Merck & Co Inc: Building On A History Of Biologics Expertise
At Merck, our primary corporate responsibility is discovering, developing and delivering innovative medicines and vaccines that can help make a difference in people’s lives and create a healthier future. We believe that fulfilling this responsibility in a sustainable manner entails high ethical standards and a culture that values honesty, integrity and transparency. We are delivering on our commitment to find innovative ways to solve the many medical and scientific challenges that remain in the fight against disease in a number of ways, including product access and innovation and the formation of a new division at Merck, Merck BioVentures.
Access and Innovation
Vaccines are one of the public health success stories of the 20th century, having led to some of the greatest and most cost-effective achievements in public health. Merck has a deep and long-standing commitment to vaccine development. Almost a decade ago, when many companies decided not to continue in the vaccine business, Merck re-affirmed its commitment and continued its research efforts.
Merck continues to make progress in our mission of preventing disease and saving lives by continuing to bring forward new vaccines and making them accessible to those who need them around the world, while also helping to build capacity in developing countries. Infectious diseases cause the greatest illness and death in the developing world. For this reason, Merck believes we can have a significant impact on global health and can help to improve the lives of people around the world by expanding access to our innovative vaccines and infectious disease products.
Over the past several years, Merck has helped to expand access to vaccines through a combination of product innovation, critical public private partnerships, pricing and implementation. While there is still more that can be done, Merck remains committed to increasing the availability of vaccines around the world to those who need them.
Merck BioVentures
Biologic therapies play an important and growing role in the treatment of a wide range of illnesses, from diabetes to cancer. Over 150 biologic therapies have now been approved worldwide, and the majority of these are protein-based therapeutics. As an increasing number of biologics approach the end of their patent life, there has also been a growing interest in developing biosimilars, which promise to expand the choice for patients.
In December 2008, Merck introduced a new division, Merck BioVentures. This built on Merck’s acquisition of GlycoFi in 2006, a company that had developed a breakthrough technology for manufacturing proteins in specialized yeast cells (Pichia pastoris). Importantly, it provided industry-leading expertise in the manufacture of biologics, as well as proprietary technologies that streamline the production of protein-based therapies.
By combining Merck’s traditional strengths with the latest scientific innovations in protein manufacturing, Merck BioVentures gives Merck the potential to become a leader in the emerging field of biosimilars and novel biologics. Most importantly, through Merck BioVentures, Merck hopes to improve access to biologic therapies for patients with some of the most deadly and debilitating diseases.
Merck recognizes the significance and global opportunity of launching our biologics as soon as possible, therefore in the absence of a US regulatory pathway, Merck BioVentures’ initial strategy is to conduct a full development program, including complete analytical and preclinical toxicology packages, Phase III clinical studies and a complete Biologics License Application,(BLA), for each of our new biologics. We will fully adapt our approach as regulatory standards and abbreviated pathways are further developed and implemented.
Merck supports the creation of regulatory pathways that will enable regional health agencies to develop regulatory frameworks, scientific standards, and administrative processes for the review and approval of all biosimilars and allow for the molecules to be fully characterized. Further, we support efforts by regional health authorities to harmonize such standards to ensure consistency on a global level.
