Asenapine Strategic and Marketing Plan

Asenapine Strategic and Marketing Plan

Harshil Patel Pharmaceutical Advertising Final Spring 2007

Market Understanding: Drug Background: Asenapine is an antipsychotic compound jointly promoted by Organon and Pfizer for the treatment of schizophrenia and bipolar disorder. Unlike earlier agents, this compound has a unique mechanism of action. This makes Asenapine able to treat symptoms that the earlier medications were not able to improve. Earlier agents focused solely on improvement of positive symptoms of schizophrenia without helping with the negative or cognitive symptoms.

Furthermore, these older medications caused a whole host of adverse effects, as listed below: a.

Extrapyramidal Symptoms (EPS) b.

Weight gain c.

QT prolongation (which can lead to heart problems) d.

Diabetes e.

Increased prolactin levels in the blood These adverse events as well as the drugs’ inability to fully treat patients have led to many compliance issues and treatment failures. However, Asenapine works in a different way.

It works as a mixed receptor antagonist, causing reduction of D1, D2, and Serotonin receptor activation. This allows Asenapine to treat positive symptoms equally well as older therapeutic options, while also providing vast improvement of negative and cognitive symptoms, as seen in clinical trials. Furthermore, the different pharmacology gives Asenapine a much better safety profile, in which none of the aforementioned side effects have been significant. Currently, Asenapine is in Phase III of clinical trials and is to be released onto the market in Q3 of 2008. It is presently formulated as sublingual or buccal wafers which are to be taken twice a day.

Current Therapy: The past few years of therapy for schizophrenia has been based on a group of drugs known as the atypical antipsychotics. These have been and continue to be the first line of therapy for schizophrenia patients. The market leaders of this group of compounds seem to be Quetiapine (Seroquel), Risperidone (Risperdal), Olanzapine (Zyprexa), and Ziprasidone (Geodon). It is important to note that Risperidone seems to have become a standard of therapy, as it is often the drug of choice in clinical trials, including those used to test Asenapine. All these drugs have similar pharmacological effects. They all block serotonin, dopamine or some mixture of both receptors. This group of drugs, therefore, all leads to similar efficacies and side effect. The drugs have been a huge advance from prior therapy, however as with all drugs, they will soon be losing their patent protection. By 2012, all of these drugs will have generic versions available. The last of the drugs to become generic will be Geodon, a Pfizer product. As these drugs no longer compete for the brand name market share, new drugs will be able to replace the market leaders. However, the generic incursion will also lead to shrinkage.

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In order to successfully launch or sustain a brand in the anti-schizophrenia market after generic incursion, it will be most important for new drugs to fill an unmet need. To doctors, drugs must complete four basic functions, given in order of decreasing importance: I. Efficacy II. Safety III. Unmet needs that drug meets IV. Frequency and duration of drug The current drug therapy has met the first two criteria to an extent; however psychiatrists will expect more out of future medications. These new medications must be able to complete the unmet needs left by the current drug therapies. These needs include: I. Creating long-term depot therapies and increase awareness of their usefulness II. Creating therapies for negative and cognitive symptoms III. Creating therapies with better side effect profiles IV. Creating drugs that can address common comorbidities V. Reduction of misdiagnosis and better early detection of schizophrenia VI. Improved patient compliance VII. Creating therapies that completely treat symptoms (reducing incidence of partial response) The drug therapies that will prove to be successful will be those that can fulfill at least some of these needs. Drugs that cannot offer any of these additional benefits will be seen as simply me-too drugs, thus quickly falling out of favor.

Developing Therapies: Though many new medications are in the pipeline, not all of them provide any substantive advantage over current therapy options. These medications are most likely not going to strong competitors even if they reach the marketplace, since the generic version of current therapy will be able to give the same results for a lower cost. However, there are also several medications that have differentiated themselves through innovative mechanisms of action to meet the needs of the market.

One major change coming to the market will be long-acting depot versions of current drugs, including Johnson and Johnson’s Paliperidone, Lilly’s Olanzapine, and Vanda’s Iloperidine.

All of these drugs fall into the class known as atypical antipsychotics. They have all been on the market as once-daily formulations for years, and each has seen relative success. As they are all facing generic incursion, the brands have created intramuscular depot formulations that will require an injection every four weeks. This is to help improve compliance in patients, which is often a major issue in schizophrenic patients. Because the current therapy options have difficult side effects and do not create a sense of “wellness”, many patients give up on the drugs. By having the doctor administer the medication once a month, the issue of noncompliance is no longer a problem.

