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GlaxoSmithKline (GSK) Pulls US Bid to Use Tykerb With Roche (RHHBY)'s Herceptin


7/13/2012 7:06:04 AM

12 July 2012, London UK -- GlaxoSmithKline plc announced today that it has withdrawn a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Tykerb (lapatinib) in combination with trastuzumab for the treatment of patients with HER2 (ErbB2)-positive metastatic breast cancer who have received prior trastuzumab therapy. Regulatory reviews are ongoing in the European Union and other regions.

“Our discussions with FDA highlighted questions that could not be addressed with the data currently available.” said Rafael Amado, Head of Oncology R&D for GlaxoSmithKline. “We have decided to withdraw our application in the US with the intent to wait for ongoing studies testing the combination of lapatinib with trastuzumab.”

For information about the currently licensed indications for Tykerb/Tyverb, please visit http://www.gsk.com/products/prescription-medicines to view the full Tykerb US Prescribing Information including BOXED WARNING risk for hepatotoxicity and the Tyverb EU Patient Information Leaflet.

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.

GlaxoSmithKline Enquiries:

UK Media enquiries:

David Mawdsley

+44 (0) 20 8047 5502

(London)

Stephen Rea

+44 (0) 20 8047 5502

(London)

Sarah Spencer

+44 (0) 20 8047 5502

(London)

David Daley

+44 (0) 20 8047 5502

(London)

US Media enquiries:

Kevin Colgan

+1 919 483 2933

(North Carolina)

Melinda Stubbee

+1 919 483 2510

(North Carolina)

Rob Perry

+1 407 497 4049

(Philadelphia)

Analyst/Investor enquiries:

Sally Ferguson

+44 (0) 20 8047 5543

(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)

Ziba Shamsi

+ 44 (0) 20 8047 3289

(London)

GlaxoSmithKline cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, 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 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.


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