1. The long and
difficult 13-
year journey
to the
marketplace
for Pfizer’s
viagra
Lecturer: Sergio Pinzon

2. Introduction
There are many stories that have emerged over the years
concerning Pfizer’s product Viagra. Some of these are
true, but many are simply fictional stories developed to
try to reinforce a particular argument. One of the most
common is that Viagra was the result of luck. This case
study explores the long 13-year journey from laboratory
to the marketplace and looks at some of the key
challenges faced by Pfizer; most notably, project
evaluation considerations, when the available market
research evidence suggests a small market for the
product, and product launch considerations, when
impotence is such an unpopular topic that it is almost
impossible for advertisers to refer to it without alienating
the very consumer base they are trying to reach

3. What is Viagra?
Pfizer’s Viagra is now part of business folklore in terms of an example of a successful new
product. Viagra is now one of the most recognised brands in the world; it has become a social
icon with annual sales in excess of $1.7 billion in 2012 and $2 billion in 2015. And it has
transformed Pfizer from a medium sized pharmaceutical firm into the world’s leader. Yet,
Viagra was almost dismissed during clinical trials as interesting, but not clinically or financially
significant. It is true that Viagra was something of an accidental discovery. Scientists testing an
angina drug found that, as a side effect, it seemed to cure impotence in many patients. It did
not take long for Pfizer to decide to focus on its unexpected benefit and to develop the
product further as an anti-impotence drug. The drug was licensed by the US FDA (Food and
Drugs Administration) and launched in the USA in April 1998, amidst a huge fanfare of serious
and not so serious media hype. At the time, many news organisations used attention-grabbing
headlines, often stretching the product’s capabilities, such as how Viagra could enhance
sexual performance. In the first month, 570,000 new prescriptions for Viagra were issued,
generating $100 million in revenue.

4. What is Viagra?
One of aspect of the story that frequently seems to get highlighted is that this
product was due to serendipity or luck. Whilst this may be true for a very small
part of the story, as this case shows, the vast majority of the product’s success
was due to effective management, excellent research and development and
very clever marketing. Unfortunately, the serendipity aspect of the Viagra case
overshadows the ground-breaking science involved (the Nobel Prize for
physiology was awarded to scientists involved in the related research for Viagra)
and the effective management by Pfizer of the new product development
process. Moreover, this story reinforces in the minds of the public that science
and research are dependent on luck. This is misleading at best and, at worst,
dangerous.

5. What is Viagra?
According to some journalists, Viagra owes its existence to serendipity. They
argue it started its life as a potential treatment for angina and was being tested
in clinical trials. As an angina treatment, it was pretty useless, but then the
researchers began to get reports of some unexpected side effects and, hence,
Viagra was born. This, of course, is not only incomplete but is misleading. Of
course, it would be naive to think that the complexities of scientific research will
always be relayed accurately to a mass audience but, for medicine and science
to be portrayed as scientists playing around in the laboratories in the hope that
something will drop from their test tubes, is, quite simply, untrue. If science is
not careful, Viagra will end up like the discovery of penicillin and, therefore,
antibiotics: that it was all down to luck. Few people realise that, whilst
Alexander Fleming discovered penicillin in 1928, it took another 20 years for
scientists Howard Florey and Ernst Chain to develop a method of producing a
product that could be used by patients for treatment in the form of antibiotics
that we know today..

6. From angina to
Viagra
The true story of Viagra is more
complex and illustrates that the
research project team had to fight
hard for the huge investment that
was required to develop the
compound into a product. Table 1
illustrates the stages from initial
concept to final product.

