- Merck becomes first pharmaceutical company to collaborate with multiple diagnostic providers to support RAS biomarker testing
- Collaboration allows Merck to provide complementary molecular testing solutions to various laboratory segments
- Biocartis' fully automated Idylla? system will enable more clinics to assess RAS mutation status in metastatic colorectal cancer (mCRC) patients
- New diagnostic test will be fast, minimally invasive, easy-to-perform and support timely decision making
Merck, a leading science and technology company, today announced that it has signed a collaboration agreement with Biocartis for the development and commercialization of a new liquid biopsy RAS biomarker test for patients with metastatic colorectal cancer (mCRC). The test will be developed on Biocartis' innovative, fully automated molecular diagnostics system, Idylla?, which is designed to offer accurate and reliable molecular information from virtually any biological sample in virtually any setting. The new test aims to support clinical practice in performing integrated liquid biopsy RAS biomarker tests, independently of the laboratories' volume of testing or level of expertise.
To view the Multimedia News Release, please click: http://www.multivu.com/players/English/7728751-merck-biocartis-new-biopsy-technology/
Understanding metastatic colorectal cancer (mCRC) patients' individual biomarker status is key to support timely treatment decision-making.
"Through this collaboration, our desire is to have more metastatic colorectal cancer patients gain access to liquid biopsy RAS testing, regardless of their geographical location," said Rehan Verjee, Chief Marketing and Strategy Officer of Merck's biopharma business. "As the first pharmaceutical company to collaborate with multiple diagnostic providers of liquid biopsy RAS testing, we are living our commitment to supporting patients and physicians by going beyond treatment. The Biocartis technology will be complementary to other technology previously developed, and will allow for liquid biopsy RAS offerings to a wide range of lab segments, regardless of size and expertise levels."
The Idylla? system is a fully automated sample-to-result PCR-based (polymerase chain reaction) molecular diagnostics system. It is designed to offer real-time, reliable and sensitive molecular diagnostic tests. Whereas most of today's solutions only look for the most prevalent RAS mutations, the Idylla? RAS test, comprising two Idylla? cartridges, will be designed to detect an extended panel of RAS mutations. In addition, the new test will also provide a BRAF V600 mutation analysis directly integrated with the Idylla? RAS test, to allow clinicians to evaluate BRAF and RAS mutation status simultaneously. Based on a direct sample of only 2 ml of blood plasma, the test aims to provide high sensitivity and ease-of-use. The test will be designed to require less than 2 minutes of hands-on time and a turnaround time of approximately 2 hours, enabling clinical decision-making in a timely manner.
"Today, complex diagnostic laboratory infrastructure and specialized expertise requirements are important barriers when it comes to the implementation of personalized medicine on a global scale," said Rudi Pauwels, CEO Biocartis. "We are pleased to partner with Merck, who supports us in putting personalized medicine into daily practice with this collaboration, through the development of rapid and accurate tests on the Idylla? system. After having already launched solid biopsy RAS tests, the Idylla? liquid biopsy RAS test is a logical next step in our rapidly expanding menu of oncology tests."
Merck and Biocartis plan to implement the Idylla? liquid biopsy RAS test in numerous medical centers across the world, excluding the U.S., China and Japan. The test will be available for Research Use Only (RUO) in H2 2016 and is shortly thereafter planned to be submitted for a CE Mark. A concordance study is currently also being undertaken to substantiate the value of the test.
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.
About mCRC
Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors.[1] 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.[2-6] Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually.[7] 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.[7] 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.[7]
References
1. Vaughn CP, et al. Genes Chromosomes Cancer. 2011;50(5):307?12.
2. Douillard J-Y, et al. N Engl J Med 2013;369(11):1023-34.
3. 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 January 2016.
4. Bokemeyer C, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30-June 3, 2014.
5. Stintzing S, et al. European Cancer Congress 2013:Abstract No:LBA17.
6. Ciardiello F, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30-June 3, 2014.
7. 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 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available at: http://globocan.iarc.fr . Last accessed January 2016.
About Biocartis
Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla? platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Idylla? addresses the growing demand for personalized medicine by aiming to allow fast and effective treatment selection and treatment progress monitoring. Biocartis launched the Idylla? platform commercially in September 2014 together with its first assay to identify BRAF Mutations in metastatic melanoma. Its second assay, a KRAS Mutation panel for colorectal cancer, was launched in June 2015. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide. Further information can be found at: http://www.biocartis.com .
About Idylla?
Idylla?, Biocartis' fully automated, real-time PCR based molecular diagnostics system, is designed to offer fast and easy access to clinical molecular diagnostic information, anywhere and anytime. The Idylla? platform covers the entire process from sample to result in a time frame of 35 to 150 minutes with less than two minutes hands-on time. Idylla? is applicable for a wide range of clinical sample types and can analyze both RNA and DNA. The fully integrated system enables clinical laboratories to perform a broad range of applications in oncology, infectious diseases and beyond. The Idylla? system's first diagnostic tests, the Idylla? BRAF Mutation Test for metastatic melanoma, the Idylla? KRAS Mutation Test for colorectal cancer and the first infectious disease test, the Idylla? Respiratory (IFV-RSV) Panel developed in collaboration with Janssen Diagnostics, have obtained CE-IVD marking. Further information can be found at: http://www.idylla.com .
About Erbitux
Erbitux? is a 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 world-wide 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. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.
About Merck
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2014, Merck generated sales of € 11.3 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
(Logo: http://photos.prnewswire.com/prnh/20151019/278052LOGO )
Video: http://www.multivu.com/players/English/7728751-merck-biocartis-new-biopsy-technology/
Source: Merck
PRNewswire
Showing posts with label Merck. Show all posts
Showing posts with label Merck. Show all posts
Tuesday, January 12, 2016
Wednesday, October 21, 2015
Merck Unites With UNESCO to Build Research Capacity in Africa
- UNESCO-Merck Africa Research Summit aims to define interventions to prepare for the road ahead in Africa's development as an international hub for research excellence and scientific innovation
- Summit will put specific emphasis on how to translate knowledge into action to improve health
- Summit to be conducted on a yearly basis to ensure significant sustainable impact; 2015 edition will be dedicated to emergent infectious diseases
Merck, a leading science and technology company, today launches in partnership with United Nations Educational, Scientific and Cultural Organization (UNESCO) the first edition of the UNESCO-Merck Africa Research Summit, to be held in Geneva, Switzerland. The summit aims to address the vital role of scientific research in the improvement and sustainable development of the African population health, with specific emphasis on how to translate knowledge into action.
(Logo: http://photos.prnewswire.com/prnh/20151019/278051LOGO )
(Logo: http://photos.prnewswire.com/prnh/20151019/278052LOGO )
(Photo: http://photos.prnewswire.com/prnh/20151019/278053 )
"Merck is very pleased to join forces with UNESCO and take together an active role in addressing health challenges and strengthening the role of scientific research in life sciences and medical sciences for Africa," said Stefan Oschmann, Vice Chairman of the Executive Board and Deputy CEO of Merck, at the inauguration of the UNESCO-Merck Africa Research Summit. "The summit will bring together researchers from across Africa to discuss the generation, sharing and dissemination of research data with the aim of identifying development opportunities that will contribute to building research capacity, accelerating access to innovative health solutions and sustaining innovation in Africa."
"The UNESCO-Merck Africa Research Summit was initiated to address in parts the vital role of research in the improvement and sustainable development of population health with specific emphasis on how to translate knowledge into action - the 'know-do gap' - to improve health," emphasized Flavia Schlegel, Assistant Director-General of Natural Sciences, UNESCO. "Moreover, the summit will provide a platform for dialogue on improving global cooperation on life science and health research and narrowing the disparities in health systems performance between developing and developed countries."
Uganda Minister of State of Health, Sarah Opendi emphasized at the summit "New Health Challenges are expected in the future and therefore this noble initiative by UNESCO and Merck will significantly contribute towards enhancing policy environment, support and build capacity of researchers in low and middle income countries."
The summit will be conducted on a yearly basis to ensure significant sustainable impact on access to high-quality and innovative healthcare solutions, building research capacity and sustaining innovation across Africa.
The 2015 UNESCO-Merck Africa Research Summit will focus on the role of building capacities in the life sciences to address challenges of infectious diseases, most notably the Ebola crises.
