A Project report On

TO STUDY THE PROBLEM OF NEW PRODUCT MARKETING IN PHARMACEUTICALS INDUSTRY

POST GRADUATE DIPLOMA IN MANAGEMENT Under the Guidance of

Mr.Neeraj Chatterjee Regional Business Manager Management (For Uttarakhand) School Aventis Pharma Ltd.

Mr.A.K.Tomar Faculty of Doon Business Dehradun

SUBMITTED BY Pradeep PGDM (2010-12 Batch) Doon Business School Dehradun

Pradeep PGDM 3RD Trimester

Page 1

C ONTENTS
Bonafied Certificate ......................................................................................................... 3 Executive Summary ....................................................... Error! Bookmark not defined. Introduction ...................................................................................................................... 5 Objective of the Project .................................................................................................... 6 Company Profile .............................................................................................................. 7 Vision and Mission statement ........................................................................................ 12 Product Range ................................................................................................................ 13 Swot Analysis ................................................................................................................. 15 Marketing /New Product Marketing Problems .............................................................. 16 Suggestion For New Product Marketing ........................................................................ 17 Conclusion ...................................................................................................................... 18 Bibliography .................................................................................................................. 19 QUESTIONNAIRE ....................................................................................................... 20

Pradeep PGDM 3RD Trimester

Page 2

CERTIFICATE:

This is to certify that I am Pradeep, currently a 3rd Trimester student of the course PGDM, has successfully completed my project TO STUDY THE PROBLEM OF NEW PRODUCT
MARKETING IN PHARMACEUTICALS INDUSTRY

Thanking You,

Pradeep PGDM 3RD Trimester

Page 3

EXECUTIVE SUMMARY We know that Sanofi-Aventis Pharmaceuticals have more than 55 years of its existence. Up till 2009 it has gone through many changes as far as its communication and marketing methodology is concerned. It has been regular to update itself as per latest concern be it technology or environmental. The recent change in its communication methodology is driving with the values of Ecological concern. It is trying to attract customers towards more updated and close of ecology technology with best in its class functionalities & value for money. The following analysis has enabled us to understand the followings 1. 2. 3. 4. Marketing Strategy New product development strategy Media Vehicle Media Planning & Budget Allocation Strategies for measuring the effectiveness of the campaign.

Pradeep PGDM 3RD Trimester

Page 4

INTRODUCTION
OVERVIEW OF PHARMACEUTICAL SECTOR: Accounting for two percent of the world's pharmaceutical market, the Indian pharmaceutical sector has an estimated market value of about US $8 billion. It's at 4th rank in terms of total pharmaceutical production and 13th in terms of value. It is growing at an average rate of 7.2 % and is expected to grow to US $ 12 billion by 2010. Over the last two years the pharmaceutical market value has increased to about US $ 355 million because of the launch of new products. According to an estimate, 3900 new generic products have been launched in the past two years. These have been by and large launched by big brands in the pharma sector. And in the year 2005 Indian pharmaceutical companies captured around 70% of the domestic market. As in the present scenario, only a few people can afford costly drugs, which have increased price sensitivity in the pharmaceutical market. Now the companies are trying to capture the market by introducing high quality and low price medicines and drugs. With the Product Patent Act, which came into action in January 2005, this industry is able to attract big MNCs to India. Earlier these big firms had apprehensions in launching new drugs in the Indian market. At present, a large number of Indian pharmaceuticals companies are looking for tie-ups with foreign firms for in-license drugs. GlaxoSmithKline is among the top choices for the firms that wish to launch their product in India, but do not have any branch over here. Contract research and pharmaceutical outsourcing are the new avenues in the pharmaceutical market. Contract manufacturing is growing at a very fast pace and is estimated to grow to US $30billion, whereas contract research is estimated to reach US$6-10 billion. Indian multinational companies like Dr.Reddy's Lab, Cipla, Ranbaxy, etc have created awareness about the Indian market prospects in the international pharmaceutical market. Approvals given by Foods and Drugs Administration (FDA) and ANDA (Abbreviated New Drug Application)/DMF (Drug Master File) have played an important role in making India a costeffective and high quality

Pradeep PGDM 3RD Trimester

Page 5

product manufacturer. Furthermore, the changes that took place in the patent law, change of process patent to product patent, have helped in reducing the risk of loss for intellectual property.

