branded generic for la ( all slide deck) 2 26 pdf

BRANDED GENERICS: NEW AVENUE FOR RX EXPANSION INTO EMERGING

MARKETS FEBRUARY 27-28, 2012

HUB CIRA CENTER IN PHILADELPHIA, PA

D A I S Y R I V E R A - M U Z Z I O , R . P H , M S , M B A P R E S I D E N T

A C U M E N B I O P H A R M A , L L C

Business, IP, and Clinical Strategies for Expansion into

Latin America with Branded Generics

Panel Members

Elias Rios Navarro-Intellectual Property - Arochi, Marroquin& Lindner - Mexico

Ana Claudio Mamede- Intellectual Property - Danneman Siemsen, Biger & Ipanema Moreira - Brazil

Janet Mora-Regulatory & Marketing – Link Pharma

Woody Bryan - Business Development - Supernus Pharmaceuticals

Daisy Rivera-Muzzio - Business Development & Intellectual Property -Acumen BioPharma

What is a branded generic in the US?

Off Patent drug molecule

New Dosage form

Differentiated drug delivery system

New Product Strength

New combination of API’s

Intellectual property

Formulation /Manufacturing Process

Components

New Indication(s)

Technology

Method of Use

Regulatory

NDA- 505 (b) (2)

Clinical studies to support label information

3-5 years market exclusivity

A novel invention

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February 27-28, 2012

Differences between Branded vs. Commoditized Generics


Require clinical studies

Not necessarily bioequivalent to the innovator

Distribution channels- Requires commercial promotional strategies

Premium Price

More expensive development

Proprietary technology

May have market exclusivity 3-5 years

It is NOT an Authorized Generic

Branded generics: Rest of the world

¡  Value added or Branded generics also exists in the rest of the world, different regulations applied and a real benefit to the patient must be proven to get premium price approval in those countries with drug product price regulations

¡  A generic product can be commercialized under a brand or trade name following retail promotion strategies similar to those of innovator products. Examples: Greece, France, Spain, Eastern EU, Latin America


FDA and UK’s National Health Services ( NHS) Definition of Branded Generics

“Prescription products that are either

1) novel dosage forms of off-patent products produced by a manufacturer that is not the originator of the molecule,

or

2) a molecule copy of an off-patent product with a trade name”.


Examples of Branded Generics- US

Intermezzo offers a new dosage form, new strengths and new indication for off patent molecule-(middle of the night awakening)

Tirosint is the first and only T4 therapy in a liquid gel cap formulation

The NitroMist Aerosol Delivery System Unique aerosol delivery system that maintains the potency and stability of nitroglycerin for up to 36 months (or approximately 230 sprays)

Suprenza is the first and only orally disintegrating tablet(ODT) phentermine formulation.


Generic Evolution

�  “The generics makers that will grow most are those that focus on higher-tech formulations and specialty drugs, rather than the easily commoditized tablets and capsules common in primary care. The trend is shifting towards less competitive, yet commercially attractive segments such as difficult-to-produce generics, specialty generics and biosimilars.”

Frost & Sullivan

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Source: EMC managers, BSCH, BBVA, JPM, DB 9

Global Growth - 2003-2012E(%)


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2008 sales $28.8 bn

$11.4 bn

$7.8 bn

$3.0 bn

$4.0 bn Expected growth >70% in 5 years: • Launch of new products, • Increased out of pocket

spending • Public demand for quality

pharmaceuticals Steady population growth of 1%, and a balanced sex ratio 10 % of the population is over 60 years old Non-communicable diseases especially neuropsychological and CVS disorders cause more casualties in LA than communicable diseases

Resistors to growth: • Compulsory Licensing ( Brazil) • Intellectual property Annulment

( Venezuela) • Prohibition of use of second patents Characteristics of generic drug policy in Latin America: • Lack of separate generic approval protocol • Absence of a link between patent and

regulatory agencies impedes the flow of knowledge regarding the authorization of infringing products;