Scientifically supported by UNESCO, the University of Cambridge (UK), and the University of Rome (Italy), the summit will be a valuable opportunity for young researchers who are engaged and interested in health and life science research in Africa to learn about the full spectrum of ground-breaking scientific research currently underway, and prepare for the road ahead in Africa's development as an international hub for research excellence and scientific innovation. Abstracts were invited from final year African PhD students and young investigators involved in HIV, Ebola and other infectious diseases research. All are primarily based at African research institutes and universities. All abstracts were peer reviewed by scientific committee and will be eligible for fellowship award in Merck R&D hub and further number of research awards which will be announced at the end of the summit.
References:
http://www.unesco.org/new/en/unesco/events/programme-meetings/?tx_browser_pi1%5BshowUid%5D=31599&cHash=311dfece4d
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.
About Merck
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 40,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2014, Merck generated sales of EUR 11.3 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.
Source: Merck
PRNewswire
- Summit will put specific emphasis on how to translate knowledge into action to improve health
- Summit to be conducted on a yearly basis to ensure significant sustainable impact; 2015 edition will be dedicated to emergent infectious diseases
Merck, a leading science and technology company, today launches in partnership with United Nations Educational, Scientific and Cultural Organization (UNESCO) the first edition of the UNESCO-Merck Africa Research Summit, to be held in Geneva, Switzerland. The summit aims to address the vital role of scientific research in the improvement and sustainable development of the African population health, with specific emphasis on how to translate knowledge into action.
(Logo: http://photos.prnewswire.com/prnh/20151019/278051LOGO )
(Logo: http://photos.prnewswire.com/prnh/20151019/278052LOGO )
(Photo: http://photos.prnewswire.com/prnh/20151019/278053 )
"Merck is very pleased to join forces with UNESCO and take together an active role in addressing health challenges and strengthening the role of scientific research in life sciences and medical sciences for Africa," said Stefan Oschmann, Vice Chairman of the Executive Board and Deputy CEO of Merck, at the inauguration of the UNESCO-Merck Africa Research Summit. "The summit will bring together researchers from across Africa to discuss the generation, sharing and dissemination of research data with the aim of identifying development opportunities that will contribute to building research capacity, accelerating access to innovative health solutions and sustaining innovation in Africa."
"The UNESCO-Merck Africa Research Summit was initiated to address in parts the vital role of research in the improvement and sustainable development of population health with specific emphasis on how to translate knowledge into action - the 'know-do gap' - to improve health," emphasized Flavia Schlegel, Assistant Director-General of Natural Sciences, UNESCO. "Moreover, the summit will provide a platform for dialogue on improving global cooperation on life science and health research and narrowing the disparities in health systems performance between developing and developed countries."
Uganda Minister of State of Health, Sarah Opendi emphasized at the summit "New Health Challenges are expected in the future and therefore this noble initiative by UNESCO and Merck will significantly contribute towards enhancing policy environment, support and build capacity of researchers in low and middle income countries."
The summit will be conducted on a yearly basis to ensure significant sustainable impact on access to high-quality and innovative healthcare solutions, building research capacity and sustaining innovation across Africa.
The 2015 UNESCO-Merck Africa Research Summit will focus on the role of building capacities in the life sciences to address challenges of infectious diseases, most notably the Ebola crises.
Scientifically supported by UNESCO, the University of Cambridge (UK), and the University of Rome (Italy), the summit will be a valuable opportunity for young researchers who are engaged and interested in health and life science research in Africa to learn about the full spectrum of ground-breaking scientific research currently underway, and prepare for the road ahead in Africa's development as an international hub for research excellence and scientific innovation. Abstracts were invited from final year African PhD students and young investigators involved in HIV, Ebola and other infectious diseases research. All are primarily based at African research institutes and universities. All abstracts were peer reviewed by scientific committee and will be eligible for fellowship award in Merck R&D hub and further number of research awards which will be announced at the end of the summit.
References:
http://www.unesco.org/new/en/unesco/events/programme-meetings/?tx_browser_pi1%5BshowUid%5D=31599&cHash=311dfece4d
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.
About Merck
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 40,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2014, Merck generated sales of EUR 11.3 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.
