Merck Serono Announces Recipients of the Third Annual €1 Million Grant for Multiple Sclerosis Innovation

• Four research grants awarded out of 146 applications, highlighting continuing commitment to multiple sclerosis

Darmstadt, Germany, October 8, 2015 – Merck Serono, the biopharmaceutical business of Merck, today announced the recipients of the third annual Grant for Multiple Sclerosis Innovation (GMSI) at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) being held in Barcelona, Spain.

Four recipients, from The Netherlands, Finland, Italy, and the UK, will share the overall €1 million grant to support their research:

• Dynamics of M1/M2 polarization of microglia in multiple sclerosis: a PET imaging study: Helga E de Vries, Professor in Neuro-immunology, MS Centre Amsterdam, Dept. Molecular Cell Biology and immunology, VU University Medical Center, The Netherlands.
• Role of microglia in the pathogenesis of progressive multiple sclerosis: Laura Airas, Associate Professor, University of Turku, Finland.
• Driving microglia metabolism toward remyelination and restoration of brain damage in multiple sclerosis: Claudia Verderio, Senior Researcher, National Research Council, Institute of Neuroscience, Italy.
• Molecular markers of multiple sclerosis disease progression: Gabriele De Luca, Associate Professor of Clinical Neurology, Nuffield Department of Clinical Neurosciences, University of Oxford, UK.

Dr. Steven Hildemann
Global Chief Medical Officer
Merck Serono

“At Merck Serono, our long-term commitment to MS patients is evident in our medical research and development programs. The Grant for Multiple Sclerosis Innovation is another manifestation of our commitment and the interest in advancing the science behind MS is clear from the number of proposals this year,” says Steven Hildemann, Chief Medical Officer, and head of Global Medical Affairs and Global Drug Safety at Merck Serono. “I am impressed by the breadth, depth, and quality of the proposals, and it is further confirmation that there continues to be a deep interest within the scientific community to gain further understanding of the disease.”
The complete Merck News Release can be downloaded at the following link:
http://news.merck.de/N/0/4450F7FE2BA1DE2BC1257ED800352C13/$File/GMSI_Press_Release.pdf

 

Merck and Pfizer Collaborate with Dako, an Agilent Technologies Company, on Development of Companion Diagnostic for Investigational anti-PD-L1 Antibody, Avelumab

• Merck and Pfizer collaborate with Dako in developing an immunohistochemistry (IHC)-based companion diagnostic (CDx) in immuno-oncology

Darmstadt, Germany, and New York, U.S., September 24, 2015 – As part of the global strategic alliance between Merck and Pfizer to jointly develop and commercialize avelumab*, an investigational immune checkpoint inhibitor, the companies have announced today that they have a collaboration agreement in place with Dako, an Agilent Technologies company, for the development of a potential companion diagnostic test (CDx).

The complete Merck News Release can be downloaded at the following link:
http://news.merck.de/N/0/B736E6FBE0045CAEC1257ECA004F418C/$File/Alliance_DAKO_Eng.pdf

 

Merck Serono Introduces New Eeva Test Version Aiming for Optimized Assisted Reproductive Outcomes

• Merck Serono continues to provide health care professionals with innovative fertility technologies that aim to improve embryo assessment during ART cycles
• The new Eeva Test 2.3 features the Xtend Algorithm, utilizing new parameters to capture a more complete picture of embryo development

Darmstadt, Germany, June, 30, 2015 – Merck Serono, the biopharmaceutical business of Merck, today announced the launch of the new Eeva® (Early Embryo Viability Assessment) Test with the Xtend Algorithm, the advanced version of a non-invasive test to aid embryo assessment within assisted reproductive treatment (ART). The new version builds upon the scientific and clinical record of Merck Serono’s established Eeva System and utilizes a new algorithm to provide a multi-dimensional model for assessing and predicting the development of embryos. The advanced Xtend Algorithm enables ART labs to capture a more complete picture of embryo development and – when used adjunctively with traditional morphology – increases the chances of identifying embryos that have the highest developmental potential compared to traditional morphology alone. With the launch of the improved system, Merck Serono further expands its portfolio in fertility technology which is becoming increasingly important to improve fertility treatment outcomes.

Meeta Gulyani, Head of Global Strategy and Franchises, Merck Serono

“Introducing the Eeva System 2.3 and its Xtend Algorithm shows our commitment to continuous innovation to ultimately improve success rates in ART,” said Meeta Gulyani, Head of Global Strategy and Franchises at Merck Serono. “We see strong opportunities for scientific innovation in fertility technologies and will continue to invest in developing new products and evolving existing ones, such as the Eeva Test. As the world’s leader and pioneer in fertility treatment, we are drawing upon our strong heritage in the field to further support IVF clinicians in helping women and couples realize their dream of welcoming a baby to their family.”

The Eeva System uses automated image analysis software to capture and analyze embryo cell activity that the human eye is not capable of detecting, providing objective and consistent test results for ART clinicians. Building upon the robust scientific foundation of its established predecessor, the improved Eeva System 2.3 includes a new multi-dimensional algorithm to address the demand for more objectivity and standardization within ART and optimized outcomes. The Xtend Algorithm was identified through a rigorous R&D process, which investigated over 1,000 potential parameters before determining the most relevant ones for improving the chance of identifying the embryos with the highest potential of ART success if used adjunctively with traditional morphology. Extending beyond measurement of cell division timings, the Xtend Algorithm includes additional parameters, leading to five parameters overall that are applied to each embryo and mapped against a multi-dimensional prediction model. The Xtend Algorithm was developed on a large data set from 12 sites, 373 women and 3,328 embryos, and validated on an independent data set to demonstrate objective and consistent test results. The Eeva System 2.3 further provides a new five-tier classification system, designed to offer more assessment options to better distinguish the embryo with highest developmental potential when used adjunctively with traditional morphology.

