2nd Chances

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Elisabeth Pena

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2nd Chances By Elisabeth Pena For products that are not performing to expectations, a relaunch can revitalize a stale brand, highlight new clinical evidence, or give a product another chance to reach the patients it was designed to treat. With each therapy that a pharma company produces, the goal is to create and own a sustainable competitive advantage in the marketplace. Sometimes that goal is not met. Sometimes the marketplace changes. Or sometimes marketers want to reinvigorate a brand. This may require a relaunch, which means marketers often have to retrace their steps to discover what was lacking in the brand’s message and positioning. “To justify a relaunch of a product, there has to be a serious enough shift or change with the product or the marketplace that either strengthens or erodes its competitive advantage,” says Sean McLoughlin, product manager, new product planning, at GlaxoSmithKline. “Internal variables that may justify a relaunch would include a new indication, a new formulation, or significant new clinical studies. Some external variables include a change in the competitive landscape, such as a void created by a product that was pulled from the market; epidemiological shifts, for example large TB outbreaks may be cause to relaunch a TB product; or cultural shifts, for example renewed interest in international travel may be cause to relaunch an antimalarial product.” What Went Wrong? When a product is not optimally launched it can languish in a company’s portfolio not receiving support or, more frequently, it is sold. When the decision to relaunch a product is made, either by the original marketer or by an acquiring company, the next step is to evaluate what went wrong in the first place. “Getting the position right means the brand team has figured out how the customer views the problem the brand intends to solve,” says Maureen Mangiavas, senior director of business development at The Hal Lewis Group. “If that initial position is not on target, other problems are likely to follow. Optimal positioning requires that the brand team accepts that the customers’ needs and wants must intersect with their aspirations for the brand. If something has gone wrong with the initial launch, the first thing to look at is the positioning.” David Stern, VP, marketing of metabolic and endocrinology, at Serono Inc., was involved in a relaunch at a former company, where his marketing team determined the problem with a product’s campaign was that it was too broad. “We found through message testing and a lot of competitive intelligence that one of our oral contraceptives didn’t have a very good image,” he says. “By looking at what the other companies were doing from a marketing standpoint, we noticed that we were trying to be all things to all women without specifically showing the benefits of the product in certain patient types. Our problem was that we were trying to be too broad with our messaging.” When any launch strategy is too broad and not clearly focused, it will become a significant challenge for that product to achieve market success and, hence, become a prime reason for a relaunch or modification of the strategy, says Donato Tramuto, CEO of i3 Magnifi. Other key reasons for a relaunch might be that new evidence may have been uncovered around the clinical value, or evidence may have been identified that will help to differentiate a product in a crowded market. “In a very mature market, such as hypertension, if a team has a broad-based strategy without the right evidence around the clinical claims, it will be very difficult to succeed,” he says. “In these instances, the bar is elevated significantly; brand teams have to come up with a more evidence-based strategy. One of the advantages when relaunching a product is that a pharmaceutical company can tap into retrospective databases to understand what worked in the market and what didn’t.” Mark Stinson, principal of Stinson Brand Innovation Inc., believes that most products are launched based on a solid foundation of market research, have memorable logos, and so on; in other words, all the right things were done. The problems exist in maintaining brand loyalty. “There is a reason a company didn’t get traction from a launch,” he says. “The ‘likeability’ factors didn’t translate into loyalty. This might be because of other brand associations or maybe the reps’ attitudes or the company’s attitude were wrong. While it might have been a quality product, physicians didn’t have a quality experience; patients may have experienced more side effects than expected; there might have been reimbursement pushback; or the product may have been on back order and was unavailable.” Best Practices Although many of the strategies for an initial launch apply, relaunches require their own set of best practices. Before beginning the process, the most important step is to have the full support of the company. “Making sure that everybody in the company is fully engaged in the product is very important before beginning a relaunch,” says Frank Ciriello, VP of sales and marketing at Eisai Inc. “There are a lot of different players on the team — medical, sales, regulatory, legal — and everybody has to understand the reason behind the relaunch as well as what the goals are. Without having all the internal