Saturday, November 26, 2016

THE RIBONYL CASE STUDY

Marketing is about expecting the unexpected!  When marketers dive into creating value offerings, they confront one of the three situations:

a)      A me-too crowded market
b)      A me-too niche market
c)      A novel market

The above image from here.

Each of these situations requires a different marketing treatment! 

When there is a novel product, it entails market building effort.  The diffusion of innovation becomes a challenge.  Locating early adopters becomes the necessity.  There are after all those doctors who look to provide novelty in their practice.  One has to win the confidence of such trend setting doctors.  Providing enough clinical experience and trial data becomes the order of the day.  Such doctors are ready to risk new products in their practice, provided they buffet their decision making practice, through hard and dependable confidence building clinical evidence.  Doctors need to see beyond the jargon and obtain confidence through pertinent scientific material.  Other conservative doctors prefer to hitch onto the novel product bandwagon only after the product has shown its mettle over time. 

A niche product has a narrow spectrum of users.  The number of prospects is limited.  Hence, a niche product is focused through targeted marketing approaches.  For instance, a monoclonal antibody such as trastuzumab for Herceptin positive breast cancer patients, is a totally niche product.  Only highly qualified oncologists can recommend the use of this product to appropriate patients. 

Entering a larger crowded me-too pharma product market is a different cup of tea!  To gain even a small market share and hit breakeven is a challenge to such a product manager or mini marketing manager.  To make a mark through the me-too product, the communication mix becomes handy in providing messaging differentiation and gain mindshare of potential prescribers. 

The communication mix includes:

a)    Packaging and labelling – with some novelty (even simple 3 D printing innovation with spot UV lamination on the pack, perhaps on the brand logo, can act as an impelling point to make the prescription decision)
b)   Personnel selling by trained MRs who can create attention value through attention grabbing talking points.  A related point is unique set of in-clinic activities supported by creative collaterals, which will work to help gain mindshare
c)      Sales promotion (aka bonus offers and bundled gifts to pharmacies or dispensing doctors)
d)     Advertisements to indulge in messaging in a non-obtrusive manner, yet effectively achieving brand registration and brand recall (eg., mobile based permission sms messaging, permission email messaging, product website, banner advertisements in therapy oriented web properties, social media viral marketing approaches, strategically placed medical journal advertising, mailer advertising (enclosing simple utility items for engagement, eg., pens), “influencing the influencer through other personal influencers” mailers (eg., sending interesting appeals through mailers to wives of doctors or parents of doctors), courier mailing of samples to doctors, and patients on recommendation of doctors, patient education material mailers to consumers, phone marketing through call centres etc.
e)  Publicity through CMEs, medical journal articles and other media articles, e-articles for surrogate word-of-mouth of the focused me-too brand

It is not possible to ride only on the winds of niche products and novel products, a large market is me-too products of proven moieties.  It is better to understand this reality and penetrate the me-too marketing through awesome communication mix.

Ribonyl: the azalide antibiotic with better patient compliance

Ribonyl is the brand name of azithromycin, a macrolide antibiotic or antibacterial.  The idea was to develop messages that are differentiated and will provide a cachet to the brand.

Brand name potency: Ribonyl comes from the word ribosome (protein factories of cells).  Azithromycin acts as an antibiotic or antibacterial by disrupting or disturbing protein synthesis on the 50 S (S = Svedberg unit) ribosomal subunit of susceptible bacteria.  Azithromycin halts protein synthesis through preventing action of peptidyl transferase, this enzyme is involved in attaching appropriate amino acid to the growing polypeptide chain on the 50 S ribosomal unit.  This way azithromycin provides bacteriostatic effect, and bacterial population stops growing, WBCs find it easier to exert phagocytic activity on these weakened pathogenic bacterial colonies.  Hence, the new brand of azithromycin is named Ribonyl, which has vigorous brand name potency.  (Note: the main competitor brands of azithromycin have brand names such as Azee, Azithral, Azimax, Aziwok, Azibact, ATM and so on).

The very name Ribonyl is attractive, scientific; explaining the name itself gives some time to engage the doctor, and compellingly offers an off-beat name and prescription secrecy.

Brand positioning statement: the azalide antibiotic with better patient compliance.

