PHARMACEUTICAL LIFE CYCLE MANAGEMENT

MAKING THE MOST OF EACH AND EVERY BRAND

Presenters: Rachana Shetty (PA-14) Dhairya Maheshwari (PA-04) Tanmay Dodal (QA-20) Sagar Patel ( PA- 16) Pushpita Rakshit ( QA-14)

PRODUCT LIFECYCLE MANAGEMENT (PLM)

Process of managing the entire lifecycle of a product

Conception

Design

Manufacture

Service and Disposal

Integrates People Data Processes and Business systems Provides a product information backbone for companies and their extended enterprise

PRODUCT LIFECYCLE

Current View of Pharmaceutical Market environment

Lifecycle of Drug for Pharmaceutical Industry

Market/Product Age: How to Measure the Stage of the Product Life Cycle

Market/Product Age: How to Measure the Stage of the Product Life Cycle
Stage No. of Competitors Unknown Few High Good Low None Negative Low Growing High Lowering High & Low Small Modest Largest Stable Declining High High Stable Declining Stopped Market Growth (%) 0 Highest Profits Market Size Investment

R&D Product Introduction

0 0

0 Small

Growing High

Development Growing Fast Exploitation Maturation Saturation Decline Moderate Growth Stable Stable Reducing

Source: Frost & Sullivan

Source of the Problem

Source: Goldman Sachs Factsheet

Current Scenario

Increasing complexity of pharmaceutical products Drying of drug pipelines

Knowledgeable patients and payers

Drugs becoming off-patent ($140 Bn worth drugs would lose patent protection by 2016) Threats from generics

The New Business Model

The role of information has changed from a peripheral point to a integrated level.

Reasons behind a product Life cycle changes

Diffusion of innovation Evolving competitive structure of industry Evolving internal product portfolio priorities Evolving cost structure of the product Evolving dosage strength and formulation of the product Evolving design and manufacturing of the product

Challenges in LCM

Development times getting longer

Extending patent life

The drug approval rate is under pressure Product uptake slowing down Lower level of market penetration Therapeutic substitution

The Starting Point

Accept that a major change is happening in the market Understand what is changing so as to accept the change One of the most critical steps in developing a cohesive LCM strategy for any product portfolio is to dissect the strategy in

various dimension and target each dimension with right tactic

Patent Strategies and Market Exclusivities

Developmental LCM

Commercial LCM

Late LCM

LCM Strategies
New Indication

New formulation
Pediatric Market exclusivity Disease Management Programs Strategic Pricing Changes Authorized generics Combination Products Next Generation Products

New dosing regimens

Patent litigation Rx to OTC switches

Top Performing Lifecycle Management Strategies: Return Per Dollar invested

140 120 100 80 60 40 20 0 130$

Return Per Dollar Invested

29.92$

26.2$

11.33$

10.8$

10$

Indication Expansion

Most common strategy employed

Increase their product longevity in the market or

To mitigate the effects of patent expirations.

Indication Expansion early in Lifecycle: Broaden the Potential Population (Sales) Indication Expansion Later in its Lifecycle: Additional Period of Data Exclusivity and Patent

Protection

Drugs with approved indication expansion

Company Name GSK Drug Rilenza Original Indication Influenza Expansion Indication Prevention of Influenza

Pfizer

Aricept

Mild to moderate Alzheimer's disease

Severe Alzheimer's disease

Topamax

Epileptic Seizures

Migraine

Abbott

Humira

Rhematoid Arthritis

Inhibiting structural joint damage

Source: Frost and Sullivan

Indication Expansion
Drivers
Gain additional period of Data Exclusivity / Patent protection Gain higher peak sales pre-patent expiry In the EU lower level of off-label use limit generic erosion of patented indication Capitalize on brand equity established for original product

Resistors
Generics are still able to launch by excluding the new indication from their label

High level of off-label usage of generics undermine the success of this strategy
High level of investment is needed with risk of failure.
10

Reformulation
Development of new formulations that allow for less frequent daily, weekly or even monthly dosing or involve change in the chemical composition of a product which may allow for new delivery formats.

Objectives: Extend the product line and capture additional sales Match competitive moves, and re-capture lost share, particularly in the case of extended release formats Protect a product from imminent generic competition
12

Drugs with approved reformulation

Drug Paroxetine Indication Major Depressive Disorder Treatment and Prophylaxis of frequently recurring ventricular fibrillation and unstable ventricular tachycardia Hypertension Parkinsons Disease Male Pattern Baldness Diabetis Mellitus New Indication Original Formulation Paxil (I.Rtablet) New Formulation Paxil CR ( Extended or Controlled Release) Cordarone (IV)

Amiodarone

Cordarone ( Oral)

Minoxidil Bromocriptine

Tablet Standard Release

Topical Use Quick Release Source: Frost and Sullivan

Drivers
Improving efficacy or compliance or meeting unmet need through reformulation Switch patients to new formulation before generic entry Lower investment than new product development

Capitalize brand equity of established or original product

Resistors
Increasing use of restrictive drug plan formularies may limit uptake Physician skeptical of reformulated product

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Additional Indications- Monotherapy/Combination Therapy

Additional indications for which the current marketed drugs can be used. can be physiologically related to the primary approved indication or even for unrelated indications. Can be extended for use in a combination therapy/monotherapy or as a second line therapy. The move to monotherapy from a combination therapy offers a range of advantages: adverse effects lower drug-drug interactions improved convenience and

patient compliance.

