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Tools and Strategies for Launching a Successful Generic in Today’s
Tools and Strategies for Launching a Successful Generic in Today’s
TOP 10 COMPANIES BY NUMBER OF PATENT CHALLENGES
TOP 10 COMPANIES BY NUMBER OF PATENT CHALLENGES
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Tools and Strategies for Launching a Successful Generic in Todays Ultra Competitive Environment

содержание презентации «Tools and Strategies for Launching a Successful Generic in Todays Ultra Competitive Environment.ppt»
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1Tools and Strategies for Launching a 14time to changes in market dynamics
Successful Generic in Today’s Ultra Potential delays due to regulatory issues
Competitive Environment. KATE KUHRT BERLIN Potential loss of IP Challenges with
SEPTEMBER 27, 2008. managing long-distance relationships.
2BEST OF TIMES… Population all over the 15COPING STRATEGIES: SOURCING API FROM
world getting older Increase in the size LOWER-COST COUNTRIES. Examples Teva,
of middle class in many countries Apotex, Watson has been sourcing from
Governments and employers promoting use of India for years Indian companies
generic drugs in efforts to slow down increasingly sourcing out of China Pros
increase in health care spending Increased Cost savings Many qualified API sources to
acceptance of generic drugs by patients choose from Cons Many API sources with
and physicians A number of blockbusters limited track record FDA inspections more
losing patent protection. lax overseas? Language barrier QA costs
3…AND WORST OF TIMES. Innovation Potential shortages due to stricter
drought ANDA backlog and authorized enforcement of local environmental laws.
generics Pressure on prices and 16COPING STRATEGIES: SOURCING API FROM
diminishing margins Government regulation LOWER-COST COUNTRIES (cont). +33. Change
Consolidation among wholesalers and from 2006. +7. +2. +4. -1. +2. Source:
retailers Increased competition Generic Newport Strategies Horizon Global ™.
filings and approvals at all-time high A 17COPING STRATEGIES: FOCUS ON NICHE
number of new entrants, many from India, PRODUCTS. Examples Ranbaxy, DRL eyeing
often with access to low-cost APIs Bradley Pharmaceuticals (dermatology) Pros
Overcapacity in manufacturing Focus on Less competition Margins in difficult
market share rather than bottom line formulations likely to remain higher
Authorized generics in the U.S. Inhaled products, certain injectables,
4ANDA APPROVALS BY INDIAN GENERICS. controlled release Cons Even $20M products
*Through August 15, 2007. Source: Newport attracting interest If multiple generics
Strategies’ Horizon Global system. get involved, may not recoup investment
52007 YTD FINAL ANDA APPROVALS BY Costly barriers to entry for certain
COUNTRY. *Through August 15, 2007. Source: products.
Newport Strategies’ Horizon Global system. 18COPING STRATEGIES: INNOVATION. New
6ARE THE GENERICS INDUSTRT’S GOLDEN formulations Andrx – Altoprev
YEARS OVER? Expectation that only the (controlled-release lovastatin) Ranbaxy –
fittest will survive Coping strategies Riomet (metformin oral solution) New
aimed at: Reducing cost Reducing risk molecules Best known examples: Pliva –
Improving speed to market Differentiation Zithromax (azithromycin), Teva – Copaxone
Achieving critical mass. (glatiramer) Ranbaxy expects to be the
7COPING STRATEGIES: CONSOLIDATION. first Indian pharma co to launch a new NCE
Consolidation expected to continue in (exp. 2011) Pros Potential for big returns
pursuit of Top-line growth Opportunities during patent and exclusivity period Cons
in new markets Synergies Example: Barr’s Original R&D very expensive and risky:
acquisition of Pliva Biogenerics New dose It may take 1000s of failures before a
forms Presence in emerging markets Access successful NCE Possible reimbursement
to API Result: Industry will likely be issues and higher marketing costs for
dominated by a handful of global players “generic plus” products.
plus many small, focused players. 19COPING STRATEGIES: PARAGRAPH IV PATENT
8LEAGUE TABLES ARE CONSTANTLY SHIFTING. CHALLENGES. Pros Generic companies can
Source: TS Research. make a considerable amount of money during
9COPING STRATEGIES: GEOGRAPHIC the 180-day exclusivity period
DIVERSIFICATION: EUROPE. Recent Examples First-to-market generic company often
Barr-Pliva Mylan-Merck Generics maintains a big market share even after
Hospira-Mayne DRL-Betapharm the end of the exclusivity Cons Expensive
Matrix-Docpharma Ranbaxy-Terapia and risky Authorized generics and shared
Aurobindo-Milpharm Alkem close to buying exclusivity reduce the potential payoff
two firms in UK and Germany Pros from the initial 180 days.