Azithromycin belongs to the azalide sub-class in the chemical class of macrolide antibiotics.  By bringing out this fact the word azalide has additional attention catching potential.  It is all about riveting the mind of the potential prescriber to the brand name and registering the brand name.

The other brand positioning statement: ‘the triple benefit antibacterial’ brings out the three cardinal benefits of azithromycin:

a)      Broad spectrum of action
b)      Convenient dosing (once a day)
c)      Patient compliance

The above are placed in the three sides of triangle brand logo in visual aid and communication literature.

Talking points for Ribonyl: it is essential to build a professional story through some off-the-routine talking points.  A repertoire of talking points was built for use in appropriate printed material:

a)    Ribonyl is effective against pathogenic typical bacteria (Gram positive and Gram negative) and Atypical bacteria.  Typical bacteria are those which are easily stained through Gram staining technique.  Atypical bacteria are those that are not easily or can’t be stained through Gram staining.  Azithromycin is active against atypical bacteria such as Chlamydia trachomatis and Mycoplasma pneumoniae.  Hence, a talking point generated was Ribonyl is effective against pathogenic typical and atypical bacteria.  This not only highlighted the unique aspect of Ribonyl, it also served to register the brand among prescribers
b)  Ribonyl is not affected by beta lactamase.  The latter is an enzyme produced by resistant bacteria and renders beta lactam antibiotics (such as penicillins, cephalosporins, monobactams and penems) ineffective.  Since Ribonyl does not have a beta lactam ring, it is not broken down by beta lactamase, Ribonyl is potentially active against beta lactamase producing bacteria as monotherapy or in combination.  This point was also a cachet for Ribonyl
c)  Ribonyl concentrates on phagocytes, and is carried to infected tissues, where it achieves manifold higher concentration compared to plasma
d)     Ribonyl has short duration of therapy, high compliance (due to once-a-day therapy, in normal cases) and is cost effective.

The above four main talking points were used for brand building communication in various printed material and while presenting Ribonyl to potential doctors.

The foundation of uniqueness in Ribonyl branding and presentation has provided robustness for its success journey.

In pharma marketing, brands form a preferred approach for gaining business.  By making novel presentations, marketers can create the unexpected and gain mindshare of potential prescribers.

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Wednesday, November 23, 2016

NUB OF THE MATTER

All marketers are confronting daily challenges of slicing through the market.  Most succeed partially, and a handful are declared winner marketers.  How do these winners get made?

The starting point for a winner formula in marketing is KNOWLEDGE.  To know is to win!  The knowledge starting point should be as granular (or even molecular) as it can get.  Swimming through the detailed knowledge throws up insights and ideas.  These get translated into decisions, followed by action plans and then execution.  The output decides if it was a winner approach or a mediocre one.

Is there a strategy for knowledge mining?

Knowledge (practical and theoretical) should arise from the ‘nub of the matter’.  You can call this as the ‘nub-of-the-matter approach to knowledge creation and understanding’.  In the case of developing medicinal molecules, it is normally target molecule centric R and D strategy.  Hence, to develop a knowledge that aids training and marketing, it is judicious to begin with the target molecule and develop knowledge in a nutshell in that vein.  Thus, knowing more about the target molecule responsible for the medicine’s development becomes the “nub of the matter” for developing pharma marketing strategy.

Consider the following example:

Dipeptidyl peptidase 4 enzyme (DPP4): Like all enzymes - this enzyme too is a biocatalyst, and belongs to the family of dipeptidyl peptidase enzymes (EC 3.4.14 classification).  There are many such enzymes in this family – such as, DPP3, DPP6, DPP7, DPP8, DPP 9 etc.  DPP4 is also known as CD26. 

DPP4 AND CANCER:

DPP4 has a wide ranging role in cell metabolism.  DPP4 enzyme can bind with many molecules (proline or alanine containing peptides) like growth factors and neuropeptides.  It is popular among cell biologists as an enzyme, which has association with cancer!  DPP4 enzyme levels are increased in certain cancers and reduced in certain other types of cancers.  DPP4 is marker molecule for various cancerous tumors!

DPP4 AND FIBROSIS:

Fibrosis is development of hard connective fibrous tissue in organs.  Eg., liver fibrosis.  DPP4 has been implicated in fibrosis of various organs (eg., liver and kidney).

DPP4 AND GLUCOSE METABOLISM 

DPP4 is involved in glucose metabolism.  DPP4 degrades or breaksdown molecules that are collectively called as incretins.  The umbrella term incretins refers to a group of metabolic hormones (chemical messengers).  Most accurate examples of incretins are: GLP 1 (glucagon like peptide 1) and GIP (gastric inhibitory peptide).  These two are a part of the glucagon peptide family.  DPP4 breaksdown GLP 1 and GIP.

What do GLP and GIP (the two incretins do?)

GLP 1 and GIP (the two incretins) decrease glucagon blood levels and increase insulin blood levels.

K cells in the intestines secrete GIP and ‘L’ endocrine cells in the intestines secrete GLP 1.

a)      GLP 1 (a 30 amino acid peptide gut hormone)
-          stimulates beta cells in pancreas (Islets of Langerhans) to produce more of the blood glucose lowering hormone: insulin (the chemical messenger in blood that transfers glucose from blood into cells, thus, lowering blood glucose and ensuring glucose for cell energy production)
-          GLP 1 also increases beta cell mass in pancreas
-          GLP 1 inhibits glucagon secretion (thus overall GLP 1 helps in rapid postprandial decrease of blood glucose) (Glucagon is a hormone with opposite effects of insulin.  Thus, glucagon tends to increase blood sugar levels and insulin tends to decrease blood glucose levels.  Glucagon the peptide hormone is released in large quantities when blood glucose levels decrease below normal, glucagon stimulates liver to convert stored glycogen into glucose and this gets into the blood stream)
b)      GIP (a 42 amino acid gut hormone)
-          stimulates release of insulin
-          GIP helps promote growth and survival of beta cells of pancreas
-          GIP has a role in fat and bone metabolism

In a healthy body, the release of  insulin and glucagon from pancreas are in balance.

THUS, WHEN DPP4  proteinaceous enzyme BREAKSDOWN GLP 1 AND GIP - THE TWO INCRETINS; more glucagon is released and less insulin is produced from the pancreas.

WHAT ARE DPP4 INHIBITORS?

DPP4 inhibitors are a class of medicines that inhibit the enzyme DPP4, hence, degradation of incretins is decreased.  This in turn increases levels of the two incretins (GLP 1 and GIP), resulting in

-          decrease of glucagon release from pancreas
-          increase of insulin release from pancreas.

Thereby, DPP4 inhibitors have a hypoglycemic effect (lower the levels of blood glucose) and have application in Type 2 diabetes management.

Examples of DPP4 inhibitor drugs:

Sitagliptin (the first in this class), TENELIGLIPTIN (the most widely prescribed and sold, and most economical gliptin in India.  This is the only gliptin manufactured from API stage to formulation stage in India), saxagliptin, vildagliptin (currently the costliest gliptin in India), alogliptin and lindagliptin

Any side effects of DDPP 4 inhibitors (or incretin enhancers)?: the following may happen in some patients (not all)

-          Statistically significant increase in heart failure (scary?  Remember rofecoxib and pioglitazone controversies?  Sitagliptin the first DPP4 inhibitor was invented by Merck, the same people who invented rofecoxib!!), however, medical literature says there is overall good safety profile for gliptins
-          Diarrhea
-          Increased incidence of URTI (upper respiratory tract infections)
-          Sore throat

DPP4 inhibitors do not increase body weight nor cause hypoglycemic episodes.  Dosage adjustment is not normally required in case of renal stress and hepatic dysfunction.

GIP is also known as glucose dependent insulinotropic polypeptide.

Teneligliptin is a research product of Mitsubishi Tanabe Pharma, Japan and it was launched first in the world by both Tanabe Pharma and Daiichi Sankyo, in Sep 2012! (By the way, Daiichi Sankyo purchased the company Ranbaxy and sold it for a loss to Sun Pharma).  Teneligliptin is sold in Japan, Korea and India, currently.

