Company Announcement
- Arzerra® receives Priority Review from FDA
- PDUFA date of April 19, 2014
Copenhagen, Denmark; December 17, 2013 – GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Priority Review designation to the supplemental Biologics License Application (sBLA) for the use of Arzerra® (ofatumumab) in combination with an alkylator-based therapy, to be used for treatment of CLL patients who have not received prior treatment and are inappropriate for fludarabine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of April 19, 2014 for the sBLA for Arzerra®.
Ofatumumab is not approved or licensed anywhere in the world for use in patients who have not received treatment for CLL. For the approved indication, please visit http://us.gsk.com/html/medicines/index.html for full US Prescribing Information and http://health.gsk.com/ for the EU Summary of Product Characteristics (SPC).
About the Prescription Drug User Fee Act (PDUFA)
PDUFA is US legislation which was initially enacted in 1992 and renewed in 1997, 2002, 2007 and 2012. The legislation authorizes the FDA to collect fees from companies that produce certain drugs. These fees, called “user fees”, play an important role in expediting the drug approval process. A PDUFA date is the date by which the FDA aims to complete its review of a drug application.
About Chronic Lymphocytic Leukemia
CLL is the most common form of leukemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the United States of America alone in 2013.1 At present, no curative chemotherapy is available.
About Arzerra (ofatumumab)
Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops2. Ofatumumab has been granted Breakthrough Therapy Designation from the US FDA. Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and the GlaxoSmithKline group of companies.
About GlaxoSmithKline
One of the world's leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For further information please visit www.gsk.com.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company’s first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab’s validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
Genmab Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
GlaxoSmithKline Enquiries:
UK Media enquiries:
David Mawdsley +44 (0) 20 8047 5502 (London)
Simon Steel +44 (0) 20 8047 5502 (London)
David Daley +44 (0) 20 8047 5502 (London)
Catherine Hartley +44 (0) 20 8047 5502 (London)
US Media enquiries:
Melinda Stubbee +1 919 483 2510 (North Carolina)
Catalina Loveman +1 215 751 4958 (Philadelphia)
Anna Padula +1 215 751 4271 (Philadelphia)
Karen Collins +1 919 483 2527 (North Carolina)
Stephen Rea +1 215 751 4394 (Philadelphia)
Analyst/Investor enquiries:
Sally Jackson +44 (0) 20 8047 5543 (London)
Ziba Shamsi +44 (0) 20 8047 3289 (London)
Kirsty Collins (SRI & CG) +44 20 8047 5534 (London)
Tom Curry +1 215 751 5419 (Philadelphia)
Gary Davies +44 (0) 20 8047 5503 (London)
James Dodwell +44 (0) 20 8047 2406 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Lucy Singah +44 (0) 20 8047 2248 (London)
Forward Looking Statement for Genmab
This Company Announcement 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 pre-clinical and clinical development of products, 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 risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement 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 logoTM; the DuoBody™ logo; HuMax®; HuMax-CD20®; DuoBody®, HexaBodyTM and UniBody®. Arzerra® is a registered trademark of the GlaxoSmithKline group of companies.
Cautionary statement regarding forward-looking statements for GSK
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
1American Cancer Society, Estimated Number of New Cancer Cases and Deaths by Sex, US, 2013, http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-037124.pdf, accessed September 18, 2013.
2 Teeling et al, J Immunol 2006; 177:362-371
Company Announcement no. 58
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
