Identification of the strategic issues and problems
Prozac, a leading brand medication for depression, and also the flagship of Eli Lilly has only a few years left of patent protection before the generic version can be sold in the U.S. After the distribution of generic versions, Lilly will have a annual sales of more than 2 billion revenue gap to fill. This is the reason why Eli Lilly created a New Antidepressant Team (NAT) to develop a successor to Prozac. In the pharmaceutical development industry, many constraints exist due to Food and Drug Administration (FDA) compliance and regulations. On an average, only 1 in 1,000 compounds that enter the preclinical testing continues onto human testing, and only 1 in 5 of those compounds gets approved by the FDA for sales and use.
There are 5 alternatives strategies available for the successor. 1) R-Flouxetine: This compound has similar effectiveness when compared to fluoxetine and avoided some of Prozac’s side effectives, the development was discontinued due to patient tolerability issues. 2). Olazapine-fluoxetine combination (OFC): This compound is approved by the FDA, however only treats bipolar depression, which has a small market size. 3).   SHT2 antagonist SSRI: This compound is expected to eliminate side effects such as anxiety, restlessness, insomnia, agitation, and sexual dysfunction. However, it was discontinued in early development due to animal toxicity findings. 5). Cymbalta (duloxetine): This medication did not show adequate efficacy for treating MDD at 20mg/day, however it was not discontinued. Also it showed potential in achieving similar or better efficacy compared to other medications, there were no safety or toxicity problems and there is a possibly to meet a unmet need of patient. From these 5 alternatives, Cymbalta seemed to be the best alternative.
John Kaiser, the marketing director at Eli Lily developed 3 option routes in order to bring Cymbalta into the market, and making it the next...