About the Eeva Test
The non-invasive Early Embryo Viability Assessment (Eeva®) Test when used adjunctively with traditional morphology may improve IVF outcomes by providing IVF clinicians and patients with objective information on embryo viability. The Eeva System utilizes proprietary software that automatically analyzes embryo development against scientifically and clinically validated parameters. With Eeva’s quantitative data on each embryo’s potential development, IVF clinicians can optimize the treatment path for their patients undergoing IVF procedures.

Progyny, Inc. formed March 2015 is the combined entity of Auxogyn, Inc. and FertilityAuthority, LCC. In March 2014, Auxogyn Inc. granted Merck Serono exclusive rights to commercialize Auxogyn’s proprietary Early Embryo Viability Assessment (Eeva) Test in Europe and Canada, with the option to extend to selected countries. Progyny retains the commercial rights to the Eeva Test in the United States. The agreement is the latest development in the ongoing collaboration between Merck Serono and Progyny, which began in 2010 when Merck invested in Auxogyn through its corporate venture capital fund, MS Ventures.

Auxogyn received the CE mark for Eeva in July 2012, and at the end of the first half of 2015, Merck will have launched the test in 13 countries across Europe and Canada. In the United States, clearance for the Eeva System was granted by the U.S. Food and Drug Administration through its de novo classification process in June 2014.

About Merck Serono
Merck Serono is the biopharmaceutical business 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

 

Merck Launches “More than a Mother” Campaign Aiming to Reduce Social Suffering of Infertile Women in Africa

• “More than a Mother” will first be implemented in Kenya in partnership with University of Nairobi and Kenya Women Parliamentary Association and progressively rolled out in further African countries

Nairobi, Kenya, June 23, 2015 – Merck, a leading company for innovative, top-quality high-tech products in healthcare, life science and performance materials, today announced the launch of the “More than a Mother” campaign as part of the Merck Capacity Advancement Program. The campaign will first be implemented in Kenya, in collaboration with the University of Nairobi and the Kenya Women Parliamentary Association, and progressively rolled out in further African countries.

In some cultures, childless women still suffer discrimination, stigma and ostracism. As such, a central difficulty associated with infertility is that it can transform from an acute, private distress into a harsh, public stigma with complex and devastating consequences. An inability to have a child or to become pregnant can result in being greatly isolated, disinherited or assaulted. This may result in divorce or physical and psychological violence.

Belén Garijo, Member of the Executive Board of Merck and CEO Merck Healthcare, while kicking off the campaign during her meeting with the University of Nairobi and the Kenya Women Parliamentary Association

“Providing access to infertility care is important, but it is even more important to intervene to decrease stigmatization and social suffering arising from this condition,” said Belén Garijo, Member of the Executive Board of Merck and CEO Healthcare at Merck, during her meeting with the University of Nairobi and the Kenya Women Parliamentary Association to kick off the campaign.

Merck’s Capacity Advancement Program (CAP) forms a key pillar of the Group’s Corporate Responsibility activities in the strategic area of activity health. The 5-year program aims at expanding the professional capacity in developing countries in the areas such as research and development, advocacy building, medical education or community awareness. By the end of 2018, Merck plans to target more than 19,000 students in African, Asian, Latin American and Middle Eastern countries, with special focus on non–communicable diseases such as diabetes, cancer and fertility management.

Prof. Koigi Kamau, University of Nairobi stressed: “Through the “More than a Mother” campaign, we will challenge the perception about infertile women, their roles and worth in society, both within and beyond the medical profession in order to achieve any systemic shift in the current culture of gender discrimination in the context of fertility care.”

The program will provide medical education and awareness for medical students and general practitioners and will also support governments to define policies to improve access to safe and effective fertility care, address the need for interventions to reduce stigmatization and social suffering of infertile women and raise awareness about male infertility and the necessity for a team approach to family building among couples.

Through this campaign Merck, a pioneer in reproductive health, will address together with local stakeholders, the key challenges that are associated with resource-constrained settings such as prevention of infertility, education and self-development, regulation of assisted reproductive technology (ART) and in-vitro fertilization (IVF), geographic barriers, reproductive rights and over-population and limited resources arguments. A particular emphasis will be put on prevention programs, as infertility is caused by infections in over 85% of women in the Sub-Saharan region, compared to 33% worldwide.

Hon. Joyce Lay, Member of the Kenyan Parliament, emphasized: “In order to improve access to safe and effective fertility care, a discussion with the relevant authorities will be needed to discuss the strengthening of infertility services, education, auditing, regulation, community awareness and the need to integrate them in programs which already exist in the local health infrastructure.”

About the Merck Capacity Advancement Program (CAP)
The Merck CAP is a 5-year program aiming to expand the professional capacity in developing countries in the areas of research and development, advocacy building, supply-chain integrity and efficiency, pharmacovigilance, medical education, and community awareness.

