HORSHOLM, Denmark, July 14 -- The Board of Directors of Santaris Pharma has
approved the Interim Report for the period 1 January to 30 June 2009.
- The loss after tax realised in the 2nd quarter of 2009 was 21,6m DKK (2,9m
EUR) compared to 29,8m DKK (4,0m EUR) in the 2nd quarter of 2008. - As at June
30, 2009 the capital resources totalled 175,4m DKK (23,6m EUR). - In Q2 the
SPC3649 compound targeting hepatitis C finalized a single dose First/In/Man
study with encouraging results and a multiple ascending dose study in healthy
volunteers is scheduled to commence in Q3 2009. - Santaris Pharma’s new
lead candidate SPC4955 targeting apoliproteinB, the major cholesterol carrying
protein in the blood, has been selected for preclinical trials. - Lead
candidates targeting PCSK9, which is known to play a critical role in regulating
cholesterol levels, have been selected for pharmacological studies. - The
Collaboration with the Company’s 3rd partner, Wyeth, was initiated during
the first months of 2009 and is progressing according to the plan.
(Logo: http://www.newscom.com/cgi-bin/prnh/20090420/344344 )
During the first half of 2009 Santaris Pharma continued to make satisfactory
progress in its research and development programs within miRNA, metabolic
disorders and infectious diseases. Key milestones achieved and other events
during the quarter are summarized below.
Development
SPC3649-HCV
SPC3649 is a potent and specific inhibitor of microRNA-122 known to be involved
in cholesterol metabolism and in hepatitis virus replication in the liver. In
April 2009, Santaris Pharma completed a Phase I First-in-Man single dose study
of SPC3649 with 60 healthy volunteers and the Company expects to publicize the
encouraging results of this study in the 2nd half of the year. An IND regarding
a Phase I multiple dose clinical study with SPC3649 in healthy volunteers has
been submitted and the trial is scheduled to be commenced later in 2009. Further
a three months tox study will be initiated during the 2nd half of 2009.
EZN2968-HIF-1alpha
Santaris Pharma’s collaboration partner Enzon Pharmaceuticals announced
preliminary results of the jointly developed Hif-1alpha inhibitor targeting
solid tumors at the AACR meeting in May. Enzon expects to report the results of
its phase I clinical trials targeting solid tumors with EZN2968 in the 2nd half
of 2009. Further Enzon has announced its intention of initiation of a phase II
trial with this compound later in 2009.
SPC2996-CLL
In accordance with Santaris Pharma’s refocusing of own development
activities within metabolic disorders and infectious diseases, it has been
decided to divest the activities within the development of SPC2996 targeting
CLL. This process is ongoing.
EZN3042-Survivin
In February 2009 Santaris Pharma’s collaboration partner Enzon
Pharmaceuticals initiated a phase I clinical trial in solid tumors with the
LNA-based drug Survivin targeting cancer.
SPC4955-ApoB inhibitor
Santaris Pharma has in rodent and primate studies shown that ApoB inhibitors
are able to lower LDL cholesterol and triglycerides effectively. In Q2 2009 the
Company selected a lead candidate SPC4955 for preclinical development.
PCSK9-inhibitors
Santaris Pharma has selected lead candidates targeting PCSK9 related to high
cholesterol. These candidates are ready for pharmacological studies.
Collaborations
Santaris Pharma has collaboration agreements with three partners, covering up
to 22 novel LNA-based RNA therapeutics:
Wyeth Pharmaceuticals (December 2008)
By the end of 2008 Santaris Pharma entered into an agreement with Wyeth
Pharmaceuticals, covering 10 LNA-based drug candidates targeting various
diseases selected by Wyeth. Under the terms of the collaboration Santaris Pharma
will design and generate the drug compounds and Wyeth will be responsible for
all preclinical- and clinical development as well as the commercialization on a
worldwide basis.
GlaxoSmithKline Collaboration (December 2007)
Under the terms of the collaboration with GlaxoSmithKline (GSK) on new drugs
for the treatment of viral diseases, Santaris Pharma is responsible for the
discovery and development of RNA inhibiting drug candidates through to
completion of Phase IIa (Clinical Proof of Concept) for four viral targets, at
which point GlaxoSmithKline will have an exclusive option to license each
compound for further development and commercialisation on a worldwide basis.
Presently GSK has selected one viral disease target and Santaris Pharma has
identified several strong drug candidates against the target.
Enzon Collaboration (August 2006)
Under the terms of the collaboration with Enzon Pharmaceuticals, Santaris
Pharma will design and generate a total of eight drug candidates and Enzon will
fund and manage the preclinical- and clinical development of the drug candidates
and file for regulatory approvals outside Europe. Santaris Pharma has maintained
all commercial rights for the eight drug candidates in Europe.