Another move by many current brands is to expand their indications to make up the ground they will lose to generic incursion. This includes AstraZeneca’s Seroquel SR, which is trying to

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become first line therapy for many psychological disorders, beyond schizophrenia and disorder, to remain competitive. The current opinion of thought leaders is that this will be successful for Seroquel SR. Other brands are also trying to expand their use include common schizophrenia comorbidities, such as alcohol abuse and depression. If brands can show superior results by targeting multiple morbidities, they may be able competitive despite the entry of generic compounds.

bipolar path to these to stay

The most important reformulation is that of a novel compound already on the market. It has a different mechanism of action thereby creating a safer side effect profile. Its pharmacology is based on effects on the dopamine receptors. It keeps dopamine levels constant by working as an agonist when dopamine is low while antagonizing with higher-than-normal amounts of dopamine. This drug is Aripiprazole, branded as Abilify by Bristol-Myers-Squibb. It was originally offered as a once-day-a-day oral therapy. However, now it is being reformulated as a short-acting IM injection for acute onset of schizophrenia. It provides improvement of all types of symptoms in schizophrenia and boasts a safety profile very similar to that of Asenapine. The sponsor company hopes to push the two forms of Abilify simultaneously by claiming that the use of Abilify IM in the acute setting is the best choice to calm patients without excessive sedation, followed by a switch to the oral Abilify, as the safest choice, because the patient does not switch drugs. Abilify IM will come onto the market soon, and will probably make Abilify a likely competitor of Asenapine.

Beyond reinventions of current medications, many novel drug therapies are also being created.

This includes alpha-2 adrenergic receptor blockers, glutamate receptor agonists (which look very optimistic), MAOIs, M1 receptor agonists, Nuerokinase 3 receptor antagonists, Nicotinic Acetylcholine receptor modulators, and active peptide Secretin. Many of these hold great promise, however they are too early in development to properly assess their potential position in the market. However, there is one product, Bifeprunox, a joint effort by Wyeth and Solvay that has great potential. It is mechanistically very similar to Aripiprazole, and therefore has a nearly identical efficacy and safety profile, except for one point.

Bifeprunox may have the potential to treat many comorbidities of schizophrenia, thereby filling an additional unmet need. This includes depression, anxiety, psychotic depression, bipolar disorder, and possibly more.

It is set to be available in the United States by the

first quarter of 2008, making it a very likely competitor of Asenapine as well.

Thus, over the coming few years there are many new treatment options that will be available for schizophrenia patients. Of these, the depot IM formulations of current therapies, the generics of current therapies, Aripiprazole, and Bifeprunox will most likely be the therapy options that Asenapine will have to compete with. All these medications fill some of the unmet needs, and are set to release near the same time as Asenapine. Two of them even meet the same needs as Asenapine and are on the market before Asenapine. However, these therapies also face several hurdles before they can establish themselves and become a part of regular therapy. In the case of the depot formulations, there is a great need to increase awareness of their benefits, because many people may be turned off by the idea of having to get injections on a monthly basis. Also, the cost of the depot formulations must remain competitive, which will be very difficult if generic versions of similar drugs are available.

As for Aripiprazole, the IM formulation lacks sedative properties, which is often something

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doctors look for, in order to calm down patients in the acute setting. Also, despite their wish to claim better safety with switching from the IM version acutely to the oral version for long term therapy, they have yet to provide any proof, through clinical trials, that this is the case. Until the brands are able to resolve these issues, the drug will not be able to achieve its potential.

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Strategic Development: Asenapine is a strong competitor and has the potential of being a highly successful antipsychotic brand if it is developed and marketed well. Though there may be other medications coming to market that offer very similar benefits, Asenapine will be able to gain significant market share if the brand seizes the opportunities that arise while avoiding the threats early on. In addition, it is important to keep the weaknesses of the brand in mind, and search for ways to make these drawbacks into new opportunities. The following strategic plan provides a method to create the successful brand that Asenapine can be.

SWOT Analysis: Strengths i. Treats positive and negative symptoms ii. Good safety profile iii. Can also treat bipolar disorder iv. The wafer formulation is good for people who cannot swallow v. Because of Geodon and other products, Pfizer has a strong background in antipsychotic medications, with sales force already in place to launch the product.

Weaknesses i. BID dosing ii. Not sedating therefore not useful in ER setting iii. No IM formulation

Opportunities i. Can be used at long-term therapy after giving Geodon IM in acute setting.

