Cymbalta

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 competition since all the leading treatments are QD dosing, it is important that this dosing formulation be proven a viable option to improve patient compliance and encourage physician's prescribing decisions.

2. Based on the patient segmentation study reference in Exhibit 10, patients are mostly middle-aged women who suffer from multiple symptoms associated with depression. Anxiety and pain make up a large portion of these symptoms and this is why a fair percentage of these patients take more than one drug simultaneously. This is the reason why patients are less compliance with taking a product BID as they are already taking multiple medications and sometimes simply forget to take the extra dose. This also supports the fact that they tend to comply less regularly if tolerability issues exist in a product. Social stigma is also a major concern and is the reason why most men do not seek medical attention. A way for Lilly to alleviate this problem and potentially capture a bigger market share is to minimize the visibility of the product