Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON

MarketScreener Homepage  >  Equities  >  London Stock Exchange  >  GlaxoSmithKline    GSK   GB0009252882

GLAXOSMITHKLINE

(GSK)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsPress ReleasesOfficial PublicationsSector newsMarketScreener StrategiesAnalyst Recommendations

GlaxoSmithKline : GSK submits US regulatory application for single-dose tafenoquine for Plasmodium vivax malaria

share with twitter share with LinkedIn share with facebook
share via e-mail
11/28/2017 | 05:28am EST

Issued: London, UK; Geneva, Switzerland

GSK and Medicines for Malaria Venture (MMV) today announced the submission of a new drug application (NDA) by GSK to the United States Food and Drug Administration (FDA), seeking approval of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older. If approved, tafenoquine would be the first new medicine for the prevention of relapse of P vivax malaria in more than 60 years, potentially addressing the need for a single-dose and effective medicine for this debilitating disease.

The submission follows the decision made by FDA in December 2013 to grant tafenoquine Breakthrough Therapy Designation, an initiative aimed at expediting the development and review times of drugs for serious or life-threatening conditions. The NDA submission includes Phase III data from the previously reported GATHER and DETECTIVE studies conducted by GSK in partnership with MMV.[1]

Pauline Williams, Head of Global Health R&D, GSK said: 'This regulatory filing marks a significant and historical milestone in our global health efforts. Treating Plasmodium vivax malaria is particularly challenging because the parasite can lie dormant in the liver resulting in relapses. Poor compliance to primaquine in real-world settings can lead to higher relapse rates than those seen in the controlled setting of clinical trials, so a single dose treatment is an attractive proposition. GSK and MMV have been working together since 2008 to develop single-dose tafenoquine as an alternative to primaquine. If approved, tafenoquine will potentially become an important tool to help eliminate P vivax malaria for good. We look forward to the outcome of the filing.'

David Reddy, CEO of Medicines for Malaria Venture said, 'MMV and GSK are committed to the development of single-dose tafenoquine for relapsing malaria. Following a long-standing partnership, we have now reached the exciting milestone of regulatory filing. This is significant because without treatment to stop the relapses, infected patients live with the constant threat of malarial symptoms returning without warning. Relapsing malaria thereby contributes significantly to the burden of disease in affected countries. The world has been waiting over 60 years for a new medicine for this indication. A single dose medicine would be unprecedented.'

Tafenoquine is not approved for use anywhere in the world. GSK plans to progress regulatory filings in other countries in 2017 and 2018.

About Plasmodium vivax malaria
The Plasmodium parasite is a complex organism with a lifecycle spanning both humans and mosquitoes. After an infected mosquito bite, the P. vivax parasite has the ability to lie dormant in the liver (known as a hypnozoite) and periodically reactivate causing relapses of P. vivax malaria. Hence, a single P. vivax infection can give rise to multiple episodes of malaria, in the absence of a new mosquito bite. These relapses can occur weeks or even years after the initial infection.

P. vivax malaria has a significant public health and economic impact, primarily in South and South East Asia, Latin America and the horn of Africa. The disease is estimated to cause around 8.5 million clinical infections every year.[2] Each of these infections keeps a child or adult from school or work for at least 3 days.[3] Studies have shown that beyond lost time, malaria can also have adverse effects on cognitive ability.[4][5]

About tafenoquine
Tafenoquine was first synthesised by scientists at the Walter Reed Army Institute of Research in 1978. GSK entered into a collaboration with MMV in 2008 to develop tafenoquine as an anti-relapse medicine for patients infected with P. vivax. It is an investigational 8-aminoquinoline derivative with activity against the P. vivax lifecycle, including hypnozoites.

GSK's commitment to malaria
Malaria is one of the greatest global healthcare challenges of today. Whilst progress has been made in the fight against malaria this progress is fragile. At GSK, we want to help change this and maintain momentum. That's why we will continue to make our expertise available and continue to collaborate with many different types of organisations across the world in a number of key areas including investing in research to help discover new medicines and vaccines for malaria, making treatments available to as many people who need them as possible, working in collaboration with communities to help build core skills through education helping improve local healthcare services and advocating in support of the global malaria community to ensure that there are sufficient resources to combat malaria.

