Bavarian Nordic A/S - Half Year Interim Report 2009
28 Agosto 2009 - 7:00AM
PR Newswire (US)
KVISTGAARD, Denmark, August 28 /PRNewswire-FirstCall/ -- Today
Bavarian Nordic published the company's half-year interim report
2009. The full financial statements are available on the company's
website: http://www.bavarian-nordic.com/. Below is an extract of
the most significant matters in the report as well as events after
the balance sheet date. In the first half of 2009 Bavarian Nordic
generated revenue of DKK 33 million and recorded a loss before tax
of DKK 188 million. As of 30 June 2009 the Group's net free
liquidity was DKK 489 million. Bavarian Nordic's new prostate
cancer vaccine - PROSTVAC(TM) has been further validated and shows
blockbuster potential. Bavarian Nordic is progressing the
development and Phase III preparations of PROSTVAC(TM): - End of
phase II meeting with the FDA in Q4, 2009 and expected initiation
of Phase III in 2010 - Five ongoing clinical Phase I and II studies
in different patient populations - Preparing the production for
Phase III studies - Scientific publication of data - Ongoing
discussions with prospective licensing partners The U.S. Food and
Drug Administration (FDA) has performed a GMP inspection of the
IMVAMUNE(R) manufacturing facilities. These GMP inspections
occurred at both Bavarian Nordic's Kvistgaard facility and at IDT
in May 2009. The management of Bavarian Nordic consider these
inspections to be successfully completed, and the corrective
actions triggered by the inspections will be implemented within
short time, causing no further investments. Bavarian Nordic has an
ongoing and positive dialogue with FDA which confirms the
expectations to start deliveries of IMVAMUNE(R) under the RFP-3
contract following the satisfactory implementation of the
corrective actions. On this background the company expects delivery
of IMVAMUNE(R) to the US government to be initiated during the
period between fourth quarter of 2009 and the end of second quarter
2010. As the company is awaiting the exact timing of the FDA review
and final acceptance the timing of the actual initiation of
delivery is at present uncertain. In order to reflect this, the
expectations for the financial result for the full year 2009 are at
present indicated as a range. The expected revenue of DKK 375
million was based on the delivery of 2 million doses of IMVAMUNE(R)
in 2009. Depending on the timing for initiation of delivery, the
revenue is now expected to be in the range of DKK 100-300 million,
based on a maximum delivery of 1.5 million doses. The result before
tax is expected to be a loss between DKK 275-325 million
(previously DKK 225 million). The net free liquidity at year-end is
expected to be in the range between DKK 175-350 million (previously
DKK 400 million). Bavarian Nordic maintains its long-term
expectations to the net free liquidity to be around DKK 800 million
by year-end 2012. In order for the company to maintain a solid cash
position, the company has implemented a number of operational
activities, thus postponing certain costs and investments until
deliveries under RFP-3 can begin. IMVAMUNE(R) - third generation
smallpox vaccine candidate Deliveries under the RFP-3 contract In
order to initiate the delivery of the 20 million doses of
IMVAMUNE(R) to the US under the RFP-3 contract, Bavarian Nordic has
to fulfil certain requirements set by the U.S. Food and Drug
Administration (FDA) to potentially support the use of IMVAMUNE(R)
following a declared emergency. These requirements include animal
efficacy data, clinical safety data and the demonstration that the
manufacturing of IMVAMUNE(R) is in accordance with industry
standards associated with a marketed product. Bavarian Nordic has
successfully completed a number of data submissions to the FDA in
this regard the latest in November 2008. Bavarian Nordic's
published timelines for initiating delivery in 2009 was based on an
assumption of the timely review and acceptance of Bavarian Nordic's
last summary data submission made in November 2008. This data
submission triggered a USD 25 million milestone payment and
represented the successful completion of a major milestone of the
RFP-3 contract. The completion of the milestone from BARDA followed
by an FDA review of the data was expected to be the last hurdle
before deliveries under the RFP-3 contract could start. However, by
the spring this year, the FDA responded to this submission with the
notice that, as a final step before deliveries, they would perform
a Good Manufacturing Practice (GMP) inspection of the IMVAMUNE(R)
manufacturing facilities. These GMP inspections were carried out at
both Bavarian Nordic's Kvistgaard facility and IDT (the company's
contract filling partner, already GMP approved by the European
authorities) in May 2009. While the FDA did not raise any concerns
regarding the facilities or the IMVAMUNE(R) validated manufacturing
process, a number of observations were noted, requiring corrective
actions. This is usual following an inspection by regulatory
authorities. The company has already initiated its responses to
these observations but the corrective actions and FDA review and
acceptance will take additional months. Implementation of the
corrective actions will cause no further investments. While this
represents a delay in the planned delivery of IMVAMUNE(R),
following review of the data, the FDA have not raised any concerns
regarding the animal, clinical or manufacturing data that has been
submitted to support the use of IMVAMUNE(R) in a declared
emergency. Thus satisfactory implementation of the corrective
actions following the FDA inspection should trigger the start of
IMVAMUNE(R) delivery. Therefore the company expects delivery of
IMVAMUNE(R) to the US government to be initiated during the period
between fourth quarter of 2009 and before the end of second quarter
2010. Negotiations with the US authorities for the further
development of IMVAMUNE(R) The US authorities have initiated
negotiations with Bavarian Nordic for a new contract to develop a
freeze-dried version of the IMVAMUNE(R) smallpox vaccine. This
potential new project will have no influence on the ongoing RFP-3
contract for the procurement of 20 million doses of IMVAMUNE(R) and
the licensure of the current liquid-frozen formulation, but
represents an additional business opportunity. Earlier this year
BARDA published a Broad Agency Announcement (BAA) soliciting
proposals for the advanced development of medical countermeasures
against chemical, biological, radiological and nuclear (CBERN)
threats. In June, Bavarian Nordic submitted a proposal for the
development of a freeze-dried formulation of the MVA-based smallpox
vaccine, IMVAMUNE(R). The proposal included the validation of the
production process and the preclinical and clinical development to
support the use of the new freeze-dried formulation of IMVAMUNE(R)
following a declared emergency. A freeze-dried formulation of
IMVAMUNE(R) offers various new advantages in terms of increased
shelf-life and improved stability of the vaccine compared to the
current liquid-frozen formulation. Additionally, this will improve
the cold-chain shipping logistics and storage. These are all
important criteria for governments around the world that prioritise
their bio terror preparedness. The new technology for freeze-drying
the vaccine will also be applicable for other MVA-BN(R) based
vaccines. PROSTVAC(TM) - therapeutic prostate cancer vaccine
candidate In February 2009 PROSTVAC(TM) data were presented at the
2009 Genitourinary Cancers Symposium in Orlando, Florida. The data,
collected from three different studies confirm the excellent safety
and efficacy results previously reported, and they support the
further investigation in patients suffering from advanced prostate
cancer. Also, the data indicate that PROSTVAC(TM) can be used in
earlier disease settings and thus in a larger patient population.