7. From angina to Viagra
Table 1- The main stages in the development of Viagra
1985 Initial concept In 1985, scientists at Pfizer decided to develop a medicine to treat heart failure and
hypertension. They were looking for a medicine that would vasodilate, or ‘open’,
arteries, lower blood pressure and reduce strain on the heart. They chose to target
the medicine to act on an enzyme found in the wall of blood vessels.
1986–90 Research and
development starts
Between 1986 and 1990, hundreds of possible medicines were synthesised and
tested in laboratory experiments. The most promising compound was given the code
name UK-92.480. It showed properties that suggested it would be a good medicine
to treat angina. Research was redirected to look at this heart disorder. The medicine
was later called Sildenafil and finally renamed Viagra (Sildenafil citrate).
1991 Volunteer trials In 1991, healthy volunteers took part in clinical trials to test the safety of Viagra and
how the body metabolised the compound. These showed that it was safe. In trials
over 10 days, the healthy volunteers reported some unexpected side effects. Male
volunteers reported more frequent erections after taking the angina medicine!
1992 Erectile dysfunction Following the unusual side effects seen in the volunteer trials, researchers switched
to looking into using Viagra to treat erectile dysfunction (ED). This serious condition
causes psychological and emotional problems that affect many families. Research
into using Viagra to treat angina continued but the medicine did not prove powerful
enough to be really useful.

8. From angina to Viagra
Table 1- The main stages in the development of Viagra
1993–6 ED clinical trials start ‘Double-blind, placebo controlled’ clinical trials started in 1993 to test how well Viagra
treated patients with erectile dysfunction. To make the trials a fair test, neither the
patients nor their doctors knew if they were receiving the medicine or an inactive
placebo. Viagra proved to be a great success.
1997 Licence application All medicines need to be licensed by the medical authorities before they can be
prescribed by doctors. To achieve this, trials must show it is safe and effective. Approval
usually takes about 12 months but in the case of Viagra it received its licence in only 6
months.
1998 Licence approva Viagra was given a licence. It could be used in the treatment of erectile dysfunction in
1998. In its first three months, there were 2.9 million prescriptions for the medicine.

9. From angina to Viagra
To develop this one successful medicine, scientists screened over
1,500 compounds and spent an estimated £600 million (at today’s
prices). Furthermore, it took 13 years (1985–98) to bring Viagra from
conception to production. This level of investment is sometimes
needed for research, development and to prove that the new
medicine is safe and effective. Viagra started life as a medicine
intended to treat angina pectoris. Alfred Nobel – an explosives
manufacturer from Norway – suffered from angina (angina is defined
as brief attacks of chest pain due to insufficient oxygenation of heart
muscles).

10. From angina to Viagra
In 1890, he was prescribed nitro-glycerine (called trinitrin) to
relieve the pain of angina attacks. It is still used today. Over
100 years later, the work of Robert Furchgott, Louis Ignarro
and Ferid Murad showed that nitric oxide (NO) was an
important signalling molecule in the cardiovascular system. It
is released from nerve endings and cells lining the walls of
blood vessels. The effect is to make the blood vessel relax or
dilate. It is also involved in the prevention of blood clots. In
1998, they received the Nobel Prize for Physiology. The
Nobel Prizes were set up by the same Alfred Nobel who had
been treated with nitro-glycerine.

11. From angina to
Viagra
Building on this knowledge, research by other
groups is being undertaken to develop new
medicines that moderate the actions of nitric
oxide for the treatment of cardiovascular and
other disorders (Pfizer, 2005).

12. Dilating arteries
Researchers started by trying to understand the
process of vasodilation (what makes the arteries
dilate). They decided to target the action of the new
medicine on to the enzyme PDE (Phosphodiesterase).
This enzyme breaks down the signalling molecule
cGMP, which causes vasodilation. Enzymes have a
very specific shape. Viagra fits into the active site and
blocks it.

13. Dilating arteries
This prevents the PDE from breaking down the
cGMP, which then stays in the blood and continues
to cause vasodilation. The first step to developing
the new medicine was to isolate and characterise
the PDE enzyme (later called PDE-5). Once the PDE
had been isolated, researchers could use it to find
out the optimum conditions in which it works and
also do tests to find efficient inhibitors. This enables
molecules to be modified and designed to affect the
enzyme.

