focus on brazil 1.6

AmbianceVenturesUSA

Focus on Brazil & Latin AmericaFocus on Brazil & Latin America

AmbianceVentures USA

Ambiance Ventures USAAmbiance Ventures USA INTRODUCTIONINTRODUCTION

Pennsylvania, US-based International Consulting Company with offices and operations in India, Philippines and Dubai. Affiliates in China.

Specialized in Business Development and Exports of Life Science products – Generics, Biologics, Diagnostics

End-to-end solution:

GENERICS, BIOSIMILARS & BIOGENERICS– Formulation, Analytical Development

– Import APIs, Finished Products, POC / In-vitro Diagnostics

– Contract Manufacture

– Neutral Label & Private Label Manufacture

– Global Marketing Assistance


Strategic Consulting & Market Development Strategic Consulting & Market Development

Client Profile:Client Profile:Biotechnology, Pharmaceutical, Medical Device and HealthcareBiotechnology, Pharmaceutical, Medical Device and Healthcare

Companies in US, Canada, Brazil, India & China.Companies in US, Canada, Brazil, India & China.

Areas of Expertise:Areas of Expertise:

Contract ManufactureBulk Drugs, API Imports

Generic Drug Formulation, Development & Validation

Alliance Management: Identify partners, Due Diligence, Venture CapitalCountry Representation: US, India, Latin America, Europe

Medical Conventions, Trade Shows, Speakership, Advisory Boards

Strategic Marketing, New Product CommercializationOutsource Clinical Trial Design, Site Management, BA/BE Studies

Thought Leader Development, Business IntelligenceExpertise in multiple therapeutic areas


FOCUS:FOCUS:

Opportunities for GENERICS IN Opportunities for GENERICS IN BRAZIL, Latin America:BRAZIL, Latin America:

An OverviewAn Overview


•Generics in Brazil have only 10% of the overall market share (value).

•Domestic generic manufacturers are over-dependent on the domestic

market with less participation in foreign markets.

•Argentina, Chile, Cuba, Colombia, Mexico, Peru, Venezuela present

significant opportunities for exports from Brazil.

•The Brazilian government has made it mandatory to prescribe generics in

the public sector.

•Strengthening of the Brazilian Real has increased the margins of domestic

players who import raw materials to manufacture generic drugs.

•The domestic industry mainly focuses on finishing generic pharmaceuticals.

•Significant imports from India, China, EU, Thailand, etc.

EnvironmentEnvironment


•The biggest opportunities in the generic sector : Antiretroviral drugs.

• Non-bioequivalent “similar drugs” (much cheaper than generics) dominate the

market.

•Cardiovascular diseases are the biggest cause of death in Brazil.

•Medley and EMS Sigma are the biggest generic manufacturers 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. Key

products affected include: Plavix® , Mercilon®, Viagra®, Lipitor®

•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.

EnvironmentEnvironment


The Prescribing Challenge in BrazilThe Prescribing Challenge in Brazil

•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.

•For some specific substances, generic medicines

have achieved high prescription levels:

oFor instance - Omeprazole (88%), Cephalexin

(77%) and Fluconazole (65%).


Local Situation: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


Advantage – Ambiance Ventures, USAAdvantage – Ambiance Ventures, USA

•By partnering with us, local producer will dominate with low prices, imports

and production capabilities.

•NEWEST PRODUCTS & FORMULATIONS – Far Superior to existing players!

•Rapid formulation, development and commercialization per US FDA standards

• Client will own the Intellectual Property for formulation, development and

manufacture.

•Leverage local know-how to deal with bureaucracy and the government that

favors generics.

•Enjoy benefits of local manufacture and exports to other Latin American

countries

•Import finished products in Generics, Diagnostics and APIs


THE OPPORTUNITY IN BRAZIL THE OPPORTUNITY IN BRAZIL & LATIN AMERICA:& LATIN AMERICA:

……..Right Time, Right Market!..Right Time, Right Market!(with the Right approach!)(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


Blockbusters in Brazil: 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

Key Products:Key Products:Plavix® in 2007 (US$ 41 million)Mercilon® in 2009 (US$58 million)Viagra® in 2011(US$73 million)Lipitor® in 2011 (US$54 million)

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


HIV Generics: Market Potential in BrazilHIV Generics: Market Potential in BrazilBrazil 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 2012ireuld expire


Exports of Generic Drugs from Brazil:Exports of Generic Drugs from Brazil:

•If India, China and Thailand can do it, so can Brazil!If India, China and Thailand can do it, so can Brazil!•Exports! Foreign Exchange Revenues! Capitalize on MERCOSUR!Exports! Foreign Exchange Revenues! Capitalize on MERCOSUR!

