A project report on Marketing POLICIES ofGLAXOSMITHKLINE

SUBMITTED FOR THE PARTIAL FULLFILMENT OF THE DEGREE OF BACHELOR

OF BUSINESS ADMINISTRATION

TO

INVERTIS UNIVERSITY, BAREILLY (U.P.)SESSION 2014-2015

SUBMITTED BY:

Certificate

TO WHOM IT MAY CONCERN

This is certify that Mr./Ms_____________________________student of BBA-V Sem.

In our institute has successfully completed his/her project work entitled
_______________________________________________________________________
For the partial fulfillment of the degree of Bachelor of Business Administration for the
session 2014-15.

Dr.RachnaSaxena

Name of Project Guide

(HOD, BBA & B.Com Program)

S. No.
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Title
Objective
Research Methodology

Data Analysis

Page no.

7.

Findings

8.
9.

Conclusion
Recommendations

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11.

Limitations
Bibliography

CONTENT

ACKNOWLEDGE

I would like to express my sense of gratitude to all those people who have helped directly or indirectly
in the completion of this project.
My special thanks to MrDheeraj Gandhi project head who gave me an opportunity to undergo my
project.Iwould like especially like to thanks to Assit. Professor Mr. Ashish Sir for the given project
who spend his valuable time and knowledge and gave me wholehearted support and encouragement in
carring out this project.

I am thankful to my friends for their generous support and the respondents who gave their valuable
piece of time for participating in the survey to complete the study
At last but not the least, I heartily acknowledge the moral support of my parents.

OBJECTIVE

To study the STP of Glaxosmithkline.

To study the PEST.
To study the market share.

RESEARCH METHODOLOGY
MEANING OF RESEARCH :Research is an art of scientific investigation.
Research means a careful investigation or inquiry specially through search for new facts in any
branch of knowledge

ACCORDING TO CLIFFORD WOODY:Research comprises defining and redefining problems, formulating, hypothesis or suggested
solutions, collecting, organizing and evaluating data, making deduction and reaching conclusions

and at last carefully testing the conclusions to determine whether they fit the formulating
hypothesis.
Research means the systematic method consisting of enunciating the problem, formulating a
hypothesis, collecting the facts o data, analyzing the facts and reaching certain conclusions either
in form of solutions towards the concerned problem or in certain generalization for some
theoretical formulation.
Research methodology is a systematic and scientific approach in attain the purpose of research it
contain systematic steps to attain use full conclusion.

The type of research is Descriptive Research

As the name implies ,the purpose of descriptive research is to describe something.

In this type of research the researcher is only required to report what has happened or what is
happening.

The main objective of descriptive research is carried out with specific objectives and

hence it results in definite coclusions.

In this research the researcher tries to describe the characterstics of respondents with
respect a particular product. For Ex- the degree of use of television by different types of

respondents is an example of descriptive research.

For ex
What is the absentee rate in particular offices?
What are the qualifications of different groups of employees?
What type of packaging for a box of chocolates do consumers prefer?
Which car advertisement on television do men and women of different ages prefer?
Types of Data
There are 2 types of data for research
1-primary data
2- secondary data
Primary data:- Primary data are those which ae collected afresh( again but in a new or
different way) and for the first time and thus happen to be original in character and
known as primary data.

Primary data is based on primary source of information.

The investigator gets ii in original or raw form i.e. it is not been processed earlier- coded ,
tabulated, classified and summarized in some form for use by someone for some
purposes.
Methods for collecting primary data:There are several methods of collecting primary data:
Direct personal observation
Interview
Questionnaire
Schedules
Observation
Observation involves recording the behavioral patterns of people by investigators own
direct observation without asking from the respondent.
For ex- in a study relating to human behaviour , the investigator instead of asking the
brand of the wrist watch used by the respondents, may himself look at the watch.
Interview:
Interviewing is a technique that is primarily used to gain an understanding of the
underlying reason and motivation for peoples attitudes, preferences or behaviour .
interviews can be personal as well as telephonic interview.
Questionnaire:
A Questionnaire is a document that contains a set of questions printed or typed in

a proper sequence.
Questionnaires are a popular means of collecting data, but are difficult to design
and often require many rewrites before an acceptable questionnaire is produced

Schedule method:

A schedule is a performa containing a set of questions which are asked and filled

in by an interviewer in a face-to-face situation with another person.

In certain situations, schedules may be handed over o the respondents and the
enumerators may help them in recording their answers.

Secondary data:Secondary data is the data that already collected by and readily available from oher
source. Such data are cheaper and more quickly obtainable than the primary data and also may
be available when primary data can not be obtained at all.
Secondary data is any information collected by someone else other than its user.it is data that
has already been collected and is readily available for use. Secondary data saves on time as
compared to primary data which has to be collected and analyzed before use.
Secondary data are second hand informations. They are ot collected from the source as the
primary data. In other words, secondary data are those which have already been collected.
Secondary data can be collected from the number of sources which can broadly be classified into
two categories.
(i)
(ii)

Published sources
Unpublished sources

Published sources:
Mostly secondary data are collected from published sources. Some important sources of
published data are the following
1- Published reports of central and state governments and local bodies.
2- Statistical abstracts, cencus reports and other reports published by different ministries of
the government.
3- Official publications of the foreign governments

Unpublished source:Statistical data also be collected from various un published soures. Some of the important
unpublished sources from which secondary data can be collected are:
1- The research works carried out by scholars, teachers and professionals.

