...Executive summary: With the fast approaching expiration of its Prozac patent, Eli Lilly has to decide regarding the future course of action of its next generation anti-depressant drug. In this case analysis, the company faces three critical decisions before NDA submission: 1) establish Cymbalta as efficacious for treating major depressive disorders (MDD) using once-a-day (QD) dosing, 2) pursue a separate pain indication in addition to submitting for an MDD using twice-daily (BID) dosing, and 3) delay submission until both issues were established. All of these options are complex and not without difficult trade-offs but based on market research of its customer segments and market potential, the best strategic option is to prove efficacy for treating MDD using QD and only after launch get FDA approval for treating pain. 1. FDA approval for once-a-day dosing for Cymbalta is more important to have at launch. First, Cymbalta is the successor to Prozac and with it carries the brand that creates this resonance in the mind of consumers (patients/physicians). This is a successful brand that patients trust, value and can identify with. With this brand, Lilly has established a perceptual positioning and differentiation from its competitors, and so as to introduce this next generation product for the first time for a different indication, Lilly could run the risk of losing their large customer base. Second, establishing efficacy for treating MDD using QD dosing is more promising than pursuing...
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...Cymbalta Case Study Analysis Executive Summary Introduction: The Problem It’s April 2000 at Eli Lilly and Company where their flagship product Prozac is the leading brand of anti-depression medication and is set to expire in December 2003. Even though that is the official patent expiration date, no one within the company could be sure exactly how much time Prozac had left (Okef & Laufner, p.1). Patent expiration would mean that generic versions of the drug would flood the market and Prozac’s current $2 billion in annual sales would create a huge revenue gap (Okef & Laufner, p.1). John Kaiser, Marketing Director at Lilly is asked to give a presentation on a topic developing a successor to the now legendary anti depressant Prozac, which later on Kaiser titled “No Pain, No Gain.” He presented an overview of what depression is exactly and analyzed the effectiveness of Cymbalta comparing it to Prozac. After a four-and-a-half long marathon, some challenges and concerns were raised by some of the senior leaders of Lilly about their doubts that Cymbalta could in fact replace the leading brand. Strategic Planning In 1998, the New Antidepressant Team (NAT) was formed by two colleagues at Lilly: Mark Demitrack and Brett Schmidli, and later asked two other members Jim Lancaster and John Kaiser to join them based on their professional experience. The mission of the team was to find and develop a drug that would later replace Prozac. They quickly and efficiently narrowed...
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...Risk and Return “Believe me! The secret of reaping the greatest fruitfulness and the greatest enjoyment from life is to live dangerously!” —Friedrich Wilhelm Nietzsche Are You the “Go-for-It” Type? The financial crisis has people buzzing about “systematic risk.” This term means different things in different contexts. Traditionally, systematic risk has referred to the non-diversifiable risk that comes from the impact the overall market has on individual investments. This risk is also known as “market risk” according to the Capital Asset Pricing Model (CAPM) described in this chapter. With the financial crisis, however, people have been using the term systematic risk in a somewhat different way. Many companies, especially financial firms, are connected to each other in significant ways. With a financial instrument known as a swap, for example, one company may have a contract with another company that calls for large payments to be made by one to the other according to specified terms. If the company that is obligated to pay does not, then the company that was supposed to receive the funds might fail. If that company that was supposed to receive the funds fails, then other companies that it owed money to according to other swaps might also fail. This chain reaction of default, failure, default, failure could affect a large number of firms. The larger the firm, the more such relationships it is likely to have and the greater the chain reaction failures that...
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...Eli Lilly: Developing Cymbalta Student: AMBA 650 University of Maryland University College January 31, 2012 Professor: Eli Lilly and company is a pharmaceutical company that has been in business since 1876. In 2000 their new antidepressant team (NAT) was tasked with identifying a suitable replacement for Prozac their most profitable antidepressant drug. Prozac’s patent was due to expire in December of 2003. The expiration of Prozac’s patent would allow other pharmaceutical companies to market their generic version of the drug at a lower price. There are four members of the members of the NAT John Kaiser the marketing director at Eli Lilly, Mark Demitrack a psychiatrist and co-leader of NAT, Brett Schmidli a project development expert and co-leader of NAT, and Jim Lancanster the Prozac expert. The NAT was tasked with discussing and evaluating what drug could be developed to elevate depression in its patients and serve as the predecessor to Prozac. The NAT begin its evaluation by focusing on Eli Lilly’s five assets. The five assets were drug products that could be developed into the predecessor. The NAT decided to conduct research on the five assets to determine, which one could be developed into its next flagship depression drug. Asset 1 is R-fluoxetine, which Eli Lilly entered into a licensing agreement with Sepracor to further develop and market this drug but clinical trial stopped due to patient inability to stomach the drug. Asset...