players on the same page, it is going to be very difficult to achieve success.” Thorough research is another important best practice. “It is very important that the brand team does its homework and understands the market and how the brand is currently being used by physicians,” Mr. Stern says. “Even if it doesn’t go well the first time, the benefit of having a product on the market is that there is information available about how doctors are using the product and where it falls in the continuum of care. Many times the data show that physicians are using the product as a second- or third-line therapy, but the pharma team believes it should be a first-line therapy. In this case, the message hasn’t been communicated strongly enough.” Similarly, hypothesis-driven patient databases or registry programs, which are becoming more important as a data and message resource for all campaigns, are even more valuable in a relaunch setting, according to Jim Metropoulos, M.D., copresident of Sudler & Hennessey. “The information and data included in registry databases can be used to create credible messages to communicate to physicians as to why they should try or retry the product — why they should rethink their approach to the product,” he says. “Obviously, the existence of registry data is evidence that their peers are using the product as well.” Relaunch situations also provide marketers with the opportunity to be more creative and take more chances than they may have been comfortable with the first time around. “There might be a need for a relaunch because the previous marketing team and the previous launch may have been too conservative,” Dr. Metropoulos says. “It’s important that brand teams don’t fall into the same traps.” Changing Focus The next important step is focusing the product’s message. Through market research and feedback from the salesforce and physicians, marketers can begin to determine how to better position the product for success. When Eisai acquired the North American and European rights to Zonegran from Elan Corp. in April 2004, the company began the relaunch process by evaluating the entire epilepsy market. Eisai researched what physicians and patients were looking for in a medication. Zonegran was approved and launched in March 2000 in the United States for adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Eisai believed the product had not captured the market share or generated the attention it should have. The product is a once-a-day treatment, but Eisai marketers found that they needed to explain to neurologists why that was particularly important for patients. “Since many people with epilepsy have other underlying diseases, they are already taking many medications for other conditions,” Mr. Ciriello says. “We found that the biggest question neurologists had was how a product could control epilepsy with once-a-day dosing and minimize drug-to-drug interactions.” Using these insights, the company decided to focus the brand’s message on Zonegran’s once-daily dosing regimen as well as its half-life benefits. Zonegran has a 63-hour half life, so even if a patient is taking medications that might decrease the half life of Zonegran, it is still effective over 24 hours. “When we started to highlight the message to physicians of the half-life benefits and once-a-day dosing, it was as if a light bulb lit up,” Mr. Ciriello says. “Physicians never doubted the efficacy and safety of the product, but now they understood how Zonegran was a useful drug in their armamentarium.” Changing Targets With a refined and renewed message, a marketing team must then decide what audience to target. Whether the initial launch was too broad or the customer experience wasn’t satisfactory, a team relaunching a brand may want to reposition the product for a new market. This was the scenario Cephalon Inc. experienced in its relaunch of Gabitril, a selective GABA reuptake inhibitor that is indicated throughout much of the world as an adjunct therapy for the treatment of partial seizures associated with epilepsy in adults and children 12 years old and older. When Cephalon acquired Gabitril, Lynne Brookes, VP of U.S. marketing, began conducting primary and secondary research. Her marketing team discovered that Gabitril was almost exclusively being prescribed by neurologists, while other anticonvulsants on the market had about 30% to 40% of their prescriptions coming from psychiatrists. Cephalon acquired U.S. rights to Gabitril from Abbott Laboratories in January 2001. In January 2002, Cephalon acquired expanded rights to Gabitril from Sanofi-Synthelabo and Novo Nordisk A/S, the developers of the product. Cephalon has worldwide rights to Gabitril, excluding Canada, Latin America, and Japan. Further research with the psychiatrists who were prescribing Gabitril revealed that they believed that the product’s mechanism of action could have applications in other psychiatric disorders, much like other anticonvulsants. Ms. Brookes’ team decided that this should play a more prominent role in the marketing of the product, and Cephalon began directing efforts toward this group of doctors, a different target audience than previously addressed. “We coined the term SGRI, selective gaba reuptake inhibitor,” she says. “We thought SGRI would be accepted into the psychiatry marketplace because many of these doctors would immediately understand the product’s mechanism of action. This new term borrowed