Focus On Brazil 1.8


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  • Focus On Brazil 1.8

    1. 1. Ambiance Ventures USA Focus on Brazil & Latin America
    2. 2. Ambiance Ventures USA Ambiance Ventures USA <ul><ul><li>INTRODUCTION </li></ul></ul><ul><ul><li>Pennsylvania, US-based International Consulting Company with offices and operations in India, Philippines and Dubai. Affiliates in China. </li></ul></ul><ul><ul><li>Specialized in Business Development and Exports of Life Science products – Generics, Biologics, Diagnostics </li></ul></ul><ul><ul><li>End-to-end solution: </li></ul></ul><ul><ul><li>GENERICS, BIOSIMILARS & BIOGENERICS </li></ul></ul><ul><ul><li>Formulation, Analytical Development </li></ul></ul><ul><ul><li>Import APIs, Finished Products, POC / In-vitro Diagnostics </li></ul></ul><ul><ul><li>Contract Manufacture </li></ul></ul><ul><ul><li>Neutral Label & Private Label Manufacture </li></ul></ul><ul><ul><li>Global Marketing Assistance </li></ul></ul>
    3. 3. Ambiance Ventures USA <ul><ul><li>Strategic Consulting & Market Development </li></ul></ul><ul><ul><li>Client Profile: </li></ul></ul><ul><ul><li>Biotechnology, Pharmaceutical, Medical Device and Healthcare </li></ul></ul><ul><ul><li>Companies in US, Canada, Brazil, India & China. </li></ul></ul><ul><li>Areas of Expertise: </li></ul><ul><li>Contract Manufacture </li></ul><ul><li>Bulk Drugs, API Imports </li></ul><ul><li>Generic Drug Formulation, Development & Validation </li></ul><ul><li>Alliance Management: Identify partners, Due Diligence, Venture Capital </li></ul><ul><li>Country Representation: US, India, Latin America, Europe </li></ul><ul><li>Medical Conventions, Trade Shows, Speakership, Advisory Boards </li></ul><ul><li>Strategic Marketing, New Product Commercialization </li></ul><ul><li>Outsource Clinical Trial Design, Site Management, BA/BE Studies </li></ul><ul><li>Thought Leader Development, Business Intelligence </li></ul><ul><li>Expertise in multiple therapeutic areas </li></ul>
    4. 4. Ambiance Ventures USA
    5. 5. Ambiance Ventures USA FOCUS: Opportunities for GENERICS IN BRAZIL, Latin America: An Overview
    6. 6. Ambiance Ventures USA <ul><li>Generics in Brazil have only 10% of the overall market share (value). </li></ul><ul><li>Domestic generic manufacturers are over-dependent on the domestic market with less participation in foreign markets. </li></ul><ul><li>Argentina, Chile, Cuba, Colombia, Mexico, Peru, Venezuela present significant opportunities for exports from Brazil. </li></ul><ul><li>The Brazilian government has made it mandatory to prescribe generics in the public sector. </li></ul><ul><li>Strengthening of the Brazilian Real has increased the margins of domestic players who import raw materials to manufacture generic drugs. </li></ul><ul><li>The domestic industry mainly focuses on finishing generic pharmaceuticals. </li></ul><ul><li>Significant imports from India, China, EU, Thailand, etc. </li></ul>Environment
    7. 7. Ambiance Ventures USA <ul><li>The biggest opportunities in the generic sector : Antiretroviral drugs. </li></ul><ul><li>Non-bioequivalent “similar drugs” (much cheaper than generics) dominate the market. </li></ul><ul><li>Cardiovascular diseases are the biggest cause of death in Brazil. </li></ul><ul><li>Medley and EMS Sigma are the biggest generic manufacturers in Brazil. </li></ul><ul><li>A number of products are due to lose their patent protection between 2007 and 2012, bringing market opportunities worth US$307.2 million to the generics sector. Key products affected include: Plavix® , Mercilon®, Viagra®, Lipitor® </li></ul><ul><li>In March 2007, ANVISA authorized the registration of generic alternatives to oral contraceptives and endogenous hormones. This sector was valued at US$481 million in 2006 and generic producers are expected to account for 60% by 2012. </li></ul>Environment
    8. 8. Ambiance Ventures USA <ul><li>The Prescribing Challenge in Brazil </li></ul><ul><li>Prescription of generic medicines is still low, representing only 16% of the total in 2006, compared to 15.2% in 2005 or 11.8% in 2002. </li></ul><ul><li>For some specific substances, generic medicines have achieved high prescription levels: </li></ul><ul><ul><li>For instance - Omeprazole (88%), Cephalexin (77%) and Fluconazole (65%). </li></ul></ul>
