In her comments in today's year-end report, Elisabeth Lindner, President and CEO
of Diamyd Medical, reports that in the last year Diamyd has come ever closer to
realizing its vision of being able to prevent and cure the autoimmune form of
diabetes in the future.
The most recent quarter has seen significant success in the American Phase III
study of the Diamyd® diabetes vaccine, since the US FDA approved the inclusion
of children aged 10 and above. The number of clinics in the US will now be
gradually tripled to over forty, and an agreement has been signed with patient
recruitment firm Inclinix Inc. to accelerate the recruitment of patients. The
long-term follow-up of the company's Phase II study in children and adolescents
with newly diagnosed type 1 diabetes continues to show positive development, and
the European Phase III study is also progressing well. It will be fully
recruited in November.
- The successes in our clinical trials, taken together with increased interest
in our company and the secured financing of our Phase III results position
Diamyd as a diabetes company with an exciting future, says Elisabeth Lindner,
President and CEO of Diamyd Medical.
During the quarter the first children were also vaccinated in a Swedish
prevention study of the Diamyd® diabetes vaccine with the aim of preventing type
1 diabetes. This is the first test ever of preventive vaccination with Diamyd®
for this chronic disease.
After the end of the reporting period Diamyd resolved to implement a fully
underwritten new share issue of just under MSEK 220 with preferential rights for
existing shareholders. The last day to subscribe is October 30, 2009. The
company has also, after the end of the reporting period, executed a settlement
agreement with Apoteket AB regarding a clinical study in LADA patients, which
was invalidated in 2007. Diamyd has claimed damages from Apoteket AB for
unnecessary costs related to the invalidated study. The settlement agreement
includes a payment of SEK 11 million to Diamyd as compensation for the
insufficiencies in Apoteket's routines and documentation causing Diamyd to
invalidate the study.
For more information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.)
Phone: +46 8 661 0026
For pictures and press material, please contact:
Andreas Ericsson, Diamyd Medical AB (publ.)
andreas.ericsson@diamyd.com
Phone: +46 8 661 0026
About Diamyd Medical
Diamyd Medical is a Swedish diabetes company focusing on the development of
pharmaceuticals for the treatment of autoimmune diabetes and its complications.
The company's most advanced project is the GAD-based drug Diamyd® for type 1
diabetes. Phase III trials for this drug are in progress in both Europe and the
US. In addition, the company has initiated clinical studies in the US in the
area of 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. The company currently has three clinical-phase products.
Diamyd Medical has offices in Sweden and in the US. Shares are listed on Nasdaq
OMX 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.)
Linnégatan 89 B, SE-115 23 Stockholm, Sweden. Tel: +46 (0)8 6610026, Fax: +46
(0)8 661 63 68
E-mail: info@diamyd.com. VAT no: SE556530-142001.
