Year End Report, Stockholm, October 24, 2008
Year End Report for Diamyd Medical AB (publ), Fiscal Year 2007/2008
(www.omxgroup.com ticker: DIAM B; www.otcqx.com ticker: DMYDY)
September 1, 2007 - August 31, 2008
• The 5-year results of a Phase II study demonstrates that Diamyd® significantly
reduces the risk that LADA patients will need insulin treatment
• Great interest in Diamyd at the American ADA conference in June
• The warrants that accompanied the new shares issued during the spring were
listed for trading on First North
• Diamyd's licensing partner Neurologix initiates Phase II studies with GAD in
Parkinson's disease
• Positive 30-month results of a Phase II study with Diamyd® for type 1 diabetes
were published together with an editorial in the most prestigious medical
journal in the world, The New England Journal of Medicine (after reporting
period)
• Ten percent of the type 1 diabetes patients have been screened in a European
Diamyd® Phase III study (after reporting period)
• The NTDDS product NP2 with Enkephalin proves to be effective against diabetes
pain in preclinical studies (after reporting period)
• Diamyd received great exposure at the EASD conference in Rome (after
reporting period)
• Group net sales for the year amounted to kSEK 1,092 (531). Net sales for the
fourth quarter were kSEK 133 (115)
• The loss before taxes for the year amounted to MSEK -63.9 (-53.5). The loss
before taxes for the fourth quarter was MSEK -20.3 (-15.6)
• Group liquid assets amounted to MSEK 81.9 (68.8) as of August 31, 2008
• Result per share after dilution was SEK -6.3 (-5.5)
CEO OVERVIEW
The summer has been a time of intense activity for Diamyd Medical. The Swedish
part of our Phase III study in type 1 diabetes has begun, and we have applied to
regulators and ethics committees in eight more European countries for approval
of the study. The study has either been approved or is close to approval in most
of the countries, and we have nearly 70 European clinics under contract. In the
US we will have 20 clinics under contract soon. The process is time-consuming
because the majority of the American clinics have their own local ethics
committees, but it is proceeding swiftly nevertheless.
At the time of writing, we have screened more than 10 percent of the patients
for the European study, and administered injections to more than 10 percent of
the Swedish patients. A handful of patients in the US have received injections
up to this point. I am grateful and delighted that our team has such a wonderful
spirit of enterprise, and is so committed that we have succeeded with these
measures of progress in such a short time and with limited resources.
In October we had a great breakthrough when the prestigious scientific journal
The New England Journal of Medicine, together with an editorial published the
results of our Phase II study with the diabetes vaccine Diamyd® in children and
adolescents with type 1 diabetes. We see this as the ultimate scientific
validation of the results of our study.
We also announced the 5-year results of our Phase II study in adult patients
with autoimmune diabetes, which demonstrated that treatment with Diamyd® has a
significant effect in preventing the need for insulin treatment.
One building block is laid upon another, and they demonstrate unequivocally that
the Diamyd® diabetes vaccine has a significant clinical effect and great
potential to help children, adolescents and adults with diabetes.
In the turbulent times caused by the financial crisis that is reigning over the
entire world, I am both proud and humble that Diamyd Medical has fared so well
nevertheless. At the present time we have secure financing and stable long-term
owners with decision powers, and our research demonstrates positive results time
after time. Diamyd is a virtual company with low fixed costs as well as low
variable costs relative to the industry, this minimizes our burn rate.
Our strategy stands firm, and we have achieved our objectives, one after
another. We expect to have included the last patient in the Phase III program in
the third quarter 2009; the program will then yield the first Phase III results
at the end of 2010. At that point we will apply for market approval for the
world's first diabetes vaccine!
Elisabeth Lindner, President and CEO, Diamyd Medical AB
SIGNIFICANT EVENTS DURING THE PERIOD
ADA, Diamyd was well represented at ADA (American Diabetes Association, 68th
Annual Meeting), the large American annual diabetes conference that was held in
San Francisco this year. GAD and Diamyd's research were described in three
different sessions, and TrialNet president Jay Skyler announced during his
presentation that the planned intervention study with Diamyd® for type 1
diabetes is intended to start in the coming months.
The warrants that accompanied each newly issued share from the directed
placement of the spring 2008 were listed for trading on the marketplace First
North as of June 10, 2008.
Mangold Fondkommission AB has taken over the role of liquidity provider for
Diamyd Medical's B share and warrant as of June 10, 2008.
Phase III studies with Diamyd® for type 1 diabetes began in Europe and the US in
the spring and summer. In Europe, Sweden is proceeding according to plan and
eight additional European countries are at various stages of the startup
process. The study has begun in the US according to plan. Patients have been
screened and received injections on both continents.
5-year results from the Diamyd® Phase II study with LADA patients were presented
at the EASD conference (European Association For The Study Of Diabetes, 44th
Annual Meeting) in Rome, Italy in September. The results demonstrated that, even
after five years, vaccination with Diamyd® significantly reduces the risk that
LADA (Latent Autoimmune Diabetes in Adults) patients will need insulin
treatment. No serious treatment-related side effects were observed in the study,
which strengthens the safety profile of Diamyd®.
Diamyd's licensing partner Neurologix Inc. reported that they have initiated a
Phase II study with the GAD gene in Parkinson's disease. This demonstrates that
GAD can also be used successfully in therapeutic areas other than diabetes.
To read the complete report, please see attached pdf, or visit www.diamyd.com
For more information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.),
elisabeth.lindner@diamyd.com
Phone: +46-8-661 0026
For pictures and press material, please contact:
Sonja Catani, Chief Communications Officer Diamyd Medical AB (publ.),
sonja.catani@diamyd.com
Phone: +46-8-661 00 26
Diamyd Medical AB (publ.)
Linnégatan 89 B, SE-115 23 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8
661 63 68
E-mail: info@diamyd.com. VATno: SE556530-142001.
Diamyd Medical is a Swedish biopharmaceutical company focusing on development of
pharmaceuticals for treatment of autoimmune diabetes and its complications. The
company's most advanced project is the GAD-based drug Diamyd® for type 1
diabetes and for which Phase III trials are ongoing in both the US and Europe.
Furthermore, the company has initiated clinical studies within chronic pain,
using its Nerve Targeting Drug Delivery System (NTDDS). The company has also
out-licensed the use of GAD for the treatment of Parkinson's disease.
Diamyd Medical has offices in Sweden and in the US. The share is quoted on the
OMX Stockholm Nordic Exchange (ticker: DIAM B) and on OTCQX in the US (ticker:
DMYDY) administered by the Pink Sheets and the Bank of New York (PAL). Further
information is available on the company's web site: www.diamyd.com
This information is disclosed in accordance with the Securities Markets Act, the
Financial Instruments Trading Act or demands made in the exchange rules.