    9. 9. Ambiance Ventures USA Local Situation: There are approx. 100 producers with registrations for generic medicines in Brazil. Medley and EMS are the leaders (65% combined market share). Eurofarma and Aché (15% combined market share) Problem with sub-bioequivalent products of smaller manufacturers
    10. 10. Ambiance Ventures USA <ul><li>Advantage – Ambiance Ventures, USA </li></ul><ul><li>By partnering with us, local producer will dominate with low prices, imports and production capabilities. </li></ul><ul><li>NEWEST PRODUCTS & FORMULATIONS – Far Superior to existing players! </li></ul><ul><li>Rapid formulation, development and commercialization per US FDA standards </li></ul><ul><li>Client will own the Intellectual Property for formulation, development and manufacture. </li></ul><ul><li>Leverage local know-how to deal with bureaucracy and the government that favors generics. </li></ul><ul><li>Enjoy benefits of local manufacture and exports to other Latin American countries </li></ul><ul><li>Import finished products in Generics, Diagnostics and APIs </li></ul>
    11. 11. Ambiance Ventures USA THE OPPORTUNITY IN BRAZIL & LATIN AMERICA: … ..Right Time, Right Market! (with the Right approach!) Nearly $140 billion of branded products coming off patent by 2016 President of Brazil: The Hon. Luiz Inácio Lula da Silva
    12. 12. Ambiance Ventures USA Blockbusters in Brazil: A number of products are due to lose their patent protection between 2007 and 2012, bringing market opportunities worth US$307.2 million to the generics sector in Brazil In March 2007, ANVISA authorized the registration of generic alternatives to oral contraceptives and endogenous hormones: Valued at US$481 million in 2006 and generic producers are expected to account for 60% by 2012
    13. 13. Ambiance Ventures USA HIV Generics: Market Potential in Brazil Brazil had an estimated HIV population of 620,000 adults and children , with 14,000 individuals dying from AIDS each year. President Lula da Silva has issued a 'compulsory license' that bypasses the patent on the HIV drug Sustiva® (Efavirenz), marketed by Merck & Co. as Stocrin® in developing countries Brazil's will therefore bypass Merck's patent Sustiva® (efavirenz) in order to manufacture it as a lower-priced generic. This will increase therapy-access for many HIV/AIDS patients. The Brazilian Govt. is seeking lower prices to limit the cost of its program providing free treatment to all people in Brazil infected with HIV. Brazil can issue ‘Compulsory Licences’ and allow local generic production of imported Antiretrovirals. Thus far, it has negotiated drug price reductions and encouraged local production under license. ……a great business opportunity for local manufacturers. Brazil will save $30 million this year by purchasing generic Efavirenz and will cut $237 million from its HIV/AIDS drug bill through 2012 ireuld expire
    14. 14. Ambiance Ventures USA <ul><li>Exports of Generic Drugs from Brazil: </li></ul><ul><li>If India, China and Thailand can do it, so can Brazil! </li></ul><ul><li>Exports! Foreign Exchange Revenues! Capitalize on MERCOSUR! </li></ul><ul><li>Major Latin American markets: </li></ul><ul><ul><ul><ul><li>Argentina </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Brazil </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Chile </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Colombia </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Cuba </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Mexico </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Peru </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Venezuela </li></ul></ul></ul></ul><ul><li>These markets represent 500 million people and a GDP of US$3.4 trillion in 2008..Access to medicines in the public sector has increased, particularly among the least well-off population. </li></ul>
