MARKETING PLAN FOR NEUGROW (Filgrastim 300 mcg PFS)

Today most oncologists encounter patients with infection post-chemotherapy which become a public health concern that requires a better knowledge of its management strategies.

Much can be done to improve the quality of life, improve function and relieve the suffering of many patients who suffer from infection post CT (Chemotherapy).

By taking advantage of every tool available, being cognizant of and committed to overcoming numerous barriers and by gaining a clear understanding of therapeutic options in management of infection post CT, G-CSF (Human granulocyte colony stimulating therapy) is the recommended therapy in treating the incidence of febrile neutropenia.

Patients with neutropenia have significant morbidity due to bacterial infection which require a treatment in hospital with intravenous antibiotics. Human granulocyte colony stimulating (G-CSF) factor is a protein which regulates the production and release of functional neutrophils from bone marrow.

Wintac limited is dedicated to meet the needs in the anticancer market having the chemotherapy drug and cancer supportive drug in its product portfolio.

EXECUTIVE SUMMARY

APAC (Asia specific) oncology market 2010: US $ 3bn; up from1.4 bn in 2004.

Cancer treatment is a global healthcare priority and over 20 million new cancer are predicted in 2025, compared with 12 million in 2008 (WHO).

Strong R&D pine-line make the anticancer sector dynamic and highly promising. With the coming of the G-CSF therapy and its biosimilars drug in the market much can be done to improve the QOL, improve function and relieve the suffering of patients suffering from post-CT.

SITUATION ANALYSIS

GlobalData estimated that the global neutropenia market was valued at $5.3 billion in 2009 and forecasts it to grow by 0.8% annually for the next eight years.

Global neutropenia market is moderately served by the current product options and significant scope is available to new entrants that can capture value from underserved segments. Designing highly efficacious products that will encourage physician compliance is one of key challenges of this market and could provide a significant market share for any company achieving this.

a). MARKET SUMMARYGROWTH

Global Data found that the global neutropenia market is highly competitive. The pipeline is considered to be strong because it consists of major promising drugs that will become blockbuster drugs in the coming years. These pipeline molecules also have improved efficacy and safety profiles over the currently marketed products, which means that they may meet patients’ and physicians’ expectations. The unmet need in the neutropenia market is high and if a company wants to capture this unmet need, it will need to overcome the prevailing product weaknesses and efficacy profile.

The global biosimilars market may be worth $19.4 billion by 2014, growing at an expected CAGR (Compound annual growth rate) of 89.1% from 2009 to 2014.

Historically, India had certain inherent advantages in the traditional generics market place such as low cost manufacturing and a highly skilled, reasonably priced workforce.”

b). MARKET DEMOGRAPHICS

Filgrastim is one of the first biopharmaceuticals for which biosimilars have entered the market.

The treatment of cancer with cytotoxic agents used for chemotherapy may cause neutropenia (a below normal count of neutrophils or white blood cells) or febrile neutropenia (fever and neutropenia) through damage or destruction of bone marrow. Granulocyte colony-stimulating factors, such as filgrastim and pegfilgrastim, have been shown to be effective in accelerating the recovery of neutrophils and in preventing neutropenia.

With increase in competition for the launching of G-CSF therapy its cost-effectiveness is still needs to be determined because of its cost, followed by quality, efficacy and affordability.

c). MARKET NEEDS

The global neutropenia market was valued at $5.3 billion in 2009 and forecasts it to grow by 0.8% annually for the next eight years.

The market share of NEUPOGEN in 2009 was $ 4.64 of AMGEN subsidary of Roche.

The report assesses market attractiveness, the potential for generic entries and for the first time, gives profiles of CSFs production initiatives in developing countries like Cuba, China and India.

d). MARKET TREND

STRENGTH WEAKNESS

•A unique, current business-environment-appropriate business model. •Excellent staff who are highly trained and very customer attentive.

•Known in anticancer market all over India.

•Meet unmeet need related to Quality, Safety, affordability, compliance and efficacy of the product which is still a question.

•Not a company own research molecule.

•Advanced form of drug with new technology available in the market.

OPPORTUNITY THREAT•Safety ,efficacy and affordability still a need to be furnished in G-CSF therapy market.

•The filgrastim market is growing by 89% as per CAGR.

•Already biosimilars drugs are available in the market.

•Lenograstim & Sargograstim are coming in the market.

•MNC’s company are already present in the market and cost is major constrain for this product.