1. Positive symptoms occur mostly during acute attacks, while long term therapies should focus on the negative and cognitive problems, which Asenapine does 2. Those currently on Geodon PO therapy can be easily switched over the Asenapine, before it becomes generic ii. Bifeprunox and Abilify have very similar mechanisms of action; therefore it is likely that they will be fighting over the same market share. This provides Asenapine the chance to hold its own, while the other two competitors compete. iii. As generics of current therapy enter the market, there will be room for a new medication to take the market share lost by others Threats iv. Increasing awareness and knowledge of the i.

Abilify will try to market its people rapid-acting disease can improve sales as more seek IM version along with its PO long-term therapy therapy 1. They will argue that not switching medications will be safer for the patient ii. Bifeprunox may potentially cover many more comorbidities than Asenapine iii. Because of generics, the market size will shrink iv. Both Bifeprunox and Abilify will be available on the market before Asenapine, providing them more time to build share

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The SWOT analysis serves a basis for all further strategy for Asenapine. Looking at Asenapine’s SWOT analysis, it seems that aiming to become the best therapeutic option in class is feasible over the next 10 years. As current market leaders suffer from generic incursion and newer agents suffer from being too much like each other, Asenapine can rise above the rest. Therefore, the brand vision reflects this goal, and the objectives work to meet it.

Brand Vision:

Asenapine strives to be the market leader as a long-term therapy choice for patients suffering from schizophrenia alone and with bipolar disorder.

Objectives: In order to achieve this brand vision, the brand must focus on the following objectives: a. Raise awareness in general population and among PCPs about early detection and treatment of schizophrenia b. Use the current sales force for Geodon to convince doctors to switch their patients to Asenapine to maximize recovery of Geodon market from generic intrusion. c. Push the positioning of Asenapine of providing superior therapy with minimal side effects to psychiatrists and to the patient population that is aware of therapy options.

Issues: In addition to simply trying to better position Asenapine, the brand must be able to overcome the shortcomings pointed out in the SWOT analysis, including product weaknesses and market threats. Thus, it is important to proactively search for solutions to these key issues. The following few paragraphs describe the four key issues that Asenapine faces, and also provides potential solutions to the problems. The solutions given here have already been incorporated into the rest of the strategic and tactical plan.

The first issue faced by Asenapine is one that is shared by all drugs that treat schizophrenia. Across the United States, schizophrenia, as well as many other mental illnesses is vastly under diagnosed. This is because in the general population there is not a good understanding of these mental illnesses, and therefore they have gotten a stigma. People will often refuse to even receive medical attention from a psychiatrist for the fear of being found to have a mental illness. Because of this under diagnosis, there is also underutilization of medications which are critical to managing and treating the mental illnesses. Therefore, to maximize utilization of Asenapine, the brand must work to increase awareness and empathy for schizophrenia. Only when this social stigma on schizophrenia is dispelled will people voluntarily come seek treatment for their illness. This is best done using a mass media campaign, including television and print advertisements, and working with non-profit organizations that raise awareness for the illness. Furthermore, primary care physicians must be given extra training to pick up on the finer signs and symptoms of mental

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illness, so that they may be able to get their patients help at the earliest signs. Once again, this would help increase utilization of the medication and vastly improve the patient’s life.

A second issue faced by Asenapine is the stiff competition from Bifeprunox and Aripiprazole, both of which offer similar efficacies and safety profiles. In addition, both of these medications will be on the market already when Asenapine is first released, therefore they will have already had time to build market share. To combat this, the best method for Pfizer is to use the relationships created with psychiatrists while selling Geodon. The same audience is most likely to try Asenapine, especially since Geodon has been such a successful drug. Also, use the sales force to emphasize the strengths of Asenapine and the shortcomings of the competitors (the shortcomings are discussed later on, along with competitive positioning in the Brand Constitution).

Thirdly, a weakness of Asenapine has been its twice-a-day dosing regimen, compared to the more convenient once-a-day dosing offered by most of the other therapy options or even the once-a-month options coming to market. This may reduce patient compliance, and therefore doctors may be averse to using it as their first choice for long-term therapy. However, the twice daily dosing also creates a unique opportunity for the brand to differentiate itself from its competitors. Having two doses a day can be a point advertised directly to patients as something by which to remember the product, so that they may discuss it with their doctor at their next visit. This advertising campaign will be further elaborated within the tactical plan. Though simply changing the formulation to a single daily dose is also an option, it would be something that takes time and additional money to accomplish; therefore creating new dosage formulations may take more time and would simply push back the launch of the medication. Rather, reformulation may be best if it is left until after launch, to see how well the drug is received.

