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‡ Eli Lilly: Developing Cymbalta

KISHAN LAL SHARMA VARUN KUMAR DUREJA SHRADDHA SANKHYAN SUDHIR YADU SHARMA PAWAN KUMAR YADAV Roll No. 7 8 9 10 11 12

Overview of the case study
‡ ‡ ‡ ‡ ‡ ‡ The primary problem The secondary problem Current Situation (At the Time of Case Study) Alternatives Decision Q&A

Introduction of Eli Lilly
‡ Founded by Colonel Eli Lilly in 1876, ‡ Company first success gelatin coating to pills ‡ Next major success in 1923 introduced Iletin the first mass produced insulin invented with university Toronto. improved diabetes ‡ Throughout the decade 1950. no. of advancement invented 1. Oral penicillin product

.Cont. ‡ Shifted on Zyprexa in 2000.success 1990. Erythromycin antibiotic ‡ In 1988 introduced Prozac . for treating schizophrenia. 2. . ‡ Next Gemzar a chemotherapy.

Overview Of Depression ‡ Depression is characterized by sustained emotional disturbance that interferes with daily activities as work. sleep. or eat for short term as well as long term. ‡ Only 50% receive treatment. . ‡ Facts of Depression ‡ 10-25% population suffers from depression with women twice as likely as men to suffer an episode of depression. study.

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‡ Rating the severity of Depression ‡ Done on Hamilton rating Scale of depression(HAMD) ‡ 15-18 is minimum scale ‡ Severity can go to a score of 25 or more .Types of Depression ‡ Most Common form ‡ ‡ ‡ ‡ Major Depressive Disorder Dysthymic Disorder(Chronic Depression) Adjustment Disorder with Depression Bipolar Depression.

.Treatments available before Prozac ‡ Tofranil was used as antidepressant. known as tricyclic antidepressants(TCAs) ‡ Side effect of TCAs ‡ ‡ ‡ ‡ Dry Mouth Blurred Vision Serious Cardiac Complication Could be lethal if misused at high dosages.

. .Cont. MAOIs showed more severity than TCAs in ‡ Dry Mouth ‡ Blurred Vision ‡ Serious Cardiac Complication ‡ Could be lethal if misused at high dosages. ‡ Second Class of medications. . Monoamine oxidase inhibitors(MAOIs) ‡ Side effect of MAOIs ‡ With certain foods and alcoholic beverages as well as other medication .

Zoloft and Celexa came in market in 1990 s .5 million of prescription/ month in first year ‡ New SSRIs such as Paxil.Arrival of Prozac ‡ Eli Lilly launched Prozac in 1988 ‡ Prozac was a Selective serotonin re-uptake inhibitors or serotonin-specific reuptake inhibitor (SSRIs) ‡ Safer than TCAs ‡ Result of launch of Prozac ‡ 2.

Primary Issues of the Case Study ‡ Finding a successor of Prozac before the patent expires in December 2003 ‡ Evidences/Facts  Eli Lilly expects generic brands to be priced 80% lower than Prozac s current price.  Competitors Zoloft and Paxil expected to cut Prozac sales to 1/5 within 2 years .

Key Factors to address successor ± Differentiation of the company & the brand ± Symptoms/ Evidence: ‡ Eli Lilly has been known for 10 years as the Prozac Company. ‡ Link between pain and depression .

Strengths/ Weaknesses ± Strengths ‡ History of innovation ± SSRI Class » Lack of side effects ‡ Meeting unmet needs ± Prozac ± Weaknesses ‡ High costs ‡ Patent to expire soon ‡ Internal resistance for successor .

Alternatives for Prozac ± In Combination with selected alternative ‡ Drop price of Prozac ±Due to ethical concerns ‡ Or to find successor of Prozac .

‡ Asset 3 : 5 HT2 was intended to selectively block the stimulation of serotonion but increased anxiety. had a much smaller market than MDD. . restlessness.Alternates Available ‡ Asset 1 : R-fluoxetine -Same chemical molecule as fluoxetine but tolerability problems in Patients was a issue. agitation. Though approved for use by the FDA. insomnia. ‡ Asset 2: OFC combined the active ingredient in Zyprexa and the active ingredient in Prozac.

