BRESSO, Italy, May 15, 2002 (PRIMEZONE) -- Novuspharma SpA (Nuovo Mercato: NOV.MI) (ISIN:IT0001482444), a biotechnology company focused on cancer, today announced financial results for the first quarter ended March 31, 2002.
Highlights:
-- Continued progress with lead product BBR 2778 for Non-Hodgkin's
Lymphoma (NHL):
- Phase III study in indolent NHL approved by the University of
Pisa (Italy)
- Trial protocol submitted to the U.S. Food and Drug
Administration (FDA) under its Special Protocol Assessment
procedure to reach binding agreement on trial design
- Letter of Intent signed with clinical research organization PRA
Inc. to conduct global studies in indolent and aggressive forms
of the disease
- Phase I combination studies with standard therapy underway in
the U.S. to determine optimum dose for pivotal Phase III
combination studies
-- Phase II trials with BBR 3438 and BBR 3576 are underway in
patients with gastric cancer and prostate cancer refractory to
hormone therapy. A preliminary efficacy evaluation of both
compounds is expected around mid-2002
-- Phase II studies with BBR 3464 continue in non small-cell lung
cancer at a higher dose (1mg/m2)
-- Formed research agreement with Cephalon Inc. (Nasdaq:CEPH) to
discover and develop anti-cancer drugs based on proteasome
inhibitors
-- Loss of EUR 7.3 million (Q1 2001: EUR 3.7 million) in line with
expectations
-- Net cash burn on operating activities EUR 6.8 million (Q1 2001:
EUR 3.8 million)
-- Net financial position at March 31, 2002 of EUR 135.7 million
(December 31, 2001: EUR 141.8 million)
Announced today (see separate release):
-- Acquisition of full rights to anti-angiogenesis research project
from Prolifix Ltd (previously 50:50 owned)
Dr. Silvano Spinelli, Chief Executive Officer, said: "I am pleased to report continued clinical progress during the quarter, particularly with approval of our lead compound BBR 2778 to begin Phase III studies. We also continue to diversify our R&D pipeline. The signing of an agreement with Cephalon to conduct research into a novel class of proteasome inhibitor compounds providing us with valuable European marketing rights, and today's announcement on anti-angiogenesis research, further strengthen our technology base in our chosen field of cancer."
Financial Review
Loss for the first quarter 2002 was EUR 7.3 million (Q1 2001: EUR 3.7 million). The increased loss is in line with expectations and reflects the advanced stage of the Company's products in development, particularly in respect of the large-scale Phase III studies with BBR 2778 for NHL. As a result of this progress, research and development costs were EUR 5.7 million for the first quarter 2002 compared to EUR 3.4 million for the same period in 2001.
Revenues for the first quarter 2002 were largely insignificant as they were derived from third party contract research which does not fall within the Company's core business.
As at March 31, 2001, the Company had a net financial position of EUR 135.7 million compared to EUR 141.8 million at December 31, 2001.
Novuspharma SpA
Profit and Loss highlights
amounts in Euro/000 I Q 2002 I Q 2001
Revenues 8 44
R&D costs - 5.677 - 3.398
Other operating costs - 1.658 - 1.128
EBITDA - 7.327 - 4.482
Depreciation, amortization and
write-downs - 1.188 - 1.048
EBIT - 8.515 - 5.530
Net financial result 1.209 1.856
Result before income taxes - 7.306 - 3.674
Income taxes - -
Result for the period - 7.306 - 3.674
Balance Sheet highlights
amounts in Euro/000 31/03/2002 31/12/2001 31/03/2001
Cash and cash equivalents 87.840 97.342 151.790
Short/medium term
financial investments 47.816 44.495 -
Net intangible and tangible
fixed assets 9.882 10.382 12.197
Total 145.538 152.219 163.987
Net working capital 2.352 1.767 1.528
Long-term obligations 865 825 737
Net equity 142.321 149.627 161.722
Total 145.538 152.219 163.987
Notes to Editors
Novuspharma SpA, based in Bresso, Milan, is a biotechnology company focused on the discovery and development of innovative anti-cancer therapies. It has four products in clinical development and a dynamic research program. Novuspharma was created in 1998 as a spin-off from Boehringer Mannheim and Hoffmann-La Roche, and has a proven track record in product development. Novuspharma makes use of a complete range of discovery and development platforms and focuses its specific expertise on the most critical part of the development process from the initial identification of leads to late clinical development stages as far as New Drug Application.
Novuspharma has recently relocated its headquarters and research operations to join the growing number of start-up biotechnology and healthcare enterprises already situated in Bresso. One of the objectives of the relocation was to enable Novuspharma, as one of Italy's publicly-quoted biotechnology companies, to foster bio-entrepreneurship within the country and encourage the development of an innovative research environment.
BBR 2778 is an intercalating agent with reduced cardiotoxicity conceived and developed by Novuspharma in collaboration with the University of Vermont (UVM). Novuspharma has the exclusive international licence on the original patent to the drug, as well as additional patents to the drug and related production processes.
BBR 3438 is an aza-anthrapyrazolic intercalating agent conceived and developed by the Company on the basis of a patent which is co-owned by Novuspharma and UVM. Novuspharma has obtained an exclusive licence on the patent from UVM.
BBR 3576 belongs to the same chemical class and intellectual property area as BBR 3438. The compound has also proved to be active on a variety of types of solid tumor, and also appears to work in combination with Taxol.
BBR 3464 is part of a class of innovative platinum compounds, including bisplatinum compounds. Novuspharma has an exclusive international licence to the technology from Hoffman-La Roche (HLR). Under the terms of the licence, HLR has option rights on BBR 3464 and other work resulting from the research area.
For further information, please visit the Company's website at www.novuspharma.com.