Diamyd Medical announces today that the company has executed a settlement
agreement with Apoteket AB regarding a clinical study in LADA patients, which
was invalidated in 2007. The cause of the invalidation was contradictory data,
which gave reason to suspect a mix-up of active drug and placebo.
Diamyd contracted Apoteket AB in 2004 for handling of blinding, randomization
and labeling of the study drug for a clinical study with 160 LADA patients. As
the study was unblinded and reported during summer 2007, the data was found to
be inconclusive. An inspection at the pharmacy, that had handled the study drug,
revealed insufficiencies in routines and documentation, which made it impossible
to conclude which patients had received active drug and which patients had
received placebo. The study was invalidated on these grounds.
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.
“We have now agreed on a settlement with Apoteket AB and we are looking forward
to, in new LADA studies, confirm earlier positive results that have been
reported in this patient group after treatment with the diabetes vaccine
Diamyd®”, says Elisabeth Lindner, President of Diamyd Medical.
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. Diamyd Medical 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.
