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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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Merck Serono Announces FDA Clearance for Auxogyn’s Early Embryo Viability Assessment (Eeva®) System

  • FDA clearance validates Eeva System, which enables in-vitro fertilization (IVF) clinicians to offer the proprietary Eeva Test and further demonstrates commitment by Merck Serono and Auxogyn to bring innovative technologies to the IVF community
  • Eeva Test first-of-a-kind prognostic, non-invasive test that provides IVF clinicians objective information regarding embryo development to help optimize treatment plans for their patients

Darmstadt, Germany, June 10, 2014 – Merck Serono, the biopharmaceutical division of Merck, today announced that the proprietary Early Embryo Viability Assessment (Eeva®) System of Merck Serono´s strategic partner Auxogyn received clearance from the U.S. Food and Drug Administration (FDA) through its de novo classification process, a regulatory pathway for select novel, low-to-moderate risk medical devices that are first-of-a-kind. Merck Serono is the exclusive commercial partner of Auxogyn, Inc., for the Eeva System in Europe and Canada.

Eeva® TestThe Eeva Test, used adjunctively to traditional morphology, is the first and only prognostic, non-invasive embryo test to receive clearance from the FDA. The Eeva Test utilizes proprietary software that automatically analyzes embryo development against scientifically derived cell-division timing parameters captured through continual video imaging. This objective information provided to reproductive endocrinologists and embryologists helps to optimize treatment plans for their patients.

“The FDA clearance of the Eeva System reinforces the value of the applicability of the Eeva Test in the IVF lab and may improve IVF outcomes. It marks another significant and exciting milestone in our continued collaboration with Auxogyn to further support the clinical development and commercialization of their Eeva Test,” said Meeta Gulyani, Head of Strategy and Global Franchises at Merck Serono. “We, therefore, welcome this further validation for the potential of the Eeva Test to objectively identify the embryos with the highest implantation potential, which may ultimately improve patient outcomes.”

Merck_Serono_AuxogynThe Eeva System received the CE Mark in 2012 and has been commercially available in the European Union ever since, and more recently in Canada since 2013. The potential of the Eeva System led to an expansion of the original partnership agreement to include a licensing agreement between Merck and Auxogyn, announced in April 2014 for the exclusive rights to commercialize the Eeva Test in Europe and Canada. Auxogyn plans to commercialize the Eeva Test in the United States later this year.

“We’re excited to receive the de novo FDA clearance for the Eeva System and believe this marks a significant milestone in the field of IVF,” said Lissa Goldenstein, president and CEO of Auxogyn. “We have followed a rigorous, years-long clinical validation process and regulatory pathway to bring the Eeva Test to market. Our clearance provides a new level of confidence to IVF clinicians who, for the first time, have quantitative information that can be used in addition to traditional morphology to aid in deciding which embryo or embryos to transfer.”

According to the European Society of Human Reproduction and Embryology (ESHRE), approximately five million additional babies have been born worldwide since 1978 as a result of assisted reproduction technologies (ART), like IVF.1 This trend may increase due to advancements in ART and IVF technologies such as the Eeva Test.

1. European Society of Human Reproduction and Embryology. (2012). The world’s number of IVF and ICSI babies has now reached a calculated total of 5 million [Press release]. Retrieved from http://www.eshre.eu/Press-Room/Press-releases/Press-releases-ESHRE-2012/5-million-babies.aspx

About Auxogyn
Auxogyn is contributing to the field of reproductive medicine by translating scientific discoveries in early embryo development into clinical tools. The company’s flagship product, the Eeva Test, delivers consistent, objective and quantitative information regarding embryo viability that IVF clinicians and infertility patients can use to make important treatment decisions. Auxogyn is privately held and funded by Kleiner Perkins Caufield & Byers, MS Ventures, SR One and TPG Biotech.
For more information regarding Auxogyn, please visit http://www.auxogyn.com.

