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International Business Case 7

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Elvedin Custovic

on 30 January 2013

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Transcript of International Business Case 7

Demand for Etretinate (Tigason) in USA Psoriasis One in three Americans possess a skin condition serious enough to require medical attention
Psoriasis ("Itching Condition"): A malfunction in the body's control of skin-cell division, can affect more than 50% of skin; not contagious
Plaque Psoriasis: Cracking, bleeding, infection
Erythrodermic Psoriasis: Plaques converge, drawing blood to the surface and straining heart
Edema: Swelling of Joints
Constant Fatigue
Pustural Psoriasis: Constant danger of infection, can cause arthritis Background Hoffman-LaRoche ("Roche"): Swiss global pharmaceutical corporation
Tigason: Developed by Roche to treat psoriasis
Approved by FDA in 1986
Removed from Canadian Market in 1996
Removed from U.S. Market in 1998
High risks of birth defects Was prescribed only when other therapies had failed Clinical Trials Process Hoffmann-La Roche approach Isotretinoin First oral retinoid approved in US
May 7, 1982
Indication: the treatment of severe recalcitrant nodular acne
Initial risk management: labeling
Pregnancy category X
Precautions The Case of Hoffman-LaRoche & Tigason An Ethical Situation Continued removed from the United States market in 1998, and the Canadian market in 1996! Personalized Healthcare will put use of
Tigason on target and under control
Hofmann-La Roche What EU is doing on
drug approval? Clinical Trial Opportunities India,China,Brazil,Russia cRMP Labeling: Package Insert (boxed warning)
Negative pregnancy test 7d before treatment initiation
Monthly pregnancy testing and contraceptive counseling
Use of two forms of contraception for one month before, during and one month following treatment

Labeling: package
Blister pack
“Avoid pregnancy” icon
Boxed warning Targeted education
Instruction guides for prescribers and pharmacists
Patient brochures Reminders Systems

Yellow stickers placed on prescriptions
Prescribers: patient has been qualified
Pharmacists: 30 day supply, no refills, fill w/in 7d of qual date

Controlled distribution
Letter of Understanding signed by prescribers
Attestation of relevant competencies and agreement to comply with RMP
Yellow stickers provider to prescriber upon receipt

Mandatory registration of all patients, prescribers, pharmacies How would you market Tigason in an ethical way? Conclusion 1.comprehensive contraception counseling and pregnancy testing,
2.distribute education and test the patient's understanding of the serious risks
3.letters to physicians and pharmacists
4. 24-hour, toll-free information hotline for patients and healthcare providers
5.train sales reps
6.monitor reported pregnancies and submit reports to FDA
Full transcript