Enzon is expected to disclose final results from the clinical development of
EZN/SPC2968, a HIF-1alpha inhibitor, which is currently being evaluated in two
separate Phase I/II clinical trials in patients with advanced solid tumors, in
the 2nd half of 2009.
Enzon has initiated a Phase I study in various solid tumors for EZN/SPC3042,
the Survivin inhibitor, in the 1st quarter of 2009.
In addition to EZN/SPC2968 and EZN/SPC3042 Enzon has now received all the
remaining six novel cancer drug candidates from Santaris Pharma and Enzon has
announced the targets for four of these compounds: Her3, beta catenin, PIK3CA
and the androgen receptor.
Pipeline Summary
In H1 2009 Santaris Pharma continued the progress for both the drug discovery
programs and the drug development pipeline. At the end of June Santaris Pharma
had four drugs in clinical development:
- SPC3649, an LNA-antimiR(R) against microRNA-122, being developed for the
treatment of HCV infections - EZN/SPC2968, a HIF-1alpha inhibitor, being
developed for the treatment of various solid tumors - SPC2996, a Bcl-2
inhibitor, being developed for the treatment of cancer. Santaris Pharma has
initiated the process of divesting this candidate - EZN3042, an LNA-based
Survivin inhibitor, being developed for the treatment of various solid tumors
In addition to the four clinical development stage compounds Santaris Pharma
and its partners have several other compounds in the discovery, research and
preclinical stages, including the new apoB inhibitor, SPC4955 which now enters
preclinical development and the PCSK9 lead candidates which are ready for
pharmacological studies.
See Santaris Pharma’s pipeline through this link:
http://www.santaris.com/Library/documents/Santaris_Pharma_Interim_Report_1_Ja
nuary_to_30_June_2009.pdf
(Due to the length of this URL, it may be necessary to copy and paste this
hyperlink into your Internet browser’s URL address field. Remove the space
if one exists.)
Research
During H1 2009 Santaris Pharma and/or partners have published six scientific
articles and more have been submitted for publication:
Proc Natl Acad Sci USA
In the January 2009 issue of the journal Proc Natl Acad Sci USA Santaris Pharma
and its collaboration partner Claes Wahlestedt published data on LNA-based
inhibition of microRNA-219 associated with schizophrenia.
Clin Cancer Research
In January 2009 Santaris Pharma and academic partners publiched an article
titled: Uncovering growth suppressive microRNAs in lung cancer.
Cancer Research
In January 2009 Santaris Pharma published an article titled: microRNA silencing
in primates: Towards development of new therapeutics.
Clin Cancer Res
In first half of 2009 Santaris Pharma and academic partners published an
article titled: Uncovering growth suppressive microRNAs in lung cancer
Nature Cell Biology
In first half of 2009 Santaris Pharma and academic partners published an
article titled: A functional screen implicates microRNA-138-dependent regulation
of the depalmitoylation enzyme APT1 in dendritic spine morphogenesis.
BMC Med Genomics
In June 2009 Santaris Pharma and academic partners published an article titled:
Identification and analysis of miRNAs in human breast cancer and teratoma
samples using deep sequencing.
During H1 2009 the Company made presentations at several scientific
conferences:
- Small RNAs and cancer/Paris/France - Keystone, Scientific Advisory Board
Meeting/Colorado/USA - Executing the promise of RNAi/Cambrigde/MA/USA - Cell
Gene Therapy/Washington/USA - St. Kitts microRNA symposium/(organizer)/St.
Kitts/ Caribbean - Molecular Imaging and Drug Development/London/UK - BioEurope
Spring/Milan/Italy - microRNAs in human disease/Boston/USA - Girindus Leadership
in Oligonucleotides Symposium/Ohio/USA - Innov. Biotechn. Seoul, South Korea -
microRNA in Denmark, BRIC, Cph. University, Denmark - European Association for
the Study of the Liver, Copenhagen - AACR, Annual meeting. - 15th Annual
Scandinavian Atherosclerosis Conference - Meeting Medicon Valley arranged by
Medicon Valley Alliance, Cph. - DxRx Summit, Boston, USA - Danish Biotech Annual
Meeting - Tides, Las Vegas, USA - BIO, Vancouver, USA - microRNA Symposium 2009,
Vienna. - DDD Meeting Japan - SMI 4th conference on RNAi, miRNA and siRNA - XV
International Symposium on Atherosclerosis - 4th Nucleic Acid Chemical Biology
(NACB) Symposium, Odense
Santaris Pharma is represented in the Advisory Board of the Keystone Symposia.
Guidance for 2009
Santaris Pharma guidance for the year ending 31 December 2009 is a loss after
tax in the range of DKK 115 - 125 million.
