Eli Lilly: Developing CymbaltaKISHAN 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. .2. Erythromycin antibiotic In 1988 introduced Prozac ,success 1990. Shifted on Zyprexa in 2000. for treating schizophrenia. Next Gemzar a chemotherapy.

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

Types of Depression Most Common form Major Depressive Disorder Dysthymic Disorder(Chronic Depression) Adjustment Disorder with Depression Bipolar Depression.

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

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

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 2.5 million of prescription/ month in first year New SSRIs such as Paxil, Zoloft and Celexa came in market in 1990 s

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

Alternates Available Asset 1 :R-fluoxetine -Same chemical molecule as fluoxetine but tolerability problems in Patients was a issue.

Asset 2:OFC combined the active ingredient in Zyprexa and the active ingredient in Prozac. Though approved for use by the FDA, had a much smaller market than MDD.

Asset 3 :5 HT2 was intended to selectively block the stimulation of serotonion but increased anxiety, restlessness, insomnia, agitation.

Alternates Available Asset 4 :Business Development Opportunities , Lilly identified 13 opportunities to in license compounds for the treatment of depression from the other pharmaceutical companies at various stages of their development. The analysis resulted in two offers made by Lilly but both were declined.

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 relieverBenefits / 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

If Cymbalta is launched as a pain reliever and anti-depressantBenefits / Advantages Cymbalta can block the reuptake of both serotonin and norepinephrine. 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

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

Personnel and Responsibilities John Keiser (Marketing Director) Will oversee entire implementation plan

Dr. Iyengar and John Hayes (Scientists) Will oversee the clinical trials

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 ofDepression

Sep 7, 2004 FDA Approves Cymbalta for Neuropathic PainAssociated With Diabetes

Nov 30, 2007 FDA Approves Cymbalta for MaintenanceTreatment of Major Depressive Disorder

Nov 30, 2009 FDA Approves Cymbalta for MaintenanceTreatment of Generalized Anxiety Disorder

Q&A