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...It will be more effective for Cymbalta to have an additional indication of efficacy in treating pain than once-a-day dosing for Major Depressive Disorder (MDD). There are many drugs available on the market claiming to treat depression, which have already been proven effective. However, there are currently no drugs on the market that can treat chronic pain in addition to depression. Thus, it would be to the advantage of Eli Lilly to strategically pursue clinical studies of Cymbalta for the pain indication. The goal of Eli Lilly is to develop a successor to their blockbuster antidepressant drug, Prozac, which only has a few years remaining on its patent protection. Therefore, the looming introduction of competing generic drugs and the soon to be approved Paxil are in the midst of potentially taking away some of its market share. The antidepressant drug market is highly competitive (See APPENDIX A), which means that companies must spend a lot to promote and advertise these products to remain viable. Of note, many patients that suffer from depression also have other underlying issues such as chronic pain in the head, neck and/or shoulders. Unfortunately, in the past physicians had not taken the pain aspect very seriously. In fact, many physicians/psychiatrists believed that the pain did not really exist, and was merely in the minds of the patients that were suffering from depression. Neurologists on the other hand, postulated that the presence of physical pain could cause depression...
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...University of Maryland Case Study Analysis Eli Lilly: Developing Cymbalta Case Study AMBA 650 Section 1131 Kelvin Harris January 24, 2012 Executive Summary Eli Lilly and Company resounding success was the arrival of Prozac in 1988. By mid-1988, a new anti-depressant team was formed to find and develop a drug that would be the successor to Prozac. The strategic issues and problems they faced were developing a new drug to replace Prozac, meeting the company budget constraints to perform clinical trials, and finally launch the new drug by mid-2001. The analysis and evaluation revealed that the pharmaceutical industry is changing fast and it usually takes a long time and millions of dollars to develop a new drug. The recommendation for Eli Lilly is to take the lead in developing the new drug Cymbalta, invest a stable share of the company revenue, seek the FDA approval for the development of Cymbalta before going to market, and not change their market plan from the FDA approved Cymbalta dosage of 20 mg twice daily. Introduction Eli Lilly and Company was founded by Colonel Eli Lilly, Lilly’s namesake, in 1876 when he purchased a laboratory on Pearl Street in Indianapolis, Indiana. Eli Lilly was a pharmacist who had served in the Union Army during the Civil War. The company success included creating the process for applying gelatin-coating to pills for easier swallowing and the introduction of Iletin which was the first mass-produced insulin. Iletin...
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...Running head: ELI LILLY – DEVELOPING CYMBALTA CASE ANALYSIS 1 Week 4: Eli Libby – Developing Cymbalta Case Analysis Mary Juanita Hawkins University of Maryland University College Author Note This individual assignment was prepared for AMBA650, Section 9245, taught by Professor Philemon O. Oyewole. Introduction Eli Lilly and Company was established on May 10, 1876 in Indianapolis, IN and has been in business more than 132 years. The founder of this pharmaceutical company was Colonel Eli Lilly who was a union army member during the Civil War. This company deals with the development, discovery, sell, and manufacturer of drugs, such as Prozac and integrates supply-chain management within its departments. The first success that the company achieved was the coating of pills using gelatin. In 1923, the company marked another success by introducing Iletin that was used in improving diabetes. This project was the first largest insulin production that the company together with the University of Toronto invented. All through the 1950’s, various advancements were introduced such as the invention of the oral penicillin and the antibiotic known as Erythromycin. Prozac was produced in 1988 and latter succeeded in 1990. In 2000, the drug Zyprexa was utilized in the treatment of schizophrenia and later, the drug Gemzer was introduced for chemotherapy. Before Prozac the treatment available was Tofranil also known...
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...Cymbalta case Analysis Mohamed A. Kamara AMBA 650: Marketing Management and Innovation January 22, 2013 Table of Contents 1.0. Identification of the strategic issues and problems. 2.0. Analysis and evaluation. 3.2. Recommendations. 1.0. Identification of the strategic issues and problems. In April 2000, Eli Lilly’s New Antidepressant Team (NAT) convenes to review the potentials of alternative medications, and to subsequently adopt a replacement to the company’s premier antidepressant drug, Prozac, a form of fluoxetine molecule (Ofek & Laufer, 2008). Prozac’s huge market success after its market entry in 1988, these authors argue, is predicated on its ability to produce fewer side effects that resulted from targeted serotonin uptake; its tolerance to overdose; and, of course, its efficacy. However, Prozac’s success, with revenues of $2 billion a year, is without challenges. First, Prozac’s patent term expires in less than three years [in 2003], a patent already challenged by competitor, Barr Laboratories. In addition, the field of drugs that comprises Prozac has become crowded with available substitutes, such as Paxil, Zoloft, and Celexa, to name three. Also the market introduction of a much cheaper generic fluoxetine was imminent (Ofek & Laufer, 2008). The NAT’s task is to formulate a pre-mortem strategy for the highly profitable Prozac, specifically to find a replacement in Cymbalta. Cymbalta, the front runner among Prozac’s successors, bore encouraging...
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...circulating volume. S.W.’s Blood Urea Nitrogen level (BUN), and Creatinine were elevated. BUN is a measurement of how much urea and nitrogen are in the blood. When the kidney’s stop filtering these toxins out it is an indication that kidney is losing its ability to filter. Creatinine is a byproduct of muscle breakdown. This is also an indication that the kidney is not filtering properly. Both of these labs are elevated during an acute kidney injury and during kidney failure. This is an indication of her diagnosis of an Acute Kidney Injury. The current medications that S.W. is on for her depression have the potential to cause further damage to her kidneys. Benicar and Cymbalta are both metabolized in the kidney. Benicar also inhibits the angiotensin system, which is directly operated by the kidneys. Cymbalta is metabolized in the kidney and this put excess work on an already damaged...
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...Clayton State University Duloxetine (Cymbalta) is an FDA approved selective serotonin norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder (MDD). Television commercials for Cymbalta can be viewed on major and cable networks, during daytime and early evening hours. The television commercials are run during the broadcast of soap operas and other daytime programming. Advertisements also appear on home improvement channels such as Home and Garden (HGTV) and the Food Network. The commercials depict active, attractive women and men that appear to be in their mid-forties and fifties participating in enjoyable life activities. The emphasis of the message in the advertisement for major depression disorder is depression is treatable and manageable by the use of Cymbalta. Cymbalta commercials also advertise the treatment of Fibromyalgia pain. The television commercial briefly describes the major side effects of Cymbalta such as nausea, dry mouth and constipation. The commercial also states that Cymbalta should not be taken by patients that take monoamine oxidase inhibitor (MAOI) and in patients with uncontrolled narrow angle glaucoma. Even with air time being limited, I believe the television advertisement to be truthful however, the focus of the advertisement is on the benefits of the medication and they do not give adequate time to disclose side effects, adverse reactions or contraindications. Duloxetine (Cymbalta, Ariclaim, Xeristar, Yentreve, Duzela...
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...Eli Lilly: Developing Cymbalta Study AMBA 650 University of Maryland University College (UMUC) Professor: Dr. Minkus-Mckenna Brian Natoli October 31, 2010 TABLE OF CONTENTS 5.0 Strategy5 6.0 Alternative Actions6 7.0 Recommendations7 8.0 Conclusion8 5.0 Strategy Based on the strengths, weaknesses, opportunities, and threats, the following strategies should be adopted by Lilly: 1. Taking advantage of its positive brand image can present advantages in obtaining opportunities that exist in their market. This will help Lilly broadening its portfolio. 2. Their long presence in the market and being one of the oldest companies in the pharmaceutical industry will be very positive for the company to obtain alliances for faster growth, better brand recognition, and to meet market’s competitive forces. 6.0 Alternative Actions: For the resolution of the lowered sales volume and the firm's shared market, there are three suggested alternative course of actions. Lilly’s first alternative includes the launching of new products with required features, such as pain relief, and one time dosage, however, capital consumption would be required for the production process, time and labor for marketing of new products would need longer lead times, and clinical trials would be required which create additional expenses for the Lilly. The next alternative for the company is to conduct preliminary market research. The customers' response for the existing drugs as well for...