As part of the CAP, by end of 2015, more than 5,000 medical students in partnership with African universities such as University of Nairobi, Makerere University, Namibia University and University of Ghana, in addition to Asian universities such as Maharashtra university, India and University of Indonesia will benefit from European-accredited clinical chronic diseases management training, which is seeking to equip them with skills to better manage and prevent these diseases.

Merck is planning to target more than 19,000 students by the end of 2018 expanding to more African, Asian, Latin American and Middle Eastern countries with special focus on non–communicable diseases such as diabetes, cancer and fertility management. The program will also kick off initiatives on building research capacity and improving supply chain in order to improve patient safety in Africa.

 

Merck Inaugurates Biomass Plant in Goa, India

• Co-generation unit promotes climate protection and energy efficiency
• To manufacture vitamin preparations, industrial and laboratory chemicals as well as microbiological products, among others

Goa/Mumbai, November 25, 2014 – Merck, a leading company for innovative and top-quality high-tech products in the pharmaceutical, chemical and life science sectors, today commissioned a climate-neutral co-generation plant at its production site in Goa, India.

In doing so, Merck is underscoring its commitment to climate protection and energy efficiency in line with its corporate responsibility. The project is part of a company-wide climate protection program. Merck previously commissioned a new co-generation plant at its headquarters in Darmstadt in July.

Dr. Thierry Hulot, Executive Vice President, Head of Global Manufacturing & Supply
and Member of Merck Pharmaceutical Executive Committee

Dr. Thierry Hulot, Executive Vice President, Head of Global Manufacturing & Supply and Member of Merck Pharmaceutical Executive Committee visited India on the occasion and inaugurated the plant. He said, “Merck’s new climate-neutral co-generation plant in Goa has a tremendous power output for our pharmaceutical and chemical production operations. In the manufacture of our products, we seek to impact the environment as little as possible. As a responsible company, we express our respect to the environment in an Industrial Plant that provides medicines for millions of patients in India.”

Merck’s Goa site is located in Usgao, around 45 kilometers from Panaji, the capital of the Indian state of Goa. This co-generation unit, which has a power output of three megawatts, generates electricity and steam for the pharmaceutical and chemical production operations in Goa. Merck is mainly recycling the shells of cashews and coconuts, two crops that are farmed in the region, to use as biomass. Overall, this will make it possible to reduce carbon dioxide emissions by around 11,500 metrics tons, corresponding to around 85% of the site’s total CO2 emissions. The biomass plant, which represents an investment of more than € 3 million, will ensure that the site has a reliable supply of energy and can operate independently of the public power grid. More than 300 employees manufacture vitamin preparations, industrial and laboratory chemicals as well as microbiological products, among other things.

Mr. Pramod Pimplikar, Director – Technical Operations, GMS- Merck Serono

Speaking on the occasion, Mr. Pramod Pimplikar, Director – Technical Operations, GMS- Merck Serono said, “We are extremely excited in being able to make a positive difference to our business, the environment and capacity building efforts. With this Green field site, we aim to reduce CO2 emission by 85% and deliver clean, green, efficient, reliable power and steam supply, improving efficiencies and contributing to the nation’s interest. By 2020 Merck KGaA has committed to reduce its global CO2 emissions by 20% and we are happy to be in a position to contribute to those efforts.”

The climate protection program Edison comprises around 300 climate protection and energy efficiency activities of the Merck Group. The objective is to reduce greenhouse gas emissions from energy generation as well as to enhance the energy efficiency of research and production processes. Merck aims to reduce its total direct and indirect greenhouse gas emissions by 20% by 2020, measured against the 2006 baseline. At its site in Jaffrey, New Hampshire (USA), Merck plans to commission a further biomass central heating plan next year.

Merck is a leading company for innovative, top-quality high-tech products in the chemical, pharmaceutical and life science sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of around € 11.1 billion in 2013. Around 39,000 employees work for Merck 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% interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany holds 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.

 

Merck Advances to Sixth Place in the 2014 Access to Medicine Index

• Merck moves up two places from previous rank 8
• Access to Medicine Foundation acknowledges Merck’s strategic approach to access to health

Darmstadt, Germany, November 18, 2014 – Merck, a leading company for innovative and top-quality high-tech products in the pharmaceutical, chemical and life science sectors, announced today that it now ranks sixth in the Access to Medicine Index published yesterday by the Access to Medicine Foundation. Merck has moved up two places compared to the 2012 ranking. This improvement underlines the company’s commitment to helping overcome barriers to access for underserved populations and communities in low- and middle-income countries as part of its corporate responsibility and sustainable business approach. Every two years, the Access to Medicine Index benchmarks the top pharmaceutical companies on activities and initiatives that are advancing access to medicines in developing countries.

“Merck has revised its Access to Health strategy and has launched new initiatives since 2012 including a pro-access business model in India and an innovative initiative to increase local manufacturing capabilities,” the Access to Medicine Foundation cited as reasons why Merck has advanced in the new ranking.

“Our efforts have been well-recognized by the Access to Medicine Foundation and we are proud to be ranked among the top leading companies only three years after starting our Access to Health initiative,” Stefan Oschmann, Chief Executive Officer Pharma and Vice Chairman Elect of the Executive Board of Merck, said. ”The fact that we’ve once again improved our ranking proves that access to health has become an integral part of how we conduct business. Of course we will continue our endeavors to better help patients, who are at the core of all our efforts, and to possibly further contribute to alleviating the various barriers to access for those most in need.”