In May 2009 detailed PROSTVAC(TM) data were presented at the 2009
ASCO Annual Meeting in Orlando, Florida. The presentation was made
by Philip Kantoff MD, Professor of Medicine, Harvard Medical
School, and the Dana-Farber Cancer Institute who is also the
principal investigator of the study. The more detailed analysis
supports the headline data that were reported in October 2008. In
the Phase 2 double-blind, prospective randomized placebo-controlled
study of 125 patients with metastatic prostate cancer, patients in
the PROSTVAC(TM) group had a significantly longer median overall
survival by 8.5 months compared to the control group. The hazard
ratio estimate for overall survival from the study is 0.56 (95% CI
0.37-0.85). The statistical significance in the final data set is
(p=0.006). These data were improved compared to the headline data
presented in the fall in connection with the first announcement.
PROSTVAC(TM) immunotherapy was well tolerated, with some patients
having injection site reactions (40-60%), and brief systemic
symptoms of fatigue, fevers, and chills (10-30%) reported. In July
2009, a review on PROSTVAC(TM) from key investigators from the
National Cancer Institute (NCI) was published in the publication
"Expert Opinion on Investigational Drugs", Volume 18, Issue 7 2009.
This is the most comprehensive and updated review on PROSTVAC(TM)
so far. Quote from the article: "Preliminary clinical trials have
indicated negligible toxicity, and Phase II trials have suggested a
survival benefit after treatment with PROSTVAC(TM), especially in
patients with indolent disease characteristics." A PROSTVAC(TM)
abstract has been accepted for an oral presentation at the European
CanCer Organisation (ECCO), ECCO 15 - 34th ESMO Congress, taking
place in Berlin September 20-24 2009. Ongoing PROSTVAC(TM) studies
There are a number of ongoing clinical studies with PROSTVAC(TM) in
both early and late stage prostate cancer, all of which are funded
and conducted by NCI under the ongoing collaboration with Bavarian
Nordic. Ongoing studies with active patient enrolling: - Phase II
study comparing the radioactive drug, samarium with or without
PROSTVAC(TM) therapy in men with metastatic prostate cancer - Phase
II study comparing antihormone therapy (flutamide) with or without
PROSTVAC(TM) therapy in men with non-metastatic prostate cancer
Ongoing studies with enrolment completed: - Phase II study
investigating PROSTVAC(TM) in men with PSA progress after local
therapy (surgery and/or radiation) - Phase I dose-escalation,
combination study with PROSTVAC(TM) and MDX-010 (CTL4-antibody) in
men with metastatic prostate cancer - Phase I study investigating
PROSTVAC(TM) by intraprostatic injection in patients with
progressive or locally recurrent prostate cancer Forward-looking
statements This announcement includes "forward-looking statements"
that involve risks, uncertainties and other factors, many of which
are outside of our control that could cause actual results to
differ materially from the results discussed in the forward-looking
statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance
and/or other information that is not historical information. We
undertake no obligation to publicly update or revise
forward-looking statements to reflect subsequent events or
circumstances after the date made, except as required by law. About
Bavarian Nordic Bavarian Nordic A/S is a leading industrial
biotechnology company developing and producing novel vaccines for
the treatment and prevention of life-threatening diseases with a
large unmet medical need. The company's pipeline is focused in the
three areas; biodefence, cancer and infectious diseases, and
includes seven development programmes. Two programmes are ready for
Phase III: IMVAMUNE(R), a third-generation smallpox vaccine is
being developed under a contract with the US government, and
PROSTVAC(TM), a therapeutic vaccine for advanced prostate cancer is
being developed under a collaboration agreement with the National
Cancer Institute. Bavarian Nordic is listed on NASDAQ OMX
Copenhagen under the symbol BAVA. For more information please visit
http://www.bavarian-nordic.com/ DATASOURCE: Bavarian Nordic A/S
CONTACT: Contact: Anders Hedegaard, President & CEO, Bavarian
Nordic, +45-23-20-30-64
Copyright