Navigation Links
GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervical Cancer Vaccine
Date:12/17/2007

PHILADELPHIA, Dec. 17 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that it has received a complete response letter from the U.S. Food and Drug Administration related to its application for the cervical cancer vaccine, CERVARIX(R). A complete response letter is issued by FDA's Center for Biologics Evaluation and Research (CBER) when the review of a file is completed and questions remain to be answered prior to approval. GSK will work closely with the FDA to prepare its response, which it intends to submit to the agency as soon as possible.

"We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX(R) to the U.S. market."

The application filed for the GSK cervical cancer vaccine included safety, efficacy and immune response data from clinical trials involving almost 30,000 females 10 to 55 years of age from ethnically and racially diverse populations.

To date, CERVARIX(R) has been approved in 45 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines. Licensing applications have been submitted in more than 27 additional countries including Japan. GSK also submitted CERVARIX(R) to the World Health Organization (WHO) for prequalification in September 2007.

Notes to Editors

Burden of Cervical Cancer

Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and over 280,000 women will die from it each year.(1) In the United States, after breast cancer, cervical cancer is the second leading cause of cancer death in women ages 20 to 39.(2)

About GlaxoSmithKline

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 company information, please visit http://www.gsk.com/media.

GSK Biologicals (GSK Bio), one of the world's leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline's activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world -- an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world's children from up to six diseases in one vaccine.

CERVARIX(R) is a registered trademark of the GlaxoSmithKline group of companies.

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, 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 the Group's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2006.

References:

1. World Health Organization. Initiative for Vaccine Research.

http://www.who.int/vaccine_research/diseases/hpv/en/ Accessed on May

2, 2007.

2. Jemal A, Murray T, Ward E, Sammuels A et al. Cancer Statistics, 2005.

Cancer Journal for Clinicians 2005; 55; 10-30

Enquiries:

UK Media enquiries: Philip Thomson (020) 8047 5502

Alice Hunt (020) 8047 5502

Joss Mathieson (020) 8047 5502

Claire Brough (020) 8047 5502

US Media enquiries: Nancy Pekarek (215) 751 7709

Mary Anne Rhyne (919) 483 2839

Liad Diamond (919) 483 2839

European Analyst/Investor enquiries: David Mawdsley (020) 8047 5564

Sally Ferguson (020) 8047 5543

US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002

Tom Curry (215) 751 5419

Biologicals: Stella Gu +32 2 656 3533

Alice Grasset +32 2 656 8774


'/>"/>
SOURCE GlaxoSmithKline
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. GlaxoSmithKline Responds to JAMA Articles
2. MedImmune Licenses Reverse Genetics Technology to GlaxoSmithKline for Use in Influenza Vaccine Development and Production
3. Congressional Black Caucus Foundation and GlaxoSmithKline Announce Supplier Business Initiative Study Results
4. AUDIO from Medialink and GlaxoSmithKline: A New Nasal Spray for Allergy Relief
5. Mylan Announces Settlement of Paroxetine Hydrochloride Extended-Release Tablets with GlaxoSmithKline
6. GlaxoSmithKline Aids California Fire Relief Efforts
7. Genmab and GlaxoSmithKline Initiate Ofatumumab Rheumatoid Arthritis Phase III Program
8. GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR(R) (lovastatin) from Merck & Co., Inc.
9. Pharmacopeia and GlaxoSmithKline Collaboration Identifies Two Additional Lead Compounds
10. GlaxoSmithKline Presents Innovative Neuroscience Pipeline
11. Lake Elsinore Family Caregiver Receives Free Power Wheelchair From The SCOOTER Store
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... June 24, 2016 , ... ... for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of ... AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
(Date:6/24/2016)... ... 2016 , ... EB Medicine presented its first-ever “Issue of ... in Ponte Vedra Beach, FL. The awards honor the outstanding work of leading ... and Pediatric Emergency Medicine Practice. , “With this award, we recognize the efforts ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... The Grove Investment Group (TGIG), has initiated cultivation and processing operations at its ... Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of a complete system ...
(Date:6/24/2016)... ... , ... National recruitment firm Slone Partners is pleased to announce ... experience, as Vice President of North American Capital Sales at HTG Molecular . ... sales team in the commercialization of the HTG EdgeSeq system and associated reagents in ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, ... less invasive and more durable cerebrospinal fluid treatments, ... funding.  The Series-A funding is led by Innova ... Fund, and other private investors.  Arkis, new financing ... instrumentation and the market release of its in-licensed ...
(Date:6/23/2016)... 2016  In a startling report released today, National Safety ... lacking a comprehensive, proven plan to eliminate prescription opioid overdoses. ... how states are tackling the worst drug crisis in recorded U.S. ... Kentucky , New Mexico , ... Of the 28 failing states, three – Michigan ...
(Date:6/23/2016)... Bracket , a leading clinical trial technology ... outcomes platform, Bracket eCOA (SM) 6.0, at the 52 ... 30, 2016 in Philadelphia , Pennsylvania.  A ... product of its kind to fully integrate with RTSM, will ... 6.0 is a flexible platform for electronic clinical outcomes assessments ...
Breaking Medicine Technology: