OPV Pharmaceutical JSC

1
OPV Pharmaceutical JSC
Management Presentation
April 2009
2
Agenda

• Background and current project
• Manufacturing Facilities
• Key products
• Otsuka OPV
• Production Contracts with multinationals
• Strategy
• Competitive advantages of OPV

3
OPV Pharmaceutical JSC
4
OPV Background

• Leading pharmaceutical company in Vietnam by
  1975, producing oral solids, oral liquids,
  injectables, and IV solutions.
• Before 1975, OPV was the exclusive licensee for
  importation, distribution, and manufacturing for
  large multinationals, including
• Merck, Upjohn, Warner Lambert, Mead Johnson
• Bayer, Ciba Geigy, Roche, Sandoz
• Nestle (for powder milk and infant formula)
• Former plant of OPV is now part of Central
  Pharmaceutical Factory 24
• Former OPV milk factory (JV with Nestle) is now
  part of Vinamilk

5
OPV Introduction

• A 100 foreign-owned company
• Foreign investment license for a project of US
  20 million to build a GMP pharmaceutical factory
  for the production and distribution of
  pharmaceuticals, IV solutions, and nutritional
  products
• Project of US 20 million
• Factory built in Bien Hoa Industrial Zone II (30
  km from HCMC)
• 2 separate plants on two separate lots of land
• One plant for pharmaceuticals, IV solutions and
  nutritional products (already built)
• One separate plant for expansion projects, such
  as additional specialized production facility and
  a distribution center

6
OPV milestones
OPV is the leading Vietnamese healthcare
organizations and PARTNER OF CHOICE of
multinational companies
7
OPV Management

• Principals of OPV
• Experienced managers in the pharmaceutical
  industry in Vietnam, starting decades pre-1975
  and resuming since 1993
• New and young professional managers
• Expatriates in key positions, with strong
  technical and business training and experience,
  including a number of Overseas Vietnamese
• Vietnamese managers with experience in
  multinational companies

8
OPV present project General Pharmaceutical Plant

• Built area 18,000 m2 on 2 floors
• land area 30,000 m2 with 20,000 m2 for expansion
• Four production areas
• Sterile area for IV solutions and injectables
• Oral solids
• Oral liquids
• Creams and ointments

9
OPV present project General Pharmaceutical Plant
(contd)
10
Facilities in factory Raw material Dispensing
Air Shower
LAF for Mtrls Weighing
11
Facilities in factory Granulation
Granulator FBD
Final Blending
Bulk Transfer
12
Facilities in factory Tabletting
Tablet Compressed
Tablet Coating
13
Facilities in factory Packaging
Blistering
Final Packaging
14
Facilities in factory Cream Ointment Mixing
15
Facilities in factory Cream Ointment Filling
- Liquids Mixing
16
Facilities in factory Liquids Filling and Capping
Bottle Washing
Liquid Filling
Bottle Capping
17
Facilities in factory Labeling and Final
Packaging
18
Facilities in factory Warehouse
Ambient Temperature W/H
Cool Temperature W/H
19
Key Products
Source IMS
20
Key Products
Source IMS
21
Otsuka OPV Joint venture

• In early 2003, OPV formed a 50/50 joint venture
  with Otsuka Pharmaceutical Co., a leading
  pharmaceutical and consumer goods company of
  Japan, and Nomura Trading Co., a large Japanese
  trading company.
• This company, named Otsuka OPV Company, produces
  IV solutions, including amino acids, at the IV
  solutions facilities built in the GMP
  pharmaceutical factory of OPV, for sale and
  distribution in Vietnam.
• This joint venture is the only manufacturer of
  amino acids in Vietnam. Amino acids, which
  previously have been imported only, offer good
  margins, and the competitive advantage of Otsuka
  OPV is strong for this category of products.

22
Production contract manufacturing for
GlaxoSmithKline

• OPV achieved the first GSKs certification in
  2005.
• In 2008, OPV has been approved by Global
  Manufacturing System (GMS) of GSK as their
  regional third party supplier for ASEAN
  countries. This important achievement validates
  the quality of the OPV factory and opens a great
  potential for quality contract manufacturing for
  other MNCs.
• The manufacturing contract with GSK has been
  officially signed on 24 November 2005 with a
  number of guests (government officials, business
  representatives, and doctors)
• The first two approved products - Actifed and
  Zentel have been produced in 2006. The program
  will continue with more products in 2007 and
  following years.

23
Production contract manufacturing for
GlaxoSmithKline

• GSK qualification is a good base for getting
  qualification from other multinational companies
  and from the Drug Administration agencies of
  developed countries, in particular Australia
  (TGA).
• Contract manufacturing with MNCs offers us
  opportunities to access their quality management
  system (QMS) and their worldwide procurement
  network.
• In 2008, additional 30 products will be
  manufactured for GSK for the next few years.