2- The records maintained by private firms and business enterprises. They may not like to
publish the information considering them as business secret.
3- Records as statistics maintained by various department and offices of the central and state
governments, corporation, undertakings etc.
TYPE OF RESEARCH DESCRIPTIVE RESEARCH
TYPE OF DATA- SECONDARY DATA
SOURCES OF DATA- INTERNET , WEBSITES, ANNUAL REPORTS,ARTICLES
ETC.

COMPANY PROFILE
GlaxoSmithKline (GSK) is one of the worldslargest research-based pharmaceutical corporations
that discovers, develops, manufactures and markets branded human health products.
Headquarters: UK, with additionaloperational headquarters in the USA
Global presence: about 160 countries
Primary markets: USA, France, Germany,UK, Italy and Japan
Employees: approximately 103,000
In 1988, SmithKline BioScience Laboratories acquires one of its largest competitors,
International Clinical Laboratories Inc., increasing the company's size by half and
becoming an industry leader.
In 1989, SmithKline Beckman and The Beecham Group plc merge to form SmithKline
Beecham plc.
In 1994, SmithKline Beecham acquires Diversified Pharmaceutical Services Inc., a
pharmaceutical benefits manager, and Sterling Health. This makes SmithKline
Beecham the third-largest over-the-counter medicines company in the world and
number one in Europe and the international markets. Focusing on human
healthcare, SmithKline Beecham sells its animal health business.
In 1995, Glaxo and Wellcome merge to form GlaxoWellcome. GlaxoWellcome
acquires California-based Affymax, a leader in the field of combinatorial chemistry.
In 1998, GlaxoWellcome acquires Polfa Poznan and becomes the largest
pharmaceutical company in Poland.
In 1999, further sharpening its focus on pharmaceuticals and consumer healthcare,
SmithKline Beecham divests SmithKline Beecham Clinical Laboratories and
Diversified Pharmaceutical Services.
In 2000, GlaxoSmithKline is formed through the merger of GlaxoWellcome
andSmithKline Beecham
Ownership structure
GlaxoSmithKline is a public limited company. Ordinary shares are traded on the London Stock
Exchange (ticker symbol GSK). American Depositary Shares (ADSs), representing two ordinary
shares, are traded on the New York Stock Exchange (ticker symbol GSK).
Some shareholders favour a pro-active company approach towards health problems in
developing countries. The Pharmaceutical Shareholders Group, a London-based group of large
institutional investors that hold shares of pharmaceutical companies, studied the business
rationale for addressing the issue and assessed how well companies are managing this. In a

recently published a report, it recommends companies to develop a pro-active, comprehensive

and consistent approach to address these problems and identifies best practices. GSK was
identified as one of the leading companies, but the report also mentioned that all companies
could still improve their approach.

Business profile
GlaxoSmithKline (GSK) is one of the worlds largest research-based pharmaceutical companies
that that discovers, develops, manufactures and markets human health products. It is an
innovative company that produces branded products only, which it has developed itself.
The company has two main divisions, pharmaceuticals and consumer healthcare. The consumer
healthcare businesses of GSK consist of over-the-counter (OTC) medicines, oral care products,
such as the toothpaste brands Aquafresh, Macleans and Sensodyne, and nutritional healthcare
drinks. The pharmaceuticals division is the largest part of GSKs businesses and can be divided
into prescription drugs and vaccines. This report deals with the pharmaceuticals division only.
The headquarters of GSK are located in the UK, with additional operational headquarters in the
USA. The company operates in some 160 national markets, the major ones being the USA,
Japan, France, Germany, the UK and Italy.
GSK conducts R&D at more than 20 sites and employs 15,000 employees in R&D. The principal
facilities are located in UK, USA, Japan, Italy and Belgium, and minor R&D sites are located in
Canada, France and Spain. All R&D for vaccines is carried out in Belgium.
GSK is involved in many different R&D partnerships with academic institutions,
biotechnology companies and other pharmaceutical companies. The company has a leading
position in genetics and in new drug discovery technologies.
The manufacture and supply system of GSK operates as a single global network. Thecompany
has 87 manufacturing sites and employs around 32,000 employees in production.It has two types
of manufacturing sites. Primary manufacturing sites produce the activecompounds used in the
drugs. There are twelve of these sites, located in the UK, Ireland,the USA, Singapore and
Australia. Secondary manufacturing sites convert the activecompounds into finished products.
There are 15 of these sites in Europe, 6 in NorthAmerica, 5 in Latin America, 5 in the Middle

