Molecules destruction in your personality

AkhinaRomdoni 26 views 32 slides Jul 13, 2024
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About This Presentation

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Slide Content

Pere temes pendents : Interview amb un geriatra ?? Regulatory Naming?? © Sun Pharmaceutical Industries Limited. All Rights Reserved. 1

Branded Generics Project Barcelona, 1 st October 2023

Index SWOT Analysis Market Situation & Requirements for a new concept Developing new Business Opportunities Definition of the New Strategy& Positioning Needed resources Building the Organization to become “1 st in Class” (SWOT review) Image & communication Marketing Plan Sales & Profitability analysis Action Plan : definition , monitoring & control © Sun Pharmaceutical Industries Limited. All Rights Reserved. 3

SUN is planning to launch new products which will require a different “Market Approach” in terms of Pricing, Market Access and Promotion. Our pipeline has opportunities based on alternative formats to some existing products such as different devices, sprinkle,etc New opportunities Business: Hemos analizado esta oportunidad de negocio en el espacio entre los Farmacos Originales / Innovadores y Genericos Presentare un analisis y una propuesta de desarrollo para posicionar nuestro pipeline en este espacio entre Originales y Genericos © Sun Pharmaceutical Industries Limited. All Rights Reserved. 4 Executive Summary Branded Generics

Market status

Branded Gx market © Sun Pharmaceutical Industries Limited. All Rights Reserved. 6 Wholesaler Little power in the decision-making process so far but key for retail products Hospital Pharmacy There are 1,500 hospitals with regional differences in prescription policies It is key to try to obtain relevance either by direct negotiating or influencing tender conditions Patient Very little decision power except for treatments of chronic diseases (push to renew their previous branded drug) Associations can play a role if there are clear advantages like for example sumatriptan Physician Main decision-maker for specialist products and still influential for some commodities depending on pricing Mandatory to identify KOLs as influencers and support for product introduction Health Authorities Responsible for legal regulations, price approvals, the reference price system and the drug evaluation and authorization, Different policies depending on region Key Stakeholder Implications Align Pharmacists and Physicians Discounts negotiation Potential tender conditioning Communication & Follow-up plan Sales force necessary to obtain prescriptions. Patients are not established as a central component of the marketing mix but can have influence over the physician Limited space for price maneuvers Good relations important Can favor fast authorization for local submissions Network of wholesalers valuable to get access to pharmacies in case of retail product Key Market Dynamics New Market Resulting in more Added value and new prices and communication Premarketing to fix clear targeting and Market Access by Region is required Both prescription and promotion to pharmacists in Hospital required Prices pending on final regulation. A low discount would be attractive Hospital Pharmacy and physician sales force targeting needed Marketing investment required

© Sun Pharmaceutical Industries Limited. All Rights Reserved. 7 Current Market structure Branded Products Generics Products developed based on I+D investment Clinical trial of several years required Usually “patent” protected for 20 years (effective 10) Price to be agreed with Health Authorities. Added value compared to existing drugs to be demonstrated. Market Access need special dedication Promotion mainly to Physicians explaining benefits of the innovative product. No discounts required Bioequivalent products to innovator No clinical trials required Bioequivalence to be demonstrated To be launched after patent protection period Price approved : 40% below the innovator. It fixes the price level for all medicines containing the same Active Principle. It obliges “innovator” to match the same price level Promotion mainly to “retail” pharmacies and pharmacists in hospitals to switch the molecule High level of discount required Branded Gxs which provide some kind of added value with the same formulation thanks to a different format by using different devices or galenic form To be approved at “generic price” based on the “Reference Pricing System”. Some kind of Market Access needed Not always easy to substitute To be promoted to both physicians and pharmacies Low level of discount. Branded Generics SunPharma has two pathways to follow to continue growing inside the Spanish market, to continue with the current strategy and grow inside the Gx market or to invest in Branded Generics and expand into a new market: Growth Opportunity

