Merck KGaA Offering Broad Expertise To Nurture China Start-Ups
This article was originally published in PharmAsia News
Executive Summary
Merck, the German health care and life sciences group, is tapping into China’s burgeoning biotech start-up community through a new grant program under which it is offering financial aid and broad technology support and hopes to help advance novel life-saving therapeutics.
SHANGHAI – To tap into China’s fast-growing biopharmaceutical sector and explore opportunities for bringing new drugs to market, Germany-based Merck KGAA is providing tailor made support to small emerging biotech companies through a grant program and will consider possible growth partnerships.
Committed to helping advance life-saving drugs to market, Merck’s first emerging biotech grant program started in 2014, awarding NGM Biopharmaceuticals Inc. up to $89,000 in products and services to help develop their molecule.
In China, scientists from the life science business of Merck have selected five winners this year: Beijing Biokey, a monoclonal antibody developer focusing on fibrotic disease; Guangdong Jida Genetic Medicine Engineering Research Center, a novel therapeutics developer for cancer and autoimmune diseases; Hangzhou DAC biotech, an antibody drug conjugates developer specializing in cancer; Akeso Biopharma, an antibodies developer targeting cancer, cardiovascular and immune diseases; and Shanghai Mattel Biotechnology, a company developing an innovative long-acting fusion Factor VIII for hemophilia A.
“The project selection and screening was based on objective criteria of equal weight, including the scientific and societal merit of the therapy being developed, and process challenges and expertise gaps associated with the development of the therapy,” Benoit Gourdier, Head of Asia Pacific Regional Accounts with Merck Life Science, explained to PharmAsia News.
According to Gourdier, the grant amounts and number of recipients are not fixed; Merck started with one winner in the US with $89,000 and this time the total award was increased in China to the equivalent of €200,000 ($224,900), to be shared by the five recipients. This year in the EU, the same amount of €200,000 will be allocated to the winners there.
The emerging biotech market is very dynamic and when the grant program returns to China, the amount of grant or number of recipients will be adapted accordingly, he noted.
Over the last decade, waves of Chinese scientists with experience in biotech are returning from western countries. With the “strong entrepreneurial mindset that lies in Chinese culture”, these returnees are focused on building innovation and developing future global blockbusters, Gourdier said.
However, these emerging biotech companies face multiple challenges as they grow and develop their pipelines. Often, they struggle with funding and regulations and have limited resources and expertise in process development and optimization, scale-up and validation.
Broad Range Of Support
“We see actually a tremendous amount of new biotech companies blossoming every year and, although they know the life science business of Merck, many of them have a limited idea of our broad range of solutions that would help them from early stage development to large scale routine manufacturing; our Emerging Biotech Grant program aims to change that thinking,” he explained.
“We see actually a tremendous amount of new biotech companies blossoming every year…[but] many of them have a limited idea of our broad range of solutions.” – Benoit Gourdier, Merck KGaA
“By understanding the technical challenges shared during grant application that have limited them [the recipients] from advancing their drug development, the life science business of Merck tailors each award to answer the recipient’s needs,” Gourdier said. “After the Emerging Biotech Grant, technical experts from the life science business of Merck will continue to support each company with state of the art technologies as well as deep scientific knowledge and know-how.”
Once a drug candidate is identified, Merck can provide support ranging from the development of cell lines and upstream and downstream process development, to manufacturing including facility design and construction, Gourdier added.
As small companies with limited experience and incomplete technical platforms for drug development, the support provided by Merck can help accelerate project development and enhance research capabilities.
“Merck’s Process Solutions expertise in the production and purification of biologics will be leveraged to support the grant recipients,” said Gourdier. “Each winner has specific challenges and needs; our collaboration consists of removing these roadblocks from their development pathway.”
Without disclosing specific support areas due to confidentiality, Gourdier added that Merck could for instance optimize a unit of operation in the process and develop an application with multiple technologies. This is made possible by a global network of process development scientists who dive into customer projects, develop experience plan with appropriate technologies, execute and deliver. “If required by the grant recipient, we can collaborate beyond process development activities and become a partner in their growth with our Biodevelopment Center located in Martillac, France,” he noted.
“This fully single-use GMP facility can support any mAb [monoclonal antibody] project starting from a DNA sequence to the manufacturing of Phase I/II clinical material. For Phase III, our customer just need to tell us where the process has to be transferred – to a CMO [contract manufacturing organization], to an existing facility or to a new facility – and we will do it,” he said.
Growing Presence
As well as tapping into local innovation, Merck has been strengthening its own presence in recent years in China, which has the world’s second-largest single pharmaceutical market with an estimated annual growth rate of about 9% through to 2018.
In 2014, the group broke ground for a new pharmaceutical manufacturing facility with an investment of €80m in Nantong, China, its second-largest such site worldwide. This will focus on the bulk production and packaging of Glucophage (metformin), Concor (bisoprolol) and Euthyrox (levothyroxine), Merck Serono's leading brands for the treatment of diabetes, cardiovascular diseases and thyroid disorders.
In 2013, Merck showed its stated commitment to establishing R&D partnerships in China by entering into two agreements with the Chinese life science company BeiGene (Beijing) Co. Ltd. for the co-development of a BRAF inhibitor (BGB-283) and a PARP inhibitor (BGB-290), in a deal that could net the Chinese biotech up to €170m.
Merck has a number of divisions in China besides its pharmaceuticals unit Merck Serono SA. In the health care sector, its Allergopharma unit is responsible for research, production and distribution of anti-allergy medicines, while Merck Millipore provides customized lab and process solutions and applications for Chinese customers. In the materials sector, it has display and integrated circuit materials.
“China is a key market for the life science business of Merck, especially Process Solutions. The China biotech industry has experienced a rapid evolution of the regulations, an increase of the quality standards and a growing number of investments to expand manufacturing capabilities,” said Gourdier.
“To support China’s growth, Merck invested tremendously to intensify its presence in the field with the largest sales organization and the broadest group of process development scientists in Asia.”
Partners’ Needs
But the high growth of the Chinese biotech market requires the company to have a range of characteristics, including: a high sense of anticipation to follow customers’ development pace; flexibility to meet specific needs; reliability in the quality and supply chains; and a high degree of expertise to quickly solve technical challenges large scale manufacturing and facility design, according to Gourdier.
The life science business of Merck has ongoing programs to address these challenges and best serve biotech customers, he added.
“Emerging biotech companies contribute significantly to innovation and it is our role to solve the toughest problems in the life science industry by collaborating with that community. The Emerging Biotech grant is one Process Solutions program to bring innovation to patients,” Gourdier concluded.