Drugs that are late to market must be early to PR.Pharmaceuticals that are late to market must contend with the sometimes daunting task of competing with their already well-established blockbuster rivals. But PR campaigns can help a late-to-market drug capture sales by differentiating it from the competition, determining what market it can own, creating a bond between the product and consumers, and entering this process as early as possible, say experts. When a drug is late to market, differentiating it from competing blockbuster brands is key. "You need a selling point that no one else can own or claim as strongly as you can," says Fleishman-Hillard's Michael Rinaldo, SVP and co-chair of the healthcare practice, Americas. Michael Durand, a partner/director of the global healthcare practice at Porter Novelli, suggests that PR plans need to differentiate late-to-market drugs by addressing both objective and subjective considerations. Objective considerations include efficacy, dosing, price, side effects, and mechanisms of action, while subjective considerations involve perceptions and beliefs about the drug. (These considerations may be different for generic drugs.) Highlighting the difference Marketing opportunities always revolve around the demonstration that a new drug is more effective than other agents on the market, and should be clearly and objectively illustrated through data, says Joe Poggi, EVP and account director of DVC Healthcare Communications. "The more competitive the marketplace, the more important it is to figure out how to support your brand from a factual basis and say you're different in some way," agrees Rinaldo. "It's all about the science. It's about the facts." For example, Fleishman focused on scientific research to relaunch Estratab, a drug used to treat symptoms of menopause. The drug was late to market considering the more popular competitors in the arena, says Rinaldo. Research indicated that Estratab helped to reduce the incidence of osteoporosis in women with menopause, and could be taken at a lower dose than its competitors - objective information that proved to be valuable marketing tools. The drug was also plant- rather than animal-derived, another differentiation appealing to consumers. More convenient dosing of the drug is another important objective consideration, says Durand. A patient might have taken an original blockbuster drug up to three times a day, but now a late-to-market competitor with a stronger dosage allows individuals to take the same type of medication just once daily. Another objective way to differentiate a drug is to focus on a new mechanism of action, says Poggi. For example, although the drug Zetia (Merck/Schering-Plough) is one of many cholesterol-lowering drugs in the marketplace, it works through a new mechanism of action different from popular statins such as Zocor (Merck) and Lipitor (Pfizer). This differentiation allows Merck/Schering-Plough to position Zetia as first in its class, notes Poggi (whose firm does not represent any of these agents). Additionally, because Zetia works in a manner unique to cholesterol medications in the way it reduces the amount of cholesterol that is absorbed from the digestive tract, patients may be able to take it in addition to a statin, making it more marketable. In addition to objective considerations, perception of the drug is also crucial to marketing campaigns, explains Durand, adding that consumers need to perceive the new drug as superior to the original product. For example, Tagamet (GlaxoSmithKline) was first on the market to treat heartburn, and was well received in the medical community, says Durand. However, the drug was surpassed by the late-to-market Zantac (Pfizer) because of the perception that it was a more powerful agent with fewer side effects. No one study could support claims that Zantac was more powerful than Tagamet or that it exhibited fewer side effects, notes Durand. "However, with clinical evidence, you conduct a number of studies, and extrapolate positioning," he explains. A number of clinical trials illustrated parts of the overall puzzle, which were then carried through to advertising and PR campaigns. Getting prominent physicians on board who believe the product is superior is also valuable, says Durand. Physicians may respond positively to a good PR or advertising campaign, and then recommend a product to consumers. Potency is another subjective component to keep in mind. A drug may be stronger, "but that in and of itself doesn't mean anything," says Durand. A pill that is 10 times stronger than a first-generation medication simply means a patient may take a smaller dose - 5mg instead of 50mg. "But what is the real advantage?" he asks. "You're still taking a pill every morning, but improved potency is perceived as a positive attribute." When differentiating a product, whether through objective or subjective marketing points, PR professionals need to be aware of FDA regulations with respect to what they can and cannot say about prescription drugs, notes Robert Nicholas, head of the FDA practice at DC law firm McDermott, Will & Emory. "A PR person designing a campaign for a drug has to understand the FDA's advertising and promotion rules," says Nicholas. Agencies and pharmaceutical companies can only say things that are consistent with the FDA-approved label for the product, he notes, adding that fair balance, which lists side effects, must also be included. Marketing generic alternatives The marketing considerations for generic drugs differ somewhat. PR campaigns for these, which by nature are late to market and compete with the branded drugs that have come off patent, are fairly uncommon, note experts. However, they add that the need for PR exists as more and more generics enter the marketplace. "Generics typically would not have public relations campaigns to save money," says Durand. They essentially ride the coattails of PR campaigns that have already been developed for branded pharmaceuticals. Generics are generally not filling a medical need that is not already being addressed, he adds. "It's a price breakthrough, so there's no advantage of creating a campaign about the need of the drug." "Our experience is that generic