24
Phase II Project

• OPV is considering some Phase II projects to
  leverage the past investments and operating
  experience and take advantage of opportunities in
  the market.
• One promising Phase II project is the development
  of the production of low-volume injectables in
  the area of the factory already built for sterile
  pharmaceutical production. The production of
  sterile products is not widely available in
  Vietnam, and there is a potential for export to
  developed markets, such as Europe.
• Another project under study for Phase II is the
  building of a cephalosporin manufacturing
  facility (injectables and orals) in a separate
  lot of land in the same industrial zone-- by
  international GMP standards.
• Another potential project in the future is to
  develop a distribution network for the products
  of the company, such as a chain of retail
  pharmacies.

25
Quality standards

• Current international GMP - WHO standards
• The quality of the OPV factory has been confirmed
  by the approval of the factory by GlaxoSmithKline
  after over a year of intensive quality audit by
  GSK audit teams.
• Conceptual design by the large US engineering
  firm of Fluor Daniel
• Detailed design reviewed by Pharmaplan, a leading
  German pharmaceutical consulting firm, for GMP
  compliance

26
Quality standards (contd)

• Most of process equipments are from leading
  European and American manufacturers.
• The entire IV solutions line is assembled,
  integrated and fabricated by the Swedish firm of
  Getinge, the world leading manufacturer of
  sterilizers (autoclaves).
• Critical construction materials are imported from
  specialized suppliers for example, epoxy
  materials and panels for clean-rooms.
• Construction follows high standards.
• Construction manager British citizen with over
  30 years of international experience in managing
  construction of large technical projects.
• In 2005, the factory of OPV was approved by
  GlaxoSmithKline as a contract manufacturer for
  GSK, after over one year of stringent quality
  audits by this leading pharmaceutical company.

27
Guiding Principle of OPV

• Technology of the World and Tradition of Vietnam

• To think global, to adopt the appropriate
  technologies and the best technical and
  managerial practices of the world,
• and at the same time
• To act local, to know the business conditions of
  Vietnam, and to leverage the strengths of Vietnam
  and the Vietnamese people.

28
OPV Quality statement

• We are dedicated to achieving the highest levels
  of quality in product development, manufacture,
  supply and sale to satisfy our customers, every
  time and in all aspects. We strive for quality
  excellence in all we think, say and do.

29
GMP Certifications

• ASEAN GMP Certified
• GMP Certification 13/2003/CN-QLD, Dated May
  30,2003
• GLP Certification 16/2003/CN-QLD, Dated May
  30,2003
• GSP Certification 33/2003/CN-QLD, Dated Nov
  25,2003
• WHO GMP Certified
• Certificate No. 115/CN-QLD, Dated Jun. 24,
  2005
• TGA Certification (Australian GMP)
• Validation expected in the 2nd quarter of 2009
• FDA Certification (US GMP)
• Validation expected in the 1st quarter of 2010

30
Competitive advantages of OPV
1
7
High quality manufacturing facility
Growing management capabilities
2
6
Large production capacities for many types of
pharmaceutical products
Strong government support
3
5
High capabilities for international cooperation
Strong image and reputation
4
Local experience and connections
31
Competitive strategy

• Manufacture and market international quality
  products with customer-oriented value offerings
  (in terms of price, packaging, and service)
• Build strong company brands on basis of quality,
  wide product portfolio, and modern professional
  marketing
• Develop strategic partnerships with international
  companies (such as with Otsuka, GlaxoSmithKline
  and other MNCs)

32
Product strategy

• Large portfolio of products in all major market
  segments (to take advantage of the large
  production and marketing capabilities)
• Ethical drugs
• Consumer health products, such as OTCs and
  personal care products
• Nutraceutical products
• Brand marketing to build the company brand and
  product brands
• Value pricing to price products to reflect
  quality, service and brand image (higher than
  local commodity products and lower than
  original products of international companies)

33
Channel and Distribution Strategy

• Market through all major medical and
  pharmaceutical channels
• Hospitals
• Doctors and private clinics
• Pharmacies
• Direct distribution through the companys own
  distribution system (for major cities, in
  particular HCMC)
• Distribution through agents in provinces.

1
2
3
34
Marketing and Promotion strategy

• Build brands through professional brand marketing
  (professional selling, modern advertising
  methods, and effective local promotion programs)
  rather than compete on price.
• Focus on quality, service and brand image (for
  both company and products)

1
2
35
International Cooperation

• OPV is continuously looking for opportunities to
  cooperate with multinational pharmaceutical
  companies.
• Cooperation can relate to marketing,
  distribution, manufacturing and technology
  transfer.
• OPV has had extensive experience in working with
  multinational companies and meeting the high
  requirements of quality assurance and
  professional relationships.

36
Thank You