• Lack of sufficient data exclusivity enables generic players to access clinical data for development of generics;

• Bioequivalence is not a mandatory requirement for generic approval in many Latin American countries

• Drug pricing Regulated by Government agencies

Gro

wth

Opp

ortu

niti

es

Resistors to grow

th

Latin America, Pharmaceutical Market


11

Country-wise sales Forecasts, 2008-2014


Latin America Pharmaceutical Market Outlook to 2014- Business insight

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Forecast Sizes of Latin American Markets



13

SWOT - Latin American Regulatory Landscape



14

Clinical Trials in Latin America



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PhRMA Special 301 submission regarding Latin America, 2009


Panel Discussion

� Discovering opportunities in the Latin American markets for branded generics drugs

�  Comparing IP and patent compliance in Latin America vs. the United States

�  Filling the gaps in the approval process for clinical trial initiated in Latin America

Daisy Rivera-Muzzio

Janet Mora Woody Brian

Ana Claudia Mamede Carneiro

Elias Rios Navarro

Acumen BioPharma Moderator

Link Pharma Regulatory & Marketing

Supernus Business Development

Dannemann-Siemsen, Bigler & Ipanema Moreira Intellectual Property- Brazil

Arochi, Marroquin& Lindner Intellectual Property- Mexico

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Panel Discussion

•  WHAT IS THE MARKET OPPORTUNIT Y FOR BRANDED GENERICS IN L ATIN AMERICA ?

•  WHAT ARE THE RISKS ASSOCIATED WITH BRINGING A PATENTED PROTECTED PRODUCT IN LATIN AMERICA

•  WHAT ARE THE STRATEGIES TO HAVE A SUCCESSFUL COMMERCIALIZATION OF THESE PRODUCTS IN LA?

• 


Intellectual Property Assessment for Branded Generics in Mexico

Elias Rios Navarro

[email protected]

Mexico.-‐ Marke5ng Authoriza5on

API Patent Expired

Secondary Patent

API Special forms

Linkage

Pharm Composi@on

Linkage by li@ga@on

Process No linkage

Marke@ng Authoriza@on Granted to No patent holder

In force

Sales Preliminary Measures

IP infringement Before MX PTO

No nullity Infringement

Damages Lost Profits 40%> + Fine

Cancelled

Bond

Counterbond

Sales Nullity Trial / Const. Action

PTO Decision

No nullity No Infringement

Nullity No Infringement

Execu@on of the bond

Counter claim

Civil Courts

dannemann.com.br © 2012 Dannemann Siemsen. All rigths reserved. 20

BRANDED GENERICS: New Avenue for Rx Expansion Into Emerging Markets

February 27-‐28, 2012 Hub Cira Center in Philadelphia, PA

Intellectual Property Issues

Ana Claudia Mamede Carneiro

© 2012 Dannemann Siemsen. All rights reserved.


BRAZIL -‐ Prosecu@on of patent cases §  Steps:

§  Request for examina5on: 3 years from filing date §  Third par5es may file a pre-‐grant opposi5on §  If allowed by PTO, for pharmaceu5cal cases, the applica5on will be sent to ANVISA (Sanitary Agency) for prior consent:

•  If ANVISA allows, the case will return to PTO (final fees) •  If ANVISA rejects, …

§  If rejected by PTO, an appeal is applied •  If the PTO allows, the case will be sent to ANVISA for prior consent

•  If the PTO rejects, the administra5ve instance will be ended §  Third par5es may file a post-‐grant opposi5on


BRAZIL -‐ Prosecu@on of patent cases

§  Backlog of 8-‐10 years for the publica5on of a first technical opinion

§  No difference between the different technical fields


BRAZIL -‐ Prosecu@on of patent cases

q  Patent Office hired approximately 350 new examiners

q  Faster prosecu5on expected

q  Fast track q  Poten5al infringement cases (warning le[er to the alleged infringer)

q  Ar5cle 40 of IP law – Minimum 10 year patent term as of grant


BRAZIL -‐ ANVISA’s prior consent

q  Provisional Measure # 2006 of Dec 14, 1999

q  Law # 10,196 of Feb 14, 2001

q  Art. 229-‐C of the IP Law 9279/96

§  “grant of patents to pharmaceu5cals products and processes are subject to prior approval by ANVISA”