East and Africa, 15 in theAsia/Pacific/Australia Region, 4 in China, and 1 in Japan. Vaccine

manufacturing isprimarily located at two sites in Belgium.
GSK employs 44,000 people in sales and has the largest sales force in the
pharmaceuticalindustry. It has various co-marketing and co-promotion agreements with
otherpharmaceutical companies.
For prescription drugs, the main therapeutic areas of GSK are central nervous system,respiratory,
anti-infectives and gastro-intestinal/metabolic. The largest selling GSKproducts are
Seretide/Advair for asthma and Chronic Obstructive Pulmonary Disease(COPD); Paxil/Seroxat
and Wellbutrin, both anti-depression drugs; Avandia/Avadamet fortype 2 diabetes; and the
antibiotic Augmentin. These all generated above 800 million5 ofsales in 2003.
In September 2003, GSK held the second position in pharmaceutical market, with a worldmarket
share of 6.9%. This is after Pfizer, which had a share of 10.3%. GSK is a leader inthe four
therapeutic areas mentioned above and in vaccines. Worldwide, it had a marketshare of over 20%
for respiratory treatments, a share of approximately 13% for antiinfectivesand close to 10% of
central nervous system drugs.
Generic drug manufacturers are seeking to bring generic versions of many of GSKs
mostimportant products to the market before patent expiry. Generic products competing
withPaxil and Augmentin, launched in 2002 and 2003, had a considerable adverse impact on
itssales and profits.
Business strategy
GSKs business goal is to be a world leader in pharmaceutical industry. In order to achievethis,
the company seeks to improve its R&D pipeline, using a focused drug portfoliostrategy and
selective in-licensing agreements for the external contracting of R&D. Thecompany links R&D
closely to commercial operations to maximise the value of its R&Dportfolio. Furthermore, GSK
seeks to increase brand name recognition among customers and to develop improved versions of
older products, on which new patents can beobtained. It is a common strategy of branded drug
producers to develop improved versionsor more convenient formulations of drugs on which the
patents have expired, and topersuade doctors and patients to use the enhanced version.
Direct-to-consumer (DTC) advertising is an important element of GSKs marketing strategyin
the US. Consumers that receive information through DTC advertising tend to requestspecific

brand name medicines to their physicians. The company is implementing a salesforce

excellence initiative to improve the already good reputation of GSK sales representatives among
healthcare professionals. It has also started marketingexcellence initiative to reduce the number
of patients that do not seek the help of adoctor and remain undiagnosed, and the number of
diagnosed patients that remainuntreated.
CSR policy: general
CSR issues in the pharmaceutical sector
The MVO-Platform, a coalition of Dutch civil society organizations and trade unions,understand
by Corporate Social Responsibility (CSR) a process in which corporations takeresponsibility
for the social, ecological and economic consequences of their actions-throughout their product
and service delivery chain making themselves accountable, andengaging in a dialogue with all
those involved. Some of the CSR issues that may be considered most important for the
pharmaceuticalsector are related to access to medicines in developing countries. These include
thefollowing:
Industry lobbying for intellectual property protection
Pricing policy for medicines
R&D for developing countries diseases
Drugs donations policy
Participation in Global Public-Private Initiatives (GPPIs)
Apart from access to medicines, other critical CSR issues in the pharmaceutical sector are
the following:
Drugs safety
Drug promotion and advertising
Clinical trials
Indigenous knowledge
Bribery, corruption and fraud
Workplace health, safety and environment
Policies

GSK's mission is to improve the quality of human life by enabling people to do more, feelbetter
and live longer. Its key values are performance with integrity, entrepreneurialspirit, focus on
innovation, a sense of urgency, and passion for achievement. In 2003 thecompany formally
adopted a set of 10 Corporate Responsibility Principles, identifying itskey CSR issues. These can
be summarized as follows.
1. Employee practices. GSK wil treat employees fairly, encourage workforce diversity,and offer
safe and healthy working conditions.
2. Human rights. GSK commits itself to upholding the Universal Declaration of HumanRights of
the UN, the guidelines for Multinational Enterprises of the Organization forEconomic
Cooperation and Development (OECD), and the core labour standards ofthe International Labour
organization (ILO).
3. Access to medicines. GSK will continue R&D on medicines for developing countries,find
sustainable ways to provide access to medicines, and seek partnerships tosupport this.
4. Leadership and advocacy. GSK will establish its own standards in CSR and seek toinfluence
others.
5. Community Investment. GSK will invest in health and education programmes and
inpartnerships for health in developed and developing countries.
6. Engagement with stakeholders. GSK will engage a range of stakeholders and
communicate openly about its CSR approach.
7. Standards of ethical conduct. GSK expects employees to meet high ethical
standards and to adhere to the Corporate Responsibility Principles.
8. Research and innovation. GSK will ensure that its products are well evaluated andtested on
safety, effectivness and quality.
9. Products and customers. GSK will promote its products in line with high ethical,
medical and scientific standards.
10. Caring for the environment. GSK will minimize waste generation and material andenergy
use.
Various of these principles include an explicit commitment to comply with all applicable
laws and regulations. A short elaboration of policies on various CSR issues is providedbelow.

With regard to employment practices, GSKs seeks to increase (US) workforce diversityand the
number of women in management positions. There is a system of individualPerformance and
Development Planning to further personal development of employees.
GSK has a Code of Conduct that deals with business integrity in general. It specifies
thatemployees must comply with the law and company policies, avoid conflicts of interest,
andreport any violations of the code.
For drug testing, GSK adheres to industry standards for the Conduct of Clinical Trials
&Communication of Clinical Trial Results.This code was developed in 2002 by
thePharmaceutical Research and Manufacturers of America (PhRMA), with the participation
ofGSK.It contains standards and guidelines for the protection of research participants,good
clinical practices, research objectivity, and the disclosure of meaningful clinical trialresults
regardless of the outcome.
GSK has a policy on the animal research that is required for R&D and the regular testing
ofsome vaccine products. The company is committed to reduce the number of animals perstudy,
to refine the research methods and to replace them with alternative methodswhenever possible.
GSK recognizes that all nations have sovereignty over their biological resources andindigenous
knowledge and supports the UN Convention on Biodiversity (CBD), which asksfor the
protection of these resources.
GSK has a corporate policy on Pharmaceutical Marketing and Promotion Activity,
whichprohibits bribery and other inappropriate ways of persuading doctors to prescribe
GSKmedicines.
Stakeholder involvement
In its annual Corporate Responsibility report, GSK provides a short description of
thecommunication and interaction with various types of stakeholders. Regular
communicationtakes place with the following groups:
Employees
Healthcare professionals
Governments and other authorities
Investors
Non-Governmental Organizations (NGOs) and communities

 Scientists
UN agencies
For EHS policies, there exist consultations with community neighbours that may beaffected by
the companys activities and with external experts. However, the outcomesof GSKs interaction
with stakeholders are not always clear.
Products
The GSK India product portfolio includes prescription medicines and vaccines. Our prescription
medicines range across therapeutic areas such as anti-infectives, dermatology, gynaecology,
diabetes, cardiovascular disease and respiratory diseases. The company is the market leader in
most of the therapeutic categories in which it operates. GSK also offers a range of vaccines, for
the prevention of hepatitis A, hepatitis B, invasive disease caused by H, influenzae, chickenpox,
diphtheria, pertussis, tetanus and others.
PEST Analysis on Pharmaceutical Industry:
Political:
Considering the Medicare in USA and UK's National Health Service, the level of political
interest developed in this industry can be determined. In addition USA and European market
hold the first and second place of industry's global market respectively. So it's very clear that the
industry has gained a massive political attention because of the increasing social and financial
burden of healthcare and safety.
In the increased political attention on the industry, has kept the industry low to live up the
expectation and their interference on most moves of the industry was a really worrying the giants
of the industry. Also the pressure of civil in rapid delivery of products has kept their quality and
the industry finds hard in delivering effective products.
Economic:
The economic growth of the industry was rapid in recent years and next to IT industry with nine
geographic markets account for over 80% of global pharmaceutical sales these are US, Japan,

France, Germany, UK, Italy, Canada, Brazil and Spain. Of the above listed markets, US market
holds a major one and fastest too however there is down fall in 2009.
"The US Pharmaceutical Industry is one of the mainstays of the Economy of America. It has
been observed that the US Pharmaceutical Industry is growing at a rapid pace and is showing no
signs of slowing down. The US Pharmaceutical Industry Growth is also considered as a very
significant part in the world pharmaceutical industry as well".
According to analysis, in 2009, global pharmaceutical sales increased by only 2.5% ~ 3.5%,
reaching a total of about 750 billion-760 billion U.S. dollars, which is lower than in October last
year the growth rate of 4.5% to 5.5%, a total of 8200 the forecast 100 million U.S. dollars. This
growth rate is the lowest in the past 25 years."

Social:
Every industry tries to have a good social relation. But this industry is many steps forward than
the other industries because; good health is an important personal and social requirement. All the
companies of this industry hold and play a vital and unique role fulfilling society's need for good
health. And threat of some killing diseases like, AIDS, SWINE FLU, SARS etc. had not only
attracted the attention of public and media but developed a more depending and demanding
situation on the industry.
This immense situation has made the industry to maintain direct relation with the society
(consumers) with the help of media and government care.
Technological:
The advance scientific technologies have increased the need for high spending in research and
development in regards to encourage the innovation. The growth of technology drives the

industry to responds faster to the expectation of the environment. This technology advancement
evolves both risks and rewards.
SWOT Analysis - Glaxo SmithKline:
Strengths

High potential staffs and experienced managers.

Wide-ranging set of documents in health sector.
Strong platform in health care division.
Strong market position
Focus to concentrate and develop leadership in Public relations i.e. to strengthen the

social context of the environment.

Modern hospital system, Clear public health and health care service purchasing
Balanced finance in the health sector
Strong IT development
Product development track record.

Weaknesses

Lack of clear and wide perspective .goals to achieve the aims

Weak bond among health care, public health and social care.
Inability to cope with the cost increases.
Low brand value for its products.
Inefficiency in motivating the experienced leader and thus failing to make maximum use

of the potential staffs.

Lack of viable training and management skills.
Not an efficient HR strategy in retaining key professionals.
Lack of right proposition of various competences.
Co-marketing agreements can limit GSK's global presence.
With mass R&D, inability to produce blockbuster products.

Opportunities

Technological development
Social changes and challenges.
Economic growth of the industry (immediately next to IT industry).
Free movement of goods, services, labour.
Developing vaccines for persistent diseases chance to have craic.
Empowerment of citizens and their greater engagement

Threats

Patent expiry on drugs that generate strong income

Ageing and demographic change.
Safety issues surrounding the products.
Ecological and public health threats.
Expectations of the raising population
As the R&D of global rivals work on similar products in most of the cases, the

competition is high and much demanding.

Emerging of potential regional market like China and India.
Political pressure in fixing the price for new drugs, which fails to fulfil even the research

cost.
Ever increasing cost of drug trials and ever higher standards imposed by national drug
approvals bodies.

Consumer Healthcare
GSK Annual Report 2014Governance & remunerationFinancial statements
Investor informationStrategic reportGSKs Consumer Healthcare business
is already among the largest in the world. Our products reach millions of people every day in
more than 100 countries, with top-selling brands including Sensodyne, Panadoland
Horlicks.Across our four categories of Wellness, Oral health, Nutrition, and Skin health, our
brands exist to help people to do more, feel better and live longer. Our Wellness category focuses
on pain management, respiratory health, gastrointestinal health and smokers selling paracetamol
brand globally and Tums
is the antacid brand health. Panadolis the topin the USA. We are the global leader in specialist Oral
health, with leading positions in Sensitivity (Sensodyne), Acid Erosion (Pronamel), Denture Care
and Gum Health. In Nutrition, our Horlicksbrand over 140 years old is the leading nutritional
supplement in the Indian subcontinent. Finally, our Skin health brands Abrevaand Zovirax hold
leading positions in some of the worlds largest markets.Our focus is to combine the best of our
Pharmaceutical and Fast Moving Consumer Goods (FMCG) capabilities to become the worlds
first and best, Fast Moving Consumer Healthcare (FMCH) company, driven by science and
values. To realise this vision, we are implementing a strategy with five key growth levers:

 Building category defining brands our consumers love. This means building
strong global brands with leadership positions.
Improving lives through scientific innovation with a strong pipeline of new products.
Becoming first choice for shoppers, retail partners and experts.
Delivering high quality products at the right time and cost.
Living our values and developing our people in a high performance culture.
In April, we announced a proposed major three-part transaction with Novartis, which once
completed, will create a new joint venture Consumer Healthcare Company with significant scale
and reach making it one of the worlds largest Consumer Healthcare companies, operating in
markets estimated to grow at approximately 3-4% per annum over the next five years.
The new GSK Consumer Healthcare business will be geographically well matched with a strong
presence in the US, emerging markets and in the CIS, Central and Eastern Europe. The combined
business will be a world leading Consumer Healthcare company with number one positions in
specialist oral health and in OTC across 36 marketsand leading positions in skin health and
family nutrition with key brands like Sensodyne, parodontax, Polident, Voltaren, Theraflu,
Panadol, Otrivin, Horlicks, Zovirax andAbreva. In total, the new company will have 19 major
brands each with annual revenues in excess of US$100 million.Approximately half of the
business will be OTC medicines creating the worlds
OTC business. The other half of the new company will comprise FMCG brands in
the areas of Oral health, Nutrition and Skin health. With increased speed to market and
investment in new products, this business will have greater opportunities to
deliver revenue growth consistently above market rates.

INTRODUCTION
SK to establish global vaccines R&D centre in the US
02 April 2015
Issued: London and Philadelphia, PA
New hub based in Rockville, MD expands GSKs global vaccines R&D footprint
GSK announced today it is further strengthening and expanding its vaccines presence in the US
by establishing a new global centre for vaccines research and development (R&D) in Rockville,
Maryland. The site will become one of three global vaccines R&D centres for GSK,
complementing the companys existing global R&D centres in Rixensart, Belgium and in Siena,
Italy, a site which GSK recently acquired from Novartis in March 2015.
The new US vaccines R&D centre will expand GSKs efforts to discover and develop novel
vaccines across a range of pressing public health threats, including those relevant to the US. It
will consolidate vaccines R&D activities currently conducted at other GSK sites including in
Philadelphia, PA and Cambridge, MA, into one centralised location. Key late stage development
programmes, as well as vaccine discovery and new platform technology development will be led
from Rockville.
The Rockville site, which was acquired by GSK in 2012, offers proximity to vaccines
collaborators and key public health stakeholders. GSK anticipates site operations for vaccines to
begin in Rockville as early as September 2015.
Luc Debruyne, President, GSK Vaccines, said: As the global vaccines leader, GSK is on the
cutting edge of vaccine development. Following the acquisition of Novartiss global vaccines
business and in recognition of the vaccines knowledge and expertise in the United States, we are
pleased to expand our US presence with the creation of a world-class vaccines R&D centre. This
will drive innovation, and enhance our capabilities for new vaccine discoveries that protect the
US and public health around the world.

Maryland Governor Larry Hogan said: I am proud that a world-class pharmaceutical

company like GSK has chosen to grow its US operations in Maryland. With key federal labs like
the Food and Drug Administration and the National Institutes of Health in our backyard, a
highly-educated workforce and a critical mass of life sciences companies, Maryland offers GSK
an excellent environment in which to grow and thrive.
This move follows GSKs acquisition of Novartis vaccines business as part of the companies
major three-part transaction that closed in March 2015. GSK and Novartiss vaccines R&D
organisations are highly complementary, bringing together respective expertise in virology and
bacterial infection.
GSK one of the worlds 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.
GSK statement on meningitis vaccination in the UK
29 March 2015
Issued: London
GSK is delighted to have reached an agreement with the UKs Department of Health that will
enable babies in the UK to receive its meningitis B vaccine through the NHS immunisation
schedule.
We have moved rapidly to conclude negotiations since we acquired the vaccine from Novartis at
the beginning of March.
We believe the agreement we have reached offers fair value for the NHS and allows a reasonable
return for GSK to ensure that we can continue to invest in creating new treatments and vaccines.
GSKs 2015 Discovery Fast Track Challenge seeks early drug discovery
partnerships with academics in Europe, Canada and US

24 March 2015
Issued: London, UK
GSK is encouraging academic scientists in Europe, Canada and the US to submit their novel
early drug discovery research proposals into its third annual Discovery Fast Track Challenge a
programme designed to accelerate the translation of early-stage research into game-changing
new medicines. The challenge provides a new template for drug discovery as it seeks to rapidly
uncover the best opportunities for discovery research.
Scientists who participate in the challenge are asked to submit details about the biological targets
or pathways they are researching and the scientific rationale detailing how this early-stage
research could direct future drug development. Up to 12 proposals will be selected, across all
regions, based on the strength of the scientists hypotheses, originality, initial progress and the
ability to deliver on an unmet medical need.
Scientists whose entries are selected will collaborate with GSKs Discovery Partnerships with
Academia (DPAc) and Molecular Discovery Research teams to test their hypotheses on potential
disease pathways or targets against GSKs extensive library of compounds. If a compound is
identified during this process that shows activity against these pathways or targets, and could
form the starting point for the development of a new medicine, the winning investigators could
be offered a formal DPAc partnership and opportunity to work together on the development of a
potential new medicine.
Carolyn Buser, Global Head of Discovery Partnerships with Academia (DPAc) at GSK said:
The Discovery Fast Track Challenge is a unique opportunity to integrate the deep biological
expertise found in academia with the extensive drug development knowledge of GSK.
Winning ideas are translated into a high throughput screen to identify tool compounds for
additional proof-of-concept studies. Pending the results and the interests from both academia
and GSK, the collaboration may be extended to a long-term partnership to jointly develop
therapeutics for the benefit of patients worldwide.

Since its initial launch in 2013, the annual Discovery Fast Track Challenge has attracted more
than five hundred proposals from more than three hundred universities, academic research
institutions and hospitals in the US, Canada and Europe. Previous entries have focused on a
broad range of disease areas, including malaria, antibiotic resistance and certain types of cancer.
Launched in the UK in late 2010, DPAc is a new approach to drug discovery where academic
partners become core members of drug-hunting teams. GSK and the academic partner share the
risk and reward of innovation, where GSK funds activities in the partner laboratories, as well as
providing in-kind resources to progress a programme from an idea to a candidate medicine. The
DPAc model is now being used by GSK globally. To date, GSK has initiated 15 collaborations in
15 disease areas worldwide.
Dr. Richard Leduc, Ph.D., Chairman of the Department of Pharmacology-Physiology at
Universit de Sherbrooke in Quebec, Canada the first academic to enter Discovery Fast Track,
and selected as a winner of the 2013 challenge proposed an innovative approach for treating
iron overload disorder (IOD). Screening Dr. Leducs biological target against GSKs chemical
libraries yielded several highly potent inhibitors. In less than a year, we went from working on
expression of the enzyme to screening for hits to discovering hits, said Dr. Leduc. That is
pretty phenomenal. It is a true partnership.
Registering for the challenge involves submitting a one-page summary of a novel drug discovery
concept, including non-proprietary details of the biological target. An expert panel of judges
from GSK will select a group of up to 30 finalists to present their proposals in person.
Registration is open from March 23 through April 24. Further details can be found
at www.gsk.com/discoveryfasttrack.
GSK one of the worlds 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.
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 'Risk factors' in the company's Annual Report on Form 20-F
for 2014.
GSK and Theravance announce outcome of US FDA Advisory Committee on
BREO ELLIPTA in asthma
19 March 2015
Issued: London, UK, and South San Francisco, CA, USA
GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced
the outcome of the joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug
Safety and Risk Management Advisory Committee of the United States (US) Food and Drug
Administration (FDA) regarding the supplemental New Drug Application (sNDA) for
BREOELLIPTA (fluticasone furoate/vilanterol [FF/VI]) as a once-daily inhaled treatment for
asthma in patients aged 12 years and older.
The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and
200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4
against). The Committee voted that the efficacy data provides substantial evidence of a clinically
meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been
adequately demonstrated (17 for, 3 against).
The Committee voted against approval for the proposed indication in 12-17 year olds (2 for, 18
against)*. The Committee voted that the efficacy data was not sufficient to demonstrate the
benefit (4 for, 16 against) and the safety (1 for, 19 against) has not been adequately demonstrated
in this sub-population.
The Committee recommended that a large LABA safety trial with FF/VI should be required in
adults (13 yes, 7 no) and in 12-17 year olds (17 yes, 2 no and 1 no-vote), similar to the ongoing

LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the
manufacturers of LABA containing asthma treatments.
FDA Advisory Committees provide non-binding recommendations for consideration by the
FDA. Based on these opinions and the data presented, the FDA will make its final decision on
approval, which is expected on 30 April 2015 (the Prescription Drug User Fee Act goal date).
Breo, a fixed-dose combination of the inhaled corticosteroid FF and the long-acting beta2-agonist
VI, is administered with the Ellipta dry powder inhaler device. The sNDA for Breo Elliptain
asthma was submitted to the FDA in June 2014 for two once-daily dose regimens, 100/25 mcg
and 200/25 mcg.
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said: We recognise the
Advisory Committees thoroughness in reviewing the data related to Breo Ellipta for asthma. We
will continue to work closely with the FDA while it considers the Committees recommendations
and our aim is to answer any outstanding questions to enable them to make a fully informed
decision.
Michael W. Aguiar, President and Chief Executive Officer of Theravance, Inc., said: "We remain
committed to the ongoing review process and will be fully cooperating with the FDA to ensure it
has all it needs to consider the sNDA for Breo Elliptain asthma. We look forward to the final
outcome expected in April.
About asthma
Asthma is a chronic lung disease that inflames and narrows the airways.1 Approximately 26
million people in the USA currently have asthma.2 Despite medical advances, more than half of
patients continue to experience poor control and significant symptoms.3
The causes of asthma are not completely understood but likely involve an interaction between a
persons genetic make-up and the environment. Key environmental risk factors for the
development of asthma are allergens, respiratory infections and airway irritants.
About Breo Ellipta

Breo Ellipta (FF/VI 100/25 mcg) was licensed by the US Food and Drug Administration under
the brand name Breo Ellipta in May 2013 as a prescription medication for the long-term, oncedaily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients
with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or
emphysema. Breo Ellipta is not indicated for the relief of acute bronchospasm or the treatment of
asthma in the US.
Full US prescribing information, including BOXED WARNING and Medication Guide is
available at us.gsk.com or US Prescribing Information Breo Ellipta.
Important Safety Information (ISI) for Breo Ellipta in the US
The following ISI is based on the Highlights section of the US Prescribing Information for Breo
Ellipta for the maintenance treatment of airflow obstruction in patients with COPD and to reduce
exacerbations of COPD in patients with a history of exacerbations. Please consult the full
Prescribing Information for all the labelled safety information for Breo Ellipta.
Long-acting beta2-adrenergic agonists (LABAs), such as vilanterol, one of the active
ingredients in Breo Ellipta, increase the risk of asthma-related death. A placebo-controlled
trial with another LABA (salmeterol) showed an increase in asthma-related deaths in
subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all
LABAs, including vilanterol. In the US, the safety and efficacy of Breo Ellipta in patients
with asthma have not been established and therefore Breo Ellipta is not indicated for the
treatment of asthma.
Breo Ellipta is contraindicated in patients with severe hypersensitivity to milk proteins or who
have demonstrated hypersensitivity to either fluticasone furoate, vilanterol, or any of the
excipients.
Breo Ellipta should not be initiated in patients during rapidly deteriorating or potentially lifethreatening episodes of COPD, or as rescue therapy for the treatment of acute episodes of
bronchospasm. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.

Breo Ellipta should not be used more often than recommended, at higher doses than
recommended, or in conjunction with other medications containing LABAs, as an overdose may
result.
Oropharyngeal candidiasis has occurred in patients treated with Breo Ellipta. Patients should
rinse their mouth with water without swallowing after inhalation to help reduce this risk.
An increase in the incidence of pneumonia has been observed in subjects with COPD receiving
the fluticasone furoate/vilanterol combination, including Breo Ellipta 100 mcg/25 mcg, in
clinical trials. There was also an increased incidence of pneumonias resulting in hospitalization.
In some incidences these pneumonia events were fatal.
Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis;
fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even
fatal course of chickenpox or measles may occur in susceptible patients.
Particular care is needed for patients who have been transferred from systemically active
corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have
occurred in patients with asthma during and after transfer from systemic corticosteroids to less
systemically available inhaled corticosteroids.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular
dosage of inhaled corticosteroids in susceptible individuals.
Caution should be exercised when considering the coadministration of Breo Ellipta with long
term ketoconazole and other known strong CYP3A4 inhibitors because increased systemic
corticosteroid and cardiovascular adverse effects may occur.
As with other inhaled medicines, Breo Ellipta can produce paradoxical bronchospasm which
may be life-threatening. Vilanterol, the LABA in Breo Ellipta, can produce clinically significant
cardiovascular effects in some patients as measured by increases in pulse rate, systolic or
diastolic blood pressure, and also cardiac arrhythmias. Decreases in bone mineral density have

been observed with long-term administration of products containing inhaled corticosteroids, as

have glaucoma, increased intraocular pressure, and cataracts.
Breo Ellipta should be used with caution in patients with convulsive disorders, thyrotoxicosis,
diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to
sympathomimetic amines.
Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients. Betaadrenergic agonist medicines may produce transient hyperglycemia in some patients.
The most common adverse reactions (3% and more common than in placebo) reported in two
6-month clinical trials with Breo Ellipta (and placebo) were nasopharyngitis, 9% (8%); upper
respiratory tract infection, 7% (3%); headache, 7% (5%); and oral candidiasis, 5% (2%). In
addition to the events reported in the 6-month studies, adverse reactions occurring in 3% of the
subjects treated with Breo Ellipta in two 1-year studies included COPD, back pain, pneumonia,
bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis,
diarrhea, peripheral edema, and pyrexia.
GSK one of the worlds 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.
Theravance, Inc. is focused on maximizing the potential value of the respiratory assets
partnered with Glaxo Group Limited (GSK), including RELVAR/BREO ELLIPTA and
ANOROELLIPTA, with the intention of providing capital returns to stockholders. Under the
Long-Acting Beta2 Agonist (LABA) Collaboration Agreement with GSK, Theravance is eligible
to receive the associated royalty revenues from RELVAR/BREO ELLIPTA (fluticasone
furoate/vilanterol, "FF/VI"), ANORO ELLIPTA (umeclidinium bromide/vilanterol,
"UMEC/VI") and if approved and commercialized, VI monotherapy. Theravance is also entitled
to a 15% economic interest in any future payments made by GSK under agreements entered into
prior to the spin-off of Theravance Biopharma, and since assigned to Theravance Respiratory
Company, LLC, relating to the combination of UMEC/VI/FF and the Bifunctional Muscarinic
Antagonist-Beta2 Agonist (MABA) program, as monotherapy and in combination with other

therapeutically active components, such as an inhaled corticosteroid, and any other product or
combination of products that may be discovered and developed in the future under these
agreements with GSK (other than RELVAR/BREO ELLIPTA, ANORO ELLIPTA and VI
monotherapy). For more information, please visit Theravance's web site at www.thrxinc.com.
ANORO, RELVAR, BREO and ELLIPTA are trademarks of the GlaxoSmithKline group of
companies.
References:
1.

Global Initiative for Asthma. Pocket Guide for asthma management and prevention.
Updated 2014.

2.

American Lung Association, Epidemiology and Statistics Unit, Research and Program
Services Division,Trends in Asthma Morbidity and Mortality, September
2012,http://www.lung.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf (Last
accessed March 2015)

3.

Demoly et al. Eur Respir Rev. 2012 Mar 1;21(123):66-74. doi:

10.1183/09059180.00008111.
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 'Risk factors' in the company's Annual Report on Form 20-F
for 2014.

Theravance forward-looking statements

This press release contains certain "forward-looking" statements as that term is defined in the
Private Securities Litigation Reform Act of 1995 regarding, among other things, statements

relating to goals, plans, objectives and future events. Theravance intends such forward-looking
statements to be covered by the safe harbor provisions for forward-looking statements contained
in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements involve substantial risks, uncertainties and
assumptions. Examples of such statements include statements relating to: the US FDA following
the joint advisory committees recommendations, the strategies, plans and objectives of the
company, the timing, manner and amount of anticipated potential capital returns to stockholders
(including without limitation, expectations of future cash dividends or future share repurchases),
the status and timing of clinical studies, data analysis and communication of results, the
potential benefits and mechanisms of action of product candidates, expectations for product
candidates through development and commercialization, the timing of seeking regulatory
approval of product candidates, and projections of revenue, expenses and other financial items.
These statements are based on the current estimates and assumptions of the management of
Theravance as of the date of this press release and are subject to risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause the actual results of Theravance to
be materially different from those reflected in the forward-looking statements. Important factors
that could cause actual results to differ materially from those indicated by such forward-looking
statements include, among others, risks related to: the disruption of operations during the
transition period following the spin-off, including the diversion of managements' and employees'
attention, disruption of relationships with collaborators and increased employee turnover, lower
than expected future royalty revenue from respiratory products partnered with GSK, delays or
difficulties in commencing or completing clinical studies, the potential that results from clinical
or non-clinical studies indicate product candidates are unsafe or ineffective, dependence on third
parties to conduct its clinical studies, delays or failure to achieve and maintain regulatory
approvals for product candidates, and risks of collaborating with third parties to discover,
develop and commercialize products. Other risks affecting Theravance are described under the
headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition
and Results of Operations" contained in Theravance's Annual Report on Form 10-K for the year
ended December 31, 2014 filed with the Securities and Exchange Commission (SEC) on
February 27, 2015. In addition to the risks described above and in Theravance's other filings
with the SEC, other unknown or unpredictable factors also could affect Theravance's results. No

forward-looking statements can be guaranteed and actual results may differ materially from
such statements. Given these uncertainties, you should not place undue reliance on these
forward-looking statements. Theravance assumes no obligation to update its forward-looking
statements on account of new information, future events or otherwise, except as required by law.
(THRX-G)