Pradeep PGDM 3RD Trimester

Page 6

OBJECTIVE OF THE PROJECT

The objective of the project is: To know the awareness about Sanofi-Aventis New Product among the people of Uttarakhand. To know the preferences of teen agree regarding Sanofi-Aventis New Product. To know the usage pattern of Sanofi-Aventis New product in various purposes. To find out the various strategies employed by the competing brands to increase the sales of their product. To know the most acceptable brand by consumers.

Scope of Study
The research helps in dealing with consumers. Future researches nay use it as a secondary source of data. It provides very useful information about usage behaviors of the Sanofi-Aventis new product brand. The research report could be further used by me in future for advanced research on the topic.

Limitation The area covered by me was very very small that is only Dehradun. Consumers were not aware about the entire new products of Sanofi-Aventis
Pharmaceuticals. There were not enough parameters or the study material available for the interpretation of the result so as to reach to a final conclusion.

Pradeep PGDM 3RD Trimester

Page 7

COMPANY PROFILE
SANOFI-AVENTIS 2009 sales: 29.3 billion A broad portfolio of pharmaceutical products: Prescription medicines, consumer healthcare (OTC) and generics World leader in vaccines (Market share from sanofi pasteur internal estimates at end December 2009 based on a global presence, including 50% of sales from the Sanofi Pasteur MSD joint venture) Presence across both traditional and emerging markets More than 100,000 employees in over 100 countries. Focused on patients needs, sanofi -aventis offers a range of essential healthcare assets, including a broad-based product portfolio and a presence worldwide.Sanofi -aventis products and services are centered on patients. Ambition: to become a diversified global healthcare leader. Sanofi -aventis strategy is built around three priorities to reach its goals and ensure sustainable growth: Increasing innovation in Research and Development Adapting Group structures to future challenges Seizing external growth opportunities. Facts Showing Growth scenario: Sanofi-aventis is a global healthcare company engaged in the research, development, manufacture and marketing of healthcare products. Our business is diversified and includes pharmaceuticals comprising Rx (prescription) drugs, consumer healthcare business (over-the-counter / combined OTC and Rx drugs) and generics; vaccines and animal health.

Pradeep PGDM 3RD Trimester

Page 8

2009 2009

net sales: 29,306 million, +6.3% versus 2008.

adjusted EPS excluding selected items: 6.49, +18.2% versus 2008 or +13.1% at constant /$ exchange rate. Pharmaceuticals business Sanofi-aventis' pharmaceuticals business focuses on six therapeutic areas: diabetes, oncology, thrombosis, cardiovascular diseases, central nervous system (CNS) and internal medicine. net sales of the pharmaceuticals business: 25,823 million, +3.7% versus 2008. The Rx drugs activity counts 8 flagship products in 2009 : Lantus, Lovenox, Plavix, Taxotere, Aprovel, Eloxatin, Apidra, Multaq.
2009

Flagship products Millions of euros 2009 net sales Lantus Lovenox Plavix Taxotere Aprovel Eloxatin Apidra Multaq Change at constant 3,080 3,043 2,623 2,177 1,236 957 137 25 exchange rates +22.5% +8.8% +0.2% +6.1% +4.7% -34.7% +38.8% -

Note: Worldwide presence of Plavix is 6,782 million, +6.2%. Worldwide presence of Aprovel is 2,012 million, +1.7%. Sanofi-aventis also has a significant presence in consumer healthcare business, in various product categories. net sales of consumer healthcare: 1,430 million, +26.8% versus 2008. In addition to Rx drugs and consumer healthcare, the pharmaceutical business comprises generics.
2009