Paediatric Extensions
Expand their drugs in the paediatric space
It offers extended exclusivity for drugs approved for paediatric indications The market players are researching expanding the use of their drugs in niche therapeutic areas
Company Merck Pfizer Drug Singulair Celebrex Indication Asthma Osteoarthritis Pain Paediatric Extension Allergies Juvenile Rheumatid Arthritis

Source: Drug Reformulation and repositioning in Pharmaceutical Industry and its impact on market access

Directed Molecular Evolution (DME)- the new trend

Introduction of novel biologics that are likely to face patent

expiration soon Introduction of biosimilars is a major threat to biologics DME technique to meet this need Involves the use of advanced combinatorial chemistry to

research on liable protein candidates that can be used to produce the next generation biologics Used to produce a biologic that has better qualities than its competitors, or it can be utilised to populate its own pipeline with novel biologics that currently not in the market

 Indian analgesic and anti-pyretic market

is a huge one, growing at 9.50%

This market actually harbours 62 nationally distributed analgesics and over 100 local brands

Crocin has a market share of 18% in systemic analgesic

categories It is also marketed as PANADOL in more than 80 countries is leading paracetamol in India

History
In India, more than 40 year back, crocin was introduced in the market by Duphar Interfran limited now DIL Limited for Rs. 45 crore

Initially it was prescription drug and

was sold through ethical route only In 1996,duphar sold the brand to Smithkline Beechline

 Soon, the govt. removed many drugs from ethical list including Crocin

And Crocin become an OTC drug

Smithkline extended its presence to the analgesic segment

GSK was leaping up the sales chart

GSK planned
several brand extension

The rapid mutation of viruses and cross border travel, the

viruses now had the opportunity of infecting more people

Mild forms of flu and cold were becoming more frequent

with more people

 This led GSK to launch Crocin Cold n flu

The new drug offered relief from multiple symptoms of cold

such as blocked nose, headache, body ache, and mild fever The major differentiator was that unlike most other medicines in this space Crocin Cold n flu did not cause drowsiness and this variant is already contributing significantly to Crocins net sales

Product line
Crocin pain relief was launched in 2003

It contains 650mg paracetamol +50 mg of caffeine

In 2007,it entered into cold

categories and launched Crocin

cold n flu It contains paracetamol +caffeine +phenylephrine

REFORMULATION STRATEGY

Used for nasal congestion, headache, body ache, sore throat

pain and chills

 Crocin cold n flu currently has a market share of

4.20% and is the

fastest growing

brand within the

crocin basket

 The brand also came out with variants like Crocin Quik
that boasted of faster relief

Crocin also came out with Crocin 1000 aiming at patients having arthritis

 In 2011, GlaxoSmithKline Asia has launched 'Crocin Advance'. Crocin's new innovation comes with OptiZorb' disintegration technology with the aim to speed up the procedure relief by 5 times Additional super-disintegrants

("OptiZorb") such as alginic acid

and calcium carbonate Strategy - majority people are keep general medicine with them

and they want fast relief from pain

because in this fast life, nobody have time.

Revital a well known drug from Ranbaxy laboratories. It contains vitamins and minerals Initially it was prescription drug

Later it changed to OTC drug i.e., switched to OTC drug

The latest data generated by market research entity AIOCD AWACS shows that Revital brands grossed Rs 158.5 crore for the 12 months ended February 2012 (on a moving annual total or MAT basis). The MAT value on February 2011 for the brand was Rs 140.7 crore. Comparable figures for the same period in 2010 and 2009 were Rs 117.5 crore and Rs 68.1 crore respectively.

Reasons for new segment

Currently Revital is in Maturity Phase. Now the sales remain almost constant for Revital. Launch of new category under Revital help company to go back in growth stage through new market. This new market is growing very high rate. So, for next few years Revital is in growth stage.

How it Switched.

Ranbaxy used a well through out television creative to target the consumer directly through advertising Revital was positioned to fit into the users hectic lifestyle empowering them with energy strength and mental sharpness, enabling them to enjoy life the fullest hence making them live the brand punch line of Jiyo Ji Bhar Ke

Increase in sales of Revital after switching to OTC channels

Case study of Clarithin and Zyrtec-D

Pfizer and Schering-Plough employed strategy multiple extensions

safety and efficacy

Zyrtec and Claritin antihistamines control of the $10bn global market

 Claritin introduced relief from allergies

1994
Competition Pfizers Zyrtec introduced similar non-drowsy variants

1996

2002

US sales of non-sedating antihistamines reaching more than $5bn after reformulation

Capture share of the $2bn global market for pediatric antihistamines Introduced products specifically designed for children, such as chewable formulations and new flavors

LIFE CYCLE

MANAGEMENT OF
BOTOX

Allergans Botox Comprised of botulinum toxin serotype A (BTX-A) Botox is a toxic substance Most widely researched and strategically extended medications (20 approved indications /70 countries) formulations Allergan has obtained patents various uses

 Block neuromuscular transmission

1949 1980
Dr. Alan Scott used to treat strabismus, a disorder in which the eyes point in different directions

1988
1989

Scott sold his rights to the drug to Allergan, a small pharma company focussing eye therapies and contact lenses

Allergan obtained FDA approva,l it named Botox, in the US for the treatment of strabismus, blepharospasm (uncontrollable blinking), and hemifacial spasm

Various Indications expansion

cervical dystonia

juvenile cerebral palsy

Allergan continued to investigate Botox

Hemifacial spasm

VII nerve disorder

2002, Allergan obtained FDA approval to utilize Botox in a cosmetic application to address forehead wrinkling

At present, the product is mainly used to soften wrinkles in the forehead, around the eyes and around the mouth.

skin tightening, pore shrinkage, enhancement of breast implantation results, facial scar reduction

and facial slimming.

Allergan will continue to pursue approvals for additional indications and off-label usage of Botox, particularly in the US, for as yet unapproved indications will rise