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Mertiva AB (former Diamyd Medical) primarily consists of holdings in liquid assets and holdings in Protein Sciences Corporation and Mercodia AB. Mertiva (former Diamyd Medical) shares are listed on Nasdaq OMX (segment Small Cap) in Stockholm (ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY) administered by the Pink OTC Markets and the Bank of New York Mellon (PAL).

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New clinical study with Diamyd’s diabetes vaccine

Diamyd Medical AB reports that a new clinical study with the diabetes vaccine Diamyd® is planned to start in February 2013. In the study Diamyd® will be tested in a unique combination with other drugs, aiming to potentiate the effect of the diabetes vaccine. The Company has entered into an agreement with Linköping University to conduct the researcher-initiated study. The study has been approved by the Swedish Medical Products Agency.The study, which is the first study of its kind, combines the diabetes vaccine Diamyd® with relatively high doses of vitamin D and the anti-inflammatory drug

Diamyd Medical limits further investment in the diabetes vaccine

Diamyd Medical AB has decided to allocate a maximum of SEK 30 million over three years for the development of the diabetes vaccine Diamyd®.Diamyd Medical’s liquid assets and short term investments amounted to SEK 380 million as of August 31, 2012. The Board has decided to allocate up to SEK 30 million of these for the further development of the diabetes vaccine Diamyd® over the next three years. The development activities are gathered in the subsidiary Diamyd Therapeutics. The diabetes vaccine Diamyd® is based on the GAD65 protein and is being developed for the treatment and prevention of

Diamyd Medical's Phase III study published in the New England Journal of Medicine

An article with the results of Diamyd Medical's European Phase III study of the antigen-based diabetes therapy Diamyd® has been published in the scientific journal the New England Journal of Medicine. The now published results were previously presented at the American Diabetes Association’s 71st Scientific Sessions in San Diego, California, USA, on June 28, 2011.The title of the published article is “GAD65 Antigen Therapy in Recently Diagnosed Type 1 Diabetes Mellitus”. The authors are J. Ludvigsson, D. Krisky, R. Casas, T. Battelino, L. Castaño, J. Greening, O. Kordonouri, T. Otonkoski, P.

Diamyd presents detailed results of European Phase III study

Diamyd Medical AB reports detailed results from the Company’s European Phase III study of the antigen-based diabetes therapy Diamyd®, which, as previously announced, did not meet the primary efficacy endpoint.Today, June 28, at the “American Diabetes Association’s 71st Scientific Sessions” in San Diego, California, USA, lead investigator Dr. Johnny Ludvigsson presents the detailed results of Diamyd Medical’s European Phase III study of the antigen-based diabetes therapy Diamyd®. The study enrolled 334 patients, 10 to 20 years old, who were diagnosed with type 1 diabetes within three

TrialNet presents results from a study with Diamyd®

Diamyd Medical AB reports that the results of a study with the Company’s antigen-based diabetes therapy Diamyd®, conducted by the research consortium Type 1 Diabetes TrialNet did not show a statistically significant effect of the study drug.The American research consortium Type 1 Diabetes TrialNet presented their results of a Phase II study with the antigen-based diabetes therapy Diamyd® yesterday, June 27, at the American Diabetes Association 71st Scientific Sessions (ADA) in San Diego, California, USA, after the closing of the stock market. At the same time a research article about the

Diamyd initiates closure of US Phase III study

Diamyd Medical AB reports that the Company has decided to suspend dosing in a US Phase III study with the antigen-based therapy Diamyd® and to initiate closure of the study.Following consultation with the US Food and Drug Administration (FDA), Diamyd Medical has decided to suspend dosing in its US Phase III study, DiaPrevent, with the antigen-based therapy Diamyd®. Study closure activities will commence promptly. The decision follows a blinded review of the efficacy data collected to date in the study as well as the previously reported negative outcome of a European Phase III study of the

Diamyd closes European Phase III study

Diamyd Medical AB reports that the Company has decided not to complete the follow-up period of a European Phase III study with the antigen-based therapy Diamyd®.On May 9, the Company reported that its European Phase III study with the antigen based therapy Diamyd® did not meet the primary efficacy endpoint of preserving beta cell function at 15 months, as measured by meal stimulated C-peptide, although a small positive effect was seen. Furthermore, Diamyd® was well tolerated as demonstrated by a similar number of adverse events in the Diamyd® treated groups as well as in the placebo treated