14. Clinical trials
In 1991, following six years of laboratory research, a clinical trial was undertaken in
Wales for a compound known as UK-92.480. The findings from the trial on healthy
volunteers revealed disappointing results. The data on blood pressure, heart rate and
blood flow were discouraging. The R&D project was in trouble. Some patients reported
side effects of episodes of indigestion, some of aches in legs and some reported penile
erections. This final point was listed merely as an observation by the clinicians involved
in the study, at that moment no one said ‘wow’ or ‘great’. Indeed, the decision to
undertake trials into erectile dysfunction was not an obvious one. This was partly
because the prevailing view at the time was that most erectile dysfunction was
psychological and not treatable with drugs. Few people believed it was possible to
produce an erection with an injection of drugs. Men, particularly older men who are
more likely to suffer from impotence, were treated as if it was their fault, that it was all
in the mind and that they should try to accept their sex life was more or less over.

15. Clinical trials
In any large research laboratory, there will be hundreds and, sometimes,
thousands of research projects being undertaken at any one time. Each
project has to give regular reports on progress to senior R&D managers,
who continually have to decide with which projects to continue
investment and which to stop and which new projects to start. In 1991,
the leader for the Viagra project had to report on progress and the
results were disappointing. Essentially, the medicine was not effective in
treating angina. The senior R&D managers were preparing to drop the
angina R&D project due to its disappointing results. It was also
considering dropping all studies on the compound, even as a possible
drug for erectile dysfunction.

16. Clinical trials
This was partly because it was not clear that it would have a clinical
use. Not all the healthy volunteers had reported erections.
Moreover, how would Pfizer be able to conduct trials for such a
condition? Furthermore, the market for such a drug was not clear. At
that time, survey results revealed only 1 in 20 million men suffered
from erectile dysfunction; hence, even if a medicine could be
developed, the market would be very small. The R&D team involved
in the project eventually managed to gain two years of funding to
develop the drug and undertake clinical trials.

17. Clinical trials
One needs to be aware that, at the time, Pfizer had many drugs under consideration for the
treatment of many other conditions, such as colonic cancer, diabetes, asthma, etc. These
markets were well-known and understood. The business case for all of these projects and others
could be made easily. Accurate predictions could be made on the number of people who
suffered from asthma and what customers would be willing to pay for such drugs. It was not
possible to draw up an accurate business case for Viagra due to the uncertainties of the market
and the condition. There simply was not a similar drug on the market with which to make a
comparison.

18. Clinical trials
This made it an even more difficult decision for R&D managers at Pfizer.
Fortunately, in 1992 the go ahead was given to provide funds for the
continuation of clinical trials into erectile dysfunction (ED). But another
problem now faced the team: how to conduct clinical trials in this very sensitive
area. Would the team be able to find people willing to participate and discuss
their experiences? Fortunately, the team did not experience any major difficulty
in recruiting volunteers. Whilst it was true that large parts of the population did
not feel comfortable in participating, sufficient numbers of people were willing
to take part, not least those suffering from ED. The pharmaceutical industry is
aware that, despite advances in technology and scientific know-how, the odds
of a drug candidate’s success has not shifted in the past 20 years. Of 12
molecules that Pfizer classes to be its best bets – those drugs that have made it
to the verge of clinical testing – only 1 will make it to market (Michaels, 2001).

19. Product and market
evaluation: decision time!
• In 1996, following successful clinical trials, the clinical success of
the drug and obtaining patent protection did not seem to be in
doubt, but that alone is not enough to proceed with the huge
investment required to take the drug to market. Major
uncertainties remained, especially with the business case:
• What is the size of the market? How many people suffer from
ED?; Could the market be bigger?
• Can we make the market bigger?
• The market for ED is not developed; can it be developed and
how?; Is it a growing market?
• Is there an existing customer base (i.e., current sufferers)?
• Is the potential big enough to warrant the investment?
• Does it support our short-term and long-term plans for the
business?

20. Product and market
evaluation: decision time!
We sometimes need reminding that virtually all businesses are established to
make a profit for their investors; hence, most decisions centre on finance. What is
the investment and what is the likely return? This decision was no exception. The
business case for Viagra certainly was interesting but there were many risks, not
least would the product sell and how would Pfizer be able to market the product
to a public that, in the USA, at least, was known to be conservative and prudish
about talking about impotence and sex? The likelihood of a television commercial
going out at 8 pm on ABC or NBC promoting the virtues of Viagra in overcoming
impotence was simply unimaginable in the mid-1990s. Hence, there were risks in
terms of the size of the market and, even if the market proved to be as big as
Pfizer hoped, how would it be able to communicate with this market and promote
the product?

