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 2 is olanzapine-fluoxetine combination (OFC), included Zyprexa and ingredient in Prozac. OFC was approved by FDA to treat bipolar, which is a smaller market compared to major depressive disorder (MDD). Asset 3 is 5HT2 antagonist SSRI drug study was stopped due to its harmful effects found in animals. Asset 4 are business development opportunities, which developed into 13 opportunities but Eli Lilly only made two offers and the companies declined. Asset 5 is Cymbalta is a serotonin and norepinephrine receptor inhibitor (SNRI) but during its initial clinical trials it was determine to be ineffective in treating MDD at a once a day dose of 20 mg. The NAT’s research also determined that a clear and distinct connection lies between depression and pain and decided to further develop asset five to replace Prozac. This paper will discuss the Eli Lilly’s strategic issues and problems, provide an analysis and evaluation of the situation, and list recommendations for a course of action.
Strategic issues and problems Before the NAT members can submit Cymbalta as a predecessor for Prozac they must strategically examine the issues and problems associated with this drug. The NAT reasons for considering Cymbalta as a sustainable replacement for Prozac are as follows: • Side effects with Cymbalta were minimal • Cymbalta exhibited a better safety record and acceptability during the study • Exhibited signs that it could be develop further to treat pain as well When Eli Lilly and Company first developed Cymbalta it yielded low levels of efficacy for the treatment of major depressive disorder. The study also indicated that in a higher dose Cymbalta provided a more effective response in patients in the study by preventing the reuptake of both serotonin and norepinephrine and relieving the pain associated with depression. The NAT faced difficulties as the neurologists and the psychiatrics differed in their opinions on whether depression caused pain such as constant headaches or severe back pain. These differences could have an effect on whether Cymbalta would receive the approval needed from management. Other problems Eli Lilly faced were their lack of experience with pain medications and the Food and Drug Administration (FDA) provided no guidance documents on the development of pain medications with a connection to depression, which could hinder the drug approval process. The NAT realized that further development of Cymbalta could cost upwards of $50 million and could take up to 18 months to complete, besides this they only had three options to select from and pursue. The first option was to develop new clinical trials to test the consumption of one 60 mg dose daily for MDD, which would place Cymbalta on the same level as its competition. Previous studies only tested in twice daily doses of 20 mg, 30 mg, and 40 mg. The second option called for an investment in clinical trials that would distinguish a difference between Cymbalta and other depression drugs. This would be a viable option because most physicians perceived all antidepressant to hold the same effectiveness. The finally option would postpone the submission of the drug to FDA so that option 1 and 2 could be further studied. This option would increase the NATs clinical trial timeframe from 18 months to possibly 36 months and cause a loss in placing the drug on the market for public consumption.
Analysis and evaluation The pharmaceutical industry is a billion dollar business and to create the same success as Prozac with Cymbalta will be a tremendous challenge. In this industry companies are faced the daunting task of following the policies and procedures when they submit a drug application for approval. These policies and procedures are enforced by the FDA, who is committed to ensuring that drugs they approve are safe and effective for consumer consumption. This could prolong the approval process. Once the drug is approved and Eli Lilly has obtained a patent it will provide them with a specific amount of time on the market before their competitors could create a generic version. In addition, consumers would be excited to know that Cymbalta not only relieved depression but the pain connected to it. This would definitely cause an increase in sales that it could double the sales of Prozac and Cymbalta could become Eli Lilly’s new supreme drug leader. In conducting an analysis the NAT is confronted with following strengths, weaknesses, opportunities, and threats.
Strengths:
• Eli Lilly is an established and well-known pharmaceutical company • Cymbalta displayed fewer side effects than other antidepressants • Cymbalta could be used to treat depression and pain
Weaknesses:
• Cymbalta currently presents that same factors as its competitors • Cymbalta has only been tested as a twice daily dose of 20 mg, 30 mg, and 40 mg
Opportunities:
• Cymbalta could be developed into a once daily dose of 60 mg • Potential use of Cymbalta to treat pain in certain medical condition such as osteoarthritis, rheumatoid arthritis, fibromyalgia, and diabetic peripheral neuropathic pain (DPNP)
Threats:
• Other drugs on the market such as Paxil and Zoloft presented the same effectiveness • Neurologists and Psychiatrists expressed different opinions on whether pain was associated with depression • Establishing a difference of treating depression and its pain between Cymbalta and current SSRIs might be difficult If the NAT ensured that Cymbalta was developed effectively the product could prove to elevate more than just depression and its pain but the pain associated with other conditions. Physicians would likely prescribe Cymbalta to its patients due to the low side effect it presents and it could be used to treat other disorders besides depression but those that exhibit extreme pain. Cymbalta could help in diminishing the pain of the 40 million Americans the National Institutes of Health say they are suffering with. The 60 mg once daily dose seems like the most logical pursuit if it can provide a unique difference from its competition by being able to be effectively used to treat MDD and pain of other conditions. The NAT will also need to come under budget of $50 million, meet the time limit of 18 months for its clinical trials, and receive approval of its application to market a new drug from FDA. If the NAT fails to accomplish any of these steps it could cause an enormous loss in profits and the marketing of Cymbalta as its new flagship depression drug.
Recommendations
In examining all of the options its seems as though option one is the best choice for the NAT as they would need to establish new clinical trials for a daily dose of 60 mg for the treatment of major depressive disorder (MDD). In selecting this option the NAT would be able to establish a difference between Cymbalta and current depression drugs. Currently, no other depression drug is prescribed at such a high dosage and takes away the pain associated with the disorder. The clinical trials could also establish Cymbalta’s effectiveness to treat the pain of other illnesses. With Cymbalta Eli Lilly could maintain its position as the market leader for treating depression. Cymbalta may exceed the sales of Prozac if it could be established as an effective drug and a leader of antidepressants.

Reference
Ofek, E. & Laufer, R. (2008). Eli Lilly: Developing Cymbalta. Harvard Business School