About Eeva
Auxogyn’s non-invasive early embryo viability assessment (Eeva) Test when used adjunctively to 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 cell-division timing 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. Auxogyn received CE mark for Eeva in July 2012, and it is currently available for use in selected countries in the EU.
For more information regarding Eeva, please visit http://www.eevaivf.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 tothis 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 10, 2014 in Industry

 

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Merck to Collaborate with Sysmex Inostics on a Blood-Based RAS Biomarker Test

  • Development and commercialization agreement on blood-based RAS biomarker mutation status test for (metastatic) colorectal cancer (mCRC)
  • This non-invasive, fast and easy-to-perform diagnostic test is expected to provide a real-time reflection of a patient’s RAS mutation status to help guide clinical decision making in mCRC

Me-Ms-Stacked-VerticalDarmstadt, Germany, June 1, 2014 – Merck announced today that the company has signed an agreement to collaborate with Sysmex Inostics GmbH, Hamburg, Germany, for the development and commercialization of a blood-based RAS biomarker test for patients with metastatic colorectal cancer (mCRC). This global agreement was formally signed at a ceremony coinciding with the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, U.S.
Blood-based biomarker testing is a faster and easier approach for determining the mutation status of tumors as it requires a small blood sample rather than a tissue biopsy procedure.1 The test has the potential to provide mutation status results within days, which in turn can help guide treatment decisions.1 In addition, it may become the method of choice where a tissue biopsy is difficult to obtain, for example in patients whose physical condition does not allow for a surgical procedure.

“We are delighted to announce our strategic partnership with Sysmex Inostics,” said Belén Garijo, President and CEO of Merck Serono. “As a company, we have embraced the principles of personalized medicine and predictive biomarkers. This collaboration reflects our commitment to leveraging our expertise in personalized medicine and predictive biomarkers in order to enhance Erbitux’s value proposition for patients, physicians and payers.”

“We are looking forward to this important collaboration with Merck Serono and to bringing our innovative technology to mCRC patients,” said Fernando Andreu, CEO of Sysmex Inostics. “Together with our non-invasive, blood-based diagnostics and Merck’s expertise in personalized medicine, we will open up new possibilities to advance biomarker testing in mCRC. This collaboration is another major step in enhancing the clinical value of Sysmex Inostics’s OncoBEAM tests and exemplifies Sysmex’s overall strategy to bring sensitive blood-based testing to the Oncology field.”

A biomarker test is a simple way of looking at the type and status of particular genes of interest in a cancer.2,3 Biomarkers have been found for many different types of cancer such as colorectal, breast and lung cancer, and have an increasingly important role in helping physicians to tailor care and treatment for their patients, known as ‘personalized medicine’.2–4 RAS − a predictive biomarker − is a group of genes that includes KRAS and NRAS and can be used to help select the most appropriate therapy for each individual mCRC patient.5−9 Currently, biomarker testing has been performed with tissue taken directly from the tumor itself, requiring an invasive biopsy, to ensure that the genes from the tumor can be isolated. However, recent technological advances embraced by Sysmex using blood samples allows very small amounts of circulating tumor DNA to be isolated and tested.

“In mCRC, RAS has been identified as a key biomarker that can help predict how well mCRC patients may respond to particular treatments, making it important to know their RAS status as early as possible,” commented Professor Sabine Tejpar, Digestive Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium. “As this test is potentially faster and easier to perform, this could mean quicker and more timely treatment decisions − supporting the ultimate goal of improved outcomes for patients.”

Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors.10 Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Erbitux (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.5–9

About Colorectal Cancer
Colorectal cancer (CRC) is the second most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually.11 An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.11 Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in men than in women.11

References
1. Diaz LA and Bardelli A. J Clin Oncol. 2014;32(6):579-86.
2. Moorcraft SY, et al. Therap Adv Gastroenterol 2013;6(5):381–95.
3. Ong FS, et al. Expert Rev Mol Diagn 2012;12(6):593–602.
4. Mallman MR, et al. EPMA J 2010;1(3):421–37.
5. Douillard J-Y, et al. N Engl J Med 2013;369(11):1023–34.
6. Schwartzberg LS, et al. J Clin Oncol 2014; March 31 [Epub ahead of print]. Available online: http://www.ncbi.nlm.nih.gov/pubmed/24687833. Last accessed April 2014..
7. Bokemeyer C, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30–June 3, 2014.
8. Stintzing S, et al. European Cancer Congress 2013:Abstract No:LBA17.
9. Ciardiello F, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30–June 3, 2014.
10. Vaughn CP, et al. Genes Chromosomes Cancer. 2011;50(5):307-12.
11. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. Lyon, France: International Agency for Research on Cancer; 2013. Available at globocan.iarc.fr. Last accessed April 2014.