21. Is there a viable marketing
plan?
The drug cannot be purchased over the counter; hence men would have to get a
prescription from their physician. The challenge for Pfizer, then, was to encourage men
to go to their doctor and ask for treatment. This poses a significant challenge. The
marketing campaign would need to focus on education and raising awareness of the
condition. Impotence, however, is such an unpopular topic that it is almost impossible
for advertisers to refer to it without alienating the very consumer base they are trying to
reach. The audience would need reprogramming. Whilst sex sells, it was important to
numb the audience and society with educating material: an audience made up of
sensitive males with problems that are often highlighted as the butt of many jokes. The
consumer had to be reprogrammed to look at the situation in a new light. In order to do
this, a large amount of money had to be there for the product launch and the
subsequent advertising that ties to it.

22. Is there a viable
marketing plan?
After much debate and discussion, Pfizer decided to attempt to
create a sense of pride in the consumer through the opposite sex’s
testimonials of newly found happiness and through mainstream
sports stars that epitomise the definition of manliness. The Viagra
ads eventually selected by Pfizer tried to break through men’s
reluctance to address the issue by using celebrity spokesmen who
embody respectability (politician Bob Dole); athleticism (NASCAR
driver Mark Martin, Brazilian footballer Pele and Texas Rangers
baseball player Rafael Palmeiro); and virility (Hugh Hefner).
Altogether, Pfizer spent more than $100 million on endorsements,
television advertising, online marketing and sports event
sponsorship.

23. Is there a viable marketing
plan?
The celebrities encouraged men to fix the problem – as they would fix a
headache with Aspirin. The campaign earned Viagra brand-name
recognition approaching that of Coca-Cola and has led to a saturation of
Viagra jokes and spam emails.
Some analysts argue Pfizer made a critical error by selecting Bob Dole as
its advertising spokesperson. Dole, in his 70s, was clearly the market for
Viagra, but he was not the target. The target is the 50-year-old married
man who is having trouble but is terrified of asking his doctor.
Positioning the product for older men tells younger men that Viagra was
not for them. Viagra would have been wiser choosing younger, more
macho-looking men to help remove the stigma of ED and make younger
men feel more comfortable talking about the problem and product.
Today, you do see much younger male models in the Viagra ads.

24. Launch
At the launch, the priority for Pfizer was to retain control over the brand image, ensuring that it was
positioned as Pfizer wanted it to be and that accurate information was given to the public. A campaign
estimated to be costing tens of millions of dollars on consumer-orientated advertising in popular
magazines, such as Time, Life and Newsweek, was undertaken. The enormous level of pre-launch
publicity that Viagra had generated was not, necessarily, a good thing. The publicity was out of Pfizer’s
control, meaning that it could be inaccurate and/or damaging to the brand image. The thousands of
jokes made about the brand could well have had a negative effect, making patients embarrassed about
owning up to an impotence problem and asking for the drug. Pfizer waited until the worst of the
publicity had died down before launching its campaign to make sure that its message was heard
properly and that the drug was taken more seriously. This, along with all the media hype, had led to a
rapid take-up after its introduction.

25. Launch
Sales continued to grow as the product was
launched progressively on worldwide markets. In
1998, total sales had reached $776 million, $1,016
million by 1999 and $1,344 million by 2000,
representing over 5 per cent of human drug sales
for Pfizer. The 2000 Annual Report proclaimed
that more than 300 million Viagra tablets had
been prescribed for more than 10 million men in
more than 100 countries: Viagra had become a
worldwide brand in a very short period of time.