    15. 15. Ambiance Ventures USA <ul><li>GOVERNMENT SUPPORT FOR GENERICS IN LATIN AMERICA: </li></ul><ul><li>Remediar - Argentina </li></ul><ul><li>PAC Saúde - Brazil </li></ul><ul><li>Auge - Chile </li></ul><ul><li>Seguro Popular - Mexico </li></ul><ul><li>Barrio Adentro - Venezuela </li></ul><ul><li>Governments will continue using their bargaining power to negotiate drug purchases to contain costs. </li></ul><ul><li>MERCOSUR members have decided to establish a drug price database to compare and monitor drug prices. </li></ul><ul><li>Public drug expenditure in the region expected to rise, as there is a considerable level of unmet demand </li></ul>
    16. 16. Ambiance Ventures USA <ul><li>GENERIC HEALTHCARE PRODUCTS – </li></ul><ul><li>Why Outsource to us? </li></ul><ul><li>Reduce capital expenditure and costs of manufacturing operations </li></ul><ul><li>Patent expiry and generic substitution </li></ul><ul><li>Need to access specialized, economical mfg technology and methods </li></ul><ul><li>Have alternate mfrs in the event of supply interruptions </li></ul><ul><li>Unforeseen increase in demand </li></ul><ul><li>One-stop-shop for all generic product and diagnostics needs </li></ul><ul><li>Our 28-year experience in sourcing for generics, contract mfr, combined </li></ul><ul><li>with buying power in India, China, Thailand, other promising supply </li></ul><ul><li>sources globally. </li></ul>
    17. 17. Ambiance Ventures USA <ul><li>STANDARDS OF MANUFACTURE & REGULATORY COMPLIANCE : </li></ul><ul><li>ISO 9001 </li></ul><ul><li>ISO 13485 </li></ul><ul><li>cGMP </li></ul><ul><li>ANVISA (Brazil) </li></ul><ul><li>FDA (United States) </li></ul><ul><li>EMEA (European Union) </li></ul><ul><li>SAHRPA (South Africa) </li></ul><ul><li>ANMAT (Argentina) </li></ul>
    18. 18. Ambiance Ventures USA
    19. 19. Ambiance Ventures USA <ul><li>READY TO SELL GENERICS, BIOSIMILARS, BIOGENERICS, etc. </li></ul><ul><li>We represent several ANVISA approved manufacturers </li></ul><ul><li>Some are also US FDA, EMEA approved facilities </li></ul><ul><li>Products can be pre-inspected / tested for quality prior to shipping </li></ul><ul><li>CATEGORIES: </li></ul><ul><li>Generic Pharmaceuticals, Biosimilars </li></ul><ul><li>Biogenerics (Cancer, other therapeutic areas) </li></ul><ul><li>Sustained Release Generic Drugs </li></ul><ul><li>Specially Formulated Products </li></ul><ul><li>Lifestyle Products – Obesity, Anti-smoking </li></ul><ul><li>Vaccines – Adult and Pediatric </li></ul><ul><li>Anti-snake venoms </li></ul><ul><li>Point-of-Care Diagnostic Tests, </li></ul><ul><li>In-vitro Diagnostic Tests </li></ul><ul><li>Over-the-counter Remedies (analgesics, cough & cold, laxatives) </li></ul><ul><li>Hospital Supplies </li></ul><ul><li>Physician Office needs </li></ul><ul><li>Miscellaneous: Disposables, Bandages, Syringes, Latex Gloves </li></ul>
    20. 20. Ambiance Ventures USA
    21. 21. Ambiance Ventures USA <ul><li>DISTRIBUTION & PRICING STRUCTURE </li></ul><ul><li>“ Right products at the right price, within quality specs” </li></ul><ul><li>Primary Consumption, Secondary Distribution </li></ul><ul><li>Government Supplies, Private Market </li></ul><ul><li>Drop shipments </li></ul><ul><li>All Customs and Shipping Documentation </li></ul><ul><li>Pricing Variants: </li></ul><ul><li>Name of Product (if branded) or Generic Name </li></ul><ul><li>Indication </li></ul><ul><li>Chemical name or composition </li></ul><ul><li>Form of Product (tablet, capsule, liquid, gel, powder) </li></ul><ul><li>Strength (100mg, 250ml, etc.) </li></ul><ul><li>Quantity per shipment (kgs., litres, units) </li></ul><ul><li>Packaging (drums, bottles, strips, bulk) </li></ul><ul><li>Shipment Packaging requirements (1000 strips/carton, 500 jars/case) </li></ul><ul><li>Labeling Requirements – Compliance </li></ul>
    22. 22. Ambiance Ventures USA <ul><li>DIAGNOSTIC TEST KITS </li></ul><ul><li>Blood Glucose </li></ul><ul><li>Pregnancy </li></ul><ul><li>HIV ( 1 & 2) </li></ul><ul><li>Hepatitis </li></ul><ul><li>Malaria </li></ul><ul><li>Dengue </li></ul><ul><li>Chikungunya </li></ul><ul><li>Syphillis </li></ul><ul><li>TB </li></ul><ul><li>Cardiac Markers </li></ul><ul><li>Dry Chemistry </li></ul><ul><li>Bio-chemistry </li></ul><ul><li>Hematology </li></ul><ul><li>Immunology, Rheumatology </li></ul><ul><li>ELISAs for Body Fluids </li></ul><ul><li>Ideal for Rural Clinics, Pharmacies; can be manufactured ‘Private Label’ </li></ul>
