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The long and difficult 13-year journey to the marketplace for Pfizer's Viagra Introduction There are many stories that have emerged over the lightod is that this product was due to serendipity or years concerning Pfizer's product Viagra. Some of luck. Whist this may be true for a very small part of these are true, but many are simply fictional stories the story, as this case shows, the vast majority of the developed to try to reinforce a particular argument. product's success was due to effective management, One of the most common is that Viagra was the result excellent research and development and very clever. of luck. This case study explores the long 13-year marketing journey from laboratory to the marketplace and looks Unfortunately, the serondipity aspect of the Viagra at some of the key challenges faced by Pfizer, most case overshadows the ground-breaking science notably, project evaluation considerations, when the involved the Nobel Prize for physiology was awarded avallable market research evidence suggests a small to scientists involved in the related research for market for the product, and product launch consid- Vagra) and the effective management by Pfizer of the erations, when impotence is such an unpopular topic new product development process. Moreover, this that it is almost impossible for advertisers to refer to it story reinforces in the minds of the public that sciwithout alienating the very consumer base they are ence and research are dependent on luck. This is trying to reach. misleading at best and, at worst, dangerous. What is Viagra? ence to secendipity. They argue it started its life as a Pfizer's vagra is now part of business folklore in potential treatment for angina and was being tested terms of an example of a successful new product. in cinical trials. As an angina treatment, it was pretty Viagra is now one of the most recognised brands in useless, but then the researehers began to get the world; it has become a social icon with annual reports of some unexpected side effects and, hence, sales in excess of $1.7 billion in 2012 and $2 birion in Viagra was bom. This, of course, is not only incom2015. And it has transformed Pfizer from a medium- plete but is misleading. Ot course, in would be naive. sized pharmeceutical firm into the world's leader. to think that the complexties of scientific research Yet, Viagra was almost dismissod during cinical triats will always be relayed accurately to a mass audience as interesting, but not clinically or financialy signiff- but, for modicine and science to be portrayed as sctcant it is true that Viagra was something of an acci- entists ploying around in the laboratories in the hope dental discovery. Scientists testing an angina drug that something will drop trom their test tubes, is, found that, as a side effect, it seemed to cure impo- quite simply, untrue. it sclence is not caretu, Vagra tence in mary paitients. It did not take long for Pfizor will end up like the discovery of penicilln and, thereto decide to focus on its unexpected benofit and to fore, antiblotics; that it was all down to luck. Fer develop the product further as an anti-impotence people realse that, whilst Alexander Fleming discovdrug. The drug was licensed by the US FDA (Food ered penicilin in 1928, a took another 20 years for and Drugs Administration) and launched in the USA scientists Howard Florey and Ernst Chain to develop in April 1988, amidst a huge fanfare of sorious and a method of producing a product that could be used not so serious media hype. At the time, mary news by pationts for treatment in the form of antibiotics organisations used attention-grabbing headlines, that we know today. often stretching the product's capabilities, such as The true story of Viagra is more complex and ilishow Viagra could enhance sexual performance. In trates that the research project team had to fight hard the firt month, 570,000 new prescriptions for Viagra for the huge investment that was required to develop were iasued, generating $100 milion in revenue. One the compound into a product. indeed, it was ainost. not developed at all. Gill Samuels was director of sci they recelved the Nobel Prize for Physiology. The ence policy at the Pfizer Central Research Site, Nobel Prizes were sot up by the same Afred Nobel Sandwich, Kent, and was one of the key developers who had been treated with nitro-glycerine. Building of Viagra. She was awarded a CBE for services to on this knowledge, research by other groups is being bioscience in the Queen's 2002 birtiday honours list. Undertaken to develop new medicines that moderate She recails some of the problems: the actions of nitric oxide for the treatment of cardio- Even in the early stages when it was known that vascular and other disorders (Pfizer, 2005) we were doing trials in the UK we had patients writing in wanting to participate, and we have had Dilating arteries some wonderful ietters from patients who particl. Researchers started by trying to understand the propated in those trials. Even before Vlagra was cess of vasodilation (what makes the arteries diate). launched in the US [in April 1998) we realised that They decided to target the action of the new medicine it had a very profound offect. The question was on to the enzyme PDE (Phosphodiesterase). This how many of those men who did have erectlle dys- enzyme breaks down the signalling molecule CGMP. function would actually want to recelve treatment which causes