companies don't put money behind a brand for marketing or public relations," agrees Rinaldo. They do, however, advertise in medical trade publications to let doctors and pharmacists know the generic is available. If a PR campaign is to exist, planning should start about a year in advance of when the blockbuster drug is to come off patent. "This is just a general guideline," notes Durand. Any specific PR messages that you want to deliver should be released when the pharmaceutical company is ready to sell the generic, he adds. If pharmaceutical companies do decide on a PR campaign, the drug company or PR agency can legally launch programs once the date for the drug coming off patent is certain and is FDA-approved, says Gene Pfeifer, a partner in law firm King & Spalding, who works in its drug practice group. Additionally, a generic cannot be marketed without the threat of a lawsuit until the relevant patents of the innovator are expired, including any extensions, explains McDermott, Will & Emory's Nicholas. "There are lots of ways that companies try to keep their monopoly on FDA approval or delay generic competition," says Nicholas. "A brand loses 40% to 60% of the market when a generic becomes available." Sometimes the producers of generic drugs appear to jump the gun. Apotex has been marketing the generic form of immediate-release Paxil while the patent status is still being debated. Apotex started preparing for launch in July 2003 when the FDA approved the generic product as being a safe and effective substitute for the brand. The company launched a generic version of Paxil on September 8, 2003. However, GlaxoSmithKline (GSK), the maker of Paxil, is pursuing litigation against Apotex for infringement of patents relating and other generic companies in Philadelphia. Apotex has already prevailed in the trial court on the main patent for this product and obtained a judgment of noninfringement, says Tammy McIntire, president of Apotex. The company believes the judgment will be upheld on appeal. "The product has been kept from consumers for far too long by GSK already, and we wanted to move forward with the launch," says McIntire in a statement. "It is that important. Every day that GSK's tactics force patients to do without an available, safe, effective, and lower-cost generic product, is a delay that is unacceptable to us." Knowing your audience While differentiating a product is important, PR agencies and pharmaceutical companies also have to focus on what specific part of the market they can own, says Rinaldo. "You can't be everything to everybody," he adds. Targeting and segmenting your audience with demographic information can help narrow down your market, says Andrew Weissberg, SVP of business development for CPRi Communications in Teterboro, NJ. PR agencies and pharmaceutical companies need to analyze demographic audiences who have compelling reasons to purchase and use the product, Weissberg explains. Demographics should not be limited to basics such as male and female, old and young, Medicare and non-Medicare, white collar and blue collar, he continues. PR professionals should also address psychographics, usage rate, and patterns and brand loyalty. Additionally, they need to consider ethnicity because the number of African Americans, Asian Americans, and Latinos is growing much faster than the population as a whole. Once you know your intended audience, establishing programs and relationships through a PR campaign to create a bond with consumers is crucial, says Susan Isenberg, GM of Rx Health at Edelman in New York City. For example, Edelman's marketing of GSK's non-steroidal anti-inflammatory inhibitor (NSAID) drug Relafen involved differentiating the drug because it was about the 16th NSAID on the market, says Isenberg. However, the agency decided not only to focus on the benefits of the compound, but also to develop a patient-education program to help people with arthritis live better on a daily basis. "We did a whole program on living with arthritis to build a brand," she says. "Building a brand includes promoting the properties of a product and building a relationship with the hearts and minds of target audiences with meaningful programs." Efficacy and safety have to be front and center, but educational information is very important when it comes to health, she adds. Consumers are much more knowledgeable, curious, and decisive than they used to be. PR should become a part of the marketing process as early as possible for late-to-market branded drugs, say experts, although limits exist for generic drugs. CPRi's Weissberg says PR should enter into the fray as soon as the branded product has reached the early stages of positive clinical development. Edelman will become involved in PR as early as Phase I or II clinical trials, says Isenberg. "Especially if the disease isn't well known, you need to start working on it early," she says, adding that you need to first ensure that the medical and healthcare-professional community knows about the compound and is comfortable with the science. Typically, PR agencies can start marketing abstracts to medical professionals during Phase II trials, says Poggi. "You can start getting abstracts in front of conferences, which is loosely described as promotion, and getting a core group of key opinion leaders and advocates in the medical profession on board." As for consumers, Phase III trials contain the data that will support the brand in marketing in the long run, notes Rinaldo. Consumers who may be directly impacted by a disease often find out what pharmaceuticals are in the pipeline, but for the masses, you need an FDA-approved agent to start marketing it, adds Poggi. Early planning gives PR agencies more time to work with pharmaceutical companies to position their drugs and to discuss where they are taking the product from a study standpoint, adds Rinaldo. PR agencies are having some input into scientific planning, he says. "There are often times when if the pharma company had done one little thing differently or looked for one more thing in their results, we would have had more to work with from a PR standpoint," he says. For example, journalists may want to know how a drug impacts women, specifically. However, if