The two companies entered a long-term commercial supply agreement for the manufacture of bulk substance in September 2010, following the completion of Phase III trials, and have partnered to complete validation and establish a well-characterized process.
Steve Bagshaw, managing director of Fujifilm Diosynth Biotechnologies’ Billingham, UK, said, “We are delighted that ThromboGenics has received FDA approval for the launch of Jetrea in the U.S. It is very gratifying for our team to see that their hard work in developing and manufacturing the product over the years has resulted in a drug being available to people suffering from distressing ophthalmic conditions. This is fifth licensed biopharmaceutical manufactured by Fujifilm Diosynth Biotechnologies and the second made at our Billingham site.”
Dr. Patrik De Haes, chief executive officer of ThromboGenics, said, “Fujifilm Diosynth Biotechnologies has been a key partner in helping to bring our first drug to market. The team at Billingham has done an excellent job in developing and validating a robust process and manufacturing material to enable us to launch the product on schedule.”