Pradeep PGDM 3RD Trimester

Page 9

net sales of generics: 1.012 million.The turnover of the generics activity approximately tripled compared to 2008, mainly reflecting the consolidation of Zentiva, Kendrick and Medley with organic growth.
2009 Sanofi Aventis

Sanofi Aventis was formed in 2004 when Sanofi-Synthlabo acquired Aventis. In early 2004, Sanofi-Synthlabo made a hostile takeover bid worth 47.8 bn for Aventis. Initially, Aventis rejected the bid because it felt that the bid offered inferior value based on the company's share value. The threemonth takeover battle concluded when Sanofi-Synthlabo launched a friendly bid of 54.5 bn in place of the previously rejected hostile bid. French government intervention also played an active role. The French overnment, desiring what they called a "local solution", put heavy pressure on Sanofi- Synthlabo to raise its bid for Aventis after it became known that Novartis, a Swiss pharmaceutical company, was in the running.
Sanofi-Synthlabo

Sanofi-Synthlabo was formed in 1999 when Sanofi (former subsidiary of Total) merged with Synthlabo (former subsidiary of L'Oral). The merged company was based in Paris, France.
Connaught Campus

The Canadian operations of Sanofi-Aventis began as Connaught Laboratories/Connaught Medical Research Laboratories of the University of Toronto from 1914 to 1972. It was purchased by federal government's Canadian Development Corporation and later privatized. Sold to the French Institut Mrieux in 1989 and renamed Pasteur Merieux Connaught. A series of mergers would follow and the Canada unit was renamed "Connaught Campus" of Aventis Pasteur. It is now the Canadian unit of Sanofi Pasteur and part of the SanofiAventis empire.
Aventis

Aventis was formed in 1999 when Rhne-Poulenc S.A. merged with Hoechst Marion Roussel, which itself was formed from the merger of Hoechst AG with Roussel Uclaf and Marion Merrell Dow. The merged company was based in Schiltigheim, near Strasbourg, France

Pradeep PGDM 3RD Trimester

Page 10

Sanofi-Aventis in INDIA
In India, sanofi-aventis operates through two entities - Aventis Pharma Limited and Sanofi- Synthelabo (India) Limited. Sanofi-aventis and its 100% subsidiary Hoechst GmbH, are the major shareholders of Aventis Pharma Limited and together hold 50.12% of its paid-up share capital. Sanofi-Synthelabo (India) Limited is a 100% subsidiary of sanofi-aventis. Aventis Pharma Limited was incorporated in May 1956 under the name Hoechst Fedco Pharma Private Limited. Over the years, its name was changed to Hoechst Pharmaceuticals Private Limited, Hoechst India Limited and Hoechst Marion Roussel Limited. The shares of Aventis Pharma Limited are quoted on the Bombay Stock Exchange and the National Stock Exchange. In India, Aventis Pharma Limited has 1,840 employees. It has state-of-the-art manufacturing facilities in Ankleshwar and Goa, where active pharmaceutical ingredients and formulations are manufactured. Sanofi-Synthelabo (India) Limited was incorporated in June 1996 under the name Sanofi Torrent (India) Private Limited. Its name was changed to Sanofi-Synthelabo (India) Limited in May 2002. Sanofi-Synthelabo (India) Limited has around 275 employees. The two companies have registered offices in Mumbai and zonal offices in Mumbai, Chennai, Kolkata and New Delhi.

