Diamyd Medical orders additional Diamyd® drug substance from Protein Sciences
Diamyd Medical orders additional recombinant GAD-protein, the clinical grade drug substance which is the main component in the diabetes vaccine Diamyd® from its CRO, Protein Sciences Corporation, Connecticut. The order is placed to ensure access to drug substance for future clinical trials, possible early market launch and other opportunities. The order totals approximately USD 750,000 (approximately MSEK 6.1) for which Protein Sciences receives a cash installment and on delivery a payment either through Diamyd Medical series B shares or cash, as then decided by Diamyd Medical.
“Diamyd® may very well become the first effective antigen specific immunomodulator in autoimmune diabetes” , says Manon Cox, President and CEO of Protein Sciences. “We are glad to see our Baculovirus Expression System Technology (B.E.S.T.) manufacturing platform continue to expand around several application areas.”
“With this order, we are planning for success and we are excited to work closely with Protein Sciences to prepare for future studies and opportunities with our diabetes vaccine”, says Ulf Hannelius, CEO of Diamyd Medical.
About the diabetes vaccine Diamyd®
Diamyd Medical’s lead candidate therapeutic Diamyd®, recombinant GAD-protein formulated in alum, has been used in clinical studies comprising more than one thousand patients in efforts to halt the autoimmune attack that destroys the patients’ insulin producing beta cells. Promising preliminary results from the researcher-initiated open-label clinical trial DIAGNODE-1, where Diamyd® is administered directly into the lymph node in combination with oral vitamin D, has prompted the Company to conduct its own follow-up pivotal randomized trial, DIAGNODE-2.
Diamyd Medical exclusively licenses the University of California, Los Angeles (UCLA) patent rights for using GAD as a therapeutic in type 1 diabetes. Granted US patents expire 2032. Diamyd Medical has additional applications pending. In addition to patent protection, biological drugs, of which Diamyd® is one, benefit from data and market exclusivity around 10 years after market approval. Diamyd® has also been given Orphan Drug Designation for newly diagnosed patients with type 1 diabetes in the US.
About Diamyd Medical
Diamyd Medical is dedicated to finding a cure for diabetes and other serious inflammatory diseases through pharmaceutical development and investments in stem cell and medical technology.
Diamyd Medical develops the diabetes vaccine Diamyd®, for antigen-specific immunotherapy based on the exclusively licensed GAD-molecule. Four clinical trials are ongoing with Diamyd®. The Company's trial DIAGNODE-2, where the diabetes vaccine is administered directly into the lymph node, is expected to start recruiting patients in the fall. An exclusive license for GABA for the treatment of diabetes and inflammatory diseases constitutes alongside with the diabetes vaccine a key asset in Diamyd Medical and the Company uses its GABA in-licensed technology to develop a GABA drug product. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB. Diamyd Medical also has holdings in the medtech company Companion Medical, Inc., San Diego, USA and in the gene therapy company Periphagen, Inc., Pittsburgh, USA.
Diamyd Medical’s B-share is traded on Nasdaq First North under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser.
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
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: email@example.com Reg. no.: 556242-3797 Website: 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 08:17 CET on August 15, 2017