The analysis resulted in two offers made by Lilly but both were declined. Lilly identified 13 opportunities to in license compounds for the treatment of depression from the other pharmaceutical companies at various stages of their development.Alternates Available ‡ Asset 4 : Business Development Opportunities . ‡ Asset 5: Cymbalta was a serotonion and norepinephrine that was developed by Lilly in 1990s but failed to show satisfactory level of efficacy for treating MDD at 20mg/day. .

Cymbalta(duloxetine) ± Three key Potential for Cymbalta to become successor to Prozac ‡ Efficacy as good as or better than existing antidepressant. ‡ No apparent safety or toxicity issues ‡ The possibility of meeting a previously unmet patient need. ± Key issue with Cymbalta ‡ Was still under trail phase and no FDA approval ‡ Lack of strong differentiation ‡ Product can meet issues of pain but not be marketed as pain reliever ‡ Cannibalization of Prozac .

Alternative for Launch of Cymbalta ± Introduce Cymbalta as a pain reliever ‡ Cost of alternative ± $25-$50 million to conduct trial ± Time 15-18 months to conduct research ± Promotional advertising for differentiation ± Introduce Cymbalta as both a pain reliever and antidepressant ‡ Cost of alternative ± ± ± ± ± $50-$100 million to conduct two clinical trials Due to financial constraints time will be 30-36 months Promotional advertising Potential loss of first mover advantage Cost of research to justify link pain and depression .

If Cymbalta is launched as a pain reliever Benefits / Advantages Problems / Disadvantages ‡ Niche market as a pain reliever ‡ First mover advantage ‡ Diversity for Eli Lilly ‡ No cannibalization of Prozac ‡ Little experience in therapeutic industry ‡ No clear guidance by the FDA for development of pain indications ‡ Resistance within Eli Lilly to focus on pain ‡ HAMD-17 only classifies 1 item for pain .

‡ Can cure both problems with one product ‡ Ability to meet patients previously unmet needs ‡ Emphasizes company objectives Problems / Disadvantages ‡ Time and money required to get product to consumer ‡ Possible loss of first mover advantage ‡ Inconsistency between physicians linking pain to depression .If Cymbalta is launched as a pain reliever and anti-depressant Benefits / Advantages ‡ Cymbalta can block the reuptake of both serotonin and norepinephrine.

Decision ‡ Cymbalta as both a pain reliever and anti-depressant ± Why alternative was chosen ‡ Cymbalta can treat both conditions simultaneously ‡ Cymbalta can differentiate from Prozac ‡ Promotes company objectives and long-term growth ± Why other alternatives were rejected ‡ ‡ ‡ ‡ ‡ Due to potential product cannibalization The alternatives don t meet company objectives Only short-term growth potential Lack of differentiation Pain segment may be limited .

Implementation Plan ± Tasks ‡ ‡ ‡ ‡ ‡ Acquire the financing for the clinical trials Conduct clinical trials Submit approval from the FDA Conduct further research to find correlation Implement marketing plan ± Detailing and direct-to-consumer advertising .

Iyengar and John Hayes (Scientists) ‡ Will oversee the clinical trials ± Dr.Personnel and Responsibilities ± John Keiser (Marketing Director) ‡ Will oversee entire implementation plan ± Dr. Kroenke (Indiana University) ‡ Research correlation between depression and pain ± Jim Lancaster (Commercial Development) ‡ Will oversee the development of Cymbalta .

When and Where and How ± Plan will be implemented upon approval from FDA ± Plan will be implemented nationally ‡ Through current resources .

Expected Outcomes ± The development of an innovative treatment ± Replacing Prozac over time ± Pain will be linked with depression* ± In the long-run ‡ Holy Grail successor to Prozac .

Success Measurement ± By differentiation through focus groups ± Research of physician prescriptions ± Revenues ± Compare sales from Prozac and Cymbalta .

Key Breakthrough in Launch of Cymbalta ‡ Aug 4. 2004 FDA Approves Cymbalta for the Treatment of Depression ‡ Sep 7. 2009 FDA Approves Cymbalta for Maintenance Treatment of Generalized Anxiety Disorder . 2004 FDA Approves Cymbalta for Neuropathic Pain Associated With Diabetes ‡ Nov 30. 2007 FDA Approves Cymbalta for Maintenance Treatment of Major Depressive Disorder ‡ Nov 30.

Q&A .