STOCKHOLM--(BUSINESS WIRE)-- Regulatory News:
Reporting period September 1, 2011 – November 30, 2011
- Group total net sales amounted to MSEK 0.1 (144.5)
- Profit before tax amounted to MSEK -7.4 (98.3)
- Earnings per share after dilution were SEK -0.26 (3.32)
- The Group’s liquid assets amounted to MSEK 414 (478) as of November 30, 2011
Significant events during the reporting period
- Diamyd Medical was awarded a USD three million grant and expanded the NTDDS portfolio
- University of Florida Research Foundation and Diamyd Medical settled lawsuit
Significant events after the reporting period
- Prevention study with Diamyd Medical´s diabetes vaccine was fully recruited
2012 will be an exciting and significant year for Diamyd Medical. We now have only a handful of subjects left to enroll in our US Phase II study in cancer pain with the drug candidate NP2 Enkephalin. Work is underway to ensure the quality of data and to prepare everything so that we will be able to obtain the results as quickly as possible after the last patient has been included in the study. Our prognosis to be able to present results from the study some time during the first half of 2012 remains unchanged. The results are important to Diamyd Medical, as it is the first time a drug candidate from the Company’s NTDDS platform is tested in a larger patient population. Sustained pain relief was achieved in a smaller, non-placebo-controlled, Phase I study with NP2 Enkephalin. That study included ten subjects with cancer pain. No serious treatment-related adverse events were observed in that study.
With positive results from the Phase II study, we will be ready to actively seek partners for the further development of NP2 Enkephalin and other applications of the NTDDS platform and to start clinical trials with the next drug candidate from the platform, NG2 GAD. We have good prospects given our financial resources and our streamlined organization with valuable experience from both clinical development and from concluding significant partnership agreements with large pharmaceutical companies.
NTDDS stands for Nerve Targeting Drug Delivery System which is an innovative technology that enables delivery of therapeutics directly to the nervous system. The purpose is to achieve a local effect in the cells where the treatment is targeted without affecting the rest of the body. It is a unique concept that, if it proves successful, may provide new opportunities to address various medical problems of the nervous system which today cannot be adequately treated, such as chronic pain, neuropathy, cancer and neurodegenerative diseases.
The Annual General Meeting was held in December and we can now put the turbulent 2011 behind us and put all our focus on the future. A few weeks before the meeting, we reached an agreement with the University of Florida and could thereby settle the dispute with them. We started the new year with the good news that the Swedish prevention study with the Diamyd® diabetes vaccine had recruited its fiftieth and final subject. The study aims to prevent type 1 diabetes in children who are at high risk of developing the disease, and it will be very interesting to follow the coming few years.
Our measures to reduce costs have certainly had an impact during the reporting period. We are now down to one third of the costs compared to the same period last year. The Company's cash position with around SEK 400 million, corresponding to approximately SEK 14 per share, means that the financing of the existing business is secured and also provides the Company with strategic leeway. The newly elected board has continued the active strategy work which was initiated last year and is continuously evaluating different scenarios. The results from the Phase II study with NP2 Enkephalin will of course affect the Company's strategic choices going forward, but we will be well prepared regardless the outcome of the study.
Stockholm, January 25, 2012
President and CEO Diamyd Medical AB
SIGNIFICANT EVENTS DURING THE REPORTING PERIOD
SEPTEMBER 1, 2011 – NOVEMBER 30, 2011
Diamyd Medical was awarded a USD three million grant and expanded the NTDDS portfolio. Diamyd Medical with collaborators received a USD three million grant from the US National Institutes of Health to develop the Company’s patented Nerve Targeting Drug Delivery System (NTDDS) for prevention of Chemotherapy Induced Peripheral Neuropathy. The grant allows Diamyd Medical to expand the NTDDS technology to also target neuropathy, in addition to the Company’s development portfolio for the treatment of pain.
University of Florida Research Foundation and Diamyd Medical settled lawsuit. University of Florida Research Foundation, Incorporated ("UFRF"), and Diamyd Medical AB jointly announced that they have settled the breach of contract litigation that UFRF filed in the United States Federal District Court in Florida against Diamyd Medical in January 2011. The dispute related to an exclusive license agreement between UFRF and Diamyd Medical, and to a sublicense of the rights under the exclusive license agreement between Diamyd Medical and Ortho-McNeil-Janssen Pharmaceuticals, Inc., which sublicense involved rights to the GAD65-based drug candidate Diamyd®. The settlement amount was in line with what Diamyd Medical had reserved in its accounts as per August 31, 2011 regarding litigation claims.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
Prevention study with Diamyd Medical´s diabetes vaccine was fully recruited. A total of 50 children aged four and older with a high risk of developing type 1 diabetes have been enrolled in a researcher-initiated Phase II study, DiAPREV-IT, with Diamyd Medical’s diabetes vaccine Diamyd®. The study is thus fully recruited. The purpose of the study is to evaluate whether preventive treatment with Diamyd® can delay or halt the progression of the disease so that the children do not develop clinical symptoms of type 1 diabetes. The first results are expected to be compiled three years after the last participant is enrolled, and can thereby be presented in 2015.
About Diamyd Medical
Diamyd Medical is a Swedish biotech company focusing on the development of pharmaceuticals for the treatment of pain, neuropathy and diabetes. The portfolio of development projects for the treatment of chronic pain and neuropathy uses the Company’s patented NTDDS (Nerve Targeting Drug Delivery System) platform to administer therapeutic agents directly to the nervous system. The development project within the area of diabetes consists of the protein GAD65 for the treatment and prevention of autoimmune diabetes.
Diamyd Medical has offices in Sweden and in the US. 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). Further information is available on the Company’s website: www.diamyd.com.
This information is disclosed in accordance with the Swedish Securities Markets Act, the Swedish Financial Instruments Trading Act, or the requirements stated in the listing agreements.
Diamyd Medical AB (publ)
Karlavägen 108, SE-115 26 Stockholm, Sweden. Phone: 46 8 661 00 26, Fax: 46 8 661 63 68
E-mail: [email protected]. Reg no: 556530-1420
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Diamyd Medical AB
Peter Zerhouni, President and CEO
Phone: 46 8 661 00 26
KEYWORDS: Europe Sweden
INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical