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    About GlaxoSmithKline

    GSK was formed in 2000 by the merger of GlaxoWellcome

    (formed from the mergers of Burroughs Welcome &

    Company and Glaxo Laboratories), and SmithKline

    Beecham (from Beecham, and SmithKline).

    As the second largest pharmaceutical company in the

    world, based on net income, the company had sales of

    22.7 billion and made a profit of 7.8 billion in 2007.

    It employs around 110,000 people worldwide, including

    over 40,000 in sales and marketing.

    Its global headquarters are GSK House in Brantford,London, United Kingdom, with its United States

    headquarters based in Research Triangle Park (RTP) in

    North Carolina and its consumer products division based

    in the Pittsburgh suburb of Moon Township, Pennsylvania.

    The research and development division has major

    headquarters in South East England, Philadelphia and

    Research Triangle Park (RTP) in North Carolina.

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    The company is listed on the London and New York stock

    exchanges. The single largest market is in the United

    States (approximately 45% of revenue), although the

    company has a presence in almost 70 countries.

    This case is about the innovative marketing strategy

    adopted by GlaxoSmithKline Plc. (GSK) for Requip.

    Requip is a drug for Parkinson's disease (PD).

    GSK created a new market for Requip by targeting the

    drug at a previously lesser known disorder, the 'restless

    legs syndrome' (RLS).

    GSK, the world's second largest pharmaceutical company,

    made good use of public relations and its marketing

    muscle to make promote awareness among doctors and

    patients about 'restless legs syndrome'.

    After gaining approval for marketing the drug as a

    treatment for RLS, the brand experienced strong growth.

    GSK's effort at marketing Requip for RLS had drawn

    criticism from various quarters

    Critics felt that RLS was a "concocted/invented" disorder.

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    What is a restless leg?

    Restless legs syndrome (RLS) is a neurological disorder

    characterized by unpleasant sensations in the legs and an

    uncontrollable urge to move when at rest in an effort to

    relieve these feelings.

    RLS sensations are often described by people as burning,

    creeping, tugging, or like insects crawling inside the legs.

    The most distinctive or unusual aspect of the condition is

    that lying down and trying to relax activates the

    symptoms. As a result, most people with RLS have

    difficulty falling asleep and staying asleep.

    Some researchers estimate that RLS affects as many as

    12 million Americans. However, others estimate a much

    higher occurrence because RLS is thought to be under

    diagnosed and, in some cases, misdiagnosed.

    Some people with RLS will not seek medical attention,

    believing that they will not be taken seriously, that their

    symptoms are too mild, or that their condition is not

    treatable. Some physicians wrongly attribute the

    symptoms to nervousness, insomnia, stress, arthritis,

    muscle cramps, or aging.

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    RLS occurs in both genders, although the incidence may

    be slightly higher in women. Although the syndrome may

    begin at any age, even as early as infancy, most patients

    who are severely affected are middle-aged or older.

    What is Parkinsons disease ?

    A movement disorder Parkinson's disease is a movement

    disorder of the central nervous system, which includes

    your brain and spinal cord.

    In your brain, certain cells make a chemical called

    dopamine, which carries messages between different

    areas of your brain. Some of the areas tell your body how

    and when to move.

    In some people, these brain cells are damaged or lost and

    no longer make enough dopamine to carry the messages.

    Movement may become difficult, resulting in symptoms

    (also known as "motor symptoms"), which are diagnosed

    as Parkinson's disease.

    Chronic and progressive Parkinson's disease is chronic,meaning that it lasts for a long time. And it is progressive,

    meaning that symptoms advance from early to moderate

    to advanced stages.

    The symptoms of PD and the speed at which it progresses

    are different for each person. Parkinson's disease is a

    condition for which currently there is no cure. But you can

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    manage your symptoms with medications. As symptoms

    progress, your treatment may be modified.

    There are over 6.5 million cases of PD worldwide.

    In the United States alone over 1.5 million people are

    believed to have PD

    About 60,000 new cases are diagnosed every year.

    As the average age of the general population increases,

    the frequency of PD will continue to increase.

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    Q: 1 Understand the issues andchallenges faced by companies in

    managing the product lifecycle of a drug

    Faced with high R&D costs, an impending onslaught of

    patent expirations, mega-merger mania and increasing

    consumer demands for improved medications,pharmaceutical companies are relying more heavily on

    advanced drug-delivery technologies to help them sustain

    the high growth and profit margins they have been

    experiencing since the 90s.

    With more than 300 products coming off patent in the

    next years and increasing generic competition, they are

    under intense pressure to replace these losses with newor improved drugs.

    Against this background, pharmaceutical companies are

    recognizing that drug delivery technologies are a powerful

    strategic marketing tool to differentiate products and

    extend product life cycles, thereby overcoming many

    marketplace

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    Challenges

    They are pursuing stronger alliances with drug -delivery

    companies, including acquisitions, to enable them to

    develop superior drugs and remain competitive.

    The application of drug delivery is a valuable, cost-

    effective life cycle management resource. By infusing

    drugs with new and innovative therapeutic benefits, drug-

    delivery systems extend products profitable life cycle,

    giving pharmaceutical companies competitive and

    financial advantages, and providing patients with

    improved medications.

    Advanced drug-delivery technologies can improve a

    products clinical and commercial value, differentiate a

    product, and serve as an effective resource to outdo

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    competitors. Clinically, they improve the

    pharmacoeconomics of drugs by reducing adverse effects,

    identifying new indications, and improving therapy,

    safety, efficacy, convenience and compliance.

    Giving product a competitive edge

    Enabling or accelerating market entry

    patents expiring

    Drug-delivery companies will play an increasingly

    important role in the future of pharmaceutical marketing,

    as pharmaceutical companies recognize new ways they

    can be used to extend a products life cycle and sustain

    profitability. There will also be an increasing demand for

    more technological advances in drug delivery to meet

    new drug challenges in the future.

    Q: 2 understand how GSK created a new

    market for its drug Requip

    GSK began running ads between September 2004 and

    November of 2005 to raise awareness of RLS. Glaxo

    began by advertising the disorder to doctors in medical

    journals.

    The ads started months before the company had

    regulatory approval to begin selling ropinirole (known as

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    Requip in the U.S.). It then sent specialists to discuss the

    condition with general practitioners. It sponsored

    seminars and continuing education in desirable locations.

    The Restless Legs Syndrome Foundation in the U.S.

    similarly started promoting the medication and raising

    awareness. And GSK set up a website, called

    restlesslegs.com as a resource for people with RLS.

    After gaining approval for marketing the drug as a

    treatment for RLS, the brand experienced strong growth.

    In the process, the company created a 'blue ocean' that it

    was expected to own for a long time.

    GSK's marketing efforts were widely appreciated by

    marketing experts, doctors and patient advocacy groups.

    Experts were particularly impressed by GSK's initial un-

    branded ad campaigns that strove to increase awareness

    about the disease. Some doctors and patient advocates

    praised GSK for raising the profile of a disorder, which

    they considered under-diagnosed and under-treated.

    GSK defended its marketing of Requip. The company

    contended that it viewed sharing medical information on

    diseases, including RLS, as a part of its mission. GSK said

    that people should not trivialize RLS as it was a real

    medical condition that afflicted a number of patients

    around the world

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    "Glaxo began its blitz by advertising the disorder to

    doctors in medical journals months before the company

    had regulatory approval to begin selling requip for RLS.

    Then, it sent specialists to discuss the disease withgeneral practitioners, who usually see RLS sufferers first.

    "Awareness of the syndrome rose within months of

    Glaxo's first TV ads, says the Restless Legs Syndrome

    Foundation, in Rochester, Minn. It had about 2,600 visitors

    a day to its Web site before the Glaxo ad campaign. Two

    months later, about 4,500 people a day were visiting, says

    Georgiana Bell, executive director of the foundation."

    Even this WSJ article left something important out here.

    Q 3: Understand the ethical issues related

    to marketing of Requip?

    RLS was a "concocted/invented" disorder, and GSK had

    resorted to disease mongering to promote the sales of the

    drug. GSK's marketing of RLS had many conflicts of interests as

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    http://www.rls.org/http://www.rls.org/http://www.rls.org/http://www.rls.org/
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    it was allegedly using patient advocacy groups and key opinion

    leaders to further its marketing agenda.

    In order to increase Requip's sales the company used Glaxo's

    marketing machine, which persuaded many consumers and

    physicians to accept restless-legs syndrome, or RLS, as a real

    condition warranting treatment."

    Glaxo began its blitz by advertising the disorder to doctors in

    medical journals months before the company had regulatory

    approval to begin selling requip for RLS. Then, it sent

    specialists to discuss the disease with general practitioners,

    who usually see RLS sufferers first.On May 5, 2005, the US Food and Drug Administration (FDA)

    approved Requip for the treatment of RLS. Soon after the FDA

    approval, Glaxo hired an army of sleep-disorder specialists and

    invited general practitioners to dinner at fancy restaurants

    across the U.S. to hear them speak about Requip

    It also used key opinion leaders (KOLs), such as sleep

    specialists, to raise awareness about RLS and the scope for

    Requip among general practitioners (GPs). GSK's efforts to

    increase awareness of RLS and its efforts to get requip

    approved for RLS got a lot of media attention, creating

    publicity for the disorder as well as the drug.

    GSK had created a market for RLS by aggressively marketing

    the disease through sales force visits to doctors,

    advertisements in medical magazine, and DTC advertising. The

    company was accused of disease mongering and critics alsocontended that there were many conflicts of interest in GSK's

    marketing of Requip in RLS.

    Disease Mongering

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    GSK were inventing new diseases in the quest for profits, a

    practice they called disease mongering. They accused the

    industry of creating a number of newly-defined medical

    conditions such as RLS, sexual dysfunction, erectiledysfunction, sleeplessness, social anxiety disorder, irritable

    bowel syndrome, etc., to keep their revenues moving

    northward.

    Conflict of Interest

    some critics contended that GSK was expanding the market for

    its drugs with the help of patient advocacy groups. In addition

    to the incident involving ESG in the UK, GSK had attracted

    criticism for using RLSF to allegedly forward its marketing

    agenda...

    Criticism of DTC advertising

    some experts believed that disease mongering was more of a

    problem in the US as DTC advertising was allowed. Critics

    contended that such ads exploited the consumers' health

    fears...

    Summary

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    This case study reviews the strategy and tactics utilized

    by GlaxoSmithKline for the Parkinson's indicated

    product, Requip/Adartrel, to manage the life and

    commercial success of the brand through re-branding fortreatment of Restless Leg Syndrome (RLS).

    Executives and managers can use this research to gain

    insights into methods for reinvigorating sales of a

    mature product.

    Success Drivers

    Coordinated Marketing Efforts Created the Groundswell

    for Requip's Commercial Success

    Patient Advocacy Helped Bring Awareness to the Restless

    Leg Condition That Aligned with Launch Goals

    Effective Patient Advocacy Starts Well before Launch

    Help Advocacy Groups Advance Disease State Awareness

    along Fronts

    That Align with New Product's Strengths Condition

    Branding Advances Disease State Understanding andExplains New-Method-of-Action

    Employ Condition Awareness Campaigns before Launch

    to Target Both Patients, Physicians and Payers

    Address All Disease State Critical Success Factors to Set

    the Marketing Roadmap

    Take Preventive Measures to Avoid ""disease

    Mongering"" Label from Hurting the Brand Proactive Media Outreach through Science and Human

    Interest Stories Spur Public Interest in the New Product

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