BRAZIL -‐ Prior approval (ANVISA)

q  Since 2003 examining substan5ve patentability criteria

q  Grounds for non-‐approval

q  lack of novelty and/or inven5ve step

q  lack of enablement

q  addi5on of new ma[er

q  second use = discovery

q  mandatory restric5on of scope of Markush-‐type claims


BRAZIL -‐ Recent Developments (ANVISA)

q  A[orney General’s Office (AGU) Opinions (2011)

q  Recent decision from the Federal Court of Brasília

“The men(oned rule [art. 229-‐C] is uncons(tu(onal since it wrongfully revokes ar(cle 4 quarter of the Paris Union Conven(on, lacking reasonability, and also duplicates the technical examina(on for patentability unnecessarily and unreasonably, a rule that is both internal and conven(onal and that executes a cons(tu(onal order to protect patent rights as a fundamental guarantee.”

(Astrazeneca v. ANVISA and BPTO – Court Ac5on n.29724-‐20.2010.4.01.3400, 01.12.2011, 8th Federal Court)


ANVISA’s recent publications

DOU 04.07.2011 DOU 07.10.2011 DOU 07.11.2011

Total 23 41 8

Approval 13 41 8

Straight 13 35 2

After rebuttal 0 3* 0

After compliance of office action 0 1 2

After appeal 0 2 4

Rejection 10 0 0

* 1) lack of enablement (Article 25 - IPL); 2) lack of inventive step (Article 13 - IPL); e 3) restriction to the content of the examples (Articles 24 and 25 - IPL)


BRAZIL – Non-‐patentable maders

§  Non-‐patentable

§  Therapeu5c, surgical and diagnos5c methods applied to human or animal bodies

§  Living beings and parts thereof, including cells even if modified

§  Naturally occurring biological material, even if isolated •  Microorganisms •  Extracts and substances •  DNA/RNA sequences

§  Second medical use (PTO accepts, but ANVISA does not)


BRAZIL -‐ Access to Brazilian biodiversity

§  Since 2000, mandatory authoriza5on to perform R&D in and to manufacture products derived from plants and animals of the Brazilian biodiversity

§  Indica5on of source of gene5c resource and access authoriza5on number through recent PTO`s office ac5ons based on Norma5ve Acts

§  Relevant fines were applied on companies


Thank you! [email protected]

Janeth Mora LinkPharma LLC

The Cira Hub Center

Philadelphia, February 27, 2012

Key Regulatory Requirements Brazil

(ANVISA) Mexico

(COFEPRIS) Argen@na (ANMAT)

Bioavailability study (if changes to innovator)

If approved in Reference country

Bioequivalence (with reference product)

If approved in Reference country

Good Manufacturing Prac@ces Inspec@on visit

Stability in Zone IVB

Cer@ficate of Pharmaceu@cal Product (CPP)

Take away Points

�  An effective due diligence to develop your own branded generic strategy in Latin America should consider : ¡  Local partnerships ¡  Collaborations with the government ¡  Understanding of markets unmet needs ¡  Innovative manufacturing technology to drive low cost ¡  Local partners are interested in manufacturing rights ¡  Regulatory Process is decentralized ¡  Prior FDA/ EMA approval could be leveraged ¡  Previous research of local patent standing ¡  Limit on royalties on technology transfers/ licensing

transactions

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FOR ADDIT IONAL INFORMATION

DR .MUZZ IO@ACUMENB IOPHARMA .COM

WWW.ACUMENB IOPHARMA .COM

Thank you Obrigada

Gracias

branded generic for la ( all slide deck) 2 26 pdf

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