Notes to editors
Please click here to view additional information on the importance of biomarkers for Merck including mCRC biomarker videos. For more information on predictive biomarkers in colorectal cancer, please visit globalcancernews.

About Sysmex Inostics
Sysmex Inostics, a subsidiary of Sysmex Corporation, is a molecular diagnostic company whose core competency is mutation detection utilizing highly sensitive technologies such as Plasma-Sequencing and BEAMing. With BEAMing being one of the most sensitive and quantitative technologies available today for the detection of tumor specific somatic mutations in blood samples, Sysmex Inostics’ BEAMing services are readily available to support clinical trials and research in oncology. Furthermore, Sysmex Inostics companion diagnostics (CDx) team offers services for the development of non-invasive plasma DNA based IVD tests supported by a growing network of partners to cover the entire IVD development process. In addition, BEAMing tests (OncoBEAM) are available through a CLIA certified laboratory for routine clinical analysis. Sysmex Inostics’ headquarters are located in Hamburg, Germany and Sysmex Inostics’ Clinical Laboratory is located in Baltimore, Maryland. For more information on OncoBEAM blood testing and the BEAMing technology refer to http://www.sysmex-inostics.com or email info@sysmex-inostics.com

About Erbitux
Erbitux is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe. Erbitux has already obtained market authorization in over 90 countries for the treatment of colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone, Bristol-Myers Squibb Company and Merck jointly develop and commercialize Erbitux. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.

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 4, 2014 in Industry

 

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Merck Serono to Release New Pipeline Data at ASCO 2014 from Early-Stage Investigational Compounds in Difficult-to-Treat Cancers

  • Robust pipeline reflects commitment to innovation in oncology and immuno-oncology
  • Data from nine Merck Serono pipeline products across oncology and immuno-oncology to be presented, including anti-PD-L1, c-Met inhibitor and TH-302

ASCODarmstadt, Germany, May 29, 2014 – Merck Serono, the biopharmaceutical division of Merck, today announced that new data from nine investigational compounds from the company’s oncology and immuno-oncology pipeline will be included at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, Illinois, U.S., from May 30 to June 3, 2014. These data represent Merck’s commitment to research and development in oncology and immuno-oncology, and to improving patient outcomes through internally developed compounds, as well as those acquired and in development with the company’s strategic partners.

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Belén Garijo, President & CEO of Merck Serono

“We are excited to present the most recent data from our oncology development candidates, including Phase I data on our promising anti-PD-L1 monoclonal antibody – a key milestone which highlights the potential of our immuno-oncology pipeline,” said Belén Garijo, President and CEO of Merck Serono. “Through the spectrum of our efforts, from discovery through development, we keep the patients at the center of our activities, with the goal of transforming innovative research into differentiated medicines that are tailored to their needs.”

Merck Serono’s oncology and immuno-oncology pipeline includes more than 22 programs in early- and late-stage development, targeting a variety of difficult-to-treat cancers. Notable data presented at this year’s ASCO include preliminary data from the investigational anti-PD-L1 monoclonal antibody (MSB0010718C) and the investigational c-Met inhibitor (MSC2156119J), both in advanced solid malignancies, and TH-302, an investigational hypoxia-activated prodrug, in multiple myeloma and glioblastoma.

