Annual Report 10/11
Q1
• Results from Phase I study in cancer pain shows promising safety data and
relief of chronic pain
Q2
• Recruitment for US Phase III study in type 1 diabetes is completed
• Phase II study in cancer pain is started
• University of Florida Research Foundation initiates court case against Diamyd
Medical
Q3
• Results of a Phase I clinical study in cancer pain is published in the medical
journal Annals of Neurology
• Peter Zerhouni is appointed President and CEO of Diamyd Medical AB
• Results are announced from European Phase III study in type 1 diabetes, which
did not meet the primary efficacy endpoint of preserving beta cell function
Q4
• Diamyd Medical regains all rights and thereby the control of the diabetes
therapy Diamyd® after Ortho-McNeil-Janssen Pharmaceuticals, Inc. terminated
collaboration agreement
• European Phase III study in type 1 diabetes is closed and closure of a
parallel US Phase III study is initiated
• TrialNet presents results from a Phase II study with the diabetes therapy
Diamyd®, which did not show a statistically significant effect of the study drug
• Diamyd Medical reduces costs and shifts the development focus from type 1
diabetes to chronic pain and diseases of the nervous system
CEO COMMENTS
Diamyd Medical towards new goals
The past fiscal year has been both eventful and turbulent for Diamyd Medical.
However, now that the dust has settled, the Company stands well-equipped to
continue its important efforts to develop innovative pharmaceuticals for
diseases for which there currently is no effective treatment option. Diamyd
Medical’s portfolio includes several highly interesting drug candidates under
development and an ongoing Phase II study in cancer pain, the results of which
are expected during the first half of 2012. Our financing is secured and we have
a lean orga- nization with valuable experience in conducting Phase III trials
and landing significant collaboration agreements with major pharmaceuti- cal
companies. A gratifying situation in our industry!
Phase III study did not reach expectations
The event that dominated the latter part of the fiscal year was the re- sults of
our European Phase III study in type 1 diabetes with the drug candidate Diamyd®,
which did not meet expectations. This was a seri- ous setback and a great sorrow
for all hopeful patients, shareholders and others who had invested their time,
money and great dedication for such a long time. The Company’s share fell to
record-low levels and we had to rapidly reformulate our plans.
Focus on pain and neuropathy
The Company’s main focus now lies on our pain and neuropathy projects, where we
have several promising drug candidates under development based on our patented
NTDDS technology. The most advanced project is the drug candidate NP2
Enkephalin, which is being evaluated in a Phase II study with 32 patients who
suffer from severe and chronic cancer pain. The results of this study are
expected sometime between January and June in 2012. The study is important not
only for the continued development of NP2 Enkephalin, but also to confirm that
the NTDDS platform can deliver therapeutic sub- stances safely and effectively
to selected nerve cells. This is a unique concept and, if successful, it will
generate many new opportunities for treating a range of medical problems in the
nervous system that are not treatable today.
Following an evaluation of the results of the ongoing NP2 En- kephalin study,
the Company plans to commence clinical studies with the next NTDDS-based drug
candidate, NG2 GAD, for the treatment of other types of chronic pain. At the
same time, we will also initiate efforts to actively seek partners for the
further development of NP2 Enkephalin and other applications of the NTDDS
platform.
The last word has not been said about the diabetes therapy Diamyd®
Parallel with the development of a competitive project portfolio in pain and
neuropathy, efforts continue in the analysis of all available information from
the Phase III programme with the diabetes therapy Diamyd®. Intense discussion is
taking place in our global diabetes- research network regarding what we have
learnt and can continue to learn from all available research data, not only from
Diamyd® studies but also from other companies’ attempts to develop therapies for
type 1 diabetes. The next stage has not been determined yet but like many
experts in the field, we remain convinced that Diamyd®, or the active substance
GAD65, can thwart type 1 diabetes albeit with a different approach to that which
has now been tested.
For Diamyd Medical, prevention is closest at hand as a Swedish study with
Diamyd® is already ongoing with the aim of preventing type 1 diabetes in
children at high risk of developing the disease. Sev- eral research groups have
shown great interest in following this lead, but also in combining the Diamyd®
treatment with other drugs, or to change the number of injections or dose per
injection.
Strict cost control and strong cash position
After the Phase III results were presented in May, we have focused on strict
cost control and have taken a number of measures to ensure that the Company’s
money is used for value-creating activities. The Phase III programme with the
diabetes therapy Diamyd® is almost terminat- ed and most employees in Sweden who
worked with the programme have unfortunately had to leave the Company. These
measures reduce the Company’s costs considerably since the Phase III programme
accounted for about two-thirds of the Company’s total costs.
At the end of the fiscal year on August 31, Diamyd Medical had cash equivalents
amounting to MSEK 436, corresponding to SEK 14 per share. The strong cash
position means that our financing is secured for several years to come with our
current development plan, but also provides us with strategic leeway. Many
companies in our sector are finding it difficult to secure financing and we are
conti- nously evaluating business prospects with an opportunistic view, such as
acquisitions of promising development projects and companies, as well as other
types of transactions.
Favorable position
To summarize, Diamyd Medical has a full agenda for the year to come. Our
circumstances have changed but the Company has adapted and with our favorable
starting position, we look forward to an intense and exciting year.
Stockholm, November 15, 2011
Peter Zerhouni
President and CEO of Diamyd Medical
*** To read the complete Annual Report, please see attached PDF, or visit
www.diamyd.com ***
For more information, please contact:
Peter Zerhouni, President and CEO Diamyd Medical AB
Phone: 46 8 661 00 26
For press material, please contact:
Andreas Ericsson, Diamyd Medical AB
press@diamyd.com
Phone: 46 8 661 00 26