Merck’s strategy to addressing the complex challenge of providing access to underserved populations and patients in low- and middle-income countries focuses upon four priority areas, known as the 4As for Availability, Affordability, Awareness and Accessibility. Whereas availability includes refining of health solutions to address unmet needs tailored to local environments, affordability entails addressing the inability to pay challenge. Awareness focuses on empowering people with appropriate tools and knowledge to make informed decisions, whether through education and training or metrics and evidence gathering, and accessibility comprises initiatives to strengthen supply chain and develop localized health solutions.

Compared to 2012, Merck now has been recognized by the Access to Medicine Foundation in particular for leading practices such as:

• Strategic approach that comprises for example a strong focus on research & development for local and unmet needs and innovative manufacturing and distribution initiatives, including forward integration of supply chains
• Multi-dimensional approach to fight the tropical worm disease schistosomiasis: a long-term donation program that aims to help eliminate the disease, as well as the development of a new diagnostic tool and a pediatric formulation
• Pro-access IP management comprising of a commitment not to file for or enforce patents in the widest range of developing countries, access policies for future on-patent products, and open innovation initiatives
• Merck established its Access to Health initiative in February 2011 and has identified access gaps and opportunities to better meet the needs of underserved patients. The unit is ensuring that access brings added value to the community at large, and is becoming an integral part of how Merck conducts business in a responsible, sustainable manner. Merck launched the Su-Swastha pilot program, a pro-access business model aiming at increasing access to healthcare products at an affordable price in rural India. Another example is the Merck Capacity Advancement Program (CAP) to raise awareness of diabetes in Africa and in India by educating the public and supporting the healthcare system on ways to prevent, diagnose and manage diabetes effectively. In summary, Merck recognizes the complexity of bringing health solutions to the poor and understands that Access to Medicine Index objectives cannot be reached by the pharmaceutical industry alone. Partnership, collaboration and continuous dialogue with a diverse array of stakeholders are key to ensuring that the delivery of sustainable access solutions is serving people’s needs.

Access to Medicine Foundation
The Access to Medicine Foundation is an international not for profit organization stimulating pharmaceutical companies to improve access to medicine to societies in need. Based in Haarlem, the Netherlands, the Foundation publishes the Access to Medicine Index, the first Index of its kind to rank pharmaceutical companies with respect to their efforts to enhance global access to medicine.

The Foundation aims to advance access to medicine in developing countries by encouraging the pharmaceutical industry to accept a greater role towards improving access to medicine in less developed countries. Please find more information here.

Access to Medicine Index
Access to medicines remains a very serious concern for billions of people suffering from disease and is still a primary challenge for the global health system. Reflecting the key role of the pharmaceutical industry in addressing the challenges of access, it is essential that the Access to Medicine Index’s approach to monitoring and evaluating the performance of the industry in this work is robust, balanced and comprehensive. The foundation every two years ranks 20 medium to large-size pharmaceutical companies with respect to their efforts to enhance global access to medicine. You can see the latest ranking as well as rankings from the past here.

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, chemical and life science sectors. With its four divisions Merck Millipore, Merck Serono, Performance Materials and Consumer Health, Merck generated total revenues of € 11.1 billion in 2013. Around 39,000 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% 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 Merck KGaA, Darmstadt, Germany.

 

Merck Announces Global Strategic Alliance with Pfizer on Anti-PD-L1 to Accelerate Presence in Immuno-Oncology

• Merck and Pfizer will jointly develop and commercialize Merck’s anti-PD-L1
• Joint investment and combined strengths and capabilities will further maximize potential of Merck’s asset in the highly competitive anti-PD-1 / anti-PD-L1 space
• Up to 20 high priority immuno-oncology clinical development programs expected to commence in 2015, including pivotal registration studies
• Alliance accelerates Merck’s entry into the US oncology market

Darmstadt, Germany, November 17, 2014 – Merck (MRK GY) announced today that it has entered into a global agreement with Pfizer Inc. (NYSE:PFE) to co-develop and co-commercialize MSB0010718C, an investigational anti-PD-L1 antibody currently in development by Merck as a potential treatment for multiple tumor types to accelerate the two companies’ presence in immuno-oncology.

The asset will be developed as a single agent as well as in various combinations with Pfizer’s and Merck’s broad portfolio of approved and investigational pipeline candidates. The two companies will also combine resources and expertise to advance Pfizer’s anti-PD-1 antibody into Phase 1 trials. As part of the agreement, Merck will co-promote Pfizer’s XALKORI, a medicine to treat non-small cell lung cancer, in the United States and several other key markets.

Karl-Ludwig Kley, Chairman of Merck’s Executive Board stated: “We live up to our promise to strengthen all three pillars of our business: Healthcare, Performance Materials and Life Science. After this year’s acquisition of AZ Electronic Materials and the proposal to acquire Sigma-Aldrich, we have now turned the focus on healthcare. The agreement with Pfizer is a very important milestone in taking our pharma pipeline forward.”

“Collaborating globally with Pfizer will allow us to benefit from the strengths and capabilities of both companies in immuno-oncology, further accelerating this promising asset in the race to address the needs of cancer patients across multiple tumor types. Up to 20 high priority immuno-oncology clinical development programs are expected to commence in 2015, including pivotal registration studies,” continued Belén Garijo, President and Chief Executive Officer of Merck’s biopharmaceutical division Merck Serono and Executive Board Member Elect. “On top of that, the global alliance will enable Merck to gain an early entry into the US oncology market as well as to strengthen our existing oncology business in several other important global markets.”