Finally, generic incursion will cause a reduction in the size of the market. With this loss of market size, it is even more important that Pfizer is able to convert those patients on Geodon therapy to Asenapine, before it becomes generic in 2012. Asenapine provides all the benefit of Geodon (and more) without the side effects; therefore there is good reason for doctors to switch their patients over. It is of the utmost importance that the sales force and other forms of promotion convince doctors to switch their patients over to the new line of therapy.

Understanding the issues and objectives facing Asenapine in the coming years provides the basis to create a strategic plan of action. This plan incorporates all the overarching points in marketing the product. For a successful brand, it is essential to consistently promote according to this strategic document. If the plan is not followed, the advertising and promotion are likely to become confusing and ineffective to the target audience. Therefore, to avoid any chance of misunderstanding or ambiguity, the plan is presented as a concise, explicit format known as the Brand Constitution. This document is attached to the end of this report, providing a succinct source of reference.

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Though the Brand Constitution provides an excellent reference to find information, it does not provide the reasoning behind the decisions. Therefore, to better understand the Brand Constitution, the following describes the logic behind each portion of the document.

Target Audience The goal of Asenapine is to become the market leader in long-term therapy for schizophrenia patients. However, the patients themselves are not the ones who have the decision as to which medication to use. Rather, the psychiatrists that wield the power to prescribe making them the gate-keepers. Only by positioning Asenapine as the best choice in the minds of the psychiatrists will it become more widely prescribed. In addition to directly advertising to psychiatrists, reaching them indirectly provides a second method to help them keep Asenapine in mind. There are three other groups that can help increase the awareness about Asenapine to psychiatrists. The first of these groups is the general public, which suffers from a lack of knowledge about what schizophrenia is and therefore has created a stigma against those who have to live with the disease. Those who are currently on therapy for schizophrenia are the second group to target. This group already understands the background of the disease, but will not know the benefits of Asenapine. Finally, the primary care physicians (PCPs) serve as the first line to be confronted about the disease, therefore it is important that they understand the disease and can pick up on early signs of the disease. All three of these groups require more knowledge; however differ in exactly what they need. If they do receive this information, they will be able to bring this to their psychiatrists, hopefully to ask about Asenapine as a solution.

Competitive Positioning: For Asenapine to be but to do so, it is is gathered through about rebuffing the

a success, it must prove its superiority to other therapeutic options, important to understand what the others offer. The following information the market understanding and serves as a guide as to how Pfizer can go positioning of likely competitors for the same market share.

1. Abilify (IM and Oral combo)

Provide relief of positive and negative symptoms as well as bipolar comorbidity with fewer side effects.

Abilify has been shown to provide effective treatment with fewer side effects than current therapy options; however the oral dosing regimen has been on the market for some time, and has not been able to overcome the current market leaders. The hope of BMS is that the intramuscular form of the medication will be used instead of Geodon IM due to its better safety profile. Furthermore, by trying to show that the switch to oral Abilify will provide increased safety, BMS hopes to increase sales of the oral regimen. However, both ideas run into major problems. First, Abilify does not offer any sedative properties, which is something that doctors look for in an acute setting, in order to calm the patient down immediately. This point alone serves to limit the uptake as a replacement for the current

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options. Furthermore, BMS has not shown any increased benefit, in terms of safety or efficacy, by using oral Abilify over any other oral medication, after administration of Abilify IM. Pfizer can counter this combination product by marketing Geodon IM, the current market leader in the acute setting for schizophrenia drugs, with Asenapine, in addition to pointing out the holes in the claims that BMS may make.

2. Long-acting Depot Administrations of current therapies

Improve compliance in patients Lack of compliance has been a major drawback with current therapy, which is the reasoning behind creation of the depot 4-week administrations. The point that the sales force must get across when asked about these medications is that creating long-acting formulations simply delays the problem, rather than addressing it. The issue patients have with the current therapy is the poor side effect profile and the inability of the medication to treat the whole disease. Current therapy only helps as prophylaxis against acute onset and positive symptoms, but patients do not see improvement in their daily lives. This is because they still must deal with the long-term negative and cognitive symptoms. By switching patients to the depot formulation, patients may temporarily improve in compliance; however it may also lead to patients not returning to the doctor’s office, to avoid taking the injection, thus harming the patient. In addition, monthly injections of maintenance therapy are something not many patients will eagerly accept, because of the hassle. Using Asenapine actually deals with the reason for the lack of compliance, rather than simply avoiding the issue.

3. Bifeprunox Provide relief of positive and negative symptoms as well as many other comorbidities with fewer side effects.

It is difficult to assess weaknesses of Bifeprunox due to lack of data. Though Wyeth hopes to be able to make this drug as one that can cover many of the comorbidities of schizophrenia, there is no real data yet for this claim. Until more information is available, the best method would be to try to show differentiation through Asenapine’s unique MOA. Bifeprunox has very similar MOA to Aripiprazole, therefore trying to show it as a me-too product while indicating that Asenapine is different may work. Also, new clinical data on the efficacy of Bifeprunox may be useful to show how well it compares head-to-head to current therapy options. Using this data and comparing it to how well Asenapine stands up to current therapies may be able to show doctors which one is better.

4. Generics of current therapies

Provide adequate relief for a lower price.

The generic compounds can only boast their lower price compared to brand name medications.

However, like their depot administration counterparts, they lack the safety and efficacy of Asenapine. The vast improvement in negative and cognitive symptoms alone will make doctors

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choose Asenapine over these older medication options, as long as the message improved efficacy and safety of Asenapine is consistently delivered to doctors.

Market and Product Changes within the Creative Window These changes are the issues discussed earlier, including how to go about dealing with them.

These include:

I. Generic entry will clear II. New treatments focus on Asenapine III. Long-acting therapies, IV. Increasing awareness of V. Asenapine’s competitors me-too product

out current leaders but also shrink the market negative and cognitive symptoms, which increases competition for if utilized, may provide much better compliance the disease and treatments may increase sales will get into market first, endangering Asenapine into becoming a

Key Insight I want my patients to be on the fewest drugs with the most benefit and least adverse effects so that they can live their normal lives.

The Key Insight tries to portray what need of the patient Asenapine will fulfill. When marketing the medication, it is of the utmost importance to keep the Key Insight in mind, and make sure that the marketing creates the perception of that particular need being filled. If the promotion does not offer that, then it is more likely to confuse customers and patients, thereby harming the brand. The rest of the Brand Constitution will ensure that this idea is constantly addressed.

Communication Objectives These objectives are to show that Asenapine is the solution to meet the need sought after in the key insight. All promotions should get across the following two ideas:

1. Persuade psychiatrists that providing a single medication that treats all the symptoms of schizophrenia, and even certain comoborbities (bipolar disorder) is the best method to improve the patient’s QOL 2. Encourage psychiatrists to use Asenapine as their drug of choice because it can complete all the aforementioned tasks without risking severe side effects.

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Positioning Statement Asenapine is the antipsychotic that safely treats all of schizophrenia to let people fully enjoy their lives.

Once more, the key insight is clearly reflected in how the brand should be perceived by psychiatrists. In fact, the basis of this statement is to set Asenapine to gain the market share of another Pfizer medication, Geodon. This medication holds a significant portion of the current market share, however it, like most of the current therapy, does not provide relief to negative and cognitive symptoms, nor does it have a better side effect profile.

Geodon can help people not suffer from acute attacks, but it is unable to truly return people to their normal lives, because the other symptoms often interfere. Pfizer can use this to have doctor’s switch patients to Asenapine, which meets the exact needs of the current Geodon therapy patients.

Key Claims These are the points that will communicate the key issue and reaffirm Asenapine’s position in the minds of psychiatrists. The same points are reinforced over time to create a singular, clear image of the medication as the drug to best help their patients. The claims are separated into three types depending on the sort of effect they will have. The first class is rational, which will show actual benefits of the medication over other choices. Beyond this type will be functional claims that show practical application of the benefits of the medications. Finally, the functional claims should lead to emotional claims, which represent what the patients should feel by being on the medication. The key insight shows that psychiatrists want their patients to be able to return to their lives, which is what the key claims build to. All three types must be presented and connected to the communication objectives to clearly convey the brand’s position. In this case, all of these claims show that Asenapine’s strengths work to improve the patient’s quality of life.

