Quarterly Report II 10/11
Quarterly report, Stockholm, April 14, 2011
September 1, 2010 - February 28, 2011
Second quarter, December 1, 2010 - February 28, 2011
· Group net sales for the second quarter were MSEK 114.5 (0.2)
· Profit before tax for the second quarter was MSEK 73.7 (-26.6)
· Earnings per share after dilution for the second quarter were SEK
2.51 (-0.2)
First half year, September 1, 2010 - February 28, 2011
· Group net sales for the first half year was MSEK 259.0 (1.4)
· Profit before tax for the first half year was MSEK 172.0 (-44.4)
· The Group's liquid assets amounted to MSEK 473.6 (200.1) as of
February 28, 2011
· Earnings per share after dilution for the first half year were SEK
5.88 (-1.7)
Significant events during the reporting period December 1, 2010 -
February 28, 2011
· Last patient completed the EU Phase III study of Diamyd® antigen
based therapy for
type 1 diabetes
· University of Florida Research Foundation initiated court case
against Diamyd Medical
· Diamyd Medical 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
Significant events after the reporting period
· Diamyd results from Phase I clinical trial in cancer pain published
in Annals of Neurology
CEO COMMENTS
All eyes on Diamyd
Diamyd Medical is currently experiencing an exceptionally intensive
period with extremely high expectations on the company, both internally
and externally. In mid-February, the last patient made the final visit
in the 15-month main trial period in the company's European Phase III
trial. Participants in the study are being treated with the
antigen-based candidate drug Diamyd® or placebo to assess whether it is
possible to preserve beta cell function and thus improve management of
blood sugar control long term among children and adolescents with
recent-onset type 1 diabetes. Extensive efforts are currently underway
to compile and process all the data. This is a comprehensive and
time-consuming undertaking and, as previously announced, we expect to be
able to report the top line results from the study in the late spring.
This is a particularly important period; not just for Diamyd, but my
immediate thoughts go to all the children and adolescents with diabetes
participating in the study, as well as all the physicians and nurses
performing the trial. We should also not lose sight of the great
importance of the results for diabetes research worldwide. If we could
show that it is possible to preserve beta cell function in recent-onset
type 1 diabetes, it would represent a breakthrough that we have not seen
since insulin was introduced in the 1920´s.
Several important events have taken place in the past quarter. At
year-end, Diamyd Medical (DIAM B) moved from the Small Cap list to the
Mid Cap list on the NASDAQ OMX Stockholm. The interest in our company
remains very high and we currently have more than 6,000 shareholders,
which we are very proud of.
The pace is also quickening in the Pain business area. In January, we
initiated a US Phase II trial aimed at testing the NP2 Enkephalin
candidate drug's potential to relieve cancer pain. Some 32 patients with
severe cancer pain are currently being enrolled in the study. Recently
the interest in Diamyd's unique method of treating pain was further
confirmed with the publication of the results of our Phase I trial with
NP2 Enkephalin in the medical journal Annals of Neurology. As announced
earlier, we also intend to launch a clinical study with the NG2 GAD
candidate drug in patients with chronic neuropathic pain in 2011.
The upcoming period will possibly be the most significant in Diamyd's
history when the results of the Phase III study are reported. We hope
our results will be the main topic of conversation at the important
diabetes meeting, the American Diabetes Association's 71st Scientific
Sessions, which this year takes place in San Diego at the end of June.
We have an incredibly exciting and intense time ahead of us.
Stockholm, April 14, 2011
Elisabeth Lindner
President and CEO, Diamyd Medical AB
SIGNIFICANT EVENTS DURING THE REPORTING PERIOD
DECEMBER 1, 2010 - FEBRUARY 28, 2011
Last patient completed the EU Phase III study of Diamyd® antigen based
therapy for type 1 diabetes. The last patient in the EU Diamyd Medical
Phase III clinical study completed the 15-month visit in February. This
important achievement in the Diamyd® Phase III program is now being
followed by an intense period where the data from the more than 60
clinics throughout Europe and from the central laboratory is compiled
and processed. The top line results are expected to be reported as
planned, in late spring 2011.
University of Florida Research Foundation initiated court case against
Diamyd Medical. The University of Florida Research Foundation (UFRF)
filed a lawsuit in United States federal district court in Florida
against Diamyd Medical claiming that UFRF is entitled to a percentage of
the license fee paid to Diamyd Medical by Ortho-McNeil-Jansen
Pharmaceuticals, Inc. (OMJPI). Diamyd Medical has licensed certain
rights from UFRF, and these rights were among the rights that Diamyd
Medical sublicensed to OMJPI.
Diamyd Medical started Phase II study in cancer pain. The Phase II
clinical trial, with the candidate drug NP2 Enkephalin, started in
January 2011 the recruitment of approximately 32 subjects with severe
cancer pain. Their pain scores and concomitant pain medication usage
will be followed. 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.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
Diamyd results from Phase I clinical trial in cancer pain published in
Annals of Neurology. The Phase I clinical trial results evaluating the
safety and efficacy of the candidate drug NP2 Enkephalin to treat
intractable cancer pain were published in the medical journal Annals of
Neurology.
*** To read the complete report, please see attached PDF, or visit
www.diamyd.com ***