Pradeep PGDM 3RD Trimester

Page 11

KEY EXECUTIVE
Mr. Chris Viehbacher , Chief Exec. Officer, Managing Director, Director and Member of Strategy Committee

Mr. Nigel Brooksby , Chairman of Sanofi-Aventis UK, Managing Director of Sanofi-Aventis UK and Gen. Mang. of Group UK

Mr. Jermoe Contamine , Chief Financial Officer and Exec. VP

Mr. Gilles Lhernould , Sr. VP of HR, Member of the Management Committee

Mr. Steve Oldfield , Chief Exec. Officer of UK Operations, Director of Commercial Operations - UK and Gen. Mang. of Sanofi - Aventis UK

Pradeep PGDM 3RD Trimester

Page 12

VISION OF THE CHIEF EXECUTIVE OFFICER

CHRISTOPHER VIEHBACHER,

CHIEF EXECUTIVE OFFICER

Ive discovered very solid foundations and many under-appreciated assets that I want to talk about. Most of our competitors say they want to reduce their reliance on small molecules in the developed world. Weve already done this. If you look at the geographic breakdown of our sales, around a third is generated in North America, slightly more than 40% in Europe and a quarter in other countries. We are already the leader in emerging markets, a clear area of future growth. We are also leader in vaccines (1), with major products ready to address major public health challenges. This business activity is less impacted by generics due to the significant levels of expertise and investment required. And our consumer healthcare (OTC) business, ranked sixth worldwide (2) is an excellent basis for further development. Our strong financial position is another key asset in a time of global economic crisis. We have a strong cash flow, giving us the strategic flexibility to find and seize new growth opportunities. Sanofi -Aventis is well equipped to face the future. Our ambition is to become a diversified global Healthcare leader, focused on patients needs

Healthcare leader, focused on patients needs

Pradeep PGDM 3RD Trimester

Page 13

VISION AND MISSION OF SANOFI AVENTIS

Pradeep PGDM 3RD Trimester

Page 14

Product Range

Amaryl (glimepiride) Amaryl M (glimepiride, metformin extended release) Amaryl MP (glimepiride, metformin, pioglitazone extended release) Apidra (insulin glulisine) Cetapin P (metformin, pioglitazone extended release) Cetapin XR (metformin extended release) Daonil (glibenclamide) Daonil M (glibenclamide, metformin extended release)

Combiflam

Combiflam Cream (methyl salicylate, menthol & camphor) Avil (pheniramine maleate) Allegra (fexofenadine hydrochloride)

Pradeep PGDM 3RD Trimester

Page 15

SWOT OF SANOFI -AVENTIS

STRENGTH: Good market position of blockbuster drugs. Good French culture/background WEAKNESS: Relative small market share (5 %) compared to Pfizer(10.9%) Same infrastructure in many countries. OPPURTUNITY: Good Market Power. Economies of scale/ R&D Synergies in administration. Many developments cannot be financed without merger. THREATS: Diseconomies of scale due to the broader organization and Complicated communications.

Pradeep PGDM 3RD Trimester

Page 16

Marketing/new product - marketing problems

1. 99% of target audience (tourists) have no idea the products exists 2. 99% of people who visit the Chemist shops don't notice the product on the shelves or in a display window. 3. 99% of people who notice the product have no idea what is that

Pradeep PGDM 3RD Trimester

Page 17

Suggestion for New Product Marketing

Create the awareness of the new product in the Market. Use campaigning for marketing. Use free sample before launched the product. Arrange the party for doctors. Give some special package to the field staff. Use advertising for marketing.

Pradeep PGDM 3RD Trimester

Page 18

CONCLUSION

Thank you

Pradeep PGDM 3RD Trimester

Page 19

BIBLIOGRAPHY

Books:
Marketing Management, Philip Kotler Research Methodology By C.R Kothari Strategic Marketing Management By Wilson Gilligan

Websites:
http://www.sanofi-aventis.com http://www.google.com http://www.wikipedia.com

Pradeep PGDM 3RD Trimester

Page 20

PHARMACEUTICAL PRODUCT QUESTIONNAIRE Global Drug Facility (GDF) I. Product identification