There are currently two clinical development programs underway evaluating Merck’s anti-PD-L1 antibody. In a Phase 1 trial, more than 550 patients have been treated with MSB0010718C across multiple types of cancers. As part of the Analyst and Investor Day hosted by Merck on September 18, 2014, interim data were presented from the ongoing Phase 1 study demonstrating a complete response and partial responses in patients with non-small cell lung cancer and ovarian cancer. Additional data are expected to be presented at medical congresses in 2015. There is also an ongoing Phase 2 trial evaluating this antibody in patients with m-Merkel cell carcinoma, a rare form of skin cancer. For more information, please visit http://www.clinicaltrials.gov

Under the terms of the agreement, Merck will receive an upfront payment of $ 850 million (around € 680 million) and is eligible to receive regulatory and commercial milestone payments up to $ 2.0 billion. Both companies will jointly fund all development and commercialization costs and all revenues obtained from selling any anti-PD-L1 or anti-PD-1 products generated from this collaboration will be shared.

“Our strategic focus in the immuno-oncology space will be significantly enhanced through this global alliance, giving us the financial firepower to fully leverage the potential of our anti-PD-L1-compound” said Stefan Oschmann, Chief Executive Officer Pharma and Vice Chairman Elect of the Executive Board of Merck. “The success of the anti-PD-L1 program and the value recognised by Pfizer is a clear reflection of the progress we have made on our R&D pipeline in recent years.”

“This global alliance enables Pfizer and Merck to join forces and combine complementary strengths with the goal of meeting the needs of patients with multiple types of cancer,” said Albert Bourla, Group President Vaccines, Oncology and Consumer Healthcare Businesses, Pfizer. “Immuno-oncology is a top priority for Pfizer. Combining this promising anti-PD-L1 antibody with Pfizer’s extensive portfolio of small molecules and antibodies provides an opportunity to potentially broaden the use of immunotherapy for patients with cancer and rapidly expand our oncology business. In addition, this alliance enables us to significantly accelerate the time-frame of our development programs and move into the first wave of potential immuno-oncology based treatment regimens.”

• Further information for journalists including a digital press kit is here
• Interview with Belén Garijo, President and Chief Executive Officer of Merck Serono and Executive Board Member Elect
• Merck on Facebook, Twitter, LinkedIn

All Merck news releases are distributed by e-mail at the same time they become available on the Merck website. Please go to http://www.merckgroup.com/newsabo to register online, change your selection or discontinue this service.
Merck is a leading company for innovative, top-quality high-tech products in the chemical and pharmaceutical sectors. With its four divisions Merck Serono, Consumer Health, Performance Materials and Merck Millipore, Merck generated total revenues of around € 11.1 billion in 2013. Around 39,000 employees work for Merck 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% 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.

Cautionary Note Regarding Forward-Looking Statements
Certain statements made herein may be deemed to be solicitation materials in respect of the proposed acquisition of Sigma-Aldrich by Merck KGaA, Darmstadt, Germany. The proposed acquisition will be submitted to the stockholders of Sigma-Aldrich for their consideration on December 5, 2014. In connection therewith, on November 3, 2014, Sigma-Aldrich filed a definitive proxy statement with the SECand began mailing the definitive proxy statement to its stockholders of record as of the close of business on October 29, 2014. BEFORE MAKING ANY VOTING OR ANY INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT REGARDING THE PROPOSED TRANSACTION AND ANY OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and stockholders may obtain free copies of the proxy statement, any amendments or supplements thereto and other documents containing important information about Sigma-Aldrich, once such documents are filed with the SEC, through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Sigma-Aldrich will be available free of charge on Sigma-Aldrich’s website at http://investor.sigmaaldrich.com under the heading “Financial Information—SEC Filings”. Stockholders of Sigma-Aldrich may also obtain a free copy of the definitive proxy statement by contacting Sigma-Aldrich’s Investor Relations Department at (314) 898-4643.

Sigma-Aldrich and certain of its directors, executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about the directors and executive officers of Sigma-Aldrich is set forth in its proxy statement for its 2014 annual meeting of stockholders, which was filed with the SEC on March 21, 2014, its annual report on Form 10-K for the fiscal year ended December 31, 2013, which was filed with the SEC on February 6, 2014, and in subsequent documents filed with the SEC, each of which can be obtained free of charge from the sources indicated above. Other information regarding the participants in the proxy solicitation of the stockholders of Sigma-Aldrich and a description of their direct and indirect interests, by share holdings or otherwise, is contained in the definitive proxy statement and other relevant materials filed with the SEC.

 

Merck reports strong top-line growth in the 3rd Quarter 2014

November 13, 2014 – Merck delivered strong sales growth of 9.3%, reporting sales of € 2.9 billion in the third quarter of 2014 (Q3 2013: € 2.7 billion). Owing to the good business performance in the first nine months and the very good organic sales growth in the third quarter, Merck is assuming slight organic sales growth for the full year 2014.

• Sales increase by 9.3% in Q3
• All regions on a growth course, Emerging Markets fuel growth further
• EBITDA pre one-time items increases by 3.1% to € 857 million
• Merck raises sales guidance and reiterates forecast for EBITDA pre one-time items for the full year 2014

 

 

Merck Lends Support in the Fight Against Ebola

• Donation of € 250,000 made to the German Red Cross

Darmstadt, Germany, October 31, 2014 – Merck, a leading company for innovative and top-quality high-tech products in the pharmaceutical, chemical and life science sectors, will be donating € 250,000 to support the German Red Cross, a member of the International Federation of Red Cross and Red Crescent Societies, in the fight against Ebola. With this donation, the company is underlining social responsibility as part of its entrepreneurial approach.