Branded Generics OTC This growth strategy is based on exiting products and future products to come Branded Generics should have low product volumes with a high margin. Such as Teriparatide and Lanreotide Promotion Strategy is based on KAM’ visiting specialists at hospitals Based on the brand strength, the growth of all markets operated by SunPharma and the existing resources of the company: Sun Care products (A supplier is needed) Paracetamol 1gr Anticatarral New Growth Opportunities © Sun Pharmaceutical Industries Limited. All Rights Reserved. 8 SunPharma has two pathways to follow to continue growing inside the Spanish market, to continue with the current strategy and grow inside the Gx market or to invest in Branded Generics and expand into a new market DELETe this slide

SWOT

Opportunities Market in growth Low Level of competition Very competitive prices in comparison with EU Lower level of discounts than generics Experience on making agreements with administration and hospitals Strengths Dynamic company Portfolio growing yearly Experience in hospital products Experience with many specialties Structure allows rapid decision making Expertise in tendering and transactional approaches Treats Branded competition Pricing policy Barriers to entry 5 large corporation are inside this market with large investments in FF and marketing Sun pharma has no EU ma manufacturing Weaknesses Low brand awareness and no company image Supply management system allows for not enough safety stock No experience in branded generics Service level: Stock-outs No global Marketing Limited resources small organization SWOT / GO © Sun Pharmaceutical Industries Limited. All Rights Reserved. 10

Market in growth Low Level of competition Very competitive prices in comparison with EU Lower level of discounts than generics Experience on making agreements with administration and hospitals Dynamic company Portfolio growing yearly Experience in hospital products Experience with many specialties Structure allows rapid decision making Expertise in tendering and transactional approaches Branded competition Pricing policy Barriers to entry 5 large corporation are inside this market with large investments in Field force and marketing Sun pharma has no EU ma manufacturing Opportunities Strengths Treats Weaknesses Low brand awareness and no company image Supply management system allows for not enough safety stock No experience in branded generics Service level: Stock-outs No global Marketing Limited resources Small organization SWOT / GO © Sun Pharmaceutical Industries Limited. All Rights Reserved. 11 S O T W

WHOLESALER PHYSICIAN PHARMACY HEALTH AUTHORITIES Key Market Dynamics WHOLESALERS NO INFLUENCE PHYSICIAN No Sales force impact required No different prescription patterns along health care regions Innovators having Product specialist visiting specialist HEALTH AUTHORITIES Setting reimbursement prices Prescription policies : i.e. Tenders, annual bids , etc PHARMACY Hospital Pharmacists main decision maker Impacts and relationship by sales force required (complete Field Force coverage ) Qualitative &Technical requirements (2D,differentiation,etc) Innovators also visiting pharmacists How to approach Generics hospital market © Sun Pharmaceutical Industries Limited. All Rights Reserved. 12 KEY MARKET DYNAMICS Market driven by tenders and/or discounts Sales force needed (5-6 KAM ). Portfolio relevance contributes to become a partner.

WHOLESALER PHYSICIAN PHARMACY HEALTH AUTHORITIES Key Market Dynamics WHOLESALERS It can be relevant in case of retail products PHYSICIAN Sales force impact required KOL´s to share products advantages Different prescription patterns along health care regions Innovators specialist visiting specialist HEALTH AUTHORITIES Setting reimbursement prices: potential new regulation Prescription policies : i.e. Tenders, annual bids , etc Regional different policies PHARMACY Hospital Pharmacists continue being relevant , not so much retail phamacies Impacts and relationship by sales force required (complete Field Force coverage ) Not so relevant for retail products Specialties Market © Sun Pharmaceutical Industries Limited. All Rights Reserved. 13 KEY MARKET DYNAMICS Market driven by added value products &prices Sales force needed to visit Specialist and pharmacists in the hospital Pre-Marketing & Market Access become relevant. Arguments &Support Communication

PHYSICIAN WHOLESALERS HOSPITAL PHARMACY HEALTH AUTHORITIES Growth Opportunity WHOLESALERS No relevant for branded generics PHYSICIAN Sales force impact required KOL´s are required to share products advantages Different prescription patterns along health care regions HEALTH AUTHORITIES Setting reimbursement prices: potential new regulation Prescription policies : i.e. Tenders, annual bids , etc Regional different policies PHARMACY Hospital Pharmacists continue being relevant Impacts and relationship by sales force required (complete Field Force coverage) “Hospital Specialties Generics” © Sun Pharmaceutical Industries Limited. All Rights Reserved. 14 KEY MARKET DYNAMICS Market driven by added value products &prices Sales force needed to visit Specialist and pharmacists in the hospital

