MILAN, Italy, August 7, 2003 (PRIMEZONE) -- Novuspharma SpA (Nuovo Mercato:NOV.MI), a biopharmaceutical company focused on cancer, today announces financial results for the six months ended 30 June 2003 and an update on its clinical development programmes.
Highlights: - Merger agreement signed with Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) to create a leading company focused on the development of cancer therapeutics. This transaction is expected to close in Q4 2003, with Novuspharma shareholders receiving approximately 16 million shares of CTI. - In June, a proposed development programme was disclosed for Pixantrone in patients with third line aggressive NHL, which could provide a second option for registering the product in the United States. Pending the results of the discussion with the FDA, a pivotal trial in this indication is expected to start in early 2004, with enrolment completed in one year. - Positive results presented for Pixantrone in the new BSHAP regimen at the 32nd Annual Meeting of the International Society for Experimental Haematology. - Positive results presented for BBR 3576 in hormone refractory prostate cancer (HRPC) at the 2003 Annual Meeting of the American Society of Clinical Oncology (ASCO). - Net loss for the first six months of 2003 of euro17.0 million (H1 2002: euro13.1 million). This increase reflects the advanced stage of our clinical programmes and is in line with projections. - Cash balance at 30 June of euro96.0 million (31 December 2002: euro109.8 million).
Mr Silvano Spinelli, Chief Executive Officer, said:
"We continue to obtain very positive results from our products, while keeping a tight control on costs. Most significantly, our planned merger with CTI, announced in June, will create one of the leading biopharmaceutical companies focused on haematology and oncology. With plans for integrating the two businesses now well advanced, we look to the future with great confidence."
Enquiries:
Novuspharma SpA
Karl Hanks Tel: +39 02 61035807
Mobile +39 335 7882247
Financial Dynamics
Jonathan Birt Tel: +44 (0) 20 7831 3113
Francetta Carr
For further information, please visit the Company's website at www.novuspharma.com.
CHIEF EXECUTIVE OFFICER'S REVIEW
FINANCIAL REVIEW
Revenues for the six months ended 30 June 2003 were euro1.7 million, compared to euro2.7 million in the first six months of 2002. Revenues in the period were mainly due to public grants supporting Novuspharma's research programmes.
Net loss for the period was euro17.0 million compared with euro13.1 million in 2002. This increase was in line with the Company's expectations and reflects the advanced stage of the products in clinical development, particularly the large-scale studies with Pixantrone for NHL.
The Company's cash balance as of 30 June 2003 was euro96.0 million (31 December 2002: euro109.8 million), leaving Novuspharma well financed to achieve its goals in 2003 and beyond.
UPDATE ON THE MERGER AGREEMENT WITH CELL THERAPEUTICS INC. (CTI)
- On 17 June, Novuspharma announced an agreed merger with Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC), a Seattle, US-based biopharmaceutical company focused on the development of improved cancer therapeutics. CTI currently markets TRISENOX(R) in the US and Europe for relapsed / refractory acute promyelocytic leukaemia (APL) and is developing XYOTAX(TM) (CT- 2103), which is in pivotal phase III trials for lung cancer. - The merger is expected to close in the fourth quarter of 2003. Since the announcement of the merger, an integration team has been established and significant progress has been made in identifying potential operating and cost synergies between the two companies. CLINICAL PROGRAMMES Pixantrone - In June, a proposed development programme was disclosed for Pixantrone in patients with third line aggressive NHL, which could provide a second option for registering the product in the United States. Novuspharma and CTI are hoping to meet the FDA later this year to discuss this strategy, which is based on conducting a single, non-comparative, open label trial, using single agent Pixantrone in aggressive NHL. This trial would include aggressive NHL patients who had failed at least two lines of prior therapy. This represents an indication for which there are currently no FDA approved products. - Pending the results of the discussion with the FDA, a pivotal trial in aggressive NHL could start in early 2004, with completion of enrolment in one year. The filing of an NDA for Pixantrone would therefore be projected in the fourth quarter of 2005, with market launch anticipated in 2006, in line with previous projections. - Novuspharma is currently conducting a phase III trial for Pixantrone in combination with rituximab in patients with relapsed indolent NHL. In view of the new registration strategy outlined above, this trial could be used to support the marketing of Pixantrone, as well as to provide additional safety data. Recent clinical results - In July, Novuspharma presented preliminary positive results from a phase I combination trial for Pixantrone in relapsed aggressive NHL, at the 32nd Annual Meeting of the International Society for Experimental Haematology. In this trial Pixantrone was used in the new BSHAP combination (Pixantrone, cytarabine, methylprednisolone and cisplatin). The results revealed an objective response rate of 58% (11/19 patients) with an impressive 32% achieving complete disappearance of their tumours. - In June, Novuspharma presented the results of a single agent phase II study for BBR 3576 in hormone refractory prostate cancer (HRPC) at the 2003 annual meeting of the American Society of Clinical Oncology (ASCO). These results revealed a promising PSA response rate of 25% and evidence of BBR 3576's ability to control the pain suffered by patients.
Notes to Editors
Novuspharma SpA based in Bresso, Milan, is an emerging biopharmaceutical company leveraging its expertise in the field of oncology to discover and develop innovative new treatments for cancer. It has three products in clinical development and a dynamic research programme. Novuspharma was established in 1998 following the merger of Boehringer Mannheim and Hoffmann-La Roche, to exploit the R&D team's proven track record in product development. On June 17, 2003, Novuspharma announced it had signed a merger agreement with Cell Therapeutics (CTI) of Seattle. CTI is a public biopharmaceutical company, which markets TRISENOX(R) in the US and Europe and is developing XYOTAX(TM) (CT-2103), which is in pivotal phase III trials for non-small cell lung cancer.
Profit and Loss highlights amounts in euro/000 H1 2003 H1 2002 Revenues 1,718 2,674 R&D costs -11,342 -11,716 Other operating costs -6,053 -3,576 EBITDA -15,677 -12,618 Depreciation, amortisation and write-downs -3,457 -2,324 EBIT -19,134 -14,942 Net financial income 2,105 1,852 Net loss for the period -17,029 -13,090 Balance sheet highlights amounts in eurouro/000 30/06/2003 31/12/2002 30/06/2002 Net financial position 96,008 109,842 127,460 Other current assets 9,934 11,001 7,703 Net intangible and 5,798 7,941 9,715 tangible fixed assets Total assets 111,740 128,784 144,878 Short-term liabilities 9,888 10,216 7,444 Long-term obligations 1,315 1,002 897 Net equity 100,537 117,566 136,537 Total liabilites and net 111,740 128,784 144,878 equity