Active Pharmaceutical Ingredient(s) (use INN if any): .. Generic name of the product: ...... Trade name (if any): Dosage form: _Tablets _ Capsules _Injectable _ Syrups/oral liquids _Other: Strength per dosage unit: .. Route of administration: _Oral _I.M. _I.V. _S.C. _Other Pack size and description of primary packaging materials (including container/closure system and details of materials composition): .. Pack size and description of secondary packaging materials (including container/closure system and details of materials composition): .. For parenteral products, all components which may be in contact with the product comply with requirements specified by BP, EP,USP? _Yes _ No II. Manufacturer of the product Name, address and activities of the manufacturer and manufacturing site(s) (or contract manufacturer(s)) where any aspect of the product manufacturer occurs: Name Physical address Telephone number, Facsimile number

Pradeep PGDM 3RD Trimester

Page 21

and e mail contact details Activity (e.g. packaging) All sites listed above are licensed by the relevant National Drug Regulatory Authority to perform the activity? _Yes _No GDF / Pharmaceutical Product Questionnaire / September 2008 Page 2 of 6 The manufacturing sites have been assessed by the WHO Pre-Qualification Program in Geneva, by a Stringent National Drug Regulatory Authority (SNDRA) and/or any International Procurement Agency (IPA) and found WHO/SNDRA GMP compliant? _ Yes WHO _Yes SNDRA _ Yes IPA _No Name and country of the SNDRA: Name of IPA: . Date of approval: Please attach a copy of the GMP Compliance notification This product is pre-qualified by the World Health Organization Pre-Qualification program (WHO PQ). _Yes _No _Submitted _Dossier in preparation for submission If yes, please indicate WHO prequalification reference number: If dossier in preparation, please indicate tentative date of submission: . III. Supplier identification (to be filled in if not identical to that indicated in question II) Name.... Address: ... ...... Telephone number:... Facsimile number: E mail contact details:.. Link with the product: _ Marketing licence holder _Distributor _Manufacturer _Other.... IV. Regulatory situation (licensing status) in the country of manufacture

Pradeep PGDM 3RD Trimester

Page 22

_Product registered and currently marketed licence n.... _Product registered for marketing in the country of manufacturing but not currently marketed licence n. _Product registered for export only licence n. _Product not registered (please clarify):. Please attach a Certificate of Pharmaceutical Product (CPP) according to the WHO Certification Scheme (WHO Technical Report Series No. 863. Earlier version is not acceptable). If CPP cannot be obtained from the National Drug Regulatory (NDR), please state the reason and send equivalent document if any: . GDF / Pharmaceutical Product Questionnaire / September 2008 Page 3 of 6 V. Regulatory situation (licensing status) in other countries List other countries where the product is registered and is currently marketed (+ registration number and validity period) .. .. VI. Finished product (FP) specifications _BP Edition . _ USP Edition _ International Pharmacopoeia Edition _ Other ... Please attach a copy of the internal finished product specifications. Additional specifications to those in the pharmacopoeia (e.g. dissolution, syringeability): .. Attach a copy of the model certificate of analysis for batch release. If specifications are in house specifications, different from BP, USP and Int Ph, attach also analytical method and its validation. The manufacturing method for each standard batch size has been validated? _Yes _No List quantities of the standard batch size: If the product is sterile, please provide details of sterilization processes and/or aseptic procedures used: .. ..

Pradeep PGDM 3RD Trimester

Page 23

Brief narrative description of the manufacturing process (indicating if there is any new process/technology /packing operation). Provide qualitative and quantitative product formula per unit. Are excipients described in BP, USP or IntPh?: If colours and flavourants are used, are these permitted by the EU or USFDA? _Yes _No State and justify any overages. VII. Stability Stability testing data available: _Yes _No If yes, type and conditions of testing: Satisfactory accelerated testing: Type and material of container: Conditions (Temperature/Relative Humidity/Duration): Number of batches: Batch sizes: Date of beginning of the study: GDF / Pharmaceutical Product Questionnaire / September 2008 Page 4 of 6 Satisfactory real time testing: Type and material of container: Conditions (Temperature/Relative Humidity/Duration): Number of batches: Batch sizes: Date of beginning of the study: Please provide stability data accordingly with the product questionnaire. Was the stability testing done on a product of the same formula, manufactured on the same site and packed in the same packaging material as the product that will be supplied? _Yes _No If no, describe differences: .. Is on-going stability data available for this product? _Yes _No If yes please share status report. If no, please indicate your plans for a study. VIII. Label and insert information Shelf-life: _2 years _3 years _4 years _5 years other... Transport and storage conditions (e.g. Do not store above 30C - Protect from light):