Sunpharma’s product Analysis Setting the opportunity for SunPharma

Molecule Selection Sunpharma currently has 12 molecules in the pipeline and portfolio that could be marketed as Branded generics This molecules are related to pathologies that are treated by the following specialties The molecules have been ordered by “time to market” from 2023 to 2025 There are 5 categories per molecule Pathologies Number of patients Specialties involved Number of specialists A brief competitor landscape including manufacturers, products and dosages © Sun Pharmaceutical Industries Limited. All Rights Reserved. 16 Rheumatology Endocrinology Neuro-endocrinology Radiology Urology Oncology Gynaecology Geriatrics Cardiology Psychiatry

Teriparatide Osteoporosis Post-menopausal women with Osteoporosis Acromegalia 2,940,000 Rheumatology Manufacturers Products 7 7 Dosage forms 3 Carnezoid Syndrome Neuroendocrinal tumours (GI/GEP-NET) 8,702 Manufacturers Products 2 2 Dosage forms 5 Endocrinology Neuro - endocrinology Neurosurgery Radiology Lanreotide Diabetes Mellitus type 2 Weight control Monotherapy 3,070,000 Manufacturers Products 1 2 Dosage forms 1 Endocrinology Liraglutide Leuprorelin Prostate cancer Endometriosis and gender change Breast Cancer 2,000,000 Manufacturers Products 2 2 Dosage forms 5 Urologists Oncologists Gynecologists Molecules 1/3 © Sun Pharmaceutical Industries Limited. All Rights Reserved. Nº of patients Indications Specialties Involved Specialists in Spain Competitor landscape 910 Total Catalonia Madrid 237 140 8,603 Total Catalonia Madrid 1,488 1,070 2,356 Total Catalonia Madrid 250 172 7,958 Total Catalonia Madrid 2,020 977

Rosuvastatin Hypercholesteremia Dyslipidemia Cardiovascular risk prevention Hypertriglyceridemia 22,168,850 Endocrinology Cardiology Geriatrics Manufacturers Products 24 87 Dosage forms 5 Vaginal atrophy 9,541,932 Manufacturers Products 6 6 Dosage forms 2 Gynecology Vaginal Estradiol Ezquinofrenia for patients older than 13 years old Bipolar disorder, Tourette, depression Autism related irritability 175,454 Manufacturers Products 31 32 Dosage forms 6 Psychiatry Aripiprazole Boprupion RT Severe depression FDA Aproved : Season affective disorder Smoking cessation 230,000 Manufacturers Products 8 8 Dosage forms 4 Psychiatry Molecules 2/3 © Sun Pharmaceutical Industries Limited. All Rights Reserved. Nº of patients Indications Specialties Involved Specialists in Spain Competitor landscape 5,502 Total Catalonia Madrid 1,032 650 4,902 Total Catalonia Madrid 1,343 563 4,219 Total Catalonia Madrid 1,135 555 4,219 Total Catalonia Madrid 1,135 555

Ranozaline Chronic Angina 1,422,600 Cardiology Manufacturers Products 8 8 Dosage forms 3 Breast cancer in post-menopausal women 361,779 Manufacturers Products 13 14 Dosage forms 1 Oncology Gynecology Fulvestrant Headache Migraine 5,927,500 Manufacturers Products 8 8 Dosage forms 5 Neurology Sumatripan Cetrolix Premature ovulation 105,000 Manufacturers Products 1 1 Dosage forms 1 Gynecologists Molecules 3/3 © Sun Pharmaceutical Industries Limited. All Rights Reserved. Nº of patients Indications Specialties Involved Specialists in Spain Competitor landscape 2,533 Total Catalonia Madrid 534 352 6,209 Total Catalonia Madrid 1,662 744 1,705 Total Catalonia Madrid 371 262 4,902 Total Catalonia Madrid 1,343 563

