Algeta ASA : Algeta Results for the Third Quarter 2013

OSLO, Norway, Nov. 6, 2013 (GLOBE NEWSWIRE) --

Intended for US media only Algeta ASA (OSE: ALGETA), a company focused on the development of novel targeted cancer therapeutics, announces its results for the third quarter 2013. A presentation of the results in Oslo will be webcast live from 10:00 CET and can be accessed through www.algeta.com. An international conference call will take place at 14:30 CET/ 08:30 Eastern Time. Details of both events are at the end of this announcement. "We are very pleased with the initial phase of the US commercialization of Xofigo(®) (radium 223 dichloride) injection", commented Andrew Kay, Algeta President & CEO. "Since approval in late May, the launch strategy has been executed well by the teams from Algeta and Bayer, and that is reflected in both the encouraging sales figures for this quarter as well as the number of facilities that are now licensed and ready to treat patients with Xofigo. The recent positive CHMP opinion for Xofigo in Europe is a key step towards its anticipated approval and highlights the need for new therapies for castration- resistant prostate cancer patients." Oystein Soug, Algeta's Chief Financial Officer, added, "The first full quarter of Xofigo sales place Algeta on a clear and defined trajectory towards profitability. Algeta is an ambitious company, and our proven development expertise, our growing commercial experience in oncology and our strengthened financial profile give us the confidence to seek to build a broad portfolio of novel cancer therapeutics beyond Xofigo." Highlights of the third quarter 2013: Xofigo (radium Ra 223 dichloride) * In the third quarter 2013, net sales of Xofigo in the US market (as recognized by Bayer) amounted to NOK 99m (USD 17m). * Xofigo was approved in the US in May 2013, and Algeta and Bayer have been working together to execute the launch strategy. A key focus has been to support the licensing of clinical centers to enable them to start treating patients. Progress has been good, and facility licensing has progressed faster than expected with 626 sites across the US classified as "Patient- Ready" on 18 October. * On 20 September 2013, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Xofigo for the proposed indication of the treatment of adults with castration- resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. The decision of the European Commission (EC) on the approval is expected in the fourth quarter of 2013. * Data from the phase III ALSYMPCA trial were published in the 18 July 2013 issue of the New England Journal of Medicine[1]. * Further analyses of data subsets from the phase III ALSYMPCA study were presented at the 2013 European Cancer Congress (ECCO/ESMO/ESTRO), on 30 September, in Amsterdam, The Netherlands. Corporate * On 4 September 2013, Algeta raised USD 120m from a Convertible Bond offering. The Company intends to use the net proceeds of the offering for general corporate purposes, for its working capital needs and the development of its product candidates. The Company may also use a portion of the net proceeds to invest in products or technologies complementary to its portfolio. * In August, Dr Andreas Menrad was appointed Chief Scientific Officer, bringing more than 20 years of experience in oncology and therapeutic antibody development. He was formerly Chief Scientific Officer at Ablynx NV, and worked previously at Genzyme (Sanofi) as General Manager and Vice President of Antibody Therapeutics. Key financials * Operating revenue for the third quarter 2013 amounted to NOK 55m compared with NOK 60m in the same period in 2012. * Algeta's recognized share of the net result of US co-promotion activities for the third quarter 2013 was an expense of NOK 27m, compared with an expense of NOK 17m in the same period in 2012. Algeta recognizes 50% of the net result of Xofigo co-promotion activities in the US. * Core operating expenses[2], which exclude currency effects, interest income and costs directly related to the commercial launch of Xofigo in the US, for the third quarter 2013 amounted to NOK 124m, compared with NOK 74m in the same period in 2012. * Cash on hand amounted to NOK 1,465m as at 30 September 2013 compared with NOK 369m as of the 31 December 2012. The Third Quarter Report 2013 and accompanying presentation will be available on www.algeta.com from 07:00 CET today. Details of presentation and webcast A presentation by Algeta's executive management team to investors, analysts and the press will take place in Oslo at 10:00 CET. KS-Agenda Møtesenter Haakon VIIs gate 9 0161 Oslo Norway. Details of international conference call Algeta will also host an international conference call at 14:30 CET/08:30 Eastern Time. To participate in the conference call, please dial the appropriate number below five minutes prior to the call: US: +1 877 423 0830 UK: +44 20 7153 9154 Norway: +47 21 06 61 13 Sweden: +46 8-506 443 86 Denmark: +45 32 71 42 62 Switzerland: +41 44 580 65 22 Participant pin code: 873878# To access the replay, please dial: US: +1 877 679 2989 UK: +44 203 364 5200 Norway: +47 23 50 02 03 Sweden: +46 8-505 564 73 Conference reference: 348995# A replay of the conference call will also be available at www.algeta.com. About Xofigo(®) (radium Ra 223 dichloride) Xofigo is approved in the United States and is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Radium Ra 223 dichloride (radium 223) is currently not approved by the European Medicines Agency (EMA) or other authorities outside the US. Bayer submitted a Marketing Authorisation Application to the EMA for radium 223 in December 2012. Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti- tumor effect on bone metastases. The active ingredient in Xofigo is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of radium-223 may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 is less than 100 micrometers which may limit the damage to the surrounding normal tissue[i]. Important Safety Information for Xofigo (radium Ra 223 dichloride) in the US Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman. In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (less than 1%) was similar for patients treated with Xofigo and placebo. Myelosuppression - notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia - has been reported in patients treated with Xofigo. Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure. Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be greater than to equal to 1.5 × 10(9)/L, the platelet count greater than or equal to 100 × 10(9)/L, and hemoglobin greater than or equal to 10 g/dL. Prior to subsequent administrations, the ANC should be greater than or equal to 1 × 10(9)/L and the platelet count greater than or equal to 50 × 10(9)/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care. Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued. Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations. The most common adverse reactions (greater than or equal to 10%) in the Xofigo arm vs. the placebo arm, respectively, were nausea (36% vs 35%) diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (greater than or equal to 10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs.53%), leukopenia (35% vs. 10%), thrombocytopenia (31% vs. 22%), and neutropenia (18% vs. 5%). For full US prescribing information visit: http://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf ### Xofigo(®) is a registered trademark of Bayer AG For further information, please contact: Mike Booth +1 646 410 1884 Communications & Corporate Affairs ir@algeta.com Media enquiries: Mark Swallow +44 207 638 9571 Citigate Dewe Rogerson mark.swallow@citigatedr.co.uk Kari Watson +1 781 235 3060 MacDougall Biomedical Communications kwatson@macbiocom.com Investor enquiries: Tricia Truehart +1 646 378 2953 The Trout Group ttruehart@troutgroup.com About Algeta Algeta is a company focused on developing, manufacturing and marketing novel targeted therapies for patients with cancer. The Company is headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA performing commercial marketing operations in the US. Algeta is listed on the Oslo Stock Exchange (Ticker: ALGETA). For more information please visit www.algeta.com. Forward-looking Statements This news release contains certain forward-looking statements that are based on uncertainty, as they relate to events and depend on circumstances that will occur in the future and which, by their nature, may have an impact on results of operations and the financial condition of Algeta. Such forward-looking statements reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance as to whether such forward looking statements will prove to be correct. These forward looking statements include statements regarding our co-promotion of Xofigo in the US and the development of our other product candidates. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. These factors include, among other things, general economic and business conditions, the impact of competition, the ability to successfully commercialize Xofigo, the risk that costs associated with the co-promotion of Xofigo may be greater than anticipated, the risk that research & business development will not yield new products that achieve commercial success, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for radium 223 and our other products and difficulties of obtaining relevant governmental approvals for new products, and the other risks and uncertainties described in our annual report. [1] Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer, Parker, C. et al. New England Journal of Medicine 2013; 369 (3) 213-223. [2] Defined as the sum of External R&D expenses, Payroll and related costs, Depreciation and General and Administrative expenses. Core operating expenses do not include costs from co-promotion activities. [i] XOFIGO Prescribing information. May 2013 Third Quarter Presentation 2013: http://hugin.info/134655/R/1740799/584684.pdf Press Release: http://hugin.info/134655/R/1740799/584686.pdf Third Quarter Report 2013: http://hugin.info/134655/R/1740799/584682.pdf [HUG#1740799] Source:Algeta ASA