Eli Lilly-Developing Cymbalta

1 January 2017

New Antidepressant Team (NAT), a cross functional team of Lilly research and development (R&D) and marketing was formed by two colleagues at Lily – Mark Demitrack and Brett Schmidli, and later two additional members were asked to joined, Jim Lancaster and John Kaiser. The mission of the team was to find and develop a drug that would later replace Prozac. The core strategy of NAT was to concentrate and devote resources to only 5 Assets: “R-fluoxetine, OFC (olanzapine-fluoxetine combination), 5HT2 antagonist SSRI, Business Development Opportunities, and Cymbalta (duloxetine)” (Ofek & Laufer, p. ). After a series of analysis and testing, Cymbalta was chosen by the team to replace Prozac. This paper will identify the strategic issues and problems that NAT faced in developing the new product. I will then analyze and evaluate the industry and market behavior by using a SWOT analysis. Finally, this paper will offer a set of recommendations based on the surrounding circumstances and options available to the Eli Lilly team. Identification of the strategic issues and problems Eli Lilly is faced with the strategic option to develop and launch a new drug that will be more effective than Prozac.

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There are several issues facing the launch of Cymbalta into the marketplace. “Cymbalta (duloxetine) appeared to have the three key ingredients of a potential successor to Prozac: 1) efficacy as good as or better than existing antidepressants, 2) no apparent safety or toxicity issues, and 3) the possibility of meeting a previously unmet patient need. ” (Laufer & Ofek, 2008, p. 2). Although, Cymbalta was considered on the basis of its compounds, several critical issues remained unresolved and needed to be made during the meeting of NAT.

NAT was faced with the decision of how to prioritize Cymbalta clinical trials and which clinical objective to approach first. Large-scale clinical trails often range from $25 million to $50 million and could last between 15 to 18 months to design, enroll patients, and to analyze and document findings. Unfortunately, NAT could only afford to purse one objective prior to the submittal of Cymbalta to the FDA for marketing approval. The following are three options available before Eli Lily:

Option 1: To invest in a new set of clinical trials to establish efficacy using once-a-day dosage of 60 mg of Cymbalta to treat Major Depressive Disorder (MDD). Option 2: To invest in clinical trials so that new indications could potentially establish a differentiator between Cymbalta and existing anti-depressants. Option 3: Delay submission of Cymbalta to the FDA for marketing approval so that the objectives mentioned above (options 1&2) could be established over a period of time by assessing the patients and physicians. Analysis and evaluation

Industry-An Overview on Depression “Depression as an illness is characterized by a sustained emotional disturbance that interferes with daily activities such as the ability to work, study, sleep, or eat, for a period of time as short as two weeks or as long as five years or even longer. ” (Laufer & Ofek, 2008, p. 3) Studies in scientific publications have estimated that depression affects anywhere from 10% to 25% of the population at some point in their life time, with women twice as likely as men to suffer an episode of depression.

Depression is often undiagnosed because of its complicated set of symptoms and there is often a social stigma attached to treatment that prevents some patients from visiting physician or psychiatrist. Scientists have developed four broad and a complex set of symptoms for depression, which are: mood changes, cognitive changes, behavior changes and physical changes. Prior to the late 1800s, depression was not recognized as an illness and often time patients went untreated or committed into a mental asylum.

It was not until the latter half of the twentieth century that pharmaceuticals became the primary source of treatment for depression. There have been several studies that directly link cases of pain accompanied by a state of depression. “Primary Care Physicians (PCPs) estimate that approximately 50% of patients suffering from depression who came to their office also suffered from pain symptoms, most commonly tension headache, neck/shoulder pain, and back pain. ” (Laufer & Ofek, 2008, p. 3) The NAT team had to decide weather to compare Cymbalta to existing SSRIs and SNRIs in the treatment of pain in order to differentiation themselves for others in the market. Even though there is an untapped market of pain medication in conjunction with the anti-depressant, it would take a lot of effort and resource from Lilly’s marketing team to educate both doctors and consumers on the application and benefit of this new drug. Market/Buyer Behavior To meet the needs of consumers, drug-manufacturing companies consult with both the physicians and patients to understand the needs of the market.

The behavior of consumer is not well defined because the ultimate consumers of all the drugs are patients, who themselves are not aware of all the facts surrounding a drug. Pharmaceutical marketing has become increasing popular in the last few years; it is the process of advertising or otherwise promoting the sale of pharmaceuticals or drugs. Physicians are perhaps the most important component in sales. Influencing the physician is the key to pharmaceutical sales because they write the prescriptions that determine which drugs will be used by their patients.

Physicians prescribe on the basis of past drugs available and their personal past experiences and opinions may have some influence. The marketing strategies employed in the pharmaceutical industry sharply contrast with those typically adopted in other markets. One of the primary reasons for this difference is that in the prescription medicine market there is a distinct breach in the traditional buying decision process: “The decision maker is the physician, who chooses among an array of medicine alternatives, but the buyer is the patient who takes the medicine and ends up paying (i. . , either out of pocket, or through health insurance coverage) for the choices made by the physician. ” (Karayanni, n. d. ) The importance of brand loyalty has been recognized by buyer behavior theorists for several decades, being described as “the core asset of any business, as future growth stems from the loyalty customers have in a company’s brands”. (Gralpois, 1998) Buyers’ behaviors and values can be measured through physician’s prescribing patterns and buyers purchasing patterns. SWOT Analysis Strengths: Successor of highly successful brand of Eli Lily, Prozac was an antidepressant leader in the market. •Effectively treats Major Depressive Disorder (MDD). Weakness: •The uncertainty of a once-a-day dosage of 60 mg for Cymbalta. •The lack of proof that Cymbalta will address chronic pain Opportunities: •To produce a product that will meet the needs of the patients. •To develop a product unlike any other antidepressant on the market by addressing chronic pain as well as depression and that would surpass its predecessor. Cymbalta doesn’t have any side effects, which is known to be one of the main concerns related to Prozac and one of the key findings reported. Threats: •Eli Lilly must be constantly on guard for patent violations and seek legal protection in new and growing global markets. •The competitors’ brands like Paxils and Zoloft with same efficacy. •The every changing pharmaceutical market and the amount of lag time and cost to develop a new drug.

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