“We want to help the people who are suffering in the affected countries quickly and in an uncomplicated manner. Therefore, we are providing the German Red Cross with € 250,000,” said Stefan Oschmann, CEO Pharma and Member of the Executive Board of Merck. “Our donation complements the many different initiatives with which Merck is helping to improve access to medicines and medical care for the people of Africa,” Oschmann added. The fight against the tropical worm disease schistosomiasis through donations of praziquantel tablets to the World Health Organization as well as efforts to contain the spread of counterfeit medicines through the use of mobile Minilabs represent two initiatives by Merck in this area.

“The entire provision of health care in Sierra Leone, Liberia and Guinea has virtually fallen apart. The conditions prevailing locally are catastrophic. We are therefore very happy to receive Merck’s contribution to the fight against Ebola,” said Rudolf Seiters, President of the German Red Cross. Local Red Cross aid workers have been in action since the outbreak of the epidemic in West Africa. The German Red Cross is supporting the national Red Cross organizations. In addition, the German Red Cross is expanding and enhancing a treatment center for Ebola patients operated by the International Red Cross in Sierra Leone. In Liberia, the German Red Cross will begin operating a treatment center for Ebola patients, with support from the German military, as of mid-November.

More information on the fight against Ebola can be found on the website of the International Federation of Red Cross and Red Crescent Societies.

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 39,000 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.

 

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.

These 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.

 

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.

The 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.

 

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.

The 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.

 

Erbitux indication expansion in Japan

Ministry of Health, Labor and Welfare in Japan granted an indication expansion for Erbitux for use in adults with squamous cell carcinoma of the head and neck (SCCHN). This comes in addition to the previously approved indication of Erbitux in combination with chemotherapy for the 1st-line treatment of adults with EGFR-expressing, curatively inoperable, advanced or recurrent colorectal cancer carrying the KRAS wild-type gene.

This indication expansion represents an important step forward for physicians treating, and patients living with, head and neck cancer in Japan as they now have an additional treatment option for the management of the disease. Patients in Japan account for approximately 20% of all head and neck cancer cases in East Asia, with 5 cases per 100,000 people.

 

Merck Advances to Eighth Place in the 2012 Access to Medicine Index

Merck moves up nine places from previous rank 17 (out of 20), thanks to scaled-up efforts in its praziquantel donation program, and ongoing activities to promote better health solutions to populations in need

Darmstadt, Germany, November 28, 2012 – Merck announced today that it now ranks eighth in the Access to Medicine Index published today by the Access to Medicine Foundation. Merck has moved up nine places compared to the 2010 ranking. Every two years, the Access to Medicine Index benchmarks twenty pharmaceutical companies on the different activities and initiatives in promoting access to medicines in low- and middle-income countries.

“Merck has moved up to eighth place in this year’s Index largely because it has provided more information about its tiered pricing, management strategy and single-drug donation programs,” the Access to Medicine Foundation cited as reason why Merck has moved up nine places.

“Today, our efforts have been well recognized by the Index and serve as a measuring tool to monitor Merck’s overall progress in the access to medicine field. We are committed to pursuing and further developing our Access to Health activities in the future to achieve sustainable health solutions to all,” said Stefan Oschmann, Executive Board Member of Merck and Head of the Merck Serono division.

The Access to Health initiative at Merck was launched in February 2011 and has identified access gaps and opportunities to better meet the needs of underserved patients. Merck’s Access to Health initiative aims at bringing added value to the community at large, and is becoming an integral part of how Merck conducts business in a responsible, sustainable manner. Merck recognizes the complexity of bringing health solutions to the poor and understands that Access to Medicines Index objectives cannot be reached by the pharmaceutical industry alone. Complementarity, synergy and partnership among the different actors in health are needed to achieve a long-term impact and sustainable results.

Compared to 2010, Merck has today been recognized by the Access to Medicines Foundation in particular for several topics such as:

• Innovative research and development for a pediatric version of praziquantel to treat schistosomiasis, and adapting this drug and anti-diabetic medication. Glucophage; five collaborations for relevant diseases and two instances of intellectual property sharing.
• Introduced access to medicine charter with board-level responsibility, stakeholder engagement reflects initiatives for product donation and research and development targeting neglected tropical diseases, and provides detailed information about access strategy and policies.
• Transparent about lobbying and public policy positions, monitored and enforced codes of conduct for ethical marketing for employees and third parties.

Access to Medicine Foundation
The Access to Medicine Foundation is an international not for profit organization stimulating pharmaceutical companies to improve access to medicine to societies in need. Based in Haarlem, the Netherlands, the Foundation publishes the Access to Medicine Index, the first Index of its kind to rank pharmaceutical companies with respect to their efforts to enhance global access to medicine. The Foundation aims to advance access to medicine in developing countries by encouraging the pharmaceutical industry to accept a greater role towards improving access to medicine in less developed countries. Please find more information here: http://www.accesstomedicineindex.org

Access to Medicine Index
Access to medicines remains a very serious concern for billions of people suffering from disease and is still a primary challenge for the global health system. Reflecting the key role of the pharmaceutical industry in addressing the challenges of access, it is essential that the Access to Medicine Index’s approach to monitoring and evaluating the performance of the industry in this work is robust, balanced and comprehensive. The foundation every two years ranks 20 medium to large-size pharmaceutical companies with respect to their efforts to enhance global access to medicine. You can see the latest ranking as well as rankings from the past here.

