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COPENHAGEN, Denmark, Aug. 12, 2015 (GLOBE NEWSWIRE) -- Interim Report First Half 2015
"During the second quarter we continued to see steady advances in our two most advanced programs, daratumumab and ofatumumab. The daratumumab program continues to progress very rapidly with the first regulatory application submitted in the U.S. by Janssen Biotech, Inc. under our collaboration. Together with Novartis, we reported positive top-line results in a pivotal study of ofatumumab in combination with fludarabine and cyclophosphamide in relapsed CLL; the data will be shared with the regulatory authorities to determine the potential for regulatory filings. Regulatory submissions for ofatumumab as maintenance therapy in relapsed CLL were submitted by Novartis to the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) in July. We also continue to focus on our technologies and effectively progress a robust early stage pipeline, having entered an agreement with BioNTech for the DuoBody platform in the field of immuno-oncology and obtaining a license from Bristol-Myers Squibb for antibodies targeting CD19," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half
Business Progress Second Quarter to Present
Genmab is maintaining its updated 2015 financial guidance published on May 20, 2015.
Genmab will hold a conference call in English to discuss the results for the first half of 2015 today, Tuesday, August 11, at 6.00 pm CEST, 5.00 pm BST or noon EDT. The dial in numbers are:
+1 646 254 3363 (US participants) and ask for the Genmab conference call
+44 20 3427 1914 (international participants) and ask for the Genmab conference call
A live and archived webcast of the call and relevant slides will be available at www.genmab.com.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: email@example.com
The interim report contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab's annual report, which is available on www.genmab.com and the "Significant Risks and Uncertainties" section in the interim report. Genmab does not undertake any obligation to update or revise forward looking statements in the interim report nor to confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis Pharma AG.
CVR no. 2102 3884
1260 Copenhagen K
Download the full Interim Report for the first half of 2015 on attachment or at www.genmab.com.
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...