26. All the US publicity was heard in Europe and made the European
market a little more difficult to enter. When Viagra eventually
was licensed in Europe late in 1998, the UK health minister
pronounced that Viagra would not be made available on the
National Health Service (NHS). This had a lot to do with NHS
priorities: impotence is not high on the list, apparently, and there
were fears about the cost to the NHS if all the hype produced the
same sort of level of demand as in the USA. There were fears
that it would cost the NHS £1 billion per year if it was available
on demand. Although some relaxation has subsequently taken
place, and doctors are allowed more say in prescribing the drug,
it is still not readily available on prescription. Impotence in itself
is not enough for free treatment – it must be caused by specific
medical conditions, such as diabetes.
Launch

27. Launch
Viagra’s advertising campaigns were never the key to its success, however.
Because of its unique clinical function, Viagra became an immediate cultural
point for all issues relating to virility, male sexuality and aging, and through
this continual popular referencing, much more than the effects of its $100
million advertising budget, Viagra has achieved a level of brand recognition
that is reserved only for superstar drugs like Tylenol and Prozac. Indeed,
Viagra continues to be a constant source of office jokes and comments for
late night talk show hosts. More than simply spreading the word on what
Viagra is, the enormous street and media buzz that Viagra has inspired has
established Viagra’s image overwhelmingly in terms of power and efficacy
as the remedy for impotence.

28. Competition
The greatest challenge to Viagra came when Pfizer lost some of its
patent protection. The main, or active, ingredient in Viagra is
sildenafil, and potential competitors Eli Lilly and Icos Corporation
challenged the legitimacy of the original patent issued in 1993. The
court ruled that the knowledge on which it had been based was
already in the public domain in 1993 and that the patent was now
restricting research by other companies. Other companies would
now be able to sell drugs that treat impotence by blocking PDE-5, a
chemical, although Pfizer retains a patent on the active ingredient in
Viagra – meaning that direct copies of the drug itself will not be
permitted. In January 2002, the Court of Appeal (UK) had agreed
with an earlier High Court ruling that knowledge covered by the
Pfizer patent on the ‘PDE-5 inhibitor’ was already in the public
domain. Similarly, in 2004, Pfizer faced increased competition in
China after Beijing overturned its domestic patent for the main
ingredient in Viagra.

29. Competition
Although the molecular structure of Viagra was still
protected, the main active ingredient was now open
to competitors. The first serious challenge came from
Uprima after it received its European licence in 2001.
Its makers, Abbott Laboratories, based in Illinois, USA,
claimed it worked more quickly than Viagra, with
fewer side effects and cost less than £5 for both low
and high dosage tablets. Quick action can help
spontaneity, unlike Viagra, which has to be taken at
least an hour before sex.

30. Competition
Pfizer continued with its legal battles as it attempted to prevent competitors copying key
elements of the drug. GlaxoSmithKline, the Anglo-American group, and its German
partner Bayer were relying on Vardenafil to revive their flagging share prices (Firn and
Tait, 2002). Critics argued that Pfizer’s goal was simply to delay competitive entry for
Viagra as long as possible and, if the patent actually were to stick, that simply would be
additional profits. In 2003, the competition for Viagra increased noticeably when Viagra
came third in the first independent comparison with its two new competitors. According
to the research, 45 per cent of the 150 men involved in the trial preferred Eli Lilly’s Cialis,
while 30 per cent voted for Levitra, jointly marketed by GlaxoSmithKline and Bayer. The
findings are likely to play an important part in the fierce marketing battle between the
four pharmaceutical groups over treatments for impotence. Pfizer said the research was
not scientifically rigorous (Dyer, 2003)

31. Competition
The challenge for the competitors is different from that faced by Pfizer. Viagra is already a well-
known remedy for impotence in the popular imagination; alternative drugs are fighting an uphill
battle against the power of the Viagra brand. The marketing challenge that faced the makers of
Cialis and Levitra is that they would have to re-establish the problem of impotence – a problem
that many consumers see as already having been solved by Viagra – in order to offer their
products as a cure. But, because Viagra already exists, Levitra and Cialis would have to rely on
advertising to increase their market share and, since ED appears to be a distasteful topic,
advertisers decided to concentrate on enhancing ED’s image, rather than its products’ image.
Cialis differentiates itself from both Viagra and Levitra by offering a 36-hour window of efficacy.
This beats Viagra’s and Levitra’s four- to eight-hour period and allows Cialis to focus its advertising
on timing rather than performance. All three advertising campaigns ultimately suggest the
discomfort, shame, embarrassment and fear that surround sex in general, and the lack of any
compassionate, humane, truthful discourse on sexual dysfunctions in our culture. Sex appears as
a paranoid game where invisible spectators cheer winners and boo losers.