Click here to download the Press Release

 

Merck Serono India utilises Z-CARD® to generate awareness for doctors and patients

Merck Serono, the pharmaceutical division of Merck, recently selected a Z-CARD® to create awareness of its new, self-injecting Gonal F pre-filled pen, which is prescribed by doctors in India to treat infertility in women.

Produced by Z-CARD® India, part of the Z-CARD® Africa, Middle East, India and Turkey (ZAMI) stable, the card was printed in eight languages and handed out to patients by doctors inside their consulting rooms.

Srinivas Madabusi, Director – Head of Biotech and Women’s Health, Merck Serono India

We also produced acrylic display boxes that could stand on the doctors desks to make distribution of Gonal F pen Z-CARD®s easy, says Floyd Fernandes from Z-CARD® India.

The Z-CARD® (234mm x 350mm in size when open) was designed with bespoke hinged covers that ensured that it was only 64mm x 85mm in size when closed.

This compact solution made it easy for patients to put inside their bag or purse when leaving the doctor’s clinic, says Srinivas Madabusi, the Director & Head of Biotech and Women’s Health at Merck Serono India.

The card contains step-by-step information on how to use the pre-filled pen right from how to attach the needle to removing air bubbles, setting the dose and injecting the medication as prescribed by the doctor. A dose chart table is also included on the Z-CARD® so that patients can keep a record of the dates and the dosage taken, Madabusi adds.

 

Merck Serono spin-off creates biomarker specialist Quartz Bio

Jérôme Wojcik
CEO and Founder, Quartz Bio
Geneva, Switzerland

Quartz Bio, a new company offering biomarker data management and exploratory biomarker analysis services to the pharmaceutical industry, has emerged as the second offshoot of Merck Serono’s Entrepreneur Partnership Program, set up to take the sting out of the company’s withdrawal from its headquarters in Geneva, Switzerland.

Quartz Bio will be led by its founder and chief executive officer Jérôme Wojcik, former director of bioinformatics at Merck Serono. He will take on four scientists with in-depth understanding of biology and bioinformatics as well as extensive experience in drug-development processes.

The new company will be based at the Blue Box offices of FONGIT, a start-up accelerator in Plan-les-Ouates, Geneva, and will be supported by the Geneva authorities. Merck Serono intends to use Quartz Bio’s services, with plans for orders worth around €2 million in total over the next two or three years, it noted.

Merck Serono unveils Parkinson’s spin-off from Geneva site Quintiles offers haven for Merck Serono staff in Geneva Merck Serono and Compugen set up biomarkers venture Merck Serono confirms Geneva closure, creates start-up fund.

Stratified approach
As Wojcik pointed out, a growing number of pharmaceutical companies are integrating a stratified medicine approach into their drug development processes.

Biomarker analyses “are at the heart of stratified medicine and we believe that Quartz Bio’s flexible and highly specialised services will bring added value to pharmaceutical companies for the development of new drugs”, he commented.

Launched in April 2012, the entrepreneur Partnership Program was part of a € 30 million commitment made by Merck Serono to support the creation of spin-off and start-up companies that could leverage activities, capabilities and compounds originated at the Geneva site.

Geneva closure
Merck Serono confirmed its intention to close the Geneva site, with the loss of some 500 jobs, last June.

The plan was part of a restructuring programme announced by parent company Merck KGaA earlier this year,

Francois Naef
Chairman of the Board of Directors
Merck Serono

whereby all headquarters functions would be consolidated at a single campus in Darmstadt, Germany, while key research and development positions would migrate from Geneva to Darmstadt, Boston (US) and Beijing (China).

Since then, the Entrepreneur Partnership Program has already produced one spin-off: Prexton Therapeutics, a new company formed around Merck Serono’s R&D portfolio in the field of Parkinson’s disease.

In addition, US-based biopharmaceutical services company Quintiles is offering jobs to around one fifth of the Merck Serono employees affected by the Geneva closure.

Essential actors
Welcoming the launch of Quartz Bio, François Naef, board chairman of Merck Serono, said: “Highly specialised service companies are essential actors of the drug-development process, and they are very complementary to the activities and structures of large pharmaceutical companies”.

The Quartz Bio spin-off “also illustrates the dynamism of Merck Serono employees, and I am convinced that the Geneva regional economic fabric will benefit from it”, Naef added.

 

Merck Expands EGFR Targeted Portfolio – Acquiring Exclusive Worldwide License of Phase II Oncology Drug Candidate Sym004 From Symphogen

DARMSTADT, Germany—Merck Serono, the biopharmaceutical division of German company Merck KGaA, recently announced that it had inked an exclusive worldwide license agreement with Copenhagen, Denmark-based Symphogen A/S for Sym004, an investigational antibody mixture targeting the epidermal growth factor receptor (EGFR).

Under the terms of the deal, Merck Serono will gain exclusive worldwide rights to develop and commercialize Sym004, while Symphogen will receive from Merck an upfront payment of some $28.5 million as well as payments for clinical development, regulatory and sales performance milestones. Symphogen will also be eligible for potential royalties on net worldwide sales.

