Diamyd Medical enters agreement to facilitate transition of manufacturing

Diamyd Medical and Protein Sciences Corporation (PSC) are entering into an agreement modifying their relationship, by which PSC will continue to support Diamyd Medical in its development of a diabetes vaccine but will no longer serve as its contract manufacturer. The agreement facilitates the transition of the manufacturing process of recombinant GAD65, the active ingredient in the diabetes vaccine Diamyd®, to a new manufacturer for future anticipated commercial manufacture. PSC will support Diamyd Medical with USD 5 million in cash, as well as certain raw materials and up to 150 man-hours of technical assistance for the transition process. The agreement has been made in light of the announcement by Diamyd Medical in October 2019 where PSC had informed Diamyd Medical that it was unable to meet Diamyd Medical’s manufacturing needs for commercial supply. The payment will be made during the first quarter of 2020.

"This agreement provides us with the opportunity to further strengthen our GAD-manufacturing process, one of the core assets of Diamyd Medical," says Ulf Hannelius, President & CEO of Diamyd Medical. ”GAD is one of the key antigens in type 1 diabetes and the antigen that defines autoimmunity in patients that have an autoimmune form of  type 2 diabetes. The addressable market for a GAD-specific immunotherapy like Diamyd® is conseqeuntly significant and growing, and we are now in a position to transition our manufacturing process in order to cater for the expected demand”.

About Diamyd Medical
Diamyd Medical develops therapies for type 1 diabetes. The diabetes vaccine Diamyd® is 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 significant effect in some pre-specified subgroups. Results from the Company’s European Phase IIb trial DIAGNODE-2, where the diabetes vaccine is administered directly into a lymph node in children and young adults with newly diagnosed type 1 diabetes, are expected to be presented in the third quarter of 2020. 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 18.30 CET on February 5, 2020.


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