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 characteristics. Cymbalta’s effectiveness is comparable to, if not better than, existing antidepressants; it is safe to consume; and it could potentially provide value-add for the patient (Ofek & Laufer, 2008).
But the path to becoming Prozac’s replacement is no picnic, Cymbalta has a number of challenges it must surmount. Primarily, the team must decide on a clinical path to pursue, since the time [of almost two years] needed for a full-scale clinical trial for Cymbalta is not affordable, coupled with the fact that a one-a-day dosage is still elusive. Additionally, the team must also decide whether instead it shoud focus on promoting Cymbalta as a pain reliever, in addition to treating depression, a form of product differentiation (Ofek & Laufer, 2008). 1.2. Analysis and evaluation.
A successfully undertaken full-scale clinical trial would ready Cymbalta for a possible quick approval by the Food and Drug Administration (FDA). But part of the reason the NAT is leery about such a trial is that Cymbalta had already failed to demonstrate affective curing ability at the 20 mg/day in Phase 2 trials. In Phase 2 trials, the right dose for a particular drug is determined, in addition to other features. For Cymbalta, it was determined to be ineffective at treating the primary infirmity of major depression at the determined dosage. If Lilly pursues a pure-pain filing, it would have to be at the 20 md/day. Although this objective might be able to establish Cymbalta as a pain reliever, its ineffectiveness at treating depression would still remain unaddressed, and distracting.
To blunt out this apparent ineffectiveness, the NAT sought to expand the array of illnesses that Cymbalta could cure – an array that transcends current offerings by competitors. Fortunately, Smriti Iyengar’s work on using Cymbalta to treat pain provided the team with much needed scientific rationale for the pursuit of the “co-joined illnesses” hypothesis. Therefore, implies the marketing strategy, it would be an added benefit to the patient if his/her depression medication were also able to deal with the pain associated with the ailment. However, the anecdotal testimonies of physicians did nothing to make the pain-accented argument a home run. First, Lilly’s limited exposure with the science of pain, along with the lack of guidelines from the FDA on the subject, makes pursing Cymbalta for pain a difficult choice. The difficulty of the choice is further validated by dissenting choruses from some members of the Psychoanalysis community. These members believe that the self-consciousness of depression patients might have triggered feelings of pain, even though pain might actually not exist beyond the mind. Neurologists, for their part, posit that pain leads to depression – treat the pain and the symptoms of depression go away. Moreover, Cymbalta’s likely competitor, Effexor, is already employed in treating diabetes-related pain; there are also highly established over-the-counter medications, such as aspirin for general pain.
Faced with low efficacy for Cymbalta at Phase 2 trials, and an inexact science to cast antidepressants as pain relievers, the NAT turned their attention to undertaking clinic trials for developing a 60 mg/day dose – in keeping with an unspoken standard in the antidepressant sector. Such a dose, if attained, would be an improvement from the twice-a-day dose of 20 mg that was used in the Phases 1 and 2 trials. The 60 mg-a-day Cymbalta would not be an added burden on the patient over its predecessor, Prozac. Compliance with a single dose a day is more likely than on twice or higher a day regimen. And to increase its effectiveness, Cymbalta’s 60 mg dose would need to be indiscriminate in blocking the reuptake of Serotonin and Norepinephrine. But the once daily dose also has its fair share of possible shortcomings. First, the increased dosage raises safety and tolerance concerns. In addition, the half-life of the 60 mg dose was unknown, prompting yet further concerns that the medication might wear off quicker than needed to provide 24 hours relief for patients (Ofek & Laufer, 2008). These two concerns: toxicity and a shorter half-life, which physicians consider as among the most important considerations, could adversely affect the prescribability of Cymbalta. 1.3. Analysis and evaluation.
It is imperative to indicate at the outset that Lilly needs a point of differentiation in order to stay competitive. Product differentiation also makes product copying a bit difficult, and buys time for the pioneering company to recover its investment. However, I do not think the twice daily dose is the way to go.
First, to minimize the impending declines in revenue due to Prozac’s absence, Lilly should focus on expanding its market in segments, such as schizophrenia, chemotherapy, osteoporosis and diabetes using rising stars, such as Zyprexa, Gemzar, Evista and insulin Humulin, respectively.
Second, the epidemiological studies should continue to find what other ailments, which form “comorbidities” with depression could be effectively cured by any drug in its existing line of products, including the twice daily Cymbalta. This study should also continue to understand the unmet needs of patients, undertake subsequent segmentation, and targeted solutions and marketing.
Perhaps, most importantly, NAT should focus on ascertaining the safety and effectiveness of the 60 mg dose. The team is aware that there exist competitors effective at treating depressing and others at treating diabetes-related pain. What is missing in the market is a drug that would offer better safety and efficacy than current offerings. Therefore, if NAT expends effort into raising the tolerance and efficacy profiles of the once-a-day Cymbalta, Lilly could pursue a credible product differentiation strategy. Subsequent to a successful profiles-lift, two separate filings should be executed for the pain and the depression with the FDA. Although, no drug had been approved by the FDA to treat diabetes-related pain, I recommend that Lilly delay the separate filings until these profiles are raised high enough to create “a distinction with a difference” from competitors.

References
Elie, O., & Ron, L. (2008). Eli Lilly: Developing Cymbalta. Harvard Business School, 1-28.