This current clinical program for Sym004 for patients with advanced metastatic colorectal cancer and in squamous cell carcinoma of the head and neck “builds upon the long history of scientific and clinical success with Erbitux and complements Merck’s existing EGFR franchise,” Merck Serono notes in a news release about the deal.

Dr. Susan J Herbert, Executive Vice President, Global Business Development and Strategy, Merck Serono

Specifically, Sym004 is under evaluation in a Phase I/II trial for the treatment of patients with advanced KRAS wild-type metastatic colorectal cancer who have previously progressed on treatment with standard chemotherapy and a marketed anti-EGFR monoclonal antibody. In addition, there is an ongoing single-arm, open-label Phase II trial in patients with squamous cell carcinoma of the head and neck who have failed anti-EGFR-based therapy.

“Sym004 further strengthens our early development pipeline by adding a product that is thought to act via a proposed synergistic mechanism of action not previously studied, but more specifically, it has the potential to become a key asset complementing our already highly successful Erbitux franchise,” said Dr. Susan Jane Herbert, head of global business development and strategy for Merck Serono. “This collaboration once again reflects our strong commitment to fighting cancer and to providing new treatment options to patients.”

As the companies describe the investigational compound, it is made up of a pair of antibodies that not only block ligand binding, receptor activation and downstream signaling “but are also thought to elicit removal of the EGFR receptors from the cancer cell surface by inducing EGFR internalization and degradation,” according to Merck Serono.

“We believe that Merck is uniquely well positioned to develop Sym004 based on its deep knowledge of the EGFR area,” said Kirsten Drejer, CEO of Symphogen. “This transaction further validates the antibody mixture approach as a highly attractive option.”

 

Merck Serono Announces the Creation of Asceneuron, the Third Spin-Off Company From Its Entrepreneur Partnership Program

Merck Serono has announced the launch of a new spin-off company called Asceneuron, which will develop therapies for Alzheimer’s disease and Tau protein-related pathologies.

Francois Naef, chairman of the board of directors of Merck Serono

The new company will receive five million euros (4.02 million pounds) in seed funding from Merck Serono and will work to advancing its parent company’s preclinical programmes in this field towards clinical testing as rapidly as possible.

Its business leaders will be Dirk Beher, Christoph Wiessner and Frank Armstrong, with eight current Merck Serono employees to transfer across in order to spearhead the research efforts.

Francois Naef, chairman of the board of directors of Merck Serono, said: “This new company creation around Merck Serono’s valuable assets in neurodegenerative diseases represents a unique opportunity to continue developing highly-needed therapies in an area that is outside the company’s current focus.”

This is the third spin-off organisation to be created through Merck Serono’s Entrepreneur Partnership Program, which was launched in April 2012.

The first was the Parkinson’s disease-focused Prexton Therapeutics, which debuted in July, followed by the introduction of biomarker research business Quartz Bio last month.

 

Patients in dark over personalised treatments

Only half of bowel cancer patients know that they can receive a biomarker test for their disease, according to new research.

Merck Serono spin-off creates biomarker specialist Quartz Bio Merck pulls Erbitux NSCLC filing, Threshold drug setback UK cancer patients “missing out on most appropriate treatments”

The multinational survey of 811 patients revealed that 52% of patients with metastatic bowel cancer were unaware of the KRAS biomarker test, which identifies they type of genetic mutation responsible for their cancer.

Almost a third (32%) was also unaware that these types of tests exist, and can help to determine which treatment could be most suitable for them.

The survey, sponsored by Merck Serono and undertaken by Ipsos MORI, was presented at the ESMO cancer congress this week.

Merck funds a biomarker test for the KRAS wild-type gene in a number of countries – including the UK – which can help determine if patients can benefit from using the firm’s drug Erbitux (cetuximab), which has licences to treat certain bowel cancers and head and neck cancers.

In patients with metastatic colorectal cancer (mCRC), the survey found that almost half remain unaware that a KRAS biomarker test can determine whether a targeted therapy – such as Erbitux – could be effective for them.

In addition, 73% of mCRC patients would be willing to delay initiation of treatment by two weeks or more (the average turnaround time for KRAS test results) to be prescribed a therapy that is targeted and effective, with around a third (31%) stating they would be prepared to wait ‘as long as it takes’.

The survey also shows that nearly three quarters (73%) of mCRC patients would be willing to undergo a re-biopsy if necessary. Patients also said they would be willing to delay the start of their treatment to benefit from a targeted therapy, even if that meant undergoing a tumour re-biopsy.

 

 

 

 

Sperm cell genome sequenced for first time

Scientists have sequenced the entire genetic code of individual human sperm cells for the first time, in a breakthrough which will help doctors understand and diagnose fertility problems.

Researchers from Stanford University mapped out the entire genomes of 91 separate sperm cells – through which fathers pass on physical characteristics to their children – which were donated by a 40-year-old man.

The results will allow scientists a closer view of the natural process called recombination, through which a baby inherits different elements of their DNA from each of their grandparents.

Recombination is important because it means children develop completely new genetic codes and add to the diversity of the human race, which would not be the case if they inherited entire chromosomes from their parents.

But problems in the process can result in sperm missing certain portions of genetic code or even entire chromosomes, potentially leading to infertility. Until now, such issues have been hard to diagnose.

Prof Stephen Quake, who led the study published in the Cell journal, said: “People have difficulty conceiving children due to reproductive disorders, and this will provide a very effective way to analyse when there are problems with their sperm.