Pradeep PGDM 3RD Trimester

Page 24

.. .. Label language (please attach a copy): _Bilingual English/French _English _French _Other:. Package insert: _Yes (attach a copy) _No IX. Samples Please provide a sample with this Product Questionnaire conforming to the product offered. Please attach a Certificate of Analysis NB: If you are not able to provide a Certificate of Analysis, please explain. X. Therapeutic equivalence 1.) _demonstrated a.) _by in vivo bioequivalence studies Reference product:... Number of volunteers: .. CRO Name and country of study: .. Performed year:. Bio batch size: . Bio batch API(s) source(s): b.) _by another method claimed by the supplier/manufacturer (please describe briefly): .. c.) _by comparative in vitro dissolution tests GDF / Pharmaceutical Product Questionnaire / September 2008 Page 5 of 6 Reference product: .. According to conditions described in WHO BCS classification document (WHO Technical Report Series N937) _Yes _No d.) _by in vitro dissolution tests 2.) _not demonstrated 3.) _not relevant, please explain why: Provide a copy of the report of the proof of therapeutic equivalence (BE study, comparative dissolution profile, dissolution tests, other). The product used in the trial or test is essentially the same as the one that will be supplied (same materials from the same suppliers, same formula, and same manufacturing method). _Yes _No

Pradeep PGDM 3RD Trimester

Page 25

If no, please explain what the differences are: .. XI. Active Pharmaceutical Ingredients(s) (APIs) (In case more than one active ingredient is used, please replicate this question) Manufacturer (name, physical address + country): GMP certified: _Yes (attach a copy of the GMP certificate if any) _No _ Unknown . Certified by: .... Specifications and standard test methods exist for this API _Yes _No API used (in INN if any): . _has a Certificate of suitability to the European Pharmacopoeia (CEP) Certificate: N: . _The CEP is in possession of the finished product manufacturer (including annex if any) (Please attach a copy of the CEP). _has a Drug Master File (DMF) registered in: (country) _The full or open part of the DMF is in possession of the finished product manufacturer _has a Technical File _ Yes _No API specifications: _BP _USP _EP _International Pharmacopoeia _Other (e.g. in-house; specify:) _No Pharmacopoeia monograph exists* Attach a copy of the API(s ) internal specifications *If there is no monograph in a recognized Pharmacopoeia, then analytical methods should be provided in addition to In House specifications. Provide a copy of the Certificate of Analysis of the API from the API manufacturer as well as from the FP manufacturer. GDF / Pharmaceutical Product Questionnaire / September 2008 Page 6 of 6 XII. Commitment I, the undersigned, .., ( position in the company, e.g. General Manager, Authorised Person, Responsible Pharmacist),

Pradeep PGDM 3RD Trimester

Page 26

acting as responsible for the company(name of the company), certify that the information provided (above) is correct and true (if the product is marketed in the country of origin, tick the adequate following box) _and I certify that the product offered is identical in all aspects of manufacturing and quality to that marketed in ..(country of origin), including formulation, method and site of manufacture, sources of active and excipient starting materials, quality control of the product and starting material, packaging, shelf-life and product information. _and I certify that the product offered is identical to that marketed in ..(name of country), except: .. ...... (e.g. formulation, method and site of manufacture, sources of active and excipient starting materials, quality control of the finished product and starting material, packaging, shelf-life, indications, product information)

Date: Signature

Pradeep PGDM 3RD Trimester

Page 27