some leverage from SSRIs and SNRIs, which physicians are very familiar with.” Cephalon has been promoting the product solely on its mechanism story for the last few years, she says, and product sales have increased to about $80 million from $20 million since acquiring the product. In addition to targeting different physician segments, experts say marketers should consider other audiences for their relaunch messages. “It is important to get other potential influence points involved, such as patients and managed-care organizations,” Dr. Metropoulos says. “These audiences need to be considered because the physician mindset may be biased from the previous positioning of the product.” Relaunch Challenges Applying metrics to benchmark the success of a relaunch is one challenge that brand teams need to address. “There is going to be a higher level of expectation for a relaunched product,” Mr. Tramuto says. “The bar is raised in terms of the value proposition for the product, which may not have been a significant factor in the original launch.” According to Mr. Stinson, companies often determine the efficiency, effectiveness, and economics of a relaunch against another product launch down the hall, which is not a good strategy. He says relaunch metrics need to be based on realistic marketplace factors. “Marketers have to be careful not to over promise,” Mr. Stinson says. “Realistic expectations make the relaunch a more positive experience.” At Eisai, the relaunch metrics Mr. Ciriello uses include new prescriptions (NRx) and total prescriptions (TRx), share of voice, how memorable the messaging is, and message recalls. “We look at how the target base of physicians responds to the new message from a NRx and TRx point of view for our relaunched product versus the competition,” he says. Selling the Salesforce Overwhelmingly, experts agree that one of the challenges marketers face when relaunching a product is overcoming the old image held by the market. “The fact that physicians already have a perception of the product, probably neutral to negative, is a challenge for the salesforce,” Dr. Metropoulos says. “If a competitive salesforce believes that there is a neutral to negative bias toward the product, it is much easier for sales reps to counterdetail; this makes it harder for the brand team to relaunch, no matter what the new launch looks like. Therefore marketing management has to consider their own salesforce’s perception of the product. The salesforce may have a right to be skeptical and will need to be convinced that things can be different the second time around.” Mr. Stinson agrees, saying the people with the longest corporate memory are the sales reps. “They will remember the first launch more than the marketing team,” he says. “This is why the sales reps should be involved in the reanalysis and relaunch process.” Because the reps talk to the customers, they can tell the marketing team what worked well, what could be done better, and what should be done differently. “If things aren’t going well in terms of brand performance, the first people the brand team should talk to are the sales reps; they are the only true surrogates for the customer,” Ms. Mangiavas says. “Brand teams must have the confidence of the salesforce to execute the brand strategy. The reps need to understand the big picture and believe that they will be successful with the tools and messages they have been provided from marketing. They are the people who have to face the customers; they want to be credible. If sales and marketing are not aligned, achieving strategic milestones will be nearly impossible.” Cephalon found that the best way to get buy in from the sales group during the relaunch of Gabitril was to give them a vested interest. This was a challenge for the company because the team had to reinvigorate a salesforce that had been copromoting the product without much success and had to overcome the perception held by physicians that the product did not work. For Ms. Brookes, personal relationships with the sales reps played a large role in changing their perception of the product. “I got on the phone with some of the reps who carried a lot of weight in the salesforce,” she says. “I walked them through the relaunch strategy and told them what we were thinking about. I asked them to do tests in the field to find out if the new message worked. All of our internal research indicated that it would. The next day, I received a phone call from a rep who was very excited because the first physician he detailed understood the message and was very receptive.” This strategy created a buzz throughout the salesforce and by the national sales meeting a month and a half later part of the marketing team’s work already was done. The salesforce believed that Gabitril could be detailed effectively with the new messaging to a new market base. “We had buy in at the grassroots level,” Ms. Brookes says. “The bigger a company is, the more it has to work top down, but if the brand team can bring on board a few key movers and shakers in the salesforce the relaunch has a much better chance of being successful.” Mr. Tramuto has found that a segmented message also can help with salesforce buy in and direct the focus of the reps. “A relaunch can’t be about a broad-based message; the marketing team has to pick the one or two areas where there is evidence that the product has real value,” he says. “All the efforts need to