Business Plan for Anti Depressant Drug

Executive summary:

Introduction:

This is a case analysis of Eli Lily's new product launch of Cymbalta after the expiry of Prozac brand of drug in year 2003. Kaiser, Head of New anti-depressant Team holds a meeting to decide on the future course of action for new drug Cymbalta. It is an analysis of the case to develop strategic options and choose the best alternative after discussing and analyzing all the facts available.

Launch of antidepressant drug cymbalta by Eli Lily

Identification of the strategic issues and problems : The Eli lily which was going to launch its new drug Cymbalta after the expiry of Prozac had several options to incorporate as new features in the drug. The strategic options in front of Kaiser, Head of New Anti-depressant Team (NAT) was to launch a true successor of Prozac in the U.S market. Although, Cymbalta was considered on the basis of its compositions, lots of issue remained to be decided in the meeting of (NAT). the various issues that needed to be incorporated simultaneously and traded-offs one against the other were areas of concerns for the decision makers. The issues were:

1. Efficacy as good or better than the existing anti-depressant drugs available in the market. The problem was complicated because efficacy of the drugs was not without side-effects. Because depression goes undiagnosed due to its complicated sets of symptoms. There is also a social stigma attached to such treatment prevents actual number of potential patients from visiting physician/psychiatrist/neurologist. In U.S alone less than 50% of the people receive treatment. Al these factors make collection of actual data difficult.

2. The toxicity and safety issues involved with the all the antidepressant drugs should be addressed as Food and Drug Administration (FDA) would not approve without proper testing.

3. The new drug should meet the various unmet needs of patients using anti depressant drugs and physicians prescribing them. It was found that the physicians and patients reported several other symptoms like pain along with depression. There were different schools of thoughts like Primary care Physicians, Psychiatrists, and Neurologists reporting the most closely associated symptoms like pain with depression diametrically differing viewpoints, thus making difficult for the decision maker to converge on one point of making decision.

The constraints face by the (NAT) members was to first prioritize the clinical trials within the range of $25 to $30 million and this too within a time frame 15-18 months. Because it included the following steps:

• Enrolling patients for trials.

• Analyze and document the findings of clinical trials.

• NAT was supposed to submit only one objective to the FDA for marketing approval.

With the expiry of patent right in 2003, the future lies in the high potential use of generic Fluoxetine because it would be much cheaper( 80% cheaper) than the available branded drugs like Prozac. So, the real challenge in front of NAT would be to develop "clinical differentiator" within the given time frame of 18 months and budget of $25-$30 billion. The options available before Eli Lily were followings:

For Kaiser and team Cymbalta had been tested with twice daily dosages of 20mg, 30 mg and 40 mg. So, the alternatives were:

1. To conduct a new sets of clinical trials to establish once-a-day dosage of 60 mg of Cymbalta to treat Major Depressive Disorder (MDD). Because this would offer more convenient dosing for patients. This is what competitors were providing to the anti depressants and so by increasing the amount of dosage per day, Cymbalta would be on par with the competitors.

2. To invest in clinical trials so that new indications could potentially establish a differentiator between Cymbalta and existing anti-depressants. As per the estimates of physicians all the present drugs were evaluated on the basis of efficacy and were found to be similar.

3. Delay submission of Cymbalta to the FDA for marketing approval so that the objective mentioned above could be established over a period of time by assessing the patients and physicians.

Analysis and evaluation:

The pharmaceutical industry was really different from other industry as there was a huge time lag between evolution of new drug from laboratory to the shelf of medical shops. There were lots of investment made in Research and Development (R&D) efforts