    23. 23. Ambiance Ventures USA OUR SPECIALTY: Leverage low cost contract manufacture at our facilities! NEUTRAL LABEL, PRIVATE LABEL CONTRACT MANUFACTURE: Generics, Cosmetics, Diagnostics Custom Packaging – For Re-distribution Neutral (‘generic drug’) labeling per Ministerio da Saude requirements In Portuguese / English / Spanish (for re-export) Private labeling with your own Brand Name, Company Identity, Compliant with regulations – Pharmacies, HMOs, Export, Secondary Distribution
    24. 24. Ambiance Ventures USA A Division of Ambiance Ventures <ul><li>Offices in Mumbai (Bombay), India: </li></ul><ul><li>Fully staffed office (52 people) </li></ul><ul><li>150,000 sq. feet of Warehouse space </li></ul><ul><li>Cold Chain refrigerated facility: 5000 sq. feet </li></ul><ul><li>Sales and Logistics Office in Manila, Philippines: </li></ul><ul><li>We are Authorized Purchasing Agents for the Govt. of Philippines </li></ul><ul><li>All requirements from India by Philippines Ministry of Health are purchased </li></ul><ul><li>through us – ‘one-stop-shop’ for generics, hospital products from multiple </li></ul><ul><li>suppliers in India </li></ul><ul><li>All logistics is coordinated by Manila office </li></ul><ul><li>All Philippine Govt. tenders are routed through us. </li></ul><ul><li>Affiliate Offices in China: </li></ul><ul><li>Sourcing offices in Guangzhou, Yiwu, Shenzhen, Hong Kong, Shanghai </li></ul><ul><li>Cosmetics, Dental Hygiene Contract Manufacturing Plant in Dubai </li></ul>
    25. 25. Ambiance Ventures USA <ul><li>Our Business Model – </li></ul><ul><li>The Power of Bulk Buying and Bulk Freighting </li></ul><ul><li>28 Years of international business with integrity and efficiency </li></ul><ul><li>One-stop-shop for multiple products resourced from numerous mfrs. </li></ul><ul><li>We specialize in small orders and shipments - consolidated into container loads </li></ul><ul><li>Not all mfrs offer all your requirements. We source for you and consolidate smaller shipments </li></ul><ul><li>Helps our buyers avoid paperwork and transactions with multiple buyers – </li></ul><ul><li>like multiple letters of credit, multiple bills of lading </li></ul><ul><li>We take on the headaches of logistics and excise /customs at port of origin even for smaller shipments to combine loads into affordable freight rates </li></ul>
    26. 26. Ambiance Ventures USA <ul><li>Our Business Model – </li></ul><ul><li>The Power of Bulk Buying and Bulk Freighting </li></ul><ul><li>Our volumes enable us to buy in bulk – hence better pricing, than if you were to direct buy from the manufacturer! </li></ul><ul><li>We pass on the benefits to you! </li></ul><ul><li>We represent the cream of manufacturers from India, China, Thailand, Europe, United States </li></ul><ul><li>All clients we represent are WHO, cGMP compliant, and many are ANVISA, US-FDA or EMEA approved </li></ul><ul><li>We work with you for Due Diligence including your visits to mfg. facilities in Asia for monitoring regulatory compliance, inspections </li></ul><ul><li>You can leverage low cost contract manufacturing at our facilities </li></ul>
    27. 27. Ambiance Ventures USA A Division of Ambiance Ventures <ul><li>We are your Office Address in India </li></ul><ul><li>As our Partner / Client, you may use our offices and warehouse facilities in Mumbai (Bombay) as your own: </li></ul><ul><li>On your Website </li></ul><ul><li>On Letterheads </li></ul><ul><ul><ul><li>In Correspondence and Applications </li></ul></ul></ul><ul><ul><ul><li>During visits to India by you or your clients </li></ul></ul></ul><ul><li>Separate Phone and Fax lines for your company </li></ul><ul><li>Assign a designated rep to respond on your behalf </li></ul>
    28. 28. Ambiance Ventures USA Contact: Jay Nadkarni Ambiance Ventures, USA Swiftwater, Pennsylvania 18370 (USA) Tel: 570/ 460-1804; Fax: 570/ 688-0975 [email_address] Contact: Valerian Lobo LOB International, India G-6 Khira Industrial Estates, B.M. Bhargava Rd. Santa Cruz (W), Mumbai 400 054 (INDIA) Tel: 9122- 2661-5006, 9122-2661-6008 [email_address]