be focused on those segments. If the efforts are focused on those key opportunities for success, then there is a greater probability that the salesforce will buy into the relaunch initiative.” F PharmaVoice welcomes comments about this article. E-mail us at feedback@pharmavoice.com. Sound Bites from the Field PharmaVOICE asked industry experts what factors lead to the decision to relaunch a product. Beverly Breitenbach is CEO of Torre Lazur McCann Healthcare U.S., Parsippany, N.J., a global healthcare advertising company. For more information, visit torrelazur.com. “One of the principal factors influencing the demand to relaunch is the discovery that there are things about the product that are new. For example, a drug may have received approval for a new dosage or delivery form — one dose a day instead of many, a patch instead of a shot — or a new indication, affecting a different therapeutic category or age group. Alternatively, researchers may have conducted new clinical trials that produced data that can significantly strengthen the drug’s claims and allow it to be repositioned in the market. Sometimes it is the market environment that has changed. Newer drugs or devices, new procedures, and new medical evidence may all have produced a shift in treatment paradigms, making the product appear irrelevant or obsolete. In situations like this, a product’s positioning may need a total makeover. On the other hand, it may be the misfortunes of the competition that provide the impetus for relaunch. The market leader may have lost its patent protection. Negative factors, such as competing drugs being withdrawn from the market or products that are forced to add a black box to their labels, may provide a major opportunity for a medication to be cast as the new market leader.” Ed Capparucci is VP, Director of Client Services, at Adair-Greene Healthcare Communications, Atlanta, a healthcare advertising agency. For more information, visit adair-greene.com. “A growing trend in relaunching products is what we like to refer to as the revitalization of a brand. These are relaunches that result from an acquisition of a product that has received little or no promotional support in recent years. This requires identifying an opportunity or a need in a particular therapeutic category that can be fulfilled with the revitalization of a unique brand positioning and message. Many relaunches are the result of big pharma companies not being able to commit resources to smaller brands. These brands are obtained by smaller companies that can commit the time and resources necessary to develop unique brand positioning and bring these products back to market. In many cases, these brands become important contributors to their organizations.” Rick Rose is General Manager of Integrated Marketing and Data at Dendrite International Inc., Bedminster, N.J., which develops and delivers knowledge-based, technology-driven solutions that increase the productivity of sales, marketing, and clinical processes for pharmaceutical and other life-sciences clients. For more information, visit dendrite.com. “One of the strong indicators for a relaunch is when performance is much lower than expected. This should trigger companies to reevaluate the success of an original launch. Segmentation and targeting are keys to success, but the segments or targets may have shifted from the time the original launch was executed, resulting in lower than expected adoption of the new product. Today, data and analytics are more granular than in the past. These new tools can help companies get to the right targets more accurately. Another area to evaluate is the indication for which the product is being prescribed. If a drug is being prescribed for treatment where it was not intended, a relaunch may be necessary. After looking at the longitudinal prescription data (LPD, which are anonymous information about physician prescribing patterns), it can be determined if a drug is being prescribed for the intended indication. If it’s not, this is an important factor that might lead a company to relaunch the product with a stronger, more rigorous message that might include the safety and compliance issues related to the improper prescription of a drug.” Christopher Tama is Executive VP of PDI Inc., Saddle River, N.J., a provider of outsourced sales and marketing services to the biopharmaceutical, medical-device, and diagnostics industries. For more information, visit pdi-inc.com. “The decision to relaunch a product occurs usually after the decision to stop supporting it has been made or it has been determined that the current marketing plan is not creating the desired impact. There are three common scenarios. Scenario one is a failed launch. In this instance the perception of the success or failure of the launch is directly related to the internal expectations that have been created and the financial targets that the company had established prior to launch. If the product fails to meet these expectations and there is a good understanding of how to correct the issues it can be a good idea to relaunch the product. Generally, launches fail for a number of reasons, including: missing the mark on positioning and messaging, execution, and resourcing and/or an unanticipated competitive response. If the plan was off the mark but the product fulfills its promise, relaunching is a viable option. If the product failed to deliver, it is doubtful that an