vasodilation. By preventing the breakforit? It was very, very difficult to predict the abso- down of cGMP, the new medicine would incraase lute numbers. There is no doubt about it that the vasodilation. Enzymes have a very specific shape. media interest in Viagra raised the awareness of Viagra fits into the active site and biocks i. This preerectile dysfunction, and probably encouraged vents the PDE from breaking down the cGMP, which men who had the problom, but did nothing about then stays in the blood and continues to ceuse vasoit, to contact their doctor. dilation, The first step to developing the new medicine (BBC.co.uk, 2006) calied PDE-5), Once the PDE had been isolated. researchors could use it to find out the optimum con- From angina to Viagra ditions in which it works and also do tests to find elfTo develop this one successful medicine, scientists ciant inhibitors. This enables molecules to be modified screened over 1,500 compounds and spent an esti- and designed to affect the enzyme. mated 8600 million (at today's prices). Furthermore, it took 13 years (1985-98) to bring Viagra from concep-- Clinical trials tion to production. This level of investment is some- in 1991, following six years of laboratory research, a times needed for research, development and to prove clinical trial was undertaken in Wales for a compound that the new medicine is safe and effective. Table 9.5 known as UK-92.480. The findings from the trial on illustrates the stages from initial concept to final healthy volunteers revealed disappointing results. product. She data on blood pressure, heart rate and blood Viagra started Iife as a medicine intended to treat fiow were discouraging. The RBD project was in trouangina pectorls. Alfred Nobel - an explosives manu- ble. Some patients reported side eftects of eplsodes facturer from Norway - suffered from angina (angina of indigestion, some of aches in legs and some is defined as brief attacks of chest pain due to insut- reported penile erections. This final point was listed ficient oxygenation of hoart muscles). In 1890 , he was merely as an observation by the clinicians involved in prescribed nitro-glycerine (called trinitrin) to relleve the study, at that moment no one sald wow' or the pain of angina attacks. It is still used today. Over 'great'. Indeed, the decision to undertake trials into 100 years later, the work of Robert Furchgott, Louls erectilo dystunction was not an obvious one. This. Ignarro and Ferid Murad showed that nitric oxide was partly because the prevalling vew at the time (NO) was an important signalling molecule in the car. Was that most erectio dystunction was psychological diovascular system. It is released trom nerve ondings and not treatable with drugs. Fow poople beieved it and cells lining the walls of blood vessels. The effect was possiblo to produce an erection with an ingection is to make the blood vessel relax or dilate. It is also of drugs. Mon, particularly older men who are more involved in the prevention of blocd ciots. In 1998, likely to sutter from impotence, were troated as it it Chapter 9 Management of research and development Table 9.5 The main stages in the development of Viagra compound was given the code name UK-92.480. It showed propertes that suggested it would be a good medicine to treat angina. fesearch was redirected to look at this heart disorder. The medicine was later caled Silderafil and finally renamed Viagra (Slildenafi citrate). 1991 Volunteer trials. In 1991, beaithy volunteers took part in clinical trials to test the safety of Viagra and how the body metabolised the compound. These showed that it was sale, In trials ovor 10 days, the healthy volunteecs seported some unexpected side otlects. Male voluntees reported more frequent erections after taking the angina medicinel 1992 Erectile dysfunction Following the unusual side eflects 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 aflect many familios. Research into using Viagra to treat angina continued but the medicine did not prove powertul enough to be realy useful, 1993-6 ED clinical trials start. "Double-blind, placobo controlled' clinical trials started in 1993 to test how wet Viagra treated patients with erectile dysunction. To make the triats a fair test, neither the potients 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 betore they can be prescrlbed by doctors. To achieve this, trials must show it is salf and effective. Approval usually takes about 12 months but in the case of Viagra it received its licence in only 6 months. 1998 Licence approval Viagra was given a ficence, It could be used in the treatrent of erectile. dysfunction in 1998. In its first three months, there wore 2.9m illon prescriptions for the medicine. Source: Pfienr com. was their faut, that it was all in the mind and that they also considering dropping all studies on the comshould try to accept their sex life was more or less pound, oven as a possible drug for erectle dysfunc-. over. tion. This was partly bocause it was not clear that it In any large research laboratory, there will be hun- would have a clinical use. Not all the hoalthy volundreds and, sometimes, thousands of research pro- teers had reported erections; Moreover, how would Jects being undertaken at any one time. Each project. Plizer be able to conduct trials for such a conditicn? has to give regular reports on progress to senior PBD Furthermore, the market for such a drug was not managers, who continually have to decide with which clear. At that