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...University of Phoenix Material Health Care Marketing Information Matrix There are a variety of information sources that may be used by consumers to obtain information relating to the marketing of health care products and services. The following matrix is intended to assist you in organizing the information contained in these sources. Consider the types of marketing messages that these information sources may contain and the reliability of the marketing message. Following the provided example, identify three examples of your own. |Source of Health Information |Type of Health-Related |Marketing Messages |How the Consumer May Assess the Accuracy or | | |Information | |Reliability of the Marketing Messages | |List the information source, such as Internet websites, WebMD, MedLine, or the news media. |Type of information |List at least one marketing|List one approach the consumer may use to verify | | |provided by the source |message being communicated |the accuracy of the marketing message. | | | ...
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...Reason for Admission On 4/12/11 A.G., a 16 year old Hispanic American female voluntarily admitted herself to Aurora Behavioral Health Care (ABHC) due worsening depression and suicidal ideation. Pt stated that she had been feeling depressed for the last six months but felt as if her depression was worse now than ever. Upon admission pt was thinking seriously of acting on her thoughts of suicide by overdoing on sleeping pills or by cutting herself. For the past few months the patient had been seeing a therapist and psychiatrist but feels like they cannot fix her depression. Major stressors upon admission include lack of support from family and friends, and doing poorly in school. For the past six months A.G. had been taking 100 mg of Zoloft and 2.5 mg of Abilify for depression. A.G.’s diagnostic and statistical manual of mental disorders (DSM) was Axis I: Major Depression, single episode, and severe, Axis II: deferred, Axis III: No diagnosis, Axis IV: Moderate, And Axis V: 30/60. Summary of Mental Status Exam During the time of assessment A.G. appearance was neat and her attitude was cooperative but she seemed depressed during the initial assessment. The patient’s speech was normal and she had a calm demeanor. She reported feelings of being anxious ever since she was admitted to Aurora because she felt as if her depression was “not getting any better”, and that she was afraid that her medications were not working. She reported having a panic attack one month ago due to stress...
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...exacerbated her chronic depression and ADHD. S.W sufferers from severe anxiety over the state of her health and what this means for her future. Her anxiety showed by her elevated vitals and external emotions. Despite S.W being very talkative she had an elevated blood pressure, pressured speech, and became tearful at times. S.W. mostly became tearful when the potentially serious outcomes of her disease process were discussed. Cymbalta is selective serotonin and norepinephrine re-uptake inhibitor. This means that these chemicals are blocked from the brain when the patient is on this type of med. Serotonin is a neurotransmitter that effects all of our daily functions It influences appetite, sleep, memory, learning, temperature regulation, and some social functions. Norepinephrine is considered the stress hormone of the body. It is released by the sympathetic nervous system and is released in response to external stimuli. When these neurotransmitters are inhibited in the brain it causes changes in the mood of the patient; it is not exactly known why this occurs. Cymbalta also helps to relieve anxiety. S.W did not present with neurological (neuro) deficits however in a patient with an AKI the potential to have neuro involvement is high. BUN is elevated it indicates the amount of toxins that are present in the blood. These toxins can effect the Level of consciousness that a patient experiences. The patient with and elevated BUN may experience confusion, lethargy, decreased level of consciousness...
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...the virus is no longer contagious. Patients with nerve pain – neuropathic pain – may require treatment with Tylenol (acetaminophen) or NSAIDS (Advil, Aleve, Naprosyn). In severe cases, their pain may need to be controlled with opiate analgesics such as: • Codeine • Tramadol • Vicodin (hydrocodone – acetaminophen) • Percocet (oxycodone – acetaminophen). Opiates should be used at the lowest dose possible and for the shortest duration of time possible. They should also be used cautiously in the elderly due to the increased risk for falls. Some patients with Shingles develop long-standing nerve pain. These patients may respond to medications used to treat peripheral neuropathy, such as: • Neurontin (gabapentin) • Lyrica (pregabalin) • Cymbalta (duloxetine) Summary: • Shingles is a very common condition characterized by unilateral rash in a dermatomal distribution – chest, abdomen, or face. • Rash is red and painful and carries a blister-like appearance. • Pain may proceed the symptoms of rash. • The disease is caused by reactivation of varicella zoster virus – the same virus that is responsible for chicken pox. • The virus reactivates in elderly patients, particularly during times of stress such as sunlight exposure, fever, infection, pregnancy, immunosuppression (eg, corticosteroid use), chemotherapy, and HIV/AIDS. • The virus can be spread via respiratory droplets – but it is most frequently transmitted by direct contact with the blisters of the rash. • Once the blisters...
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