A new manufacturing facility is being set up in Umeå by Diamyd Medical.
The first priority of the new site is to receive the process technology for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd.
“The importance of being in control of your own manufacturing process has never been higher,” says Ulf Hannelius, CEO of Diamyd Medical. “Taking over the GAD manufacturing technology, a key process for the company, is a strategic, long-term decision to maximize shareholder value. It provides Diamyd Medical with direct control of the technology for a potential future transfer to a pharmaceutical partner or third party manufacturer for securing supply from one or more sources if required. In short, a significant step towards building a fully integrated biopharmaceutical company.”
SEK 20 million investment
The 10,000 square foot site comprises clean rooms, laboratory facilities and office space. Investments, initially estimated to approximately SEK 20 million (about USD 2 million) will be allocated for systems, instruments and personnel required to set up the GAD manufacturing technology.
Diamyd Medical previously announced that it entered an agreement with its US GAD manufacturer that facilitates the transition of the manufacturing process. As part of the agreement Diamyd Medical received USD 5 million (approximately SEK 48 million) in cash.
While ongoing clinical trials with Diamyd , including the Phase IIb trial DIAGNODE-2, progress according to plans, for execution of new trials during the technology transfer period, new Diamyd study drug will be formulated from existing GAD protein.
A number of new jobs in Umeå
The move will create a number of new jobs in Umeå, which Jennie Ekbeck, CEO of Umeå Biotech Incubator, believes is important for the region’s life science industry as a whole.
“This is fantastic news and demonstrates that Umeå is a growing life science hub,” says Jennie Ekbeck, CEO of Umeå Biotech Incubator. “Umeå Biotech Incubator’s goal is to create the ideal conditions for industry growth in Västerbotten and Sweden. It is important for our region that there are several employers for people to choose from, as it increases the attraction of wanting to stay or move here.”
Photo of Ulf Hannelius, CEO, Diamyd Medical: Ellinor Colling