adjustment to the marketing plan will correct the problem. Scenario two is to invigorate growth. Life-cycle investments in drugs have produced wonderful opportunities to invigorate new product growth. New clinical data, expanded indications, new dosage forms and, at times, a change in the competitive environment create reasons to relaunch products. Scenario three is a rescue from strategic neglect. Large pharmaceutical companies all have products that are still patent protected but receive suboptimal promotional support. These decisions are made simply because there are other products in the portfolio that can better drive profitable growth for the company. When this occurs it is neither an indication that the launch nor the product failed but rather a resource allocation decision. Nevertheless, these products are considered valuable assets to the company and strategies to maximize a return are sought. Often, these products are partnered with an outsourced sales and marketing company or licensed to a specialty pharmaceutical company and subsequently relaunched.” Dale Taylor is CEO of Abelson-Taylor, Chicago, a pharmaceutical advertising agency. For more information, visit abelson-taylor.com. “The decision of whether — and how — to relaunch a product starts with a dispassionate discussion of issues surrounding the product and the market. If the product has failed, it’s vital to determine what went wrong, if the problems can be overcome, and how. Sometimes the honest answer is for a company to cut its losses. Often, however, the product hasn’t failed; it may even be reasonably successful. Even so, creating a new brand may be important. In some cases, the messaging and promotional tools may no longer resonate as they did earlier. In other cases, the product’s position may have changed as a result of new entries into the marketplace. In still other cases, the salesforce is just tired of using the same materials and needs a change.” Maureen Mangiavas Keeping a brand “young” requires vigilance — knowing what’s going on in the marketplace and, especially, understanding what’s going on in the customer’s mind. Keeping the salesforce excited, engaged, and focused needs to be a top priority for the brand team. Donato Tramuto The historical perception that the product is a tired pony is a big relaunch challenge. The No. 1 external challenge for marketers is fighting history. Frank Ciriello When we consider a relaunch, we think about what will drive the success of the product. But before we do that, we evaluate what the product has done up to this point and why the product has not performed to the level it might have. Lynne Brookes Any time a team is thinking about relaunching a product, team members need to ask what are the unique characteristics of the product, who is the information meaningful to, and what are the best ways to put forth the information. 6 Reasons to Relaunch 1. Rediscover the potential of underpromoted brands 2. Reinvigorate and grow products 3. Rethink in-licensed products 4. Retool for new indications 5. Reorganize product marketing post-merger 6. Reconsider approach to third-party payers A Case Study: A Relaunch to Underserved Populations One of Ovation Pharmaceuticals’ core strategies is to reinvigorate and relaunch products that benefit small, underserved patient populations. The company identifies products that have inherent value that can be optimized with well-defined life-cycle management and marketing strategies. During the past two years the company has acquired eight FDA-approved products, many of which needed to be relaunched, including Panhematin. Ovation acquired Panhematin, an enzyme inhibitor derived from processed red blood cells, from Abbott Laboratories in January 2003. It was a small, non-strategic asset in Abbott’s portfolio and had not been promoted since the product was approved in 1983 for acute intermittent porphyria (AIP), which is a rare genetic disorder. Manifestations of the disorder include pain, hypertension, tachycardia, abnormal mental status, and mild-to-progressive neurologic signs. AIP is an autosomal dominant disorder caused by a defect in porphobilinogen deaminase activity. The estimated prevalence of the disorder is five to 10 cases per 100,000 people. Before Panhematin’s approval there was no product indicated to treat AIP in the United States. According to Ovation Founder, President, and Chief Operating Officer Jeffrey S. Aronin, the company had to overcome several challenges to make the relaunch of Panhematin successful. First, Ovation had no relationships with key physician thought leaders or advocacy groups in the porphyria community. Second, there had been no promotion for the brand or medical education around this rare disorder for 20 years. As a result, a significant number of patients were being misdiagnosed while others were treated suboptimally. The company quickly identified the key physician thought leaders and established an advisory board to help prioritize and address key issues facing the physician community. “We worked closely with key physicians and the leadership of the American Porphyria Foundation (APF) to identify the needs of both the caregivers and patients,” Mr. Aronin says. “We then assessed the product’s value proposition and developed a new positioning and strategy designed to create value for our customers.” The company, with input from thought leaders and the advisory board, designed and