Major Latin American markets: Major Latin American markets: •ArgentinaArgentina•BrazilBrazil•ChileChile•ColombiaColombia•CubaCuba•Mexico Mexico •PeruPeru•VenezuelaVenezuela

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.


GOVERNMENT SUPPORT FOR GENERICS IN LATIN GOVERNMENT SUPPORT FOR GENERICS IN LATIN AMERICA:AMERICA:

•Remediar - ArgentinaRemediar - Argentina•PAC Saúde - BrazilPAC Saúde - Brazil

•Auge - ChileAuge - Chile•Seguro Popular - Mexico Seguro Popular - Mexico •Barrio Adentro - VenezuelaBarrio Adentro - Venezuela

•Governments will continue using their bargaining power to negotiate drug purchases to contain costs. •MERCOSUR members have decided to establish a drug price database to compare and monitor drug prices. •Public drug expenditure in the region expected to rise, as there is a considerable level of unmet demand


GENERIC HEALTHCARE PRODUCTS – GENERIC HEALTHCARE PRODUCTS – Why Outsource to us?Why Outsource to us?

•Reduce capital expenditure and costs of manufacturing operations

•Patent expiry and generic substitution

•Need to access specialized, economical mfg technology and methods

•Have alternate mfrs in the event of supply interruptions

•Unforeseen increase in demand

•One-stop-shop for all generic product and diagnostics needs

•Our 28-year experience in sourcing for generics, contract mfr, combined with buying power in India, China, Thailand, other promising supply sources globally.


STANDARDS OF MANUFACTURE & REGULATORY COMPLIANCESTANDARDS OF MANUFACTURE & REGULATORY COMPLIANCE::

•ISO 9001

•ISO 13485

•cGMP

•ANVISA (Brazil)

•FDA (United States)

•EMEA (European Union)

•SAHRPA (South Africa)

•ANMAT (Argentina)


READY TO SELL GENERICS, BIOSIMILARS, BIOGENERICS, etc.READY TO SELL GENERICS, BIOSIMILARS, BIOGENERICS, etc.

We represent several ANVISA approved manufacturersSome are also US FDA, EMEA approved facilitiesProducts can be pre-inspected / tested for quality prior to shipping

CATEGORIES:CATEGORIES:

Generic Pharmaceuticals, BiosimilarsBiogenerics (Cancer, other therapeutic areas)Sustained Release Generic DrugsSpecially Formulated ProductsLifestyle Products – Obesity, Anti-smokingVaccines – Adult and PediatricAnti-snake venomsPoint-of-Care Diagnostic Tests, In-vitro Diagnostic TestsOver-the-counter Remedies (analgesics, cough & cold, laxatives)Hospital Supplies Physician Office needsMiscellaneous: Disposables, Bandages, Syringes, Latex Gloves


DISTRIBUTION & PRICING STRUCTUREDISTRIBUTION & PRICING STRUCTURE“Right products at the right price, within quality specs”

•Primary Consumption, Secondary Distribution•Government Supplies, Private Market•Drop shipments•All Customs and Shipping Documentation

Pricing Variants:Pricing Variants:

Name of Product (if branded) or Generic NameIndicationChemical name or compositionForm of Product (tablet, capsule, liquid, gel, powder)Strength (100mg, 250ml, etc.)Quantity per shipment (kgs., litres, units)Packaging (drums, bottles, strips, bulk)Shipment Packaging requirements (1000 strips/carton, 500 jars/case)Labeling Requirements – Compliance