32. Conclusions
By virtually all measures, this product has been universally successful for Pfizer, transforming it
from a large pharmaceutical firm into the world’s leading pharmaceutical firm. The actual
market for this type of drug is now known to be far greater than the original market research
data had revealed. This is a cautionary tale of the need sometimes to encourage innovation
and support scientific freedom in the face of evidence to stop the project.
Viagra was the first-mover and first-prover in this category. However, Viagra has not been
quick to respond to competitive scientific advancements in erectile dysfunction drugs. It takes
Viagra anywhere from 30 minutes to an hour to work but Levitra, launched in 2001, improves
upon that by working in 16 minutes. And Cialis, also launched in 2001, improves upon Levitra
by being able to last up to 36 hours. Indeed, competitors argue Pfizer has already conceded
defeat by introducing a loyalty programme, which they argue is not about building a long-term
relationship with their patients, as Pfizer’s marketing director says. Rather, they see it as a
scheme by Pfizer to get the most out of the Viagra brand and it will continue to lose market
share to better, more effective options from Levitra and Cialis. The erectile dysfunction market
grew 3.5 per cent from 2003 to be worth $1.95 billion in 2005 and is almost entirely composed
of sales from the three brands: Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil).
Table 2 reveals the continued dominance of Viagra

33. Conclusions
Impotence drug: brand Sales (2015)
Levitra (vardenafil) $0.3 bn
Viagra (sildenafil) $1.38 bn (43%)
Cialis (tadalafil) $0.5 bn
Table 2: Sales of impotence drugs

34. Conclusions
One aspect of this case study that is seldom discussed is the extent to
which Pfizer has benefited from raising disease awareness. A lot of
money can be made from healthy people who believe they are sick.
Pharmaceutical companies are able to sponsor diseases and promote
them to prescribers and consumers, a practice sometimes known as
‘disease mongering’ (i.e. widening the boundaries of treatable illness
in order to expand markets for those who sell and deliver treatments).
Within many disease categories, informal alliances have emerged,
comprising drug company staff, doctors and consumer groups.
Ostensibly engaged in raising public awareness about under-diagnosed
and under-treated problems, these alliances tend to promote a view
of their particular condition as widespread, serious and treatable.

35. Because these ‘disease awareness’ campaigns are commonly linked to companies’ marketing
strategies, they operate to expand markets for new pharmaceutical products. Alternative
approaches – emphasising the self-limiting or relatively benign natural history of a problem,
or the importance of personal coping strategies – often are played down or ignored. As the
late medical writer Lynn Payer observed, disease mongers ‘gnaw away at our self-
confidence’ (Payer, 1992). For example, a double-page advertisement in the Sydney Morning
Herald’s Weekend Magazine told Australians that 39 per cent of men who visit general
practitioners have ED. The 39 per cent claim in the advertisement was referenced to an
abstract of a survey finding. However, another Australian study, not cited in the
advertisement, estimated that erection problems affected only 3 per cent of men in their
40s and 64 per cent of men in their 70s. The advertisement’s fine print cited a host
organisation, Impotence Australia, but did not mention that the advertisement was funded
by Pfizer (Moynihan et al., 2002). The key concern with ‘disease mongering’ is the invisible
and unregulated attempts to change public perceptions about health and illness to widen
markets for new drugs.
Conclusions

36. Tutorial 4 questions
• Explain why it was so necessary to ensure marketing was involved in the
early stages of this new product development project
• Explain how, despite the enormous resources of Pfizer, a lack of available
information made the evaluation of the new product proposal so very
difficult.
• Explain how the Viagra case needs to be viewed as a successful example of
excellent applied science but also an excellent example of good marketing.
• How can Pfizer manage the threat posed to Viagra by new entrants to the
market?
• How has Pfizer helped create a market for Viagra and thereby contributed
to disease mongering?