New Drug Developments 2016

Charles Sharkey M.S., M.B.A. Pharm D. Pharmacy Site Manager/PGY 1 Residency Coordinator

At the conclusion of the lecture dentists will have an increased knowledge and understanding of the following topics

Hepatitis C Drug Development Oncology Drug Development New trends in drug developments Cost analysis of pharmaceuticals

Learning Objectives

Hepatitis C Treatment Oncology Treatment HIV Management Drug Therapy Costs Paradigm shift in treating diseases

Trends In Drug Treatment

2014 represented an excellent year for the pharmaceutical industry

Sky high merger and acquisition amongst companies

High levels of drug financing Peak in drug approvals

Background Information

In 2014 there 41 New Molecular Entities (NME) approved by the FDA.

Of the 41 NME’s approved 17 represented a novel way of treating a disease

Most of the NME’s were large molecular weight compounds such as proteins, antibodies, and enzymes

There was also a glut of “me too, combination drugs” approved

Background Information

Martin Shkreli CEO Turing Pharmaceuticals

Martin Shkreli CEO Turning Pharmaceuticals PLUS FBI

Used to treat life threatening parasitic infections

Old drug out for many years. Turing Pharmaceuticals buys old drugs used

for specific condition then raises prices $13.50 per tablet to $750 per tablet

overnight 5,500% price increase overnight

What happened with Daraprim

Is this capitalism? Free market at work? Should government intervene? Price controls? What would be the effect of these actions?

Drug Pricing

FDA has a speedier approval process Collaboration in the industry Average cost of drug development $2.6

billion Time to develop from bench to market is ten

years Less than 12% chance of being developed

as a drug

Background Information

Personalized Medicine Immunobiology i.e. cancer cells presenting

themselves as foreign to the immune system

Maintenance of diseases i.e. Cancer, AIDS. Curative therapy for Hepatitis C How do we pay for all of this? Drug costs vs. Society Costs.

Pharmaceutical Model of Care

Prevalence is about 1.3% of the USA Population

Asymptomatic, chronic disease Progression over time Cirrhosis, hepatic cellular carcinoma Liver transplants

Hepatitis C Infection

Past regimens were not effective, requiring long therapy with adverse effects.

2015 new developments in antiviral therapy Ledipasvir 90mgs/Sofosbuvir 400mgs

(Harvoni) Treatment is most cases is 12 weeks with

one tablet daily Cost of treatment = $15,600+

Hepatitis C Infection

Elbasvir/Grazoprevir (Zepatier) Once daily treatment for 12 weeks Good in renal patients Cost of treatment= $23,000+

Hepatitis C Infection

Hepatic effects of Infection

Cost of therapy

Cost of Therapy

Oncology Drugs

Oncology Drugs

Oncology Drugs

Oncology Drugs

Oncology Drugs

Daratumumab (Darzalex) 400mgs $1800 Osimertinib (Tagrisso) 80mgs tablets $429 Nivolumab (Opdivo) 100mgs $1600 Cost of therapy can be as high as $100,000

per year depending on the drug Survival benefits? Quality of life? What is the endpoint used?

Oncology Drug Costs

Target therapy Immune system attacking cancer cells Programmed cell death inhibitors Maintenance therapy Ant angiogenesis drugs Add all of these on to existing drugs

Oncology Drugs

HIV Management

HIV Management

Entry Inhibitors Fusion Inhibitors Reverse Transcriptase Inhibitors Integrase Inhibitors Protease Inhibitors ****Combination therapy is the key ****Treat early in the disease

HIV Medications

HIV Lifecycle

Long term therapy Atripla is combination therapy $12,000 per patient per year Disease treatment model changes from

acute management to long term management

Live with the disease

HIV Treatment

New drugs have complex pharmacology Not sure how they effect the oral cavity Drug interaction potential exists Cost of therapy Will patients have to choice what

medication they will take?

Some final thoughts

Questions??