DIAGNOSTIC TEST KITSDIAGNOSTIC TEST KITS

•Blood Glucose Blood Glucose •Pregnancy Pregnancy •HIV ( 1 & 2)HIV ( 1 & 2)•HepatitisHepatitis•MalariaMalaria•DengueDengue•ChikungunyaChikungunya•SyphillisSyphillis•TBTB•Cardiac MarkersCardiac Markers•Dry ChemistryDry Chemistry•Bio-chemistryBio-chemistry•HematologyHematology•Immunology, RheumatologyImmunology, Rheumatology•ELISAs for Body FluidsELISAs for Body Fluids

Ideal for Rural Clinics, Pharmacies; can be manufactured ‘Private Label’


OUR SPECIALTY:OUR SPECIALTY:Leverage low cost contract manufacture at our facilities!

NEUTRAL LABEL, PRIVATE LABEL CONTRACT MANUFACTURE:NEUTRAL LABEL, PRIVATE LABEL CONTRACT MANUFACTURE:Generics, Cosmetics, Diagnostics

Custom Packaging – For Re-distribution

Neutral (‘generic drug’) labeling per Ministerio da Saude requirementsIn Portuguese / English / Spanish (for re-export)

Private labeling with your own Brand Name, Company Identity, Compliant with regulations – Pharmacies, HMOs, Export, Secondary Distribution


A Division of Ambiance Ventures

Offices in Mumbai (Bombay), India:•Fully staffed office (52 people)•150,000 sq. feet of Warehouse space•Cold Chain refrigerated facility: 5000 sq. feet

Sales and Logistics Office in Manila, Philippines:We are Authorized Purchasing Agents for the Govt. of Philippines•All requirements from India by Philippines Ministry of Health are purchasedthrough us – ‘one-stop-shop’ for generics, hospital products from multiple suppliers in India•All logistics is coordinated by Manila office •All Philippine Govt. tenders are routed through us.

Affiliate Offices in China:Sourcing offices in Guangzhou, Yiwu, Shenzhen, Hong Kong, Shanghai

Cosmetics, Dental Hygiene Contract Manufacturing Plant in Dubai


Our Business Model – Our Business Model – The Power of Bulk Buying and Bulk FreightingThe Power of Bulk Buying and Bulk Freighting

•28 Years of international business with integrity and efficiency

•One-stop-shop for multiple products resourced from numerous mfrs.

•We specialize in small orders and shipments - consolidated into container loads

•Not all mfrs offer all your requirements. We source for you and consolidate smaller shipments

•Helps our buyers avoid paperwork and transactions with multiple buyers – like multiple letters of credit, multiple bills of lading

•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


Our Business Model – Our Business Model – The Power of Bulk Buying and Bulk FreightingThe Power of Bulk Buying and Bulk Freighting

•Our volumes enable us to buy in bulk – hence better pricing, than if you were to direct buy from the manufacturer!

•We pass on the benefits to you!

•We represent the cream of manufacturers from India, China, Thailand, Europe, United States

•All clients we represent are WHO, cGMP compliant, and many are ANVISA, US-FDA or EMEA approved

•We work with you for Due Diligence including your visits to mfg. facilities in Asia for monitoring regulatory compliance, inspections

•You can leverage low cost contract manufacturing at our facilities


A Division of Ambiance Ventures

We are We are youryour Office Address in IndiaOffice Address in India

As our Partner / Client, you may use our offices and warehouse facilities in Mumbai (Bombay) as your own:

On your WebsiteOn your WebsiteOn LetterheadsOn Letterheads

In Correspondence and ApplicationsIn Correspondence and ApplicationsDuring visits to India by you or your clientsDuring visits to India by you or your clients

Separate Phone and Fax lines for your company

Assign a designated rep to respond on your behalf


Contact: Jay NadkarniContact: Jay NadkarniAmbiance Ventures, USAAmbiance Ventures, USA

Swiftwater, Pennsylvania 18370 (USA)Tel: 570/ 460-1804; Fax: 570/ 688-0975

[email protected]

Contact: Valerian LoboContact: Valerian LoboLOB International, IndiaLOB International, India

G-6 Khira Industrial Estates, B.M. Bhargava Rd.Santa Cruz (W), Mumbai 400 054 (INDIA)

Tel: 9122- 2661-5006, [email protected]

mailto:[email protected]

focus on brazil 1.6

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