To NASDAQ OMX Copenhagen A/S
Announcement No. 08-09 / Copenhagen, 19 March 2009
Topo Target A/S
Symbion
Fruebjergvej 3
DK 2100 Copenhagen
Denmark
Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-nr: 25695771
www.topotarget.com
Copenhagen, Denmark - March 19, 2009 - TopoTarget A/S (OMX: TOPO) announced
today financial results for the year ended December 31, 2008. In view of the
activities carried out during the year, the financial performance is considered
satisfactory.
• Belinostat: 2008 was the year in which the clinical success of our most
advanced product candidate belinostat was substantiated. Belinostat performed
successfully with durable complete remissions in the treatment of patients with
Cutaneous T-cell lymphomas (CTCL) and Peripheral T-cell lymphomas (PTCL) - and
accordingly we initiated the first belinostat pivotal trial in PTCL. TopoTarget
reacquired global rights to belinostat which as a consequence influenced the
cash position and increased research and development expenses.
• A total of 320 Savene® kits were sold in fourteen European countries and the
sales for 2008 totalled DKK 20.7 million. A total of 316 Totect® kits were sold
in the US for a total of DKK 18.4 million. This was in line with expectations
with sales almost doubled compared with 2007. There is growing awareness of
Savene® and Totect® which continues to gain increasing interest among and
support from healthcare professionals.
• For the year 2008 the Group recorded a loss before tax and before write downs
of certain research and development projects of DKK 212.6 million compared to a
loss of DKK 214.1 million in 2007. This is within the guidance previously given
of pre-tax loss in the range of DKK 195-220 million.
• In view of the activities carried out during the year, the financial
performance is considered satisfactory. In addition a write down of DKK 93.5
million (2007: DKK 0 million) has been made related to certain research and
development projects acquired from third parties and recognized in the balance
sheet at the time of acquisition. Such write-down does not affect the group
cash flow for the year 2008.
• On 31 December 2008 cash and cash equivalents totalled DKK 108.0 million. The
financial resources are expected to be sufficient to carry the company into the
beginning of 2010.
Highlights
The investments made during 2008 by TopoTarget led to the following
achievements:
Belinostat
• Global rights acquired for belinostat
• Pivotal trial with belinostat initiated in the cancer type PTCL
• Positive clinical belinostat results presented, among others:
• ASCO - BelCaP and belinostat monotherapy in ovarian cancer, belinostat in
combination with azacitidine in advanced myeloid neoplasms
• International Conference on Malignant Lymphoma - belinostat in PTCL and CTCL
• ESMO - BelCaP in ovarian cancer
• AACR/NCI/EORTC - BelCaP in bladder cancer, belinostat oral, Belinostat 3 and
6 hours CIV, belinostat in combination with Doxorubicin (BelDox)
• ASH - belinostat with and without Idarubicin (BelIda) in AML both as IV and
as 48 hours CIV
• Fast track designation and positive Special Protocol Assessment (SPA)
response from the FDA for pivotal trial with belinostat in PTCL
After the reporting period:
• Phase I/II study demonstrates that the new high dose of 1.400 mg/m2 daily for
the treatment of patients with inoperable hepatocellular carcinoma (liver
cancer) is very well tolerated
• Randomised Phase II part with belinostat + 5-AZA in patients suffering from
AML and Myeloid Dysplastic Syndrome (MDS)
• Belinostat in combination with 5-FU showed potential to find biomarkers to
identify patients who are likely to gain benefit
• Up-date on PTCL and CTCL which substantiates the strategy for the pivotal
trial in PTCL initiated in December
Marketed product; Savene®/Totect®
• Steady sales increase for Savene®/Totect®
• ONS, EONS and UKONS recommended Savene®/Totect® for the treatment of
anthracycline extravasation in their guidelines and diagnose code created
Organisation
• Streamlined organisation and reduced burn rate significantly
Conference call
TopoTarget hosts a conference call this afternoon, 19 March at 13.00 (CET),
where management will present and discuss the 2008 results.
The conference call will be held in English and slides to accompany the call
can be found on www.topotarget.com , before the start of the conference call.
Dial in details:
DK: +45 70 26 50 40; UK: +44 208 817 9301 and US: +1 7 18 354 1226.
A replay of the conference call will be available one hour after the conference
call and until 26 March 2009 at the following number:
+353 1 436 42 67, security code 1611160#.
TopoTarget A/S
For further information, please contact:
Ulla Hald Buhl Telephone +45 39 17 83 92
Director IR & Communications Mobile +45 21 70 10 49
For the full report see attached PDF-file