In India, teneligliptin in Dec 2015 had 16 brands, with sales of Rs. 36 crores, in the Rs. 6000 crores antidiabetic market.  Glenmark has been taking risks and fighting for its share of pie in the hot antidiabetic gliptin market, its first tryst with gliptins being with sitagliptin (first gliptin in India from Merck).  However, Glenmark lost its patent battle for sitagliptin against Merck.  Not to be outdone, Glenmark bounced back into the gliptin market, with the third generation oral gliptin.  Teneligliptin is a hot market – because it has the most players, this is the only gliptin which is not under patent. The other patent protected gliptins: vildagliptin, saxagliptin, linagliptin and sitagliptin are not doing as great as teneligliptin.  So the age old adage, more the players, more the noise and market expansion occurs!  Hence, teneligliptin is the numero uno gliptin in India.  (Ref. for data: Business Standard, dated, 20.11.16, page no. 2).

Marketing of a branded formulation containing teneligliptin (hypothetical example):

On the basis of above target molecule knowledge one can successfully create a messaging campaign.  As is the works, brand name finalization, brand name font, CMYK and B/W colour standardization, brand logo or insignia concept and details, and brand audio signature tune (for digital and audio messaging strategy)…are finalized with brain storming sessions and sorting out the available choices in co-ordination with the design team.

Background:

Brand name: Tenali
Brand positioning statement: Enhances incretins, decreases blood glucose
Brand target audience:
a)      Type 2 diabetes patients (as monotherapy or add on)
b)      Endocrinologists, Consulting Physicians treating diabetes (diabetes specialists) and top GPs

Main brand messaging tools and methods:

a)      For MRs (field personnel): visual aid, leave behind literatures, reminder cards, stickers, eye catching theme based sample cartons, electronic visual aid page for use in tablet/mobile screen and short 60 second video film (mobile phone and tablet compatible)
b)      For medical journals: 1 page advertisement material

(Other marketing parameters in terms of number of target doctors, number of visits per month, courier marketing reminders, permission email marketing, other forms of permission based digital and mobile phone medium marketing, in-clinic activities, in-booth activities, in-pharmacy activities, CME activities and campaigns to be worked out too; based on planned activities suitable collaterals like leave behinds, patient information leaflets, die-cut literatures, reminder cards etc are also created)

Let us assume we also make a simple 1 page print visual aid copy for the teneligliptin brand to get a hang of the messaging concept.  There will, of course, be more visual aid pages highlighting safety, efficacy and utility of drug; however, here is just a one visual aid page sample:

State of art therapy for Type 2 diabetes patients

TENALI (Teneligliptin 20 mg tablets)
Enhances incretins, decreases blood glucose

Ø  Dependably inhibits DPP4 enzyme to decrease degradation of endogenous incretins: GLP 1 and GIP
Ø  Increases levels of GLP 1 and GIP to help restore normoglycemia, by reduced glucagon secretion and increased insulin release from pancreas
Ø  Additionally offers vasoprotection from ‘high blood glucose’ induced oxidative stress
‘Teneligliptin (Tenali) has antioxidant properties, ameliorates oxidative stress…caused by chronic exposure to high blood glucose by blood endothelial cells’ Ref.: Endocrine. 2016 Aug 16.

Recommend STATE OF ART THERAPY IN T2DM
TENALI (Teneligliptin 20 mg tablets)                                                          (PACK SHOT)
Enhances incretins, decreases blood glucose

Detailing story: Dr., season’s greetings, (pause) presenting the state of art therapy for Type 2 diabetes patients.  Please choose to recommend Tenali, teneligliptin 20 mg tablets (pause) enhances incretins, decreases blood glucose.

Tenali dependably inhibits DPP4 enzyme to decrease degradation of endogenous incretins: GLP 1 and GIP
Tenali increases levels of GLP 1 and GIP to help restore normoglycemia, by reduced glucagon secretion and increased insulin release from pancreas
Tenali additionally offers vasoprotection from high blood glucose induced oxidative stress, as per this reference, Tenali Teneligliptin has antioxidant properties, ameliorates oxidative stress…caused by chronic exposure to high blood glucose by blood endothelial cells.

Recommend state of art therapy in type 2 diabetes mellitus, Tenali, teneliglipin 20 mg tablets, enhances incretins, decreases blood glucose.

Above is the NUB OF THE MATTER APPROACH to understanding a drug from target molecule angle, and consequently developing a marketing messaging approach.  Please scroll to read below posts, and also recommend this blog to your acquaintances!  Click on older posts to continue reading.

Monday, November 14, 2016

HARD NUT TO CRACK!