Source: Merck
PRNewswire
Tuesday, October 6, 2015
Merck Agrees to Return Kuvan(R) Rights to BioMarin Pharmaceutical to Strengthen Focus on Core Business
- Agreement with BioMarin, a leading company in the treatment of genetic and rare diseases, also includes returning option to develop and commercialize Peg-Pal
- Merck to receive upfront payment of EUR 340 million, plus up to EUR 185 million in additional milestones
Merck, a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials, today announced that it has reached an agreement with BioMarin Pharmaceutical, Inc., San Rafael, California, U.S., to return the rights to Kuvan(R), used to treat phenylketonuria (PKU), a rare metabolism disorder, as the company focuses its healthcare business on core areas.
In addition to Kuvan(R), the two companies agreed that Merck will return its option to develop and commercialize Peg-Pal, an investigational drug that is also designed for the treatment of PKU, an autosomal recessive genetic disorder caused by either a defect or a deficiency of the enzyme phenylalanine hydroxylase or its co-factor tetrahydrobiopterin. Merck will receive an upfront payment of EUR 340 million, equal to five times its annual sales, for Kuvan(R), plus up to EUR 185 million in additional milestones for both products. The agreement is expected to become effective Jan. 1, 2016.
"Returning the rights of Kuvan(R) and Peg-Pal to BioMarin will allow Merck to fully focus on its core businesses, as well as further align R&D investment behind key strategic areas," said Belen Garijo, Member of the Executive Board of Merck and CEO Healthcare. "Patients suffering from PKU will continue to benefit from these therapeutic options, as well as from BioMarin's long-term expertise in rare diseases."
Merck remains highly committed to the patients in the field of endocrinology, and in particular to advancing the treatment of growth hormone deficient patients with Saizen(R).
Over the past years, Merck has re-aligned its healthcare business with a special focus on developing novel therapies in the areas of neurology, oncology, immuno-oncology and immunology, in addition to maximizing its existing portfolio of drugs in developed countries as well as expanding its footprint in Emerging Markets.
Merck had acquired the rights for Kuvan(R) and the option to Peg-Pal in markets outside of the U.S. and Japan from BioMarin in 2005.* Since launching Kuvan(R) as a treatment alternative to diet alone, which constituted a paradigm shift at the time, Merck has significantly contributed to improving PKU management. More recently, Merck's SPARK study helped pave the way for the treatment of infants with PKU below 4 years of age with Kuvan(R). By returning the rights to BioMarin, Merck is confident that the product will continue to serve the best interest of the medical community and patients. A leading company in the treatment of genetic and rare diseases, BioMarin is dedicated to improving the treatment options and to providing all resources needed to continue to make Kuvan(R) available, as well as to explore potential future therapies in this area, such as Peg-Pal. Merck will work closely with BioMarin during the transition to ensure continuous access to Kuvan(R) for patients, physicians and health authorities.
Kuvan(R) is indicated for the treatment of hyperphenylalaninemia (HPA) due to PKU in patients of all ages who have shown to be responsive to Kuvan(R), or due to tetrahydrobiopterin (BH4) deficiency.
In a conference call later today, (October 1, 2015, 14:00 CEST) Merck management discusses key focus areas on its healthcare pipeline in immune-oncology, oncology and immunology (the call can be followed live here [http://edge.media-server.com/m/p/5i9jg9t3 ] ).
* Merck Serono also acquired the rights to Kuvan(R) in Canada as a part of this original agreement in 2005, but returned those rights in 2007.
About phenylketonuria (PKU)
PKU is an autosomal recessive genetic disorder caused by a defect or a deficiency of the enzyme phenylalanine hydroxylase (PAH) or its cofactor tetrahydrobiopterin (BH4). PAH is required for the metabolism of phenylalanine, an essential amino acid found in all protein-containing foods. It affects approximately 1/10,000 newborns in Europe. If PKU patients are not treated with a phenylalanine-restricted diet, phenylalanine will accumulate in the blood and brain to abnormally high levels, thereby resulting in a variety of complications including mental retardation and brain damage, mental illness, seizures and tremors, and clinically significant cognitive problems. Universal systematic newborn screening programs were developed in the 1960s and early 1970s to enable diagnosis of all patients with PKU patients at birth.