time, survey results revenled only 1 in projects to continue investment and which to stop 20 million men suffered from erectile dysfunction: and which new projects to start. In 1991, the leader hence, even if a medicine could be developed, the marfor the Viagra project had to report on progress and ket would be very smal. The RSD tearn imvolved in the the results were disappointing. Essentially, the medi- project eventualy managod to gain two years of tundcine was not effective in treating angina. The senior ing to develop the drug and undertake clinical trials. ABD managers were preparing to drop the angina One needs to be aware that, at the time, Pizer. RBD project due to its disappointing results. It was. had many drugs under consideration for the 332 treatment of many other conditions, such as colonic - Is the potential blg enough to warrant the investcancer, diabetes, asthma, etc. These markets were ment? well-known and understood. The business case for Does it support our short-term and long-term all of these projects and others could be made eas- plans for the business? ily. Accurate predictions could be made on the num- ber of people who suffered from asthma and what We sometimes need reminding that virtually al customers would be willing to pay for such drugs. it businesses are established to make a profit for their: was not possible to draw up an accurate business investors; hence, most decisions centre on finance. case for Viagra due to the uncertainties of the market What is the investment and what is the likely refum? and the condition. There simply was not a similar This decision was no exception. The business case drug on the market with which to make a compari- for Viagra certainly was interesting but there were soh. This made it an even more difficult decision for many risks, not least would the product sell and how. R\&D managers at Plizer. Fortunately, in 1992 the go would Pfizer be able to market the product to public ahead was given to provide funds for the continua- that, in the USA, at least, was known to be conservation of clinical trials into erectile dysfunction (ED). tive and prudish about talking about impotence and But another problem now faced the team: how to sex? The likelihood of a television commerclal going conduct clinical trials in this very sensitive area. out at 8 pm on ABC or NBC promoting the virtues of Would the team be able to find people willing to par- Viagra in overcoming impotence was simply unimag-ticipate and discuss their experiences? Fortunately. nable in the mid-1990s. Hence, there were risks in the team did not experience any major difficulty in terms of the size of the market and, even it the market recruiting volunteers. Whilst it was true that large proved to be as big as Pfzer hoped, how would it be. parts of the population did not feel comfortable in able to communicate with this market and promote participating, sufficient numbers of people were will- the product? ing to take part, not least those suffering from ED. Is there a viable marketing plan? The pharmaceutical industry is aware that, despite The drug cannot be purchased over the counter: advances in technology and scientific know-how, hence men would have to get a prescription from the odds of a drug candidate's success has not their physician. The challenge for Pfizer, then, was to shifted in the past 20 years. Of 12 molecules that encourage men to go to their doctor and ask for Plizer classes to be its best bets - those drugs that treatment. This poses a significant chailenge. The. have made it to the verge of clinical testing - only 1 marketing campaign would need to focus on educawill make it to market (Michaels, 2001). tion and raising awareness of the condition- Product and market evaluation: Impotence, however, is such an unpopular topic that decision time! it is almost impossible for advertisers to refer to it In 1996, following successful clinical trials, the clinical without alienating the very consumer base they are success of the drug and obtaining patent protection trying to reach. The audience would need reprogramdid not seem to be in doubt, but that alone is not ming. Whilst sex sells, it was important to numb the enough to proceed with the huge investment required audience and society with educating material: an to take the drug to market. Major uncertainties audience made up of sensitlve males with problems remained, especially with the business case: that are often highlighted as the butt of many jokes. - What is the size of the market? How many people situation in a now light. in order to do this, a large. sutfer from ED? - Could the market bo bigger? amount of money had to be there for the product - Can we make the market biggen? After much debate and discussion, Pfizer decided launch and the subsequent advertising that ties to it. - The market for ED is not developed; can it be to attempt to create a sense of pride in the consumer. developed and how? through the opposite sex's testimonials of newly - is it a growing market? found happiness and through mainstream sports - is there an existing customer base (l.e. current stars that epitomise the definition of manliness. The sutferers)? Viagra ads eventualy 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, tolevision advertising, online marketing and sports event sponsorship. The celebrities encouraged men to fix the problem - as they would fix a headache with Aspirin. The campaign eamed 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 Sales continued