Diamyd Medical’s manufacturing process may be moved to a new manufacturer
Diamyd Medical AB announces that its manufacturing process of rhGAD65, the active ingredient in the diabetes vaccine Diamyd®, may be moved to a new manufacturer.
Diamyd Medical’s CEO Ulf Hannelius and its founder Anders Essen-Moller report that - at a meeting in New York with Protein Sciences Corporation - they were informed that Protein Sciences will not be able to meet Diamyd Medical’s manufacturing needs for rhGAD65 as per a Purchase Agreement Order of August 8, 2017, that was issued under the Development and Commercial Supply Agreement of July 12, 2008. Protein Sciences has offered to support Diamyd Medical in a collaborative way to help Diamyd Medical transition the current process to a new manufacturer, the details of which will need to be discussed and agreed on by the parties.
About Diamyd Medical
Diamyd Medical develops the diabetes vaccine Diamyd®, as an antigen-specific immunotherapy for the preservation of endogenous insulin production. Diamyd® has demonstrated good safety in trials encompassing more than 1,000 patients as well as effect in some pre-specified subgroups. Besides the Company’s own European Phase IIb trial DIAGNODE-2 where the diabetes vaccine is administered directly into a lymph node, two investigator initiated clinical trials are ongoing with Diamyd®. Diamyd Medical also develops the GABA-based investigational drug Remygen® for regeneration of endogenous insulin production. An investigator-initiated Remygen® trial in patients living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB and has holdings in the medtech company Companion Medical, Inc., San Diego, USA.
Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser; phone: +46 8-528 00 399, e-mail: info@fnca.se.
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com
Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com
This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CET on October 17, 2019.