collective ability to positively impact the final outcome of patients undergoing assisted reproductive technology treatments.”

Every year, the GFI awardees are announced during a ceremony at ESHRE’s annual meeting. This year, nine winning projects were announced during the ceremony:

  • Marcos Meseguer – Instituto Valenciano de Infertilidad, Valencia (Spain): Embryo viability measurement combining Oxidative stress and time-lapse technology
  • Kazuhiro Kawamura – Reproduction Center, St. Marianna University School of Medicine, Kanagawa (Japan): Infertility treatment of patients with diminished ovarian reserve using in vitro activation of follicles
  • Andrea Borini – Tecnobios Procreazione, Bologna (Italy): IR Microspectroscopy on GCs: a new non-invasive oocyte assesment
  • Semra Kahraman- Istanbul Memorial Hospital, ART and Genetics Center, Instanbul (Turkey): Identifying markers of oocyte competence through a maturation analysis
  • Douglas Carrell – University of Utah, Salt Lake City, UT (USA): Micro-Electrophoresis: To select mature and genetically fit sperm
  • Nathan Treff – Reproductive Medicine Associates of NJ, Basking Ridge, NJ (USA): Predicting Reproductive Potential from the Maternal Exome
  • Marc-André Sirard- Laval Universit, Quebec City (Canada): COST2: Control Ovarian Stimulation Timing Test
  • José Gonçalves Franco Junior- Centro de Reprodução Humana Prof. Franco Junior, Ribeirão Preto (Brazil): Genetic biomarkers to predict ovarian response and pregnancy outcomes
  • Tracey Edgell- Prince Henry’s Institute, Clayton (Australia): Cytokines profile to predict Uterine Receptivity in women undergoing ART

GFI

Notes to editors
Photos of the award ceremony are available on the GFI website: http://www.grantforfertilityinnovation.com

About the Grant for Fertility Innovation (GFI)
Merck Serono announced the initiation of the GFI program in 2009 to support the advancement of science and innovative technologies in the fertility field. This grant is awarded every year to translational research projects that can potentially improve baby birth rate for the benefit of the patients. Each project is blinded and evaluated by a jury of experts according to five criteria: support to increase baby birth rate; innovative research; scientific rationale; feasibility and practical utility.
For further information about the GFI and how to apply for next year’s grants, please visit: http://www.grantforfertilityinnovation.com

About Merck Serono
Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology. For more information, please visit http://www.merckserono.com

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.
Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of € 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.

 
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Posted by on July 7, 2014 in Industry

 

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Merck Serono and Mersana to Develop Next-Generation Antibody-Drug Conjugates

  • Collaboration and license agreement allows Merck Serono to expand its oncology drug portfolio
  • Mersana Therapeutics’ Fleximer technology to be leveraged to create multiple antibody-drug conjugates

Darmstadt, Germany, June 24, 2014 – Merck Serono, the biopharmaceutical division of Merck, and Mersana Therapeutics, Inc., Cambridge, Mass., U.S., announced today an agreement to collaboratively develop next-generation antibody-drug conjugates (ADCs). ADCs are composed of an antibody linked to cytotoxic drugs, whereby the antibody part specifically targets and delivers the cytotoxic drug to cancer cells which could lead to higher drug levels at the tumor site.

Me-Ms-Stacked-VerticalMersana and Merck Serono will leverage Mersana’s Fleximer® technology to generate ADCs for multiple undisclosed targets. Both parties have agreed to test a variety of ADCs by utilizing Mersana’s platform technologies and several cytotoxic agents as conjugates. This agreement further underlines Merck Serono’s approach to employ a collaborative research and development model, creating strategic partnerships to drive innovation, being consciously agnostic of the source of potential novel assets, and technologies.

“This new collaboration provides an exciting opportunity to expand our oncology drug discovery and development portfolio into the evolving ADC space,” said Dr. Andree Blaukat, head of the Translational Innovation Platform Oncology at Merck Serono. “At Merck Serono, we have a long-standing commitment to improving oncology care, and we aim to deliver the best benefit possible to patients. Partnering with Mersana allows us to incorporate cutting-edge research and technical excellence to enrich our pipeline.”

“We look forward to working with Merck Serono to apply our proprietary platform technologies to rapidly develop and demonstrate preclinical proof-of-concept of several customized, novel Fleximer-ADC candidates,” said Timothy B. Lowinger, Ph.D., Mersana’s Chief Scientific Officer. Under the agreement, Merck Serono will provide monoclonal antibodies to Mersana, which will generate the Fleximer-ADCs and conduct drug discovery and preclinical development activities. Merck Serono will be responsible for clinical development and commercialization of any products under an exclusive license from Mersana. In addition to an upfront payment, Mersana is eligible to receive milestones plus royalties on worldwide net sales of products. Further financial details are not being disclosed.

About Fleximer Antibody-Drug Conjugate Technology
Mersana’s next-generation Fleximer® antibody-drug conjugate (ADC) technology is based on the Company’s proprietary biodegradable polymer system, known as Fleximer, and a wide variety of linkers that allow for the attachment of an extensive range of anti-tumor payloads to Fleximer. As an example, once loaded with drug(s), Fleximer is then attached through a stable linker that is different from the drug linker(s), to an antibody or antibody alternative to create a Fleximer-ADC. Mersana’s novel linker systems are designed to be stable in the bloodstream and to release the potent payloads once inside the targeted cancer cell. Mersana’s Fleximer-ADC technology provides several key advantages over currently available approaches, including: the ability to deliver diverse payloads; the opportunity to significantly increase drug loading per antibody; and the potential use with antibody fragments and alternative targeting moieties in addition to monoclonal antibodies. Mersana’s proprietary payload platforms include Dolaflexin™, an auristatin derivative; Vindeflexin™, a vindesine derivative; and Cytoflexin™, a tubulysin derivative.