SWOT ANALYSIS

BRAND NAME COMPANY STRENGTH M.R.P P.T.S

NUFILSAFE BIOCON 300 mcg 2450 1006

FEGRAST CLARIS 300 mcg 2565 1485

NEUMAX DABUR 300 mcg inj. 2000 850

GRAFIL DRL 300 mcg inj. 2694 1051

EMGRAST EMCURE 150/300 mcg

FEROGRASTIM FERON LIFE 300 mcg

NUMAN PH KABI 300 mcg 2060 880

FILCAD CADILA 300 mcg

XPHIL RANBAXY 300 mcg

NEUPOGEN ROCHE 300 mcg 2600 1550

NEUGRAF ZENOTECH 0.5 ml

NEOKINE INTAS 300 mcg inj. 2694 785

VHB 2790 500

PDPL 2100 450

COMPETITOR (DIRECT)

BRAND NAME COMPANY STRENGTH M.R.P P.T.S

NEULASTIM ROCHE 6 mg 33,800 26,000

NEUPEG INTAS PHARMA 6 mg 19,300 27,800

PEGGTRUST PANACEA BIOTEC 6 mg 27,600 19,800

PEGFIL NATCO 6 mg 27,500 20,150

PEGZENOFIL ZEN LIFESCIENCES 6 mg 28,150 20,100

COMPETITOR ( INDIRECT)

The key to success are:

Meet the unmeet need and trap the untraped segment in the market. (Safety, efficacy & affordability)

Full coverage of KOL. Superior price and service.

KEY TO SUCCESS

Already so many drugs for treating CIN is available in the market, focus should be on KOL.

Safety, efficacy and affordability still a question for G-CSF therapy.

CRITICAL ISSUES

Our product NEUGROW is recommended in treating chemotherapy induced Febrile Neutropenia.

NEUGROW containing filgrastim helps in treating severe febrile neutropenia related to myeloid leukemia, recommended in BMT, solid tumors and NSCLC.

NEUGROW is given prophylactic as primary, secondary and therapeutic use.

The global neutropenia market was valued at $5.3 billion in 2009 and forecasts it to grow by 0.8% annually for the next eight years..

As per our marketing strategy our Primary Target Customers would be Medical Oncologists, Hematologists and Surgical oncologists.

Filgrastim can also be recommended in treatment of AIDS related problem.

MARKETING STRATEGY

To safe and prevent most valuable resources i.e Human Life bringing new technology driven products satisfying the need in anticancer market ”.

With increase in competition for the launching of G-CSF therapy its cost-effectiveness is still needs to be determine because of its cost, followed by quality, efficacy and affordability, there is a scope for our product NEUGROW in the G-CSF therapy.

MISSION

To get small share in G-CSF therapy used for treating CIN.

To design the marketing strategy fulfilling the need required in market considering the cost, efficacy and safety.

To find out the KOL for filgrastim prescribing top brand available in the market and to target those KOL for our brand.

MARKETING OBJECTIVE

NEUGROW

NEU- Neutropenia , GROW- Growth

( Preferred as a prophylactic and therapeutic in Febrile Neutropenia)

TAGLINE

“Accelerates Neutrophil Recovery”

BRAND NAME

NEUGROW ( Accelerates Neutrophil recovery)

NEUGROW is a brand of filgrastim (PFS) from Wintac Limited is preferred as primary prophylaxis, secondary prophylaxis followed by therapeutic in severe neutropenia cancer patients.

NEUGROW accelerates the neutrophil recover in CIN patients.

PRODUCT POSITIONING AND STATEMENT

Comparators are other brands of filgrastim: Neupogen, Ratiograstim, Tevagrastim and Zarzio, plus lenograstim (Granocyte) and pegfilgrastim (Neulasta)

PRODUCT DIFFERENTIATION / U.S.P

Brands Name and Drug Drug Dose Regimen Cost Per Day $

Filgrastim (Nivestim) 1 to 12 microgram/kg daily 36 to 186

Pegfilgrastim (Neulasta) 6mg per chemotherapy cycle 686

Filgrastim (Ratiograstim) 1 to 12 microgram/kg daily 66 to 199

Filgrastim (Neupogen) 1 to 12 microgram/kg daily 58 to 187

Filgrastim (Tevagrastim) 1 to 12 microgram/kg daily 62 to 161

Filgrastim (Zarzio) 1 to 12 microgram/kg daily 50 to 153

Lenograstim (Granocyte) 5 microgram/kg daily 103

The v1.2010 NCCN practice guidelines for the Myeloid Growth Factors indicate there is higher level evidence supporting the use of filgrastim (prophylaxis and treatment – category than for sargramostim for the management of febrile neutropenia.