to grow as the product was Viagra, but he was not the target. The target is the launched progressively on worldwide markets. In 1998, 50-year-old married man who is having trouble, but is total sales had reached $776 million, $1,016 million terified of asking his doctor. Positioning the product by 1999 and $1,344 million by 2000, reprosenting over for older men tells youngor men that Viagra was not 5 per cent of human drug sales for Pfizer. The 2000 for them. Viagra would have been wiser choosing Annual Roport proclaimed that more than 300 million younger, more macho-looking men to help remove Viagra tablets had been prescribed for more than 10 the stigma of ED and make younger men feel more million men in more than 100 countries: Vagra had comfortable talking about the problem and product. become a worldwide brand in a very short period of Today. you do see much younger male models in the time. Viagra ade. All the US publicity was heard in Europe and made Launch the European market a littio more difficult to enter. At the launch, the priority for Pfizer was to retain con- 1998, the UK health minister pronounced that Vlagra trol over the brand image, ensuring that it was post- would not be made avalable on the National Health tioned as Pfizer wanted it to be and that accurate Sorvice (NHS). This had a lot to do with NHS priorlinformation was given to the public, A campaign eati- ties: impotence is not high on the list, apparently, and mated to be costing tens of millions of dollars on there were fears about the cost to the NHS if all the consumer-orientated advertising in popular maga- hype produced the same sort of level of demand as in zines, such as Time, Life and Nowsweek, was under- the USA. There were foars that it would cost the NHS taken. The enormous level of pre-taunch publicity Si billion por year if it was available on demand. that Viagra had generated was not, necessarly, a Athough some relaxation has subsequently taken good thing. The publicity was out of Plizer's control, place, and doctors are allowed more say in prescrib-: meaning that it could be inaccurate and/or damaging ing the drug. it is still not readlly avallable on prescripto the brand image. The thousands of jokes made tion. Impotence in itself is not enough for free about the brand could well have had a negative treatment - it must be caused by specific medical effect, making patients embarrassed about owning conditions, such as diabetes. up to an impotence problem and asking for the drug. Viagra's advertising campaigns were never the Pfizer waited until the worst of the publicity had died key to its success, however. Because of its unique down before launching its campaign to make sure clinical function, Viagra became an immediate cultural that its message was heard properly and that the point for all issues relating to virility, male sexuality drug was taken more seriously. This, along with all and aging, and through this centinual popular roferthe media hype, had led to a rapid take-up after iss encing, much more than the effects of its $100mili in introduction. advertising budget, Viagra has achieved a level of brand recognition that is reserved only for superstar ally were to stick, that simply would be additional drugs like Tylenol and Prozac, Indeed, Viagra contin- profits. ues to be a constant source of office jokes and com- In 2003, the competition for Viagra increased ments for late night taik show hosts. More than noticeably when Viagra came third in the first simply spreading the word on what Viagra is, the independent comparison with its two new comenormous street and media buzz that Viagra has petitors. According to the research, 45 per cent of inspired has established Vlagra's image overwheim- the 150 men involved in the trial preferrod Eli ingly in terms of power and efficacy as the remedy for Lilly's Cialls, while 30 per cent voted for Levitra, impotence. jointly marketed by GlaxoSmithKline and Bayer. The findings are likely to play an important part in Competition the fierce marketing battle between the four pharThe greatest challenge to Viagra came when Pfizer maceutical groups over treatments for impotence. lost some of its patent protection. The main, or Pfizer said the research was not scientifically active, ingredient in Viagra is sildenafil, and potentlal rigorous (Dyer, 2003). competitors Ell Lilly and lcos Corporation challenged The challenge for the competitors is different the legitimacy of the original patent issued in 1993 . from that faced by Pfizer. Viagra is already a wellThe court ruled that the knowledge on which it had known remedy for impotence in the popular imaglbeen based was already in the public domain in 1993 nation; alternative drugs are fighting an uphill battle and that the patent was now restricting research by against the power of the Viagra brand. The marketother companles. Other companles would now be ing challenge that faced the makers of Clalis and able to sell drugs that treat impotence by blocking Levitra is that they would have to re-establish the PDE-5, a chemical, although Plizer retains a patent problem of impotence - a problem that many conon the active ingredient in Viagra - meaning that sumers see as aiready having been solved by direct coples of the drug itself will not be permitted. Viagra - in order to offer their products as a cure. In January 2002, the Court of Appeal (UK) had But, because. Viagra already exists, Levitra and agreed with an earlier High Court ruling that knowl- Cialis would have