About Kuvan(R)
Kuvan(R) (sapropterin dihydrochloride) is the first oral therapy and approved for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) in patients of all age who have shown to be responsive to Kuvan(R) or due to tetrahydrobiopterin (BH4) deficiency(R). Kuvan(R) was developed jointly by BioMarin Pharmaceutical Inc. and Merck Serono. Kuvan(R) is to be used in conjunction with a phenylalanine-restricted diet.
Kuvan(R) is the synthetic form of 6R-BH4, a naturally occurring co-factor that works in conjunction with the enzyme phenylalanine hydroxylase (PAH) to metabolize phenylalanine into tyrosine. Clinical data show that Kuvan(R) produces significant reductions in blood phenylalanine concentration in a large subset of patients.
Most common adverse reactions reported with the use of Kuvan(R) include headache, rhinorrhea, pharyngolaryngeal pain, nasal congestion, cough, diarrhea, vomiting, abdominal pain, and low levels of phenylalanine in the blood.
Kuvan(R) is approved in 51 countries worldwide, including member states of the European Union and the USA. Under the terms of the former agreement with BioMarin, Merck Serono had received exclusive rights to market Kuvan(R) in all territories outside the USA, Canada and Japan, all these rights have now been returned to BioMarin.
About Peg-Pal
PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase or 'PAL', pegvaliase) is an investigational drug that substitutes for the PAH enzyme in phenylketonuria (PKU). PEG-PAL is being developed as a potential treatment for patients whose blood phenylalanine levels are not adequately controlled by Kuvan(R) or who have trouble controlling and maintaining their phenylalanine levels).
About BioMarin
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare and ultra-rare genetic diseases. The company's portfolio consists of five commercialized products and multiple clinical and pre-clinical product candidates.
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 healthcare, life science and performance materials. The company has six businesses - Merck Serono, Consumer Health, Allergopharma, Biosimilars, Merck Millipore and Performance Materials - and generated sales of EUR 11.3 billion in 2014. Around 39,000 employees work for Merck in 66 countries to improve the quality of life for patients, to foster 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 operates as EMD Serono, EMD Millipore and EMD Performance Materials.
Source: Merck
PRNewswire
- Merck to receive upfront payment of EUR 340 million, plus up to EUR 185 million in additional milestones
Merck, a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials, today announced that it has reached an agreement with BioMarin Pharmaceutical, Inc., San Rafael, California, U.S., to return the rights to Kuvan(R), used to treat phenylketonuria (PKU), a rare metabolism disorder, as the company focuses its healthcare business on core areas.
In addition to Kuvan(R), the two companies agreed that Merck will return its option to develop and commercialize Peg-Pal, an investigational drug that is also designed for the treatment of PKU, an autosomal recessive genetic disorder caused by either a defect or a deficiency of the enzyme phenylalanine hydroxylase or its co-factor tetrahydrobiopterin. Merck will receive an upfront payment of EUR 340 million, equal to five times its annual sales, for Kuvan(R), plus up to EUR 185 million in additional milestones for both products. The agreement is expected to become effective Jan. 1, 2016.
"Returning the rights of Kuvan(R) and Peg-Pal to BioMarin will allow Merck to fully focus on its core businesses, as well as further align R&D investment behind key strategic areas," said Belen Garijo, Member of the Executive Board of Merck and CEO Healthcare. "Patients suffering from PKU will continue to benefit from these therapeutic options, as well as from BioMarin's long-term expertise in rare diseases."
Merck remains highly committed to the patients in the field of endocrinology, and in particular to advancing the treatment of growth hormone deficient patients with Saizen(R).
Over the past years, Merck has re-aligned its healthcare business with a special focus on developing novel therapies in the areas of neurology, oncology, immuno-oncology and immunology, in addition to maximizing its existing portfolio of drugs in developed countries as well as expanding its footprint in Emerging Markets.