Rational 1. Efficacy against positive, negative and cognitive symptoms 2. Also treats bipolar disorder 3. Much better safety profile over current therapies Functional 1. Works as prophylaxis to avoid acute onset/agitation 2. With better side effect profile, allows patients to live their lives more regularly 3. By treating more than just positive symptoms, patients are able to maintain better function Emotional 1. Without having to worry acute attacks or loss of movement/function, patients will feel more alive and less distant from their world.

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Elicited Emotion Hopeful, confident, and more together with their lives The key claims lead to some sort of emotional response in the target audience. In this case, the emotional response is more empathetic, because the psychiatrists will understand the hope and confidence Asenapine can give to a patient who, with this medication, will be able to return to a more normal lifestyle. As the Market Understanding indicates, social withdrawal due to the stigma around schizophrenia is one of the most difficult things for patients to deal with. A medication that allows them to not readily look as if they are on medication will help many start their lives again. Because of this, psychiatrists will be motivated to prescribe this medication.

Brand Character/ Identity The medication Asenapine should have a name which allows people to feel as if they are in control, since the medication puts patients in control of the disease, rather than letting the disease control their lives. Therefore, the name should be branded Revesta, a simple derivation of the word “revest� meaning to return to power. The color scheme is also chosen as something that represents better times. The sky blue above a grassy green creates feelings of a new beautiful day, representing that the drug provides a new beginning.

The two blue and green pills represent a point of differentiation of the drug, since it is dosed twice a day. This concept will be further explained in the tactical plan.

The brand character should not consist of a single specific character. A major issue with schizophrenia is the misconception of what a schizophrenic patient acts like, because only the positive symptoms are highlighted in most cases. Asenapine is able to treat the other symptoms; therefore the characters should show the debilitating effect of the negative and cognitive symptoms on real people, often in social environments, and an explanation of how the use of Asenapine helps restore that ability of people function socially. Let the focus be on very basic points that everyone can relate to, such as inability to hold a job or losing a special relationship to the disease. This will work better over an animated character to represent the patient because having the human face and the pain of loss because of disease will create an indelible image in people’s minds. More detail on the actual advertising plans will be discussed in the tactical plan.

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Tactical Plan: The strategic plan provides a strong basis on the overarching concepts for marketing Asenapine. It provides direction on what the promotion should communicate. An equally important point is how to communicate the points outlined in the strategic plan. The following provides specific tactical information as to what needs to be done to best advertise Asenapine.

Advertising and Promotion: According to the Brand Constitution, the target audience for Asenapine will be psychiatrists; therefore the all marketing efforts should be put forth towards reaching this audience. As described earlier, this will be done in two separate but equally important ways. The first method will be directly communicating to psychiatrists, the gate-keepers of schizophrenia medications. These methods include standard techniques used including:

Use of sales force, including samples, medical education pieces, etc.

This is the basis of all marketing to doctors, regardless of the medication. A good sales force provides the best returns, because the doctors come to trust their representatives to provide good information about new medications. Because the same sales force used to promote Geodon will be used, a relationship of trust should already exist. Thus, doctors who are currently prescribing Geodon should be readily switched to Asenapine.

Medical journal articles and posters in conferences based on clinical trial results Doctors place great faith in medical journals as a source of unbiased information about drug therapies. By having information about Asenapine published in such journals or presented at conferences, psychiatrists can be made aware of the medication, and may even be willing to try out the medication. This is a major way to get new customers, who are not currently prescribing Geodon.

Have backing of Key Opinion Leaders (KOLs) Another trusted source to psychiatrists will be opinion leaders, which should have already been identified and contacted while advertising Geodon. By providing the KOLs with what they need in order to conduct their own independent work to show the efficacy of the drug will prove to them the value of the medication, and because they use the medication, they can influence others to follow. Another possibility is approaching them to vouch for the medication at conferences. Having a personal relationship with key opinion leaders is essential; therefore having strong ties through the sales force as well as the medical liaison team with these KOLs can provide better results. Once again, Pfizer has already done all this work while marketing Geodon, which will vastly reduce the workload and cost of marketing Asenapine.

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Make sure that doctors feel that their concerns are being addressed.

Doctors must have input on the medication, including questions or comments. By paying attention to what they have to say, doctors will be more likely to prescribe the medication.

This is because they are recognized and addressed, creating a favorable impression of the brand with the doctor. When they prescribe medications, they will be more likely to prescribe the brand that seemed to care about what they had to say, because it will stick in their minds. Beyond just using the sales force, Pfizer should consider setting up a hotline dedicated to answering any concerns that doctors may have. Also, create a website that has a section to provide information to medical professionals.