to rely on advertising to increase edge covered by the Pfizer patent on the 'PDE-5 their market share and, since ED appears to be a Inhibitor' was already in the publio domain. Similarly, distasteful topic, advertisers decided to concenin 2004, Plizer faced increased competition in China trate on enhancing ED's image, rather than its after Beling overturned its domestic patont for the products' image. Clalis differentiates itself from main ingredient in Viagra. Although the molecular both Viagra and Levitra by offering a 36 -hour winstructure of Viagra was still protected, the main dow of efficacy. This beats Viagra's and Levitra's active ingredient was now open to competitors. The four- to eight-hour period and allows Cialis to focus fisst serious challenge came from Uprima after it its advertising on timing rather than performance. received its European licence in 2001. Its makers, All three advertising campaigns ultimately suggest Abbott Laboratories, basod in lilinois, USA, claimed the discomfort, shame, embarrassment and fear it worked more quickly than Viagra, with fewer side "that surround sex in general, and the lack of any effects and cost less than E5 for both low and high compassionate, humane, truthful discourse on dosage tablets. Quick action can help spontanoily. sexual dysfunctions in our culture. Sex appears as unilke Viagra, which has to be taken at loast an hour a paranoid game where invisible spectators cheer before sex. Plizer continued with its legat batties as it attempted to prevent competitors copying key ole- Conclusions ments of the drug. Glaxosmithiline, the Anglo- By virtualy all measures, this product has been univerAmerican group, and its German partner Bayer wore sally successful for Pfizer, transtorming it trom a large. relying on Vardenafil to revive their flagging share pharmaceutical firm into the worid's leoding pharmaprices (Firn and Tait, 2002). Critice argued that ceutical fim. The actual market for this type of drug is Plizer's goal was simply to delay competitive entry now lnown to be far greater than the orighal market for Viegra as long as possible and, if the patent actur research data had revealed. This is a cautionary tale of the need sometimes to encourage innovation and Table 9.5 Sales of impotence drugs support scientific froedom in the tace of evidonce to stop the profoct. Vagra was the first-mever and first-prover in thit category. However, Vagera has not been quick to cespond to compotitive scipntific advancemen's in erectle dystunction dings, it takens Viagra anywhere from 30 minutes to an hour to work but Levitra, launched in 2001, improves upon that by woring in Because these 'disedse awareness' campaigns are 16 minutes. And Cialis, also launched in 2001, commony inkiod to ecmponies' markuting stratogies, improves upon Levitra by boing able to last up to eney operate to expand marketstor new pharmaceuti36 hours. Indeed, cempettors argue Pfizer has cal products. Aternative approsches - amphasialing aleady oonceded dofeat by introducing a loyalty the set-imitiog oe matwely benign natural nisfory of a programine, which they argue is not about bulding a preblenice the inportance of personal coping stratekang-teem relationship with their palients, as Pfizer's gies - ollen are played down or ignored, ts the late marketing director says. Rather, they see it as a medical wrter Lynn Payer observed, Gisease mon scheme by Pfizer to get the mest out of the Viagre ges 'gnvw away at cur self.confidence'. (Payer. brand and it will continue to lose market share to 1996 . For exsmple, a double-poge advertisement in better, more effective ootions trom Levitra and Clalt: the Sydwey Moming Horalefa Woekund Atagazine told: The erective dystunction market grew 3.5 per cent Austalars that 39 per cont of iten who vist genend from 2005 to be werth $1.95 billion in 2005 and is practioners bave Eb. The 39 par cant claim in the almost entrely composed of sales from the three advertisernent was relerenced to an abstract of a surbrands: Viagra (sidenath. Colis (tadalafle and Levitea wey finding. Howver, another Austratian atudy, nef (vardenafii). Table 9.6 reveals the continesed dont- otied in the adientisenent, estimuted that erection nance of Vagra. from raising disoaso awaroness. A lot of maney can. mant's fre print oled a hoat organisation, impotenoe be made trom hedethy people who beliewe they are Australe, but did not mention that the advertsennent sick. Phamaceutical companies are oble to sponsor concen with 'dsease mongering' is the invisible and disebses and promote them to grescribers and con- inreguated attorpts to change public perceptions Surbers, a practice sometimes known as 'disease. about heukth and ingas to widen markats for now mongering' fe. widening the boundarks of beotable iness in order to expand imuekets for those wht sell and delver treatments). Whia many disease catopofies, intormal allances have emerged, comprising Questions 1 Was Viagra the nesut of serendiphy or is this joumainse licence to helo set a stery. whero the reaf story ia a complex one of aitficut decis ona tall of eikiks? 2. Explain why in was so nicessary to ensure maneting wan mived in the eorly stages of this nenw prodict developenent peopiect. 335 3. Explain tow, despite the inormouin misoorces of Pfier, a lack of malack infornanion mado the evaluation of the nee procket prepesal ab very de ticuit. alse an excelunt exampio of good maketing 5 How can Plicer manage the threat poasd to Vagra by nees artacts 10 the markec