About Mersana Therapeutics
Mersana Therapeutics engineers antibody drug conjugates (ADCs) that maximize the potential of new and established therapeutic classes. Mersana is developing, with select pharmaceutical partners, a portfolio of next-generation Fleximer® ADC) with superior properties not found with current ADC technologies. The company is also advancing its own pipeline of Fleximer-ADCs with best-in-class potential to address unmet needs and improve patient outcomes in multiple oncology indications. http://www.mersana.com

About Merck Serono
Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono. Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.
For more information, please visit http://www.merckserono.com.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of € 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.

 
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Posted by on June 24, 2014 in Industry

 

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Merck Serono and MorphoSys Enter Strategic Immuno-Oncology Collaboration

  • Co-Development and License agreement that complements and further expands Merck Serono’s Immuno-Oncology portfolio
  • MorphoSys’ Ylanthia next-generation antibody technology to be leveraged for the rapid identification of inhibitors against immune checkpoints

Darmstadt, Germany, June 12, 2014 – Merck and MorphoSys AG, Martinsried, Munich, announced today that they have signed an agreement to discover and develop therapeutic antibodies against undisclosed immune checkpoints. Under the terms of the agreement, MorphoSys and Merck Serono, the biopharmaceutical division of Merck, will join forces to develop therapies that modulate the immune system’s natural ability to fight tumors. MorphoSys, a leader in fully human antibody technologies, will apply its proprietary Ylanthia® antibody phage library and technology platform to identify antibodies against the targets of interest. Merck Serono with its strong portfolio and capabilities in the field of immuno-oncology and clinical development will be fully responsible for execution of development from Phase I onwards.

Me-Ms-Stacked-Vertical“The establishment of partnerships with companies with innovative technology platforms is an integral part of Merck Serono’s strategy to further expand upon our already diverse immuno-oncology portfolio,” said Dr. Helen Sabzevari, Senior VP of Immuno-Oncology at Merck Serono. “Combining Merck Serono’s extensive expertise in immuno-oncology with MorphoSys’ next-generation antibody technology provides us with an exciting opportunity to rapidly generate novel therapies with a clear potential to benefit cancer patients.”

“Therapeutic agents in the immuno-oncology field are set to transform cancer therapy, and we are delighted to work with Merck Serono in this area”, commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys. “We believe that our Ylanthia technology has the potential to provide truly differentiated antibodies against the targets that will be the subject of the collaboration. Merck Serono’s expertise in immuno-oncology, together with their strength in developing and commercializing therapeutic antibodies make them an ideal partner for MorphoSys.”

With this partnership, Merck Serono, is committed to strengthen its existing portfolio of cancer immunotherapies that work as monotherapies or in combination with other therapeutic modalities. The company’s immuno-oncology pipeline assets currently investigated in clinical trials span from Phase l to Phase III for the treatment of different cancer types, including tecemotide, a MUC1 antigen-specific cancer immunotherapy, the two immunocytokines NHS-IL2 (MSB0010445) and NHS-IL12 (MSB0010360), and the monoclonal antibody anti-PD-L1 (MSB0010718C). Beyond this, Merck Serono has
built a robust pre-clinical pipeline in the three Innovation Clusters therapeutic cancer vaccines, cancer stem cells, and tumor immunotolerance.

Under the terms of the co-development and license agreement, MorphoSys will co-fund research & development costs with the option to opt-out at predefined stages. MorphoSys will be eligible to receive development and commercial milestone payments, and in addition, tiered royalties on product sales that will reflect the extent of MorphoSys co-funding. Merck Serono will have sole responsibility for commercializing of any resulting products. Further financial details are not being disclosed.

Disclaimer
Clinical candidates are currently under clinical investigation and have not been approved for use in the U.S., Europe, Canada, or elsewhere. These candidates have not been proven to be either safe or effective and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.

About MorphoSys
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare. Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 80 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer’s disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com\

HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla® and Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG. Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.

About Ylanthia Ylanthia®, which is the industry’s largest antibody Fab library to date, uses a unique and innovative concept for the in vitro generation of highly specific and fully human antibodies. Ylanthia uses 36 fixed, naturally-occurring heavy and light chain framework combinations, which translates into unprecedented structural diversity. Great care was invested into the antigen binding site design. The library’s diversity is expected to result in antibodies against previously inaccessible target molecules and unique epitope coverage. In addition, antibody frameworks were pre-selected for expression levels, stability and aggregation behavior. A shift towards higher stability and stress tolerance will increase shelf life and serum stability of resulting antibody-products. When needed, antibodies from the Ylanthia library are optimized using MorphoSys’s proprietary Slonomics® technology. Slonomics enables optimization of Ylanthia antibodies with unprecedented speed and flexibility.

About Merck Serono
Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono. Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.
For more information, please visit http://www.merckserono.com

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Merck is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of € 11.1 billion in 2013. Around 38,000 Merck employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany is holding the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company is known as EMD.

 
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Posted by on June 12, 2014 in Industry

 

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