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KISHAN LAL SHARMA VARUN KUMAR DUREJA SHRADDHA SANKHYAN SUDHIR YADU SHARMA PAWAN KUMAR YADAV Roll No. 7 8 9 10 11 12
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.
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
Strengths/ Weaknesses
Strengths
History of innovation
SSRI Class Lack of side effects
Weaknesses
High costs Patent to expire soon Internal resistance for successor
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.
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
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
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
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
Q&A