Compared with those who received sargramostim, patients who received filgrastim had faster recovery of an absolute neutrophil count of 0.5 3 109/L or greater (a median of 11 v 14 days; P 5 .0001), with fewer patients requiring RBC transfusions (P 5 .008), fewer patients with fever (18% v 52%; P 5 0.001), fewer hospital admissions (20% v 42%; P 5 .013), and less intravenous antibiotic therapy (24% v 69%; P 5 .001). Patients who received filgrastim yielded more CD341 cells (median, 7.1 v 2.0 3 106/kg/apheresis; P 5 .0001), and a higher fraction achieved 2.5 3 106 (94% v 78%; P 5 .021) and 5 3 106 (88% v 53%; P 5 .001) or more CD341 cells/kg with fewer aphereses (median, 2 v 3; P 5 .002) and fewer days of growth-factor treatment (median, 12 v 14; P 5 .0001). There were no major differences in outcomes between the filgrastim alone and the sequential regimens. After high-dose chemotherapy, patients who had peripheral-blood stem cells (PBSCs) mobilized with filgrastim or the sequential regimen received higher numbers of CD341 cells and had faster platelet recovery (P 5 .015), with fewer patients (P 5 .014) receiving fewer platelet transfusions (P 5 .001) than patients receiving sargramostim- mobilized PBSCs.

Conclusion: It was concluded that filgrastim alone or sequential sargramostim and filgrastim were superior to sargramostim alone for the mobilization of CD341 cells and reduction of toxicities after MC.

J Clin Oncol 18:43-53. © 2000 by American

Society of Clinical Oncology.

COMPARISION WITH SARGRAMOSTIM

NEUGROW is a brand of Filgrastim from Wintac Limited is “Drug of choice as prophylactic agent for prevention of Febrile Neutropenia in patients on chemotherapy”.

Our product NEUGROW, recommended in CSF therapy is cost-effective, with no compromise in quality, efficacy and affordability in chemotherapy induced severe neutropenia patients.

PRODUCT OFFERING / BENIFITS

Patients having severe neutropenia undergoing chemotherapy.

In patients undergoing Bone marrow transplantation.

In acute leukemia and Myelodysplastic Syndromes (MDS) patients.

In patients receiving radiotherapy with or without chemotherapy.

TARGET CONSUMERS / END CUSTOMERs

PRODUCT: NEUGROW is a brand of Filgrastim from Wintac Limited is “Preferred as prophylactic and therapeutic for prevention of Febrile Neutropenia in patients on chemotherapy”.

PRICE: The NEUGROW price will be economical, affordable near to that of competitor price fulfilling the need of poor cancer patients.

PROMOTION: By conducting campaign reaching near to the most targeted customer for NEUGROW i.e severe neutropenia patients undergoing chemotherapy.

PLACE: The product will be launch throughout the leading cancer institute and hospital all over India.

MARKETING MIX (PPPP)

Month South North East Total

March 2011 150 50 75

April 2011 250 75 100

May 2011 350 100 175

June 2011 500 150 200

July 2011 550 175 225

Aug 2011 650 200 275

Sep 2011 700 225 325

Oct 2011 850 275 400

Nov 2011 1000 325 450

Dec 2011 1500 450 500

Jan 2012 2000 500 575

Feb 2012 2500 650 750

NEUGROW FORCASTING ( Per Month)

Primary:5 x 1 (300 mcg PFS)

Secondary: Single PFS

Tertiary: Tray

PRODUCT PACKING

Suggested Price:

1. M.R.P= 2500

2. P.T.S= 600

NEUGROW PRICE

Doctor, in treating Febrile Neutropenia, the experience which you can count on, TRUST only NEUGROW having better efficacy, affordability, quality, compliance, consistency and safety.

Doctor, NEUGROW, brand of Filgrastim from WINTAC LTD. is preferred as as primary prophylaxis, secondary prophylaxis followed by therapeutic use to accelerates the neutrophil recovery in cancer patients. (EORTC Guideline as under patients assessment alogorithm).

COMMUNICATION STRATEGY

Doctor, NEUGROW, brand of Filgrastim from WINTAC LTD. is also recommended for increasing Chemotherapy Dose Intensity and Dose Density.

Doctor, NEUGROW is used as adjuncts to Progenitor-Cell Transplantation, in Acute Leukemia and Myelodysplastic Syndromes patients.

Doctor, NEUGROW, brand of Filgrastim from WINTAC LTD. is recommended in patients receiving radiotherapy, injury due to radiation and in severe neutropenia patients undergoing chemotherapy.

Doctor, to accelerates neutrophils recovery in your severe neutropenia patients undergoing chemotherapy thereby reducing hospitalization cost, trust only on NEUGROW from WINTAC LTD.

VISUAL AID FOR NEUGROW

CLINICAL TRAIL DATA- ( involving latest studies)

HANDOUT LITERATURE ( To support the study & Clinical Trials)

PROMOTIONAL INPUT

Complete doctor list

Frequent coverage of doctors

Hospital and institutional coverage

Product availability / management of supply chain

Incentive to field force on completing target.

SALES STRATEGY

Monitoring field force activities followed by there doctor coverage on daily basis.

Participation in institutional rate contracts.

Identify KOL ( Key opinion leader ) for Filgrastim and convert them for NEUGROW.

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Implementation strategy

150 vials of NEUGROW to be achieved (Incentives / Prizes on achieving the target)

Sales target

Thank you