 

Abstracts related to Merck Serono’s oncology and immuno-oncology pipeline can be read here: PipelineASCOEng

 
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Posted by on May 30, 2014 in Industry

 

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Merck Serono Launches New Software and Updated Device Designed to Engage People with Multiple Sclerosis

  • MSdialog designed to provide people with multiple sclerosis (MS) and health care providers with injection history, treatment adherence information and health reports
  • RebiSmart injection device provides updates with new version

Darmstadt, Germany, May 28, 2014 – Merck Serono, the biopharmaceutical division of Merck, recognizes World MS Day today, announcing the launch of its updated electronic injection device, RebiSmart®, for the self-administration of Rebif® (interferon beta-1a), the company’s disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS).
The new Rebismart will allow patients to self-inject. It will collect and store data such as injection times, dates and doses and send the information wirelessly to the secure MSdialog server. It is just a matter of placing the new RebiSmart in its transmitter and pressing a button.

Launch of New Software and Updated Device for Multiple Sclerosis Patients

Launch of New Software and Updated Device for Multiple Sclerosis Patients

Together with the new RebiSmart, Merck Serono is also launching a new first-of-its-kind web-based software system, MSdialog, which allows patients with MS to engage in the management of their disease by asking them to complete periodic health report questionnaires based on short forms of published instruments and standard scales, such as the Multiple Sclerosis Quality of Life Inventory (MSQLI) and the Multiple Sclerosis International Quality of Life (MusiQoL) questionnaires. In addition, MSdialog will allow physicians and nurses to monitor patients’ adherence to treatment and trends of their health status through the periodic health report questionnaires.

“Engaging and empowering patients through knowledge and technology may have the potential to improve outcomes by allowing patients to help monitor their own disease,” said Dr. Gavin Giovannoni, professor of Neurology at Barts and The London School of Medicine and Dentistry. “The new RebiSmart and the MSdialog platform can provide physicians with access to certain treatment information as it happens, allowing for time during visits to discuss relevant, patient-specific issues. And patients using these technologies may be more in touch with their own disease.”

Patients who use MSdialog can choose to receive email or SMS reminders to take their medication, and along with their nurses they can use MSdialog in between visits to their doctor to track the adherence and patient-reported outcomes. This information can save time for more patient-physician interaction during visits.

“Over the years, Merck Serono has continuously worked on enhancing our product profile, taking advantage of the latest medical and technological advances to ultimately meet patient needs,” said Belén Garijo, President and CEO of Merck Serono. “With the introduction of MSdialog, we are now leveraging digital technology to offer patients with MS a management system that can help them engage in the treatment of their disease and create a more open dialogue with their healthcare team.”

RebiSmart was the first injection device in MS that records the date, time and dosage of each injection so that an accurate dosing history can be discussed with a patient, allowing physicians to monitor and improve patient adherence to therapy. The new RebiSmart offers updates to the original device, including a larger screen, new on-screen guide, graphical display of treatment adherence and a transmitter for wireless data transfer.

The new RebiSmart is used with Rebif multidose cartridges, each of which contains one week’s worth of medicine. Interactive, on-screen instructions and signals guide patients through the injection process. Individually adjustable comfort settings give patients more flexibility with injection duration and depth, helping minimize discomfort and pain.

The new RebiSmart and MSdialog will be available in May 2014 in the United Kingdom, Ireland, France, Italy, Switzerland, Austria, Finland, Portugal, Germany, Belgium, Canada, Denmark, Luxembourg, Netherlands and Sweden. Further launches will follow. Two strengths of the multidose cartridge – 132 μg (three doses of 44 μg) and 66 μg (three doses of 22 μg) – were approved by the European Medicines Agency (EMA) in January 2009.

About Rebif*
Rebif (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif in chronic progressive MS has not been established. Interferon ß is thought to help reduce inflammation. The exact mechanism is unknown.
Rebif, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*. Rebif can be administrated with the RebiSmart electronic auto-injection device, or with the RebiDose single-use disposable pen, or the manual multidose injection pen RebiSlide. Rebif can also be administered with the autoinjector Rebiject II or by manual injection using ready-to-use pre-filled syringes. These injection devices are not available in all countries.

In January 2012, the European commission approved the extension of the indication of Rebif in early multiple sclerosis. The extension of the indication of Rebif has not been submitted in the United States.
Rebif should be used with caution in patients with a history of depression, liver disease and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif with their doctors.

About multiple sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million patients have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

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 May 30, 2014 in Industry

 

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