Diamyd reports initial results from European Phase III trial in patients newly diagnosed with type 1 diabetes

Diamyd Medical AB reports that results from its European Phase III study with the antigen-based therapy Diamyd® did not meet the primary efficacy endpoint of preserving beta cell function at 15 months, as measured by meal stimulated C-peptide, in newly diagnosed type 1 diabetes patients.In Diamyd Medical’s European Phase III study in recently diagnosed type 1 diabetes patients, 10 to 20 years old, the antigen-based therapy, Diamyd®, did not show a statistically significant preservation of beta cell function after 15 months of follow-up compared to placebo, although a small positive effect

Quarterly Report III 09/10

Third quarter report for Diamyd Medical AB (publ.), fiscal year 2009/2010 (www.omxgroup.com ticker: DIAM B; www.otcqx.com ticker: DMYDYThird quarter March 1, 2010 – May 31, 2010 · Group net sales for the third quarter was MSEK 1.3 (0.2) · Loss before tax for the third quarter was MSEK -30.9 (-26.2) · Earnings per share after dilution for the third quarter were SEK -1.1 (-1.2) Period September 1, 2009 – May 31, 2010 · Group net sales for the period was MSEK 2.8 (1.1) · Loss before tax for the period was MSEK -75.3 (-52.1) · The Group’s liquid assets amounted to

Diamyd Medical Signs Agreement for Diabetes Therapy

Diamyd Medical AB has signed an agreement with Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company, to develop and commercialize the Diamyd® diabetes therapy.The agreement relates to the development and world-wide commercialization of the GAD65 antigen-based therapy (Diamyd®) for the treatment and prevention of type 1 diabetes and associated conditions.OMJPI will make an upfront payment of USD 45 million, and under the terms of the agreement, Diamyd has the potential to receive additional development and sales milestone payments of up to USD 580 million, as

Diamyd’s Phase III studies continue to follow plan

In her comments in today’s quarterly report, Elisabeth Lindner, President and CEO of Diamyd Medical, describes the progress in the decisive Phase III studies with the Company’s lead drug candidate Diamyd®, and comments on the Company’s strategies and efforts to build a Nordic specialty pharmaceutical company.”We have exciting times ahead of us with only one year to go before we have the results from our European Phase III study. Our hard work starts to pay off,” says Elisabeth Lindner, President and CEO of Diamyd Medical. “Besides our ongoing partnership discussions, we will primarily focus

Diamyd granted Orphan Drug Designation in the US

The FDA has granted Orphan Drug Designation of Diamyd Medical´s lead drug candidate Diamyd®. Orphan drugs qualify for seven years of market exclusivity from the date of US marketing approval, tax credits for clinical research and a waiver for FDA user fees.“This is extremely good news that we finally received today”, says Elisabeth Lindner, CEO and President of Diamyd Medical. “The granted Orphan Designation confirms the unmet medical need and might speed up the process to get the product available for children with diabetes. It may also give us extended market exclusivity in the US.“

Diamyd US Phase III study well under way

Diamyd Medical announces today that one hundred study participants have been included in the ongoing US Phase III study, DiaPrevent. The global Phase III program with the company’s lead drug candidate Diamyd® has thereby enrolled more than 430 children newly diagnosed with type 1 diabetes in Europe and the USA.One hundred patients are now enrolled in the company’s US Phase III study called DiaPrevent at 33 diabetes centers throughout the USA and more sites will be added. The study will include 320 children and adolescents between 10 and 20 years of age, recently diagnosed with type 1

Diamyd informs in quarterly report of the objective to file for market approval for the Diamyd® diabetes vaccine in 2011

In her comments in today’s quarterly report Elisabeth Lindner, President and CEO of Diamyd Medical, says that the Company’s objective is to file the Diamyd® diabetes vaccine for market approval in 2011 - a goal that isn’t very far off now.During the first quarter Diamyd Medical has reported several important events that have contributed positively to the Company’s development. The financial position has been strengthened through an oversubscribed preferential rights issue, which brought in just over MSEK 219 before issue expenses. The European Phase III study with Diamyd® has been fully

