University of Maryland
Case Study Analysis
Eli Lilly: Developing Cymbalta Case Study
January 24, 2012
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.
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Lastly, they need to minimize the new drug frequency and severity of side effects to make it more competitive for its rivals. The cost of a large-scale clinical trial often ranges from $25-$50 million dollars. Therefore, the NAT could only afford to pursue one clinical trial before submission to the U.S. Food and Drug Administration (FDA) for marketing approval. One strategy for the NAT is to develop the new drug using less expensive generics. Also, they can use the results from a Cymbalta assessment from previous clinical trials and try increasing the daily dosage of 20 mg (which is identical to the dosage of Prozac). Finally, Eli Lilly need to build in the budget enough funds to cover marketing and unexpected issues during the clinical trial. The last strategic issue and problem for Eli Lilly is launching the new drug within 15 to 18 months of the expiration of the Prozac patent. Due to the ongoing court cases challenging Prozac’s patent expiration, the successor had to be submitted to the FDA by mid-2001 (a full year earlier than originally planned). On average, experimental drugs take 12 years to travel from the lab to one’s medicine cabinet. To meet the submission date to FDA, the NAT should decide which clinical trial they want to pursue first and use the research data from previous clinical trials and investigations as a starting point for the new drug. Also, they need to determine what the