In addition to directly approaching psychiatrists, using indirect advertising methods can provide a second way to make sure that psychiatrists keep Asenapine as their first antischizophrenic medication to come to mind. This includes Direct-to-Consumer (DTC) advertising as well as advertising to primary care physicians (PCPs). There are several points that need to be conveyed to these audiences. If each audience is correctly targeted, psychiatrists will see an overall increase in number of patients. Furthermore, these patients will have some understanding of the disease as well as Asenapine as a therapeutic option, which will once more have the ultimate target audience thinking about the medication as the therapy of choice. If patients ask for the medication by name, many times doctors will prescribe that medication, unless there is a specific reason not to do so. Thus advertising to these other groups should be done in the following steps, to maximize the awareness of the medication:

1. General public awareness campaign This campaign will not discuss Asenapine because there is too much stigma to approach drug therapy, without first pretexting with information on the disease. As discussed earlier, the negative and cognitive symptoms are not well known. Use mass media channels including television, internet, magazines, etc. to show what schizophrenia is and reduce the stigma around it. A powerful image would be to show that those who suffer from it, can be “normal� people that everyone can relate to, and focus on how it interferes with these people’s lives, making a stable lifestyle very difficult. In essence, those who suffer from schizophrenia need to be shown as victims of a disease, rather than the current view, which often makes people feel guilty or ashamed of suffering a mental illness. Another path is to try to work with non-profit groups that are already raising awareness. This includes raising money or sponsoring efforts of the non-profit organization to increase knowledge about the disease. All this can get people to think about schizophrenia, but it will not provide a great deal of information due to time constraints. However, creating general awareness website to provide information on the disease, on how to cope with having schizophrenia, and how to avoid it if possible will give people the opportunity to learn more about the disease.

Also, having patients come to the website is a good marker as to how effective the marketing has been. That is, the more people that visit the site means the more people that the advertisement campaign reached, and was good enough to create interest. For patients who have gotten to the point of considering their treatment options, provide a website and phone

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number for them to call. The website should have a section for doctors and a separate one for patients, as should the phone number.

2. Drug awareness “Take 2” campaign Once the general awareness campaign has created a significant amount of interest in treating schizophrenia, begin branded DTC advertisements about Asenapine. Make sure to address the communications objectives from the Brand Constitution. Stress the efficacy and safety of Asenapine. Also, using an emotional claim would be most likely to reach someone who is directly affected by the disease. Furthermore, because Asenapine will be the third drug on the market with similar efficacies and safety profile, a point of differentiation is essential, to avoid becoming a “me-too” product. The key to this differentiation is the twice-daily dosing of Asenapine. Though normally twice-daily dosing would be weakness for a medication, because of potentially lower compliance, in this case it serves as a strong point. Asenapine is to be advertised as a medication that allows patients to get back to their normal lives, by having them control the disease, and the disease not controlling their lives. Therefore, essentially patients are getting a second chance at their normal lives.

Thus, as said in making a movie, it would be “Take 2” of their lives. This provides a play on words with the fact that patients are required to take two wafers daily as the medication regimen. Thus, this campaign would focus on the following idea: Schizophrenia can take away your life. Now, take it back with Revesta. Just you, living your life, with the power of two quick-dissolving tablets. No shots, no hassles. For Life, Take 2.

The slogan serves a dual meaning, of how the drug works to give people a second chance at life, while also making sure that patients remember to take their medications twice a day. It is short and memorable, which will allow patients to bring it up when they visit their psychiatrist. Rather than trying to recall the drug name, patients are more likely to remember Asenapine as the “Take two drug.” Once again, the endpoint of all this is to make sure psychiatrists keep Asenapine as their top choice when prescribing for schizophrenia.

3. Targeting PCPs as gatekeepers to psychiatrists Psychiatrists are considered the gatekeepers to the medications and therefore, are the primary target audience. However, due to pressures of managed care, most patients are required to be referred to a psychiatrist through a PCP. Therefore, PCPs essentially serve the role as gatekeepers to psychiatrists. The problem with this is, however, they do not have experience in recognizing early symptoms of schizophrenia. This, along with the denial most

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patients go through with mental illnesses, leads to gross under-diagnosis of the disease and consequently underutilization of medications. Patients suffer from denial because of the social misunderstanding of mental illness, which was addressed through the general awareness and “Take 2� campaigns. However, more needs to be done to train PCPs in detecting mental illnesses, so that patients can get therapy before the disease progress to an acute agitation. Thus, medical education of PCPs can greatly improve the lives of patients and improve sales by reducing the underutilization of medication. Possible strategies include: I. In areas of high incidence of schizophrenia or doctors who have many patients on antipsychotic medications, ensure they have proper training on detecting early signs and how to deal with patients who may present with symptoms. This can be done by having medical education sessions in the area (like holding lunch and learn events that will be hosted by the company and taught by a KOL) II. Targeting PCPs in several ways, including looking at their prescribing history, to see if they do have a lot of antipsychotic prescriptions or by using psychiatrists to name the PCPs that refer to them.