GSK - a science-led global healthcare company with a special purpose: to help people to do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

Medicines for Malaria Venture (MMV) - MMV is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and facilitating delivery of new, effective and affordable antimalarial drugs.

Since its foundation in 1999, MMV and partners have built the largest portfolio of antimalarial R&D and access projects ever assembled, and brought forward seven new medicines that are already saving lives. MMV's success is based on its extensive partnership network of over 400 pharmaceutical, academic and endemic-country partners in more than 55 countries.

MMV's vision is a world in which innovative medicines will cure and protect the vulnerable and under-served populations at risk of malaria, and help to ultimately eradicate this terrible disease.

For more information visit www.mmv.org

Cautionary statement regarding forward-looking statements
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. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.

[1] http://www.gsk.com/en-gb/media/press-releases/gsk-and-mmv-announce-positive-headline-phase-iii-results-showing-single-dose-tafenoquine-reduces-risk-of-relapse-in-patients-with-plasmodium-vivax-malaria/

[2] World Health Organization. World Malaria Report 2016 (2016): http://www.who.int/malaria/publications/world-malaria-report-2016/report/en/

[3] Price RN et al. 'Vivax malaria: neglected and not benign.' Am J Trop Med Hyg 77:79-87 (2007).

[4] Vitor-Silva S et al. 'Malaria is associated with poor school performance in an endemic area of the Brazilian Amazon.' Malar J. 8:230 (2009).

[5] Fernando SD et al. 'The impact of repeated malaria attacks on the school performance of children.' Am J Trop Med Hyg. 69(6):582-8 (2003).

GSK - GlaxoSmithKline plc published this content on 28 November 2017 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 28 November 2017 10:27:00 UTC.

share with twitter share with LinkedIn share with facebook
share via e-mail
Latest news on GLAXOSMITHKLINE
02/24MEDIVIR PUBL : and Shijiazhuang Yuanmai Biotechnology sign licensing agreement r..
AQ
02/24GLAXOSMITHKLINE : Says FDA Accepts SNDA Application for Zejula
DJ
02/24STADA ARZNEIMITTEL : Correction to Stada Acquisition Story
DJ
02/24STADA ARZNEIMITTEL : Germany's Stada Buys 15 Consumer Brands From GlaxoSmithKLin..
DJ
02/24EXCLUSIVE : Germany's Stada buys 15 GSK consumer health brands
RE
02/24GLAXOSMITHKLINE : China's Clover in research venture with GSK on coronavirus vac..
RE
02/24GLAXOSMITHKLINE : China's Clover in research venture with GSK on coronavirus vac..
RE
02/21Pharmaceutical companies develop system to better track counterfeit drugs
RE
02/21GLAXOSMITHKLINE : Description Report of Foreign Issuer
PU
02/20LONDON STOCK EXCHANGE : FTSE 100 reverses course to end lower on Imperial slump
RE
More news
Financials (GBP)
Sales 2020 34 843 M
EBIT 2020 9 123 M
Net income 2020 4 300 M
Debt 2020 23 712 M
Yield 2020 4,91%
P/E ratio 2020 19,2x
P/E ratio 2021 18,6x
EV / Sales2020 3,01x
EV / Sales2021 2,86x
Capitalization 81 108 M
Chart GLAXOSMITHKLINE
Duration : Period :
GlaxoSmithKline Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends GLAXOSMITHKLINE
Short TermMid-TermLong Term
TrendsBearishNeutralNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 25
Average target price 1 858,83  GBp
Last Close Price 1 629,80  GBp
Spread / Highest target 37,4%
Spread / Average Target 14,1%
Spread / Lowest Target -5,69%
EPS Revisions
Managers
NameTitle
Emma N. Walmsley Chief Executive Officer & Executive Director
Jonathan Richard Symonds Non-Executive Chairman
Iain James Mackay Chief Financial Officer & Executive Director
Karenann K. Terrell Chief Technology & Digital Officer
Hal V. Barron Executive Director & Chief Scientific Officer
Sector and Competitors
1st jan.Capitalization (M$)
GLAXOSMITHKLINE-8.39%104 842
JOHNSON & JOHNSON2.78%384 432
ROCHE HOLDING AG10.13%290 942
NOVARTIS2.72%211 608
MERCK AND COMPANY-10.58%207 065
PFIZER-8.83%191 868