AMSTERDAM, May 14 /PRNewswire/ -- SynCo Bio Partners B.V., a leading GMP biopharmaceutical manufacturer, announced today that it has completed the manufacture and release of ActoGeniX' drug substance AG011 for use in a Phase II clinical trial with ulcerative colitis patients.
ActoGeniX is focused on the development and commercialization of ActoBiotics(TM), a novel class of protein-based biopharmaceuticals that can be orally administered. The Company's lead product AG011 is an ActoBiotic(TM) for treatment of inflammatory bowel disease and has previously been successfully tested in a Phase I clinical trial with Crohn's disease patients.
To provide the AG011 drug product required for the Phase II studies, due to start this summer, SynCo has developed and scaled up the manufacturing process involving cultivation, purification and lyophilisation of AG011. Although the project involved several parties, working virtually simultaneously on different aspects, the GMP batches were produced within the agreed timelines.
Announcing the successful completion of the project, Pierre Warffemius, CEO, said, "Having ActoGeniX choose us to manufacture the GMP batches for their Phase II clinical trials is a clear endorsement of our growing reputation for manufacturing live biopharmaceuticals. The fact that we were able to work on a multi-agency project and deliver the drug substance on time is also an excellent example of project management capabilities."
Mark Vaeck, CEO of ActoGeniX, "The move from Phase I to Phase II clinical trials is a critical step for ActoGeniX so it was imperative that we worked with a GMP-accredited contract manufacturing organisation that had a proven track record in developing processes for biopharmaceuticals, as well as commercial manufacturing capabilities."
ActoGeniX will, in the coming weeks, file the regulatory applications to obtain approval for the start of its AG011 clinical trial during this summer. ActoGeniX also plans to start a Phase II study with the same product in Crohn's disease patients in the course of 2009. For more information about the product please visit http://www.actogenix.com
Issued on behalf of SynCo Bio Partners by De Facto Communications
About SynCo Bio Partners B.V.
SynCo Bio Partners is a GMP-licensed bulk drug substance and final product CMO with in-depth clinical and commercial production experience with mammalian and microbial systems. This experience has been acquired by developing new production processes for a number of international clients and producing a wide variety of different vaccines, live bacterial products and recombinant proteins in our state-of-the-art, GMP-licensed facilities in the last seven years.
Financially stable and focused solely on biopharmaceuticals, SynCo Bio Partners acts as a strategic, long-term partner delivering your product on time and to the highest quality standards. All our staff are committed to exceeding customer expectations and believe that taking a truly collaborative approach to manufacture is the key to a successful outcome.
Also visit http://www.syncobio.com
About ActoGeniX N.V.
ActoGeniX is a biopharmaceutical company focused on the development and commercialization of ActoBiotics(TM), a novel class of biopharmaceuticals for the targeted treatment of severe gastrointestinal (GI) diseases, metabolic diseases, immune disorders and allergies. ActoBiotics(TM) can be orally administered and are designed to be safer and more effective than injectable biopharmaceuticals. ActoGeniX's initial focus is on GI diseases and its lead product for the treatment of Crohn's disease and ulcerative colitis has already been successfully tested in a phase 1 clinical trial.
ActoGeniX was founded in 2006 as a spin-off from VIB and Ghent University. The Company is headquartered in Ghent (Belgium) and employs close to 40 employees, half of whom are PhD's, MD's, or PharmD's. Within the first year after its inception, the Company raised 20 million Euro through a Series A equity round from a consortium of leading life sciences investors such as GIMV, Biotech Fund Flanders, Baekeland Fund (Belgium), Life Sciences Partners, Aescap (The Netherlands) and Ventech (France).
ActoGeniX has a strong and broad intellectual property position with a patent estate encompassing 16 distinct patent families. With broad patent claims already granted in major territories like the US and Europe, ActoGeniX is now in a unique position to successfully exploit the commercial potential of its promising new class of biopharmaceutical products.
For more information see http://www.actogenix.com
CONTACT: For more information, contact: De Facto Sarah Herrmann,
+44-207-861-2019, email@example.com . SynCo Bio Partners B.V., Joanne
McCudden, +31-6-5534-8074, Joanne_McCudden@synco-biopartners.com .
ActoGeniX, Dr Mark Vaeck, CEO, +32(0)9-261-0600, firstname.lastname@example.org .