Announcement no. 1/2008
To the OMX Nordic Exchange Copenhagen, January 21,
2008
Curalogic seeks new development projects
Summary: Curalogic has initiated a search process to identify development
projects offering an attractive risk profile that can replace the company's
previous pipeline of clinical projects. Curalogic discontinues the development
of oral immunotherapy, minimizing its burn rate. Curalogic expects to conclude
an agreement during 2008 that will secure future clinical development projects
for the company.
On December 21, 2007, Curalogic announced top line results from a Phase III
clinical study (RPE 04) with the product for the treatment of ragweed allergy.
Curalogic has subsequently conducted a detailed analysis of all study results
with its clinical advisers.
The conclusion is that the tested dose of the ragweed product is not efficacious
with respect to the primary and secondary efficacy measures. There is no
difference in allergy symptoms between the active group and the placebo group,
which indicates that much higher doses are required to continue with the current
formulation. The results are very surprising, because the study was conducted
during a good pollen season with relevant patients and because the patients in
the active group had concentrations of ragweed specific antibodies
(immunoglobulins) in their blood similar to the concentrations achieved with
injection and sublingual immunotherapy. The discussion with experts has failed
to shed light on the cause of the lack of effect on allergy symptoms. Curalogic
believes that the formulation must be optimized to achieve efficacy in the
ragweed product.
The active compounds in the grass and house dust mite products are proteins just
like the active compounds in the ragweed product and the formulations are
identical to the formulation of the ragweed product. Curalogic therefore
believes that the negative results of the RPE 04 study indicate that the
likelihood of achieving positive results with the grass and house dust mite
products is significantly reduced.
Curalogic has conducted a detailed strategic review of the future development of
the company's pipeline of oral allergy products. On the one hand, data from the
RPE 04 study shows that the ragweed pollen extract reaches the immune system,
but on the other hand the lack of understanding of the cause of the lack of
efficacy means that optimizing of the formulation will be a research project.
This means that the development of the company's pipeline will be set back
several years and that the risk profile will be materially adversely affected.
Curalogic has therefore decided to discontinue the development of its oral
immunotherapy projects internally.
Curalogic now intends to initiate a search process to find development projects
offering an attractive risk profile that can replace the company's previous
pipeline of clinical projects. Curalogic expects to conclude an agreement during
2008 that will secure future clinical development projects for the company.
As a result of this decision, Curalogic terminates the ongoing study with the
grass product (GPE 03). The company's ongoing study with the house dust mite
product (DME 01) is close to completion and therefore this study will not be
terminated. All other development activities, including production optimization,
stability testing, etc., have already been terminated. As a result of the lower
level of activity, the staff will be reduced from 14 to seven employees.
At 31 December 2007, Curalogic's cash resources totaled approximately DKK 330
million (unaudited figures). Estimated costs payable for 2007 and costs in
connection with discontinuing the ongoing development activities are assessed at
a total of around DKK 60 million.
For the financial year 2008, Curalogic expects to incur costs for operating the
company in the range of DKK 24-28 million. To this should be added expected
interest income at the level of DKK 11-12 million. The company expects to incur
a total loss in the range of DKK 13-16 million in 2008. Based on these
projections, Curalogic's cash resources at December 31, 2008 are expected to
range from DKK 255-260 million.
Peter Moldt, CEO, said: “I am confident that oral immunotherapy works, but the
development has been set back several years with the data from the RPE 04 study
and has become much riskier. Instead of conducting research into whether the
formulation for oral immunotherapy can be optimized, I am confident that we can
create more shareholder value by focusing on what we do best - namely clinical
development. Owing to our business model, we are able to reduce our costs to a
low level until we have found the right development project. Fortunately, we
have a buyer's market right now and we have something that is of great value to
many biotech companies today - we are listed, we have ample cash resources and
we have a strong expertise in developing drugs.”
Curalogic's annual report for 2007 will be released on March 12, 2008. The
company's annual general meeting is planned for April 21, 2008. Curalogic's
board of directors intends to propose a resolution to the annual general meeting
that the company be authorized to buy back treasury shares. The company's
financial calendar for 2008 will be published in a separate announcement
released later today.
Yours sincerely
Curalogic A/S
For additional information, please contact:
Peter Moldt, President and CEO Phone +45 99 99 24 00, mobile +45 26 25 04 22
Helle Busck Fensvig, EVP and CFO Phone +45 99 99 24 00, mobile +45 20 70 55 37
About Curalogic
Curalogic is a Danish biopharmaceutical company listed on the OMX Nordic
Exchange (CUR.CO) as a small cap + company. Curalogic has ample cash resources
and has demonstrated its ability to conduct complex clinical studies with a
small group of development experts.
This announcement contains forward-looking statements regarding the Company's
future financial development and performance and other statements which are not
historical facts. Such statements are made on the basis of assumptions and
expectations which, to the best of the Company's knowledge and belief, are
reasonable, at this time, but may prove to be erroneous in the future.