Merck had acquired the rights for Kuvan(R) and the option to Peg-Pal in markets outside of the U.S. and Japan from BioMarin in 2005.* Since launching Kuvan(R) as a treatment alternative to diet alone, which constituted a paradigm shift at the time, Merck has significantly contributed to improving PKU management. More recently, Merck's SPARK study helped pave the way for the treatment of infants with PKU below 4 years of age with Kuvan(R). By returning the rights to BioMarin, Merck is confident that the product will continue to serve the best interest of the medical community and patients. A leading company in the treatment of genetic and rare diseases, BioMarin is dedicated to improving the treatment options and to providing all resources needed to continue to make Kuvan(R) available, as well as to explore potential future therapies in this area, such as Peg-Pal. Merck will work closely with BioMarin during the transition to ensure continuous access to Kuvan(R) for patients, physicians and health authorities.
Kuvan(R) is indicated for the treatment of hyperphenylalaninemia (HPA) due to PKU in patients of all ages who have shown to be responsive to Kuvan(R), or due to tetrahydrobiopterin (BH4) deficiency.
In a conference call later today, (October 1, 2015, 14:00 CEST) Merck management discusses key focus areas on its healthcare pipeline in immune-oncology, oncology and immunology (the call can be followed live here [http://edge.media-server.com/m/p/5i9jg9t3 ] ).
* Merck Serono also acquired the rights to Kuvan(R) in Canada as a part of this original agreement in 2005, but returned those rights in 2007.
About phenylketonuria (PKU)
PKU is an autosomal recessive genetic disorder caused by a defect or a deficiency of the enzyme phenylalanine hydroxylase (PAH) or its cofactor tetrahydrobiopterin (BH4). PAH is required for the metabolism of phenylalanine, an essential amino acid found in all protein-containing foods. It affects approximately 1/10,000 newborns in Europe. If PKU patients are not treated with a phenylalanine-restricted diet, phenylalanine will accumulate in the blood and brain to abnormally high levels, thereby resulting in a variety of complications including mental retardation and brain damage, mental illness, seizures and tremors, and clinically significant cognitive problems. Universal systematic newborn screening programs were developed in the 1960s and early 1970s to enable diagnosis of all patients with PKU patients at birth.
About Kuvan(R)
Kuvan(R) (sapropterin dihydrochloride) is the first oral therapy and approved for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) in patients of all age who have shown to be responsive to Kuvan(R) or due to tetrahydrobiopterin (BH4) deficiency(R). Kuvan(R) was developed jointly by BioMarin Pharmaceutical Inc. and Merck Serono. Kuvan(R) is to be used in conjunction with a phenylalanine-restricted diet.
Kuvan(R) is the synthetic form of 6R-BH4, a naturally occurring co-factor that works in conjunction with the enzyme phenylalanine hydroxylase (PAH) to metabolize phenylalanine into tyrosine. Clinical data show that Kuvan(R) produces significant reductions in blood phenylalanine concentration in a large subset of patients.
Most common adverse reactions reported with the use of Kuvan(R) include headache, rhinorrhea, pharyngolaryngeal pain, nasal congestion, cough, diarrhea, vomiting, abdominal pain, and low levels of phenylalanine in the blood.
Kuvan(R) is approved in 51 countries worldwide, including member states of the European Union and the USA. Under the terms of the former agreement with BioMarin, Merck Serono had received exclusive rights to market Kuvan(R) in all territories outside the USA, Canada and Japan, all these rights have now been returned to BioMarin.
About Peg-Pal
PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase or 'PAL', pegvaliase) is an investigational drug that substitutes for the PAH enzyme in phenylketonuria (PKU). PEG-PAL is being developed as a potential treatment for patients whose blood phenylalanine levels are not adequately controlled by Kuvan(R) or who have trouble controlling and maintaining their phenylalanine levels).
About BioMarin
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare and ultra-rare genetic diseases. The company's portfolio consists of five commercialized products and multiple clinical and pre-clinical product candidates.
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 healthcare, life science and performance materials. The company has six businesses - Merck Serono, Consumer Health, Allergopharma, Biosimilars, Merck Millipore and Performance Materials - and generated sales of EUR 11.3 billion in 2014. Around 39,000 employees work for Merck in 66 countries to improve the quality of life for patients, to foster 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 operates as EMD Serono, EMD Millipore and EMD Performance Materials.
Source: Merck
PRNewswire
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