Flemming Ornskov Soren Tulstrup
Chairman of the Board President and CEO
FINANCIAL REVIEW
The Financial Statements in this Interim Report are presented in accordance
with IAS 34 as adopted by the EU and additional Danish disclosure requirements
for Interim Reports of listed companies. The accounting policies are consistent
with those applied in the Annual Report for 2008. The Interim Report is
un-audited and un-reviewed.
The Income Statement, the Balance Sheet, the Statement of change in Equity, the
Cash Flow Statement and the Cap table are presented below.
Income Statement (1 January - 30 June 2009)
The loss after tax realised in the 2nd quarter of 2008 was 21,6m (2,9m EUR)
compared to 29,8m DKK (4,0m EUR) in 2008. The accumulated loss after tax for the
first half of 2009 was 34,5m DKK (4,6m EUR) compared to 65,6m DKK (8,8m EUR) in
2008.
The Revenues for the 2nd quarter 2009 amounted to 12,6m DKK (1,7m EUR) compared
to 23,1m DKK (3,1m EUR) for the same period last year.
Following the refocusing of the Company’s activities, the organisation
has been significantly reduced and the total research, development and
administrative cost for the 2nd quarter of 2009 has, compared with 2nd quarter
of last year, been reduced by 21,1m DKK (2,8m EUR). The year to date saving for
the period 1 January to 30 June 2009 compared to the same period in 2008 was
29,7m DKK (4,0 EUR).
The Net Financial Income in the first half of 2009 was 9,6m DKK (1,3m EUR)
compared to 6,3m DKK (0,8m EUR) in 2008.
Balance Sheet and Cash Flow
As at June 30 2009, the Company had total assets of 234,6m DKK (31,5m EUR) of
which the Cash Cash Equivalents amounted to 175,4m DKK (23,6m EUR). This cash
position is, subject to the Company’s receipt of certain milestone
payments related to the ongoing collaboration activities, expected to be
sufficient to finance the Company’s operations beyond 2010.
The total Equity on June 30 2009 amounts to 187,5m DKK (25,2m EUR).
See Income Statement, Balance sheet, Statement of Change in Equity, Cash Flow
statement, and Cap Table through this link:
http://www.santaris.com/Library/documents/Santaris_Pharma_Interim_Report_1_Ja
nuary_to_30_June_2009.pdf
(Due to the length of this URL, it may be necessary to copy and paste this
hyperlink into your Internet browser’s URL address field. Remove the space
if one exists.)
MANAGEMENT’S STATEMENT
The Board of Directors and Executive Management today considered and approved
the Interim Report for the period 1 January to 30 June 2009. The Interim Report,
which is unaudited and unreviewed, is presented in accordance with international
accounting standards. We consider the accounting policies to be appropriate to
the effect that the Interim Report gives a true and fair view of the
Company’s assets and liabilities, financial position, results of
operations and cash flows. Furthermore, we consider the Interim Report to give a
true and fair statement of the developments in the Group’s activities and
financial affairs, results of operations and the Company’s financial
position as a whole as well as a description of the significant risks and
uncertainties the Company faces.
Board of Executives Soren Tulstrup Henrik Stage President CEO Vice President
CFO Board of Directors Flemming Walter Claus Soren Carlsen Ornskov Wenninger
Braestrup Chairman Vice Chairman Director Director Edwin de Graaf Anders Hinsby
Martien van Holger Osch Reithinger Director Director Director Director
Santaris Pharma forward looking statements
This written announcement contains forward-looking statements, identified by
the use of words such as believes, expects, may, will, should, potential,
anticipates, plans or intends and similar expressions. Such forward-looking
statements involve risks, uncertainties and other factors that may cause actual
results, events or developments to be materially different from the future
results, events or developments indicated in this announcement. Such factors
include, but are not limited to the timing, success and cost of clinical
studies; the ability to obtain regulatory approval of products, market
acceptance of and future demand for Santaris Pharma products and the impact of
competitive products and pricing. These factors should be considered carefully
and readers are cautioned not to place undue reliance on such forward-looking
statements. No assurance can be given that the future results covered by the
forward-looking statements will be achieved. All information in this press
release is as of the date of this press release and Santaris Pharma does not
intend to update this information.
For further information please contact: Henrik Stage, Chief Financial Officer
Direct phone +45-4517-9888 Cell +45-4026-0900 E-mail: hs@santaris.com Randi
Krogsgaard, Director, Corporate Communications Direct phone +45-4517-9879 Cell
+45-2048-8384 E-mail: rmk@santaris.com
SOURCE: Santaris Pharma
For further information please contact: Henrik Stage, Chief Financial Officer,
Direct phone +45-4517-9888, Cell +45-4026-0900, E-mail: hs@santaris.com. Randi
Krogsgaard, Director, Corporate Communications, Direct phone +45-4517-9879, Cell
+45-2048-8384, E-mail: rmk@santaris.com
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