the breakout of study data did not compare males to females, the PR agency won't have the needed information, says Rinaldo. If involved early enough in the process, the PR agency may be able to request this data if the breakout doesn't jeopardize the overall study results. Getting an early start will also help PR professionals to conduct the necessary research to determine what market their product can own and how to create the important bond between the drug and the consumer, both of which help to differentiate the product, conclude experts. "Once again, it all comes down to setting yourself apart," says Rinaldo. "Differentiation is the key." ----- Case study: The relaunch of Estratab Solvay Pharmaceuticals launched a brand-reinvigoration campaign of Estratab, a virtually unknown plant-based estrogen available since 1964, but long marketed as a cheaper, generic version of Premarin for relief of menopausal symptoms. The campaign capitalized on Estratab's plant heritage, a principal difference from Premarin's animal sourcing. For years, Premarin enjoyed a virtual monopoly in the estrogen-replacement market. Key to the relaunch was an anticipated supplemental FDA indication for osteoporosis prevention. Premarin and other estrogens already held this advantage. Solvay was gearing up for a sales push upon FDA approval, but had been delayed repeatedly. By fall of 1997, Estratab approval appeared to be some months off, while Evista, the much-anticipated new estrogen from Eli Lilly, was scheduled to gain FDA clearance for osteoporosis prevention - the same approval Estratab had been waiting for. Lilly had spent months priming the market for launch, focusing on the breast-cancer risk associated with estrogen and positioning Evista as an anti-estrogen. The challenge that Estratab's PR firm Fleishman-Hillard faced was how to get and keep Estratab on the radar screen with women and doctors before Evista repositioned all estrogens as old-line therapy. Planning and research Focus groups with menopausal women showed they preferred plant-based compounds and hormone-replacement products with fewer side effects. Reporters indicated an interest for anything "new and different," if supported by scientific studies. To preempt Evista's FDA approval and propel Estratab into the menopause/osteoporosis spotlight, Fleishman and Solvay had to create a news- worthy communications platform. They decided to treat a clinical trial, scheduled for publication in the December 1997 issue of Archives of Internal Medicine, as the relaunch point for the brand. The study showed that Estratab, at half the dose of conventional estrogens, protected women against osteoporosis - something no other brand could claim. The lower dose of Estratab also resulted in fewer side effects. Timed to publish just a few days before the expected Evista clearance, the Archives study allowed Fleishman and Solvay to piggyback on Evista media coverage, and talk about the pending FDA osteoporosis clearance for Estratab before it happened. Objectives The objectives were to drive sales of Estratab beyond a 1% market share, and to increase visibility for Estratab, making it part of the HRT discussion in media coverage, alongside Premarin, Evista, and non-pharmaceutical options. The target audiences were menopausal and post-menopausal women age 45 up, and physicians, particularly OB/GYNs. The strategies were to relaunch the brand as a natural, effective plant-based alternative to the current market leader, and to capitalize on timing of Evista approval to introduce a "new" kind of estrogen therapy. Additionally, Fleishman and Solvay wanted to leverage media interest in menopause and plant-based therapies to drive coverage, as well as increase interest in the publication of the scientific study. Messages included the following: Patients should use the lowest effective dose of any medication, per the FDA; plant-based Estratab delivers significant bone protection at the lowest effective dose of any estrogen, with fewer side effects; and customizing menopausal therapy is important - one size does not fit all when it comes to HRT. Execution Less than eight weeks before publication, Fleishman recruited the lead author of the Archives study as campaign spokesperson. The agency negotiated with the University of California San Francisco to release the news of the study, which added credence to the study's scientific validity. Fleishman also worked with Solvay and UCSF to create and clear all media materials, including press releases, backgrounders, spokesperson bios, product photos, b-roll, and ANRs, and conducted a media blitz on the morning of publication. To promote coverage of the Archives study upon publication, Fleishman pitched key reporters prior to the publication date, securing an ABC World News Tonight feature story on the eve of publication, and a day-of-publication Life-section cover story in USA Today. In March 1998, when FDA clearance occurred, Fleishman conducted another media blitz to reinforce the still-emerging coverage from the Archives study, identifying more than a dozen key doctors across the country to act as spokespersons. Capitalizing on the plant-based message, in May 1998, Fleishman and Solvay held a media briefing at the American College of Obstetrician and Gynecologists meeting that focused on the dangers of substituting unproven and unapproved health-food-store products for real medicine in treating menopausal symptoms. More than 20 reporters participated in the briefing. Results Estratab saw a 160% increase in brand sales in one month, following the Archives study announcement - in the absence of other stepped-up marketing efforts (such as advertising or additional detailing by sales reps), which were "on hold" until the FDA indication approval. By the end of 1998, Estratab had doubled its market share from the previous year. The drug is in a category of its own: low-dose estrogen therapy for osteoporosis and menopausal symptoms. Broadcast and print news coverage generated 578 million audience impressions in the 13-month period from December 1997 to December 1998. Ninety-six percent of print coverage was branded. More than one-third of the Evista coverage also mentioned Estratab.