Strategy 2023-2025

Estrategia Dos alternativas: Molecules oriented : focalizar en pocas especilidades y visitar muchas cuentas Customer oriented : focalizar hospitales y visitar mas especilidades Sugiero: Hospitals oriented significa focalizarnos en los key hospitales y visitar 3 especilidades Ginecologia , endocrinología geriatras 2 ciudades: Marid y Barcelona focalizado en max 5 cuentas Maximizar la relación con stakeholfers : departamentos de compras Optimizacion del tiempo Impacto mas medicos © Sun Pharmaceutical Industries Limited. All Rights Reserved. 21

Strategy: from Customer oriented to Hospital © Sun Pharmaceutical Industries Limited. All Rights Reserved. 22 Focalizing in a small quantity of specialties and a large amount of accounts Molecules oriented Focalizing in reduced number of hospitals and visiting a larger number of specialits Customer oriented Focalizing in the key hospitals of the main regions: Barcelona and Madrid Visiting a reduced number of specialist's type Maximize the relationship with stakeholders such as Purchasing department Optimizing time Greater impact on Specialists Hospital Oriented Strategy

Hospital Oriented Strategy From Hospital oriented to Top Hospitals in 2 regions © Sun Pharmaceutical Industries Limited. All Rights Reserved. 23 Target Hospitals Specialties Hospital La Paz Hospital Gregorio Marañón Hospital 12 de Octubre Hospital San Carlos Public Hospitals HM Hospitals Quirón Hospitals Private Hospitals C. Madrid Hospital Vall Hebron Hospital de Bellvitge Hospital Clinic Hospital Sant pau Clínica Tecknon Quirón Hospitals Public Hospitals Private Hospitals Catalonia Cetrolix Vaginal Estradiol Gynecology Lanreotide Rosuvastatin Liraglutide Endocrinology Teriparatide Rheumatology Lanreotide Rosuvastatin Ranolazine Teriparatide Geriatrics xxxxx Gynecology Endocrinology Rheumatology Geriatrics P1 P2 P3 P4 Cetrolix Vaginal Estradiol Liraglutide Rosuvastatin Teriparatide Ranolazine Teriparatide Liraglitude Rosuvastatin Lanreotide

Gynecologists © Sun Pharmaceutical Industries Limited. All Rights Reserved. 24 There are nearly 5000 gynecologists in Spain, out of which 1900 are distributed among Barcelona and C. Madrid This represents 40% of specialists being located in 2 regions easing reach and access to specialists with a minimal workforce 11% 27% Vaginal Estradiol Cetrolix Mainly used for vaginal atrophy in postmenopausal women This equates to a market size of nearly 10 Mn patients across the whole country, with an approximation of 3 Mn in our desired regions Its primary indication is related to fertility treatments such as In-Vitro fertilization There are only 105,000 women following this course of action, however this kind of procedures are mainly done in Barcelona and Madrid Competitor landscape The market has 9 competitors with up to 30 products in different pharmaceutical forms. We are unique with our dosage and form This market offers a unique opportunity as there is only one current competitor with 3 products

Endocrinologist 1/2 © Sun Pharmaceutical Industries Limited. All Rights Reserved. 25 Currently, 2400 endocrinologist work in Spain for the SNS. This means that approximately there are 2.5 specialist for every 100,000 people 7% 11% Lanreotide Rosuvastatin Among the symptoms that can be treated with Lanreotide , we can find Acromegalia and neuroendocrine tumors (GI/GEP-NET) Both diseases could be considered minor as the total number of patients is nearly 9,000 It is prescribed, mostly, by both Endocrinologists and Cardiologists for patients that suffer Hypercholesteremia or can have cardiologic complications Competitor landscape The market for Lanreotide is divided between Advanz and Ipsen, both with their own generic products There are 2 dosage forms with 3 different doses 60/90/120 mg Market is one of the most saturated of all the molecules studied, how ever the number of endocrinologists in the regions makes it and interesting proposition