implemented a plan to educate community-based physicians who care for AIP patients. Additionally, Ovation worked very closely with the APF to develop programs to educate patients. “It was this synergistic approach of educating physicians and patients that has resulted in the consistent volume growth that Panhematin is now experiencing,” Mr. Aronin says. “Because of our ability to add value to our customers, sales are robust.” Ovation has found that the traditional marketing approach of segmenting, targeting, and defining a clear positioning that is meaningful for each segment infuses stagnant products with new value. “The fundamentals are the same, but the key element to success for a relaunch is to execute crisply and concisely these fundamentals to create significant value,” Mr. Aronin says. He adds that new growth opportunities and life-cycle management strategies must be pursued tenaciously for relaunched products. The ability to extend exclusivity or create new markets through the development of new indications for a brand greatly impacts the overall value. Source: Ovation Pharmaceuticals Inc., Deerfield, Ill. For more information, visit ovationpharma.com. Jeffrey Aronin A relaunch will be viewed positively if the customers, the physicians who prescribe, and the patients who consume the product, perceive value to the event. Dr. Jim Metropoulos Companies need to think outside of the box more than ever when relaunching a product. As much pressure as there is on the team to stay with tried-and-true measures, that just repeats history. Mark Stinson To relaunch a brand, companies need to evaluate the role of the product as part of the overall corporate strategy. Senior management has to determine what the larger corporate objectives are and whether these are compatible with the product’s objectives. David Stern Relaunching and rebranding are different. A relaunch examines the many different aspects of the campaign and changing the message as to how the brand is perceived by the market. Evidence-based Marketing: A Relaunch Strategy Borrowing a phrase from their clinical counterparts, marketers have identified evidence-based data as a key part of a relaunch strategy. Evidence-based data assert that making clinical decisions based on best evidence, either from the research literature or clinical expertise, improves the quality of care and the patient’s quality of life. These data should be taken with due weight according to all valid, relevant information. “When relaunching a product, a company has a unique opportunity to drive its strategy with a very focused evidence-based initiative,” says Donato Tramuto, CEO of i3 Magnifi. “These type of data will undoubtedly have a huge impact on how the team will mobilize not just the constituents on the allied healthcare side, but also their own sales people.” An evidence-based marketing campaign is grounded in best-in-class research methods and tactical benchmarking that take into account validated market insights, according to Jim Metropoulos, M.D., copresident of Sudler & Hennessey. “This doesn’t mean spending half a million or a million dollars sitting on the wrong side of a one-way mirror,” Dr. Metropoulos says. “Senior marketing executives need to be out in the field with the customers, they need to ride along with the salesforce, and they need to spend time in physicians’ offices.” He adds that the marketing team has to take the time to present the evidence that forms the foundation for the new positioning and launch in a convincing fashion to the salesforce and consistently show them that there is strong internal commitment and support for the relaunch. Experts on this topic Jeffrey S. Aronin. Founder, President, and Chief Operating Officer, Ovation Pharmaceuticals Inc., Deerfield, Ill.; Ovation is a specialty pharmaceutical company. For more information, visit ovationpharma.com. Lynne Brookes. VP, U.S. Marketing, Cephalon Inc., West Chester, Pa.; Cephalon is an international biopharmaceutical company. For more information, visit cephalon.com. Frank Ciriello. VP, Sales and Marketing, Eisai Inc., Teaneck, N.J.; Eisai is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co. Ltd. For more information, visit eisai.com. Maureen Mangiavas. Senior Director, Business Development, The Hal Lewis Group, Philadelphia; HLG is a healthcare marketing communications agency. For more information, visit hlg.com. Sean McLoughlin. Product Manager, New Product Planning, GlaxoSmithKline, Philadelphia; GlaxoSmithKline is a research-based pharmaceutical company. For more information, visit gsk.com. Jim Metropoulos, M.D. Copresident, Sudler & Hennessey, New York; S&H is a global healthcare communications company. For more information, visit sudler.com. David L. Stern. VP, Marketing, Metabolic and Endocrinology, Serono Inc., Rockland, Mass; Serono is a global biotechnology company. For more information, visit serono.com. Mark Stinson. Principal/Innovator, Stinson Brand Innovation Inc., Chicago; Stinson Brand Innovation is a life-sciences consultancy. For more information, visit stinsonbrandinnovation.com. Donato J. Tramuto. CEO, i3 Magnifi, Basking Ridge, N.J.; i3 Magnifi conducts early market viability and research design that influence how a product develops, and manages the critical later phases of research that help commercialize products. For more information, visit i3magnifi.com.

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