Firms will work together to develop pandemic H5N1 vaccine for manufacture in Japan.
Baxter and Takeda Pharmaceutical inked a development, license, and technology transfer agreement that gives the latter an exclusive license to Baxter’s Vero cell culture-based influenza vaccine technology for the Japanese market.
The deal builds on a previous collaboration centered on bringing the Vero technology into Japan, and will involve the firms working jointly to develop and obtain marketing approval of an H5N1 vaccine. The manufacturing process for the Vero vaccine will also be transferred to Takeda, with a view to the firm being able to manufacture the H5N1 vaccine at commercial scale by the end of Q1 2014. In return, Takeda will make up-front cash payments to Baxter and pay the firm development cost reimbursements along with development, technology transfer, regulatory, and commercial milestones, plus sales royalties.
Baxter will, in addition, help Takeda seek funding from the Japanese government for the construction of a Vero cell-based flu manufacturing facility. The firm was previously awarded up to ¥ 3.6 billion from the Japanese government as part of its program to support the development of pandemic influenza vaccines. The deal with Baxter means Takeda will now apply for a second award under the government’s subsidy for establishing commercial facilities for vaccine production.
“The agreement with Takeda is an important milestone in extending the field of cell culture-based vaccine development and production,” remarks Robert L. Parkinson Jr., chairman and CEO at Baxter. “We believe our joint efforts will help support Japan’s public health efforts, particularly in the high priority area of pandemic preparedness.”
Baxter’s Vero cell technology uses a well-established mammalian cell line that has been cleared by the regulatory authorities in the U.S. and Europe for the production of human vaccines. The firm claims that in contrast to the use of embryonated chicken eggs, the Vero cell-based manufacturing uses a highly standardized, antibiotic-free closed production process. The Vero cell line can, in addition, be grown and infected on microcarrier beads and cultivated in fermenters for large-scale vaccine production.