2. Decision Request Approval of marketing plan for Neoslim™ to be presented to the committee on October 04, 2011
3. Mission Our mission is to reduce the incidence of obesity and related co-morbidities, by consistent reduction of body fat and its maintenance in a safe and efficacious manner.
4. Overall Objectives To establish Neoslim as the biggest brand name for anti-obesity drugs, attaining blockbuster status To minimize the prevalent patient drop-out trends in this class of drugs and increase market penetration in the US and later in Europe
5. Long Term Objectives To develop a holistic approach in the eradication of the obesity epidemic by launching the first obesity vaccine “Neoslim FTO” that knocks out the obesity gene Capture the nutraceuticals market of diet drugs and OTC products by reformulating “NeoslimSmart” capsules for overweight patients
6. Communication Objectives Communicate the positioning of Neoslim across all promotional venues: “Neoslim, the first subcutaneously administered combination anti-obesity drug for adults as well as children, which offers superior efficacy and tolerability over all other anti-obesity drugs.”
7. Promotional Objectives Achieve anti-obesity drug category leadership in journal ad inserts Achieve category leadership in total number of medical education events (including speaker programs, and teleconferences) Generate significant Neoslim-specific news coverage to consumers as well as healthcare professionals Have Neoslim included in all obesity/weight loss related round up articles/stories that discuss treatment Strive to attain entry into drug formularies and achieve co-pay to complete reimbursement of Neoslim
12. Product Neoslim™ is a combination anti-obesity drug Subcutaneous route of administration 4 doses a year Positive clinical trial results indicate Neoslim™ as a “cardiobesity” drug performing well on both criteria of safety and efficacy No serious side effects
13. Clinical trial Results Neoslim Body Mass Index of subjects who completed 6 months of treatment Xenical Mean weight loss and maintenance at year 1
15. Planning Pre-launch Design an integrated specialty distribution and patient services model in the U.S. market that meets the manufacturer’s goals and involves all constituents, including specialty pharmacy distribution, patients, patient advocacy, physicians and payers Finalize SOPs Finalize coordinated marketing and communications plans and audiences Patient and caregiver meetings Web-based Print E-mail and mail Meet with key KOLs Describe program Provide materials Assist with staffing needs Conduct training
16. Launch Post-Launch Initiate receiving, warehousing, stocking and inventory control Implement pharmacy dispensing and delivery, therapy compliance and 24/7 on-call support Reimbursement services to include billing and collection, accounts receivable and contract management Begin standard reporting and interface with company financial and management systems Schedule monthly meetings for post launch review Data collection and reporting Post launch evaluation, patient satisfaction survey Continuous improvement review and actions
23. Opportunities Increasing market and demand for anti-obesity drugs Lesser choice of drugs with significant efficacy Meridia withdrawn from US market brings extra sales of $300 million Can compete with statins as a lipid lowering drug due to proven clinical trial results
24. Threats FDA rejection Fears of general public (Phen-fen debacle, Meridia withdrawal) Doubts of achieving required efficacy
25. Market Overview Approximately 68% of all U.S. citizens are overweight. 30%, totaling approximately 100 million Americans, are obese More than 12.5 million children age 2 to 19 are overweight
27. Alternative Treatment Surgery Bariatric surgery – including gastric banding, gastric sleeve, gastric bypass, duodenal switch Invasive procedure Costly Poses physiological complications
28. Competitive Overview Neoslim™ Market Position – 1st subcutaneously administered anti-obesity drug with formulations for both children as well as adults - long-term plans of making an OTC switch and vaccine development in Phase II Product Characteristics – combination product tackling obesity through various etiologies Profile Drivers – 4 doses/year - due to lipid lowering activity, can be safely supplemented to patients with cardiovascular complications as well as with a history of diabetes - greater chances of being included in healthcare plans and formularies Profile Barriers – looming threat of FDA rejection - changing physician and patient perception of anti-obesity drugs
29. Competitive Overview Xenical/Alli Market Position – currently the only patented FDA approved Rx/OTC drug in the market Product Characteristics – Lipase inhibitor Profile Drivers – relatively safer than other anti-obesity drugs (does not cause cardiovascular or psychological complications) Profile Barriers – not covered by healthcare plans - lacks desired efficacy
30. Competitive Overview Phentermine Market Position – one of the oldest FDA approved drugs - dominant player in the US generic anti-obesity market Product Characteristics – Appetite Suppressant Profile Drivers – cheaper Profile Barriers – banned in UK and other European countries - has grave side effects like increased blood pressure & heart rate, nervousness
31. Competitive Overview Bariatric Surgery Market Position – increasing market acceptance due to underperforming drugs and FDA disapprovals Characteristics – Invasive procedure Profile Drivers – can significantly reduce weight up to 25% for morbidly obese people (BMI > 30) Profile Barriers – invasive procedure leading to resistance among patients - various physical implications, intolerances
35. Doctors General Practitioners Cardiologists Diabetologists Pediatricians Endocrinologists Gastroenterologists 127,397 (Whole US) Top 10 States West Virginia Kentucky Mississippi Arkansas South Carolina South Dakota Oklahoma Louisiana Delaware Maine Total – 10,584
36. Marketing Tactics Physician meetings and events - 8,000 events reaching out to approximately 60,000 physicians Field Samples (100units/ml, 10ml vial) 1no. Patient Starter Kits (PSKs) (Neoslim 2 dose samples + educational, branded Neoslim brochures) Speaker training Sales force training and field aids Advertising using internet and social media (Banner and Sponsored Ads) Development of product website
38. Consumers (DTC Advertising) Top magazines based on subscriptions a well as ethnic reach 1. Better Homes and Garden – 48.5 million 2. AARP The Magazine – 45.1 million 3. Ebony – 13.6 million 4. Country Living – 14.5 million 5. Hispanic Magazine – 2.9 million National Newspapers - USA Today (total circulation of 1.4 million)
39. Market Map (based on market penetration ) Treatment naïve US 900,000 UK 84,000 Previous Treatment Discontinued US810,000 UK 75,000 Satisfied US 90,000 UK 9,000 Dissatisfied US810,000 UK 75,000
40. Market Map (based on individual drugs in the market) Treatment naïve US Xenical – 0.1% Alli – 0.2% Phentermine – 0.6% Previous Treatment Discontinued US Xenical – 0.09% Alli – 0.018% Phentermine – 0.54% Satisfied US Xenical – 0.09% Alli – 0.02% Phentermine – 0.06% Dissatisfied US Xenical – 0.09% Alli – 0.018% Phentermine – 0.54%
41. Key Assumptions (Base Case) Product Gain greater market acceptance over competitors Have lesser patient drop-out incidences Achieve greater market penetration Potential of breaking the statin market Enter the European market and establish stronger market share by the 2nd year Inclusion into formularies for reimbursement Introduction of OTC reformulated “NeoslimSmart” capsules for overweight people Capture the $300 million U.S. market of Meridia Price Eventually have more bargaining power and could price higher
42. Key Assumptions (Base Case) Market Growth Global anti-obesity market forecasted to be 1.26 billion in 2011 and grow at a CAGR of 7% for the next decade Intend to capture the huge opportunity to establish brand loyalty New Entrants The growth opportunity looks enticing but high barriers to entry (tough FDA safety/efficacy criteria) Drugs in the pipeline - Zafgen, Gelesis (Launch of “Neoslim FTO” vaccine)
