ViaCell Inc. received a $20 million equity infusion from Amgen Inc. as part of a cellular therapy collaboration and license agreement.
The deal provides Boston-based ViaCell licenses to certain cellular growth factors, while Amgen retains the right to collaborate on developing and commercializing resulting products. The arrangement expands a prior relationship between the companies.
In 2002, Thousand Oaks, Calif.-based Amgen granted ViaCell a nonexclusive worldwide license to Stem Cell Factor (SCF), a growth factor for ex vivo therapeutic uses. As part of the new collaboration, Amgen also granted a nonexclusive worldwide license for ex vivo therapeutic use, but this time for Flt3-Ligand. Both SCF and Flt3-Ligand are growth factors that contribute to the survival, growth and differentiation of hematopoietic stem cells.
"The largest biotech company in the world has made a statement by collaborating with a cell therapy company to make cell therapy a reality," ViaCell Chairman and CEO Marc Beer told BioWorld Today. "For ViaCell, that means more than just the capital, which is important in building a biotech company. But more importantly in this deal, Amgen has the deepest experience in growth factors, culture media and critically thinking about enabling cell therapy to be manufactured, go through clinical development and become a product."
He declined to disclose Amgen's specific ownership percentage in ViaCell beyond characterizing its stake as significant. But Beer stressed that Amgen's infrastructure is equally crucial to maturing ViaCell's therapeutic programs, noting Amgen's investment in a portfolio of growth factors critical to the growth and manufacturing of cells.
"When you get into the specifics of the deal, we're getting a license to biologics that no one else has received and critical know-how," he said.
ViaCell's lead product, CB001, is in Phase I/II testing in adult patients with hematological malignancies. Produced through its Selective Amplification technology for the expansion of targeted populations of stem cells, CB001, which employs an Amgen growth factor, is the company's lone partnered product. The product is designed to provide a more predictable clinical endpoint in treating leukemia patients as opposed to bone marrow transplantation, a therapy associated with various side effects. The one-year study will evaluate CB001's safety profile and also provide a look at the treatment's impact.
When ViaCell gained its first license from Amgen, Beer said the companies looked ahead to expanding the arrangement as the science and relationship matured. Positive development of CB001 over that two-year period led to the broadened agreement.
In addition to its equity investment, Amgen will have an option to cover half the development costs for selected future collaborative candidates and will pay an undisclosed milestone upon approval of any resulting products. Amgen also will be responsible for late-stage clinical development and commercialization of selected products. ViaCell will be responsible for research, early clinical development and manufacturing.
The parties will share profits equally from any sales.
ViaCell's cellular medicine pipeline focuses on cancer, neurological diseases, diabetes and muscular dystrophy. Its Selective Amplification platform combines growth factors that help cells proliferate with a selection process for differentiated cells to allow the manufacture of a population of purified, pharmaceutical-grade stem cells.
"From an industry standpoint, I think it's a very exciting time because the cell therapy industry as a whole will benefit from the ViaCell-Amgen collaboration, because we're both saying that this is so important to the biotech space," Beer said. "It's a new modality of medicine, and these two organizations are going to put their assets, critical thinking and capital together for cell therapy to be a reality."
Beyond Amgen, ViaCell is in other equity and development partnerships as well. Genzyme Corp., of Cambridge, Mass., is providing a stem cell stimulant to the Selective Amplification process to create a hematopoietic stem cell transplant product. GlaxoSmithKline plc, of London, also is an equity holder in ViaCell.
In addition to its drug development plans, ViaCell offers umbilical cord blood stem cell preservation services through its Viacord subsidiary.
Amgen's stock (NASDAQ:AMGN) fell 18 cents Wednesday to close at $61.79.