Diamyd Medical (STO:DIAMB)(Pink Sheets:DMYDY):
First quarter, September 1, 2010 - November 30, 2010
• Group total net sales for the first quarter were MSEK 144.5 (1.3)
• Profit before tax for the quarter was MSEK 98.3 (-17.8)
• Earnings per share after dilution for the quarter were SEK 3.32 (-0.76)
• The Group's liquid assets amounted to MSEK 477.7 (223.6) as of November 30, 2010
Significant events during the reporting period September 1, 2010 - November 30, 2010
• Diamyd completed screening for US Phase III study in type 1 diabetes.
• Phase I trial in chronic pain showed pain relief.
• Diamyd reported promising safety findings from Phase I study in chronic pain.
Significant events after the reporting period
• Diamyd started Phase II study in cancer pain.
• The Diamyd share moved to NASDAQ OMX Stockholm Mid Cap list.
• NASDAQ OMX Stockholm Disciplinary Committee imposed a penalty on Diamyd Medical AB for inadequate disclosure of information.
Intensive and exciting times lie ahead
We are rapidly approaching the evaluation of the results from our European Phase III trial of the candidate drug Diamyd® for the treatment of recent onset type 1 diabetes. When we achieve last patient out (LPO) for the 15-month main trial period, meaning that all patients will have met their trial physician and completed their 15-month visit, much work will still lie ahead in the form of collecting the documentation from the slightly more than 60 participating clinics throughout Europe and from our central laboratory, which carried out all the analyses. Furthermore, all data will be compiled and when all of this has been completed, the database will be locked. If everything goes according to plan, the trial will eventually be unblinded and we will be able to begin reporting the results in late spring 2011.
We have also enrolled all patients in our US Phase III DiaPrevent study. Based on the fact that the US trial is approximately one year behind the European trial, we expect to be able to present the 15-month results from this study during the summer 2012.
Development in the Pain business area is advancing rapidly. In the autumn, the NP2 Enkephalin candidate drug demonstrated promising data in a small-scale Phase I study and the first patient was recently included in a placebo-controlled Phase II study in the US that will encompass approximately 32 patients with severe cancer pain. Our hope is to be able to repeat and confirm the results from the Phase I study and thus display proof of concept. Screening of patients is proceeding at a brisk pace and we now have nine clinics working on this.
In December, the disciplinary committee of NASDAQ OMX imposed a penalty on Diamyd Medical for inadequate disclosure of information, which was unfortunate. The coming activities this spring will impose rigorous demands on the Company's information disclosure and, as we strengthen our internal procedures, we will work together with our many stakeholders and partners to ensure the management and control of the dissemination of information concerning our operation.
2011 will be an eventful year for Diamyd and I look forward to this year with confidence.
Stockholm, January 25, 2011
President and CEO, Diamyd Medical AB
SIGNIFICANT EVENTS DURING THE REPORTING PERIOD
SEPTEMBER 1, 2010 - NOVEMBER 30, 2010
Diamyd completed screening for US Phase III study in type 1 diabetes. The screening of patients for the US Phase III study, DiaPrevent, was completed, ending the recruitment campaign. More than 310 recently diagnosed type 1 diabetes patients between 10 and 20 years of age had, at the completion of screening, been enrolled in the study and received their first injection of the antigen-based therapy Diamyd® or placebo.
Phase I trial in chronic pain showed pain relief. Substantial and sustained reduction in experienced pain were reported in the two highest dose cohorts of Diamyd Medical's Phase I trial investigating NP2 Enkephalin as a potential therapy for chronic pain. The Phase I study is intended to test the safety of NP2 Enkephalin and the NTDDS platform. In addition to safety data, measurements of pain relief and concomitant pain medications were compiled. The clinical trial was designed as an open label, dose escalation study in patients with intractable pain due to malignant cancer. Three dose levels were investigated and eight patients were evaluable at the four week study time point.
Diamyd reported promising safety findings from Phase I study in chronic pain. No drug related Serious Adverse Events have been reported by any patient included in Diamyd's Phase I clinical trial investigating NP2 as a potential therapy for chronic pain.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
Diamyd started Phase II study in cancer pain. The Phase II clinical trial with the candidate drug NP2 Enkephalin will recruit approximately 32 subjects with severe cancer pain and follow their pain scores and concomitant pain medication usage. It is a multi-center, randomized, double-blind, placebo controlled study designed to provide a statistical evaluation of pain relief. The trial has a four week double-blind main study period and following this period, all patients will be offered up to two additional doses of active NP2 Enkephalin in an open label study extension.
The Diamyd share moved to NASDAQ OMX Stockholm Mid Cap list. NASDAQ OMX Stockholm decided to move Diamyd Medical (DIAM B) from the Small Cap list to the Mid Cap list. The change was effective as of January 3, 2011. The Mid Cap segment includes companies with a market capitalization of between EUR 150 million and EUR 1 billion.
NASDAQ OMX Stockholm Disciplinary Committee imposed a penalty on Diamyd Medical AB for inadequate disclosure of information. In a letter dated November 5, 2010 to the Disciplinary Committee of NASDAQ OMX Stockholm, NASDAQ OMX Stockholm AB requested that the Disciplinary Committee issue a decision on disciplinary action regarding Diamyd Medical AB's disclosure of information. Diamyd Medical AB received the Disciplinary Committee's decision on December 15, 2010, instructing Diamyd Medical AB to pay an administrative penalty of SEK 576,000, corresponding to three annual fees.
SOURCE Diamyd Medical