Endocrinologist 2/2 © Sun Pharmaceutical Industries Limited. All Rights Reserved. 26 Unlike other specialties, there is a more homogeneous division of specialists around the country. As Both Catalonia and Madrid only have 422 specialists, being 250 in Catalonia and 172 in Madrid Liraglutide Liranglutide’s main use if for Diabetes Mellitus 2 treatment, weight control and monotherapy It is estimated that Spain has 3 Mn patients with diabetes that have to be diagnosis and monitored by endocrinologists Competitor landscape Currently, there is only 1 manufacturer producing any Liraglutide in Spain, Novo Nordisk The dosage form is standard for both the products, with the only variation in packaging. As the quantity of PF pens varies from 2 to 5

Rheumatologists © Sun Pharmaceutical Industries Limited. All Rights Reserved. 27 Spain has 910 Rheumatologists divided among the country working for the public health care system Out of those 40% of those work only in Barcelona and Madrid, 237 and 140 respectfully 15% 26% Teriparatide Teriparatides used only in osteoporosis, a disease affecting nearly up to 3 Mn people in Spain Its distribution is very un-equal, representing women up to 80% of patients Competitor landscape Counting Sunpharma , there are 8 competitors in this market, each with only one brand per competitor However, there is only one dosage form with to delivery methods PF pens and Cartridges

Geriatrics 1/2 © Sun Pharmaceutical Industries Limited. All Rights Reserved. 28 Spain counts with 613 specialist helping treat elderly patients (75 years or older). Compared to other specialties, Geriatrics is the Specialty with most specialists located in Barcelona and Madrid, with 61% out of the total 21% 40% Rosuvastatin Teriparatide Specifically prescribed in hypercholesteremic patients and as precautionary measure in high-risk cardiac patients Rosuvastatin has the highest number of potential patients with 22 Mn Teriparatide largest patient group are postmenopausal women that suffer osteoporosis Approximately, 1.5 Mn women are in the age group that are generally treated by a geriatrists which makes it an ideal target Competitor landscape The market is highly saturated, with many large competitors in the generic market However, Sunpahrma’s unique dosage form, creates an exclusive added potential for elderly patients Currently, there are 7 competitors, each with one product in different administration forms The most common are PF pens, which dominate the market

Geriatrics 2/2 © Sun Pharmaceutical Industries Limited. All Rights Reserved. 29 Geriatrics is a key specialty as it covers 4 molecules and nearly all the specialists are located in Madrid and Catalonia, 126 and 248 respectfully This conditions make it an ideal specialty to start a new business venture as the total number of possible patients nearly reaches 30 Mn Liraglutide Ranolazine Prescribed for patients with type II diabetes, this equates to 3Mn patients in Spain Its is estimated that 32% of elderly people in Spain can have diabetes and generally this patients are monitored by geriatric specialist The only disease for which Ranozaline is recommended is for Chronic Angina There are no precise studies for the age distribution in Chronic angina, however the best approximations are in the range of 3 to 10% of elderly patients In Spain, nearly 1.5 Mn have chronic angina Competitor landscape There is only one manufacturer in the market for Liraglutide, with 2 products: Saxenda & Victoza The market currently has 8 competitors selling Ranolazine in 3 different forms: 375/500/750 prolonged liberation capsules

Resources 2023-2025

Resources and KPI © Sun Pharmaceutical Industries Limited. All Rights Reserved. 31 Job description Job profile Demonstrated experience in generics and originals Minimum 5 years of experience Elevated decision-making ability Great communication and interpersonal capacities Educational: Life Sciences or similar degree Organization: Working directly with General manager Sales Range: outsourcing 80.000€ (full package) Skills required KPI Calling Schedule All specialists will have a schedule of 1 call/month to increase the releationships ASAP In the coming years, we expect to decrease frequency following segmentation Master Call Plan: 220 calls Physicians: 200 calls Stakeholders: 20 calls Endocrinologists Gynaecologists Geriatrics Rheumatologists Farmacy: 15 calls Purchasing: 5 calls Frequency

Resources © Sun Pharmaceutical Industries Limited. All Rights Reserved. 32 KPI’s Calling Schedule All specialists will have a schedule of 1 call/month to increase the releationships ASAP In the coming years, we expect to decrease frequency following segmentation Master Call Plan: 220 Physicians: 200 Stakeholders: 20 Endocrinologists Gynaecologists Geriatrics Rheumatologists Farmacy: 15 Purchasing: 5 Frequency
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