There are a plethora of factors affecting contemporary pharmaceutical product performance, the challenges are many and it is not an easy road to profit anymore.  Net price, more competitors, unbranded and branded generics available at pharmacies at a rock-bottom rate (these are not promoted to doctors), jan aushadhi scheme for low cost generics…all these are affecting product performance. This makes the pharma market a hard nut to crack, for pharma marketers!!


The pharmaceutical market is Rs. 1 lakh crores (non-institutional retail pharmacy market for prescribed medicines; the institutional segment and generics not promoted to doctors are additional markets).  It has taken 70 years for India to reach this figure, and pharma pandits say the next Rs. 1 lakh crores will come in 7 to 10 years!  As per AIOCD AWACS Oct 2016 report, the Indian pharma market is Rs. 105667 crores with a value growth of 10.23%.  So brace yourself for more pharma growth and more competition. 

Sun Pharmaceuticals has posted amazing sales and net profit results for the quarter July-Aug-Sep 2016.  For this quarter, Sun Pharmaceuticals has posted Rs. 8265 crores sales with net profit of Rs. 2235 crores, and this works out to 27% net profit!!  The way Sun Pharmaceuticals is evolving…the day is not far when Sun Pharmaceuticals will launch a blockbuster innovator molecule (a blockbuster achieves 1 billion USD sales in 1 year ie., approx.. Rs. 6700 crores/annum sales globally).


The evolving messaging environment

The MR (Medical Representative) is no doubt the mainstay of pharmaceutical marketing.  If there is no MR activity, there is no market presence of the pharma company and consequently there are no sales!!  This simple home truth of pharmaceutical marketing still holds good.  However, evolving technology trends and social – politico movements have brought to the fore, other empowering messaging media.  Consider the following graphic:


A robust pharmaceutical messaging environment means, the company should participate in a calibrated manner with all of above methods of messaging.  Relying only on the MR to present persuasive messages will lower the competitiveness of the pharma firm.  However, it is not possible to manage pharma sales without MRs unless there is such a unique product which can rely only on print (eg., courier based, and medical journal based) or digital (through websites, doctor oriented social sites etc).  All the same it is not possible to simply put all the eggs in the MR basket, overlooking the power of messaging resident in the above alternative messaging media available.

Challenges

Pharma marketing messaging has gotton tougher: thanks to the short attention time of doctors and other opinion builders, shortened MR-doctor interface time, there are also increased expenses and risks to attain objectives, and there is massive clutter in the marketplace (eg., messaging clutter, MR clutter, product and brand clutter, promotional avenues clutter…).

Pharma marketing is not a precise science today; it is more of an art ie., creative and appropriate application of scientific principles.  Pharma marketing involves juggling with options available in an environment of constraints; eg., How to use the various media for pharma marketing messaging? How much to rely on the MR? How much to rely on digital advertising for product A; and coming to the established product B, will only courier marketing and advertising in medical journals suffice?  Can I rely only on booth or stall activity and doctor- to-doctor word-of-mouth for my unique product C?

It is quite a challenge for marketers to craft an appropriate objective fulfulling clutter-free marketing approach, at lower costs and lower risks! 

Thus, each product or set of products will require a well thought out unique approach to create the appropriate media mix to put out persuasive messages.  It cannot be that the entire burden of messaging will be on the MR…in today’s times.  Thus, marketing has today, become a highly cerebral activity to arrive at the right ‘communication mix cocktail´ as per the product/brand and market profile, and only then will marketing be able to contribute for a pharma company’s sales growth, and net profit growth.

Today it is not just about appointing MRs and launching 15 branded pharmaceutical product SKUs…and then this army of MRs will regularly meet doctors to manage relationships with inputs, and these target doctors will generate sales results…pharmaceutical marketing includes this, yes, it does include this – yet pharma marketing has gone beyond that to accommodate other avenues of persuasive messaging as shown in the above graphic.

For day-to-day decision making the following graphic will help!


Explanation of above graphic: based on our knowledge and insights there will be a certain quality of thinking, which will be applied for decision making.  Based on the decision taken, a blueprint or action plan will be crafted.  Then comes actualising the action plan (execution of blueprint)…to generate results. 

High quality knowledge and insights will contribute to above superior sequence of result generation.  And this will make it easier to crack the hard nut…the IPM (Indian Pharmaceutical Market).


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