Cymbalta

In: Business and Management

Submitted By innoc3ntvg
Words 874
Pages 4
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 an indication for efficacy in treating pain for which the company has limited experience in, and since no medication had been approved by the FDA for this treatment (DPNP), there are no clear guidelines from the FDA. The lack of information and resources on this therapeutic area would make R&D and benchmarking very difficult to navigate. Lastly, to put Cymbalta on par with its…...

Similar Documents

Eli Lilly

...the risk that is involved in the industry today. Current risk factors that are threatening Eli Lilly are the FDA approval process, patent expirations, pipeline concerns, the purchase of Imclone and how it will be integrated into the company, and finally the ongoing recession. Eli Lilly currently has drugs pending FDA approval, notably Effient, a blood-thinner. Effient’s approval has been delayed twice, and is currently going to be reviewed by a special committee within the FDA in 2009. Analysts believe that Effient can become the dominant drug used around the world grossing billions in revenue; however, the FDA has not approved it yet. Eli Lilly also has patents running out on several of its highest grossing drugs including Zyprexa, Cymbalta, and Gemzar between 2011 and 2013. These are Eli Lilly’s top three grossing drugs and the patent expiration will raise questions about their future pipeline after 2013, especially if Effient does not get approved. Overall with all these questions and risk factors we decided to go with our relative valuation, which shows us Eli Lilly is fairly valued at the moment and recommend a hold. Recommendation: HOLD (No Action) Company Overview Eli Lilly and Co. is a major pharmaceutical company headquartered in Indianapolis, Indiana. It operates as the 10th largest pharmaceutical company in the world. The company was founded in 1867 and is currently under the control of President and CEO John......

Words: 8055 - Pages: 33

Hispanic Culure

...and her family about her prescribed medication. With that being said, it is important for the nurse to reassure the patient and their family that antidepressants are not shown to be addicting. Education about the medication Cymbalta should include the reason for use, common side effects, and side effects to report to the Doctor. Common side effects for Cymbalta include: fatigue, drowsiness, insomnia, decreased appetite, constipation, dry mouth, and nausea. It is important to educate the patient and family members of side effects to report such as seizures headache, trouble concentrating, memory problems, weakness, feeling unsteady, feelings of suicide, loss of coordination, fainting, seizure, shallow breathing or breathing that stops. Additional education about Cymbalta should include that all antidepressants have a black box warning, which means that there may be in increased risk for suicidal symptoms. It is also important to educate the patient and family that antidepressants can take two to four weeks to take effect, and even if the patients feeling of depression gets better it is important to continue this medication. The medication teaching should also include information regarding her dosage amounts and at what times to take her meds (Cymbalta 120 mg taken daily every morning), as well as that she should not double dose, discontinue medications, or add a new medication without consulting her Doctor first. It would also be helpful for the nurse to collaborate......

Words: 1986 - Pages: 8

Terms

... | |http://www.zyrtec.com/econsumer/zyrtec/index.view | |hours after a single dose. | | | | | | | | |An official site concerning|Cymbalta is used for |Use as directed to help prevent depression, | |Cymbalta Official Site. Usage and side effects (2012). Retrieved from http://www.cymbalta.como |the use of the medication |dealing with everyday |anxiety disorder and to help manage chronic | | |Cymbalta and its side |depression symptoms |muscular pain and fibromyalgia. | | |effects | | | | |An official site on how and|Celebrex is used for |Just one 200mg Celebrex taken daily can provide 24| |Celebrex Official Site. Usage......

Words: 408 - Pages: 2

Cymbalta

...A Plan for Cymbalta to Surpass its Successor Executive summary: The paper analyzes the success of Eli Lilly and Company’s legendary antidepressant Prozac and determines how to replicate the company’s success with the launch of its new and improved potential product - Cymbalta. Eli Lilly’s growth is in appreciation of its flag ship product – Prozac, however with one year left to act on its expiring patent it is time to do some heavy strategic planning to introduce its successor. The paper will review the history of the strategic plan behind the rapid switch from Prozac to generic brands. As a result of this review a recommendation is made on how to devise a plan to introduce Cymbalta into an already competitive antidepressant market. This paper reviews the achievement of Merck-Medco’s marketing plan to introduce the generic brand of Prozac into the market and the pros and cons of implementing the same strategy when introducing Cymbalta to the market. Introduction: After trying a number of antidepressant drugs and without any real success, many have turned to the help of Prozac. Some complain that others drugs were too depression focused and did not address anxiety issues. Patients who are diagnosed with depression are often told that if they also experience pain it may be in their head and due to the depression or anxiety. Eli Lilly’s flag ship product – Prozac, flooded the drug industry receiving rave reviews for providing just the right amount of balance. As...

Words: 1082 - Pages: 5

Cymbaltamkamara

...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......

Words: 1238 - Pages: 5

Eli Lilly, Developing Cymbalta, 2008

...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......

Words: 2425 - Pages: 10

Examining Truth in Drug Advertising

...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,......

Words: 1217 - Pages: 5

Drug Profile

...Interactions – There are nearly 1000 major to minor drugs that can have interactions with Fluoxetine. Some include: Abilify, Advair, Aspirin, Calcium, Celebrex, Crestor, Cymbalta, Fish Oil, Lipitor, Lyrica, Nexium, Seroquel, Xanax, and Vitamins B12, C, & D3. ANTIANXIETY – Diazepam Brand Name – Valium Action – Valium is a CNS depressant that slows brain activity. It interacts with GABA neurotransmitters, and binds strongly to the GABA A receptor in the brain to reduce arousal and to affect emotions. Diazepam further depresses the electrical after-discharge in the amygdala and hippocampus regions of the limbic system that affect emotions. Short Term Side Effects – Some may include: dizziness, drowsiness, sedation, loss of balance, confusion, disorientation, amnesia, breathing difficulties, and depression. More rare ones can include: agitation, hallucinations, and nightmares. Long Term Side Effects – Benzodiazepines can have strong effects after long term use. These can include: drug dependence, lethargy, memory impairment, personality changes, aggression, and social deterioration, which can affect your family, friend and work situations. Potential Drug Interactions – There are nearly 850 drugs, most having moderate effects, that can interact with Diazepam. These can include: Ambien, Aspirin, Cymbalta, Fish Oil, Lipitor, Lyrica, MiraLax, Nexium, Norco, OxyContin, Plavix, Singulair, Tylenol, Vicodin, and Vitamins B12, C, & D3. MOOD STABILIZER –......

Words: 1207 - Pages: 5

Future Statement

...the future you can view all of the changes that you have made in the present and past. The great thing about the time travel is that you can travel to in the future and scope out what has been affected and if it is something that you don’t like, then you can always travel back in the past and make changes to what you see fit. Another great reason to have a time travel device would be if there is a part of you past that you wish that you can just relive, you can always go back and relive the moment. Just think of how this can potentially save so many people lives. People who suffer from depression can relive happy moments and events that happened in their lives to help them cope with the depression and pull them out of it. Just like the Cymbalta medication commercial says “Depression hurts”. When someone gets in their depressed state, they can revisit there happy moments and pull themselves out of depression to prevent a lot of suicides due to depression...

Words: 363 - Pages: 2

Eli Lily: Developing Cymbalta

...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.......

Words: 1430 - Pages: 6

Eli Lilly Case Study

...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. ......

Words: 1938 - Pages: 8

Eli Lilly

...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......

Words: 850 - Pages: 4

Eli Lilly Case

...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......

Words: 2475 - Pages: 10

Introduction to Cymbalta

...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......

Words: 13535 - Pages: 55

Cymbalta Case

...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...

Words: 695 - Pages: 3