Counterweight to the U.S. market Some 20PARAGRAPH IV PATENT CHALLENGES. As of
markets still focused on branded generic September 7, 2007, challenges on products
Rapid growth of pharma industry in E. encompassing 341 unique brand names 282
Europe and Russia Cons Some markets as unique molecules or molecule combinations
competitive as U.S. Generic uptake high at 48 unique dose forms In 2006, 27 molecules
the expense of margins. (or new combinations) first were exposed
10COPING STRATEGIES: GEOGRAPHIC to patent challenges So far in 2007, 17
DIVERSIFACTION: JAPAN. Pros Japanese molecules (or combinations) have seen
generics market seen as having a their first patent challenges. Source:
tremendous growth potential Currently 5% FDA, Newport Strategies Horizon Global ™.
by value, 17% by volume Cons Some still 21TOP 10 COMPANIES BY NUMBER OF PATENT
skeptical about actual market potential CHALLENGES. Source: Newport Strategies
Difficult for foreign companies to do it Horizon Global ™.
alone Acquisitions, JVs, and marketing 22IMPORTANCE OF API IN PATENT
agreements provide ready access to: CHALLENGES. Risk of supplier failure is
Manufacturing Marketing Distribution high for companies involved with patent
relationships. challenges Even one day of delay can cost
11COPING STRATEGIES: GEOGRAPHIC the company FTF status Risk is also high
DIVERSIFACTION: JAPAN. Acquisitions Zydus for API manufacturers Generics may settle
Cadila acquired a 100% stake in Nihon with innovators or do deals with other
Universal Yakuhin in April 2007 Joint generics who use other API sources If dose
Ventures In November 2005, Ranbaxy company is backward integrated into API,
increased equity stake in Nippon Chemiphar may switch to internal API source when
from 10% to 50% Marketing Agreements In convenient If development starts too
August 2005, Lupin entered into a early, product may be withdrawn from
long-term marketing agreement with Kyowa market Backward integration into API may
Pharmaceutical In March 2006, provide crucial advantages Coordinated API
Hospira-Taiyo agreement to sell each and dose development Coordinated
other’s injection agents Additional regulatory submissions Speedy addressing
companies to watch Continued speculation of any issues Improved knowledge of
that Teva will eventually acquire a polymorphs.
Japanese firm Rumors that one of the three 23INDIAN COMPANIES (*) ARE CLEARLY
large generics (Nichi-iko, Sawai, Towa) BASING THEIR PARAGRPH IV STRATEGY ON
will come under part ownership by a large BACKWARD INTEGRATION. Source: Newport
multinational Torrent Pharma opened a Strategies Horizon Global ™.
fully-owned subsidiary in Yokohama in 24COPING STRATEGIES: SOPHISTICATED
April 2006 Dr. Reddy's considering setting PRODUCT SELECTION. Companies need to pick
up an office in Tokyo or Osaka. products for development very carefully It
12COPING STRATEGIES: BACKWARD is not enough to look at sales data! Data
INTEGRATION INTO API. Recent examples Needs during Product Selection. Sales Dose
Mylan-Matrix Barr-Pliva Pros More control Form and Strength Patents, Patent
over cost and access to API Decreasing Challenges Labeling Chemistry, Synthesis
number of established API manufacturers Data Exclusivity Market Exclusivity.
still independent due to M&A Different Approvals API Sources Company Data
parts of the value chain may make money in Manufacturing Capabilities Bioequivalence
different products Faster response times Stability. Pharmacodynamics Toxicity
Cons No one plant can make all APIs Country Regulations Pack Pricing
required by a typical generic Making just Reimbursement.
enough for captive use often not 25COPING STRATEGIES: SOPHISTICATED
economical Other dose companies wary of PARTNER SELECTION. Companies need to pick
buying API from a competitor. partners and acquisition targets
13COPING STRATEGIES: MOVING carefully. Data Needs during Partner
MANUFACTURING AND R&D TO LOWER-COST Selection. Product portfolio Product
COUNTRIES. Applies to both API and dose pipeline Geographic reach Financials
Examples Sandoz – multiple units in India Regulatory experience Manufacturing
Teva – scientists in Faridabad, acquired capabilities. Patent portfolio Patent
Regent Drugs (JK) Apotex – manufacturing challenge experience Approvals
and R&D facilities in Bangalore Backward/forward integration Current
Ratiopharm – R&D center in Goa Stada – alliances Location.
production sites in Russia, Vietnam (50:50 26TOOLS TO TH RESCUE! Access global
JV) and China Perrigo – JV in China for market, intellectual property and product
ibuprofen Actavis – API development info Predict key data in advance (e.g.
facility and CRO in India Pros Abundance competitiveness, generic launch date)
of scientists Cost savings Cons Language Flexible, fast searching across multiple,
barriers Potential for intellectual exacting criteria Identify early, viable
property theft Quality control. source of API supply and backup sources
14COPING STRATEGIES: ALLIANCES WITH Spot in- and out-licensing capabilities
COMPANIES IN LOWER-COST COUNTRIES. Applies Identify potential partner companies with
to both API and dose Manufacturing multiple, exacting criteria Keep a
Examples Alpharma-Shasun 2005 agreement watchful eye on potential acquisition
for 10 finished dose products and targets and track competitors.
undisclosed number of APIs Actavis-Orchid 27THANK YOU! Kate Kuhrt Newport
2007 agreement involving 9 cephs in Europe Strategies Thomson Reuters 215 Commercial
Development, manufacturing, and Street Portland, Maine 04101 USA + 1 (207)
distribution agreement for 10 non-cephs in 871-9700 x26
the U.S. Pros Cost savings Access to a kaire.kuhrt@thomsonreuters.com.
diverse talent pool Cons Longer response
Tools and Strategies for Launching a Successful Generic in Todays Ultra Competitive Environment.ppt
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Tools and Strategies for Launching a Successful Generic in Todays Ultra Competitive Environment

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