Diamyd close to important milestone

Diamyd Medical announces today that 90 percent of the total 320 children and adolescents with type 1 diabetes due to participate in the company’s European Phase III study with the diabetes vaccine Diamyd® have now been included and have received injections of Diamyd® or placebo. The company expects all participants to have been included in the study by November 2009.Diamyd Medical is conducting a global Phase III program with the diabetes vaccine Diamyd® comprising a study in nine countries in Europe and a study in the US. In each study 320 children and adolescents aged 10-20 newly

Diamyd makes investment in time-to-market

Diamyd Medical announces today that the company has signed an agreement with Inclinix Inc., North Carolina, for accelerated recruitment of children and adolescents recently diagnosed with type 1 diabetes in the US Phase III study of the diabetes vaccine Diamyd®.Diamyd Medical is conducting a global Phase III program with the diabetes vaccine Diamyd®, including in total 640 children and adolescents with recent-onset type 1 diabetes. The program is composed of one study in the US and one parallel study in nine countries in Europe. The US recruitment effort will soon be launched together with

4 year follow-up of Diamyd® Phase II study shows clear positive trend

Diamyd Medical announced today that the company’s 4-year follow-up of type 1 diabetes patients included in the company’s Phase II study shows a clear positive trend.Diamyd Medical received approval from the Swedish Medical Products Agency in February to follow up the children and adolescents with type 1 diabetes that were included in the company’s previously reported Phase II study with the diabetes vaccine Diamyd®. The participants were treated with 2 injections of Diamyd® or placebo; one injection at the study start in 2005 and one injection one month later. Initial analysis of new data

Diamyd to include children and accelerate patient recruitment in US Phase III study with the Diamyd® diabetes vaccine

Diamyd Medical reported today that from September 1, children from 10 years of age with type 1 diabetes will be included in the company’s US Phase III study of the Diamyd® diabetes vaccine. The company is also trebling the number of clinics and is investing in expanded recruitment activities in the US.Diamyd Medical’s Phase III study of the Diamyd® diabetes vaccine in the US has so far only been open to patients with type 1 diabetes aged between 16 and 20 years. From September 1, 2009, the study will also be open to children in the age range 10 to 15 years. Following the FDA’s decision in

Pioneering Diamyd® Study to Prevent Childhood Diabetes Approved

Diamyd Medical announces today that the Swedish Medical Products Agency has approved a study with the Diamyd® diabetes vaccine in children with high risk to develop type 1 diabetes.At Malmö University Hospital, Lund University in Sweden, large screening tests results in a continuous identification of children that are subject to a very high risk of developing type 1 diabetes. By measuring different biomarkers in blood samples, it is possible to determine in an early stage that these children are in the autoimmune disease process that destroys their insulin producing cells. If vaccination

Diamyd receives new approval for study to follow Swedish children and confirm long-term effect of the Diamyd® diabetes vaccine

Diamyd Medical has received approval from the Swedish Medical Products Agency to continue to follow the children who participated in the company’s Phase II study of the Diamyd® diabetes vaccine, which started four years ago. The aim of the follow-up study is to confirm the vaccine’s long-term effect.“Clinical studies with Diamyd® have demonstrated significant efficacy in preserving the body’s own ability to produce insulin,” says Elisabeth Lindner, President and CEO of Diamyd Medical. “We will now, in parallel with our ongoing large international Phase III trials, establish that the

Diamyd® approved for groundbreaking study in Norway

Diamyd Medical reports today that a prevention study with the Diamyd® diabetes vaccine has been approved by the Norwegian Medicines Agency. As previously communicated on December 9, 2008, the objective of the study is to investigate the disease process before type 1 diabetes onset and if treatment with the Diamyd® diabetes vaccine stops the process.In type 1 diabetes, the insulin-producing capacity is gradually destroyed by the immune system. Already before any symptoms of diabetes appear the disease can be detected through analysis of biomarkers in the blood. If Diamyd® treatment is

Diamyd® combination trial aimed at regenerating insulin-producing capacity in established type 1 diabetes gets approval from FDA

Diamyd Medical reports that the US Food and Drug Administration (FDA) has approved a study designed to preserve and possibly regenerate insulin production in patients with recent onset type 1 diabetes. The trial will test the diabetes vaccine Diamyd® in combination with drugs that are believed to stimulate new beta cell growth. The aim of the combination therapy is to try to restore lost insulin-producing capacity in established type 1 diabetes patients.The study will be carried out and funded by the National Institute of Diabetes and Kidney Disease (NIDDK), which is part of the National

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