III. A general brochure campaign on detecting schizophrenia and perhaps provides a way to get more information or sign up for training session.

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Brand Constitution Target Au dience Primary: Psychiatrists, Secondary: General population and amongst Primary Care Physicians (PCPs) Competiti on/com petiti ve Positioning Abilify (IM and PO combo)

Provide relief of positive and negative symptoms as well as bipolar comorbidity with fewer side effects.

Argue the fact that Aripiprazole lacks sedative properties which are often desired during acute attack Show that using Geodon and Asenapine is just as good LA IM formulations of drugs

Improve compliance in patients Show that the medications still lack the safety profiles of newer medications and do not cover negative/cognitive symptoms.

Requires monthly injections, which many people may be averse to Bifeprunox

Provide relief of positive and negative symptoms as well as many other comorbidities with fewer side effects.

Difficult to asses weaknesses due to lack of data. Best method would be to try to show differentiation through Asenapine’s unique MOA. Bifeprunox has very similar MOA to Aripiprazole, therefore trying to show it as a me-too product while indicating that Asenapine is different may work. Also, new clinical data on the efficacy of Bifeprunox may be useful to show how well it compares headto-head to current therapy options.

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Generics of current therapies

Provide adequate relief for a lower price Like their LA counterparts, they lack the safety and efficacy of Asenapine.

Market/pr oduct change s occurring wi thin creative w indow- issue s 1. Generic entry will clear out current leaders but also shrink the market 2. New treatments focus on negative and cognitive symptoms, which increases competition for Asenapine 3. Long-acting therapies, if utilized, may provide much better compliance 4. Increasing awareness of the disease and treatments may increase sales 5. Asenapine’s competitors will get into market first, endangering Asenapine into becoming a me-too product 6. Key insight that will drive the opportunity- strategies (axle) i.Doctors want their patients to be on the fewest drugs with the most benefit and least adverse effects.

Communica tion o bjecti ve(s) 1. Persuade psychiatrists that providing a single medication that treats all the symptoms of schizophrenia and even certain comoborbities (bipolar disorder) is the best method to improve the patient’s QOL 2. Encourage psychiatrists to use Asenapine as their drug of choice because it can complete all the aforementioned tasks without risking severe side effects.

Positioni ng sta tement Type: Against A leader (Geodon)

Asenapine is the antipsychotic that safely treats all of schizophrenia to let people fully enjoy their lives.

Key claim s Rational Efficacy against positive, negative and cognitive symptoms Also treats bipolar disorder Much better safety profile over current therapies

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Functional Works as prophylaxis to avoid acute onset/agitation With better side effect profile, allows patients to live their lives more regularly By treating more than just positive symptoms, patients are able to maintain better function Emotional Without having to worry acute attacks, or loss of movement/function, patients will feel more alive and less distant from their world.

Elicited emotio n Hopeful, confident, and more together with their lives Brand character/ identity Brand Name: Revesta

Brand identity: (example of type of image, should portray distance from life)

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Brand Wheel

Axle: Doctors want their patients to be on the fewest drugs with the most benefit and least adverse effects

Hub: Persuade psychiatrists that providing a single medication that treats all the symptoms of schizophrenia, and even certain comoborbities (bipolar disorder) is the best method to improve the patient’s QOL Encourage psychiatrists to use Asenapine as their drug of choice because it can complete all the aforementioned tasks without risking severe side effects.

Spokes: Rational Efficacy against positive, negative and cognitive symptoms Also treats bipolar disorder Much better safety profile over current therapies Functional Works as prophylaxis to avoid acute onset/agitation With better side effect profile, allows patients to live their lives more regularly By treating more than just positive symptoms, patients are able to maintain better function Emotional Without having to worry acute attacks, or loss of movement/function, patients will feel more alive and less distant from their world.

Tread: Hopeful, confident, and more together with their lives

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