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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
BEST OF TIMES…
BEST OF TIMES…
…AND WORST OF TIMES
…AND WORST OF TIMES
ANDA APPROVALS BY INDIAN GENERICS
ANDA APPROVALS BY INDIAN GENERICS
2007 YTD FINAL ANDA APPROVALS BY COUNTRY
2007 YTD FINAL ANDA APPROVALS BY COUNTRY
ARE THE GENERICS INDUSTRT’S GOLDEN YEARS OVER
ARE THE GENERICS INDUSTRT’S GOLDEN YEARS OVER
COPING STRATEGIES: CONSOLIDATION
COPING STRATEGIES: CONSOLIDATION
LEAGUE TABLES ARE CONSTANTLY SHIFTING
LEAGUE TABLES ARE CONSTANTLY SHIFTING
COPING STRATEGIES: GEOGRAPHIC DIVERSIFICATION: EUROPE
COPING STRATEGIES: GEOGRAPHIC DIVERSIFICATION: EUROPE
COPING STRATEGIES: GEOGRAPHIC DIVERSIFACTION: JAPAN
COPING STRATEGIES: GEOGRAPHIC DIVERSIFACTION: JAPAN
COPING STRATEGIES: GEOGRAPHIC DIVERSIFACTION: JAPAN
COPING STRATEGIES: GEOGRAPHIC DIVERSIFACTION: JAPAN
COPING STRATEGIES: BACKWARD INTEGRATION INTO API
COPING STRATEGIES: BACKWARD INTEGRATION INTO API
COPING STRATEGIES: MOVING MANUFACTURING AND R&D TO LOWER-COST
COPING STRATEGIES: MOVING MANUFACTURING AND R&D TO LOWER-COST
COPING STRATEGIES: ALLIANCES WITH COMPANIES IN LOWER-COST COUNTRIES
COPING STRATEGIES: ALLIANCES WITH COMPANIES IN LOWER-COST COUNTRIES
COPING STRATEGIES: SOURCING API FROM LOWER-COST COUNTRIES
COPING STRATEGIES: SOURCING API FROM LOWER-COST COUNTRIES
COPING STRATEGIES: SOURCING API FROM LOWER-COST COUNTRIES (cont)
COPING STRATEGIES: SOURCING API FROM LOWER-COST COUNTRIES (cont)
COPING STRATEGIES: FOCUS ON NICHE PRODUCTS
COPING STRATEGIES: FOCUS ON NICHE PRODUCTS
COPING STRATEGIES: INNOVATION
COPING STRATEGIES: INNOVATION
COPING STRATEGIES: PARAGRAPH IV PATENT CHALLENGES
COPING STRATEGIES: PARAGRAPH IV PATENT CHALLENGES
PARAGRAPH IV PATENT CHALLENGES
PARAGRAPH IV PATENT CHALLENGES
TOP 10 COMPANIES BY NUMBER OF PATENT CHALLENGES
TOP 10 COMPANIES BY NUMBER OF PATENT CHALLENGES
IMPORTANCE OF API IN PATENT CHALLENGES
IMPORTANCE OF API IN PATENT CHALLENGES
INDIAN COMPANIES (*) ARE CLEARLY BASING THEIR PARAGRPH IV STRATEGY ON
INDIAN COMPANIES (*) ARE CLEARLY BASING THEIR PARAGRPH IV STRATEGY ON
COPING STRATEGIES: SOPHISTICATED PRODUCT SELECTION
COPING STRATEGIES: SOPHISTICATED PRODUCT SELECTION
COPING STRATEGIES: SOPHISTICATED PARTNER SELECTION
COPING STRATEGIES: SOPHISTICATED PARTNER SELECTION
TOOLS TO TH RESCUE
TOOLS TO TH RESCUE
THANK YOU
THANK YOU

Презентация на тему: «Tools and Strategies for Launching a Successful Generic in Todays Ultra Competitive Environment». Автор: Thomas J. Vaichus. Файл: «Tools and Strategies for Launching a Successful Generic in Todays Ultra Competitive Environment.ppt». Размер zip-архива: 206 КБ.

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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1 Tools and Strategies for Launching a Successful Generic in Today’s

Tools and Strategies for Launching a Successful Generic in Today’s

Ultra Competitive Environment

KATE KUHRT BERLIN SEPTEMBER 27, 2008

2 BEST OF TIMES…

BEST OF TIMES…

Population all over the world getting older Increase in the size of middle class in many countries Governments and employers promoting use of generic drugs in efforts to slow down increase in health care spending Increased acceptance of generic drugs by patients and physicians A number of blockbusters losing patent protection

3 …AND WORST OF TIMES

…AND WORST OF TIMES

Innovation drought ANDA backlog and authorized generics Pressure on prices and diminishing margins Government regulation Consolidation among wholesalers and retailers Increased competition Generic filings and approvals at all-time high A number of new entrants, many from India, often with access to low-cost APIs Overcapacity in manufacturing Focus on market share rather than bottom line Authorized generics in the U.S.

4 ANDA APPROVALS BY INDIAN GENERICS

ANDA APPROVALS BY INDIAN GENERICS

*Through August 15, 2007

Source: Newport Strategies’ Horizon Global system

5 2007 YTD FINAL ANDA APPROVALS BY COUNTRY

2007 YTD FINAL ANDA APPROVALS BY COUNTRY

*Through August 15, 2007

Source: Newport Strategies’ Horizon Global system

6 ARE THE GENERICS INDUSTRT’S GOLDEN YEARS OVER

ARE THE GENERICS INDUSTRT’S GOLDEN YEARS OVER

Expectation that only the fittest will survive Coping strategies aimed at: Reducing cost Reducing risk Improving speed to market Differentiation Achieving critical mass

7 COPING STRATEGIES: CONSOLIDATION

COPING STRATEGIES: CONSOLIDATION

Consolidation expected to continue in pursuit of Top-line growth Opportunities in new markets Synergies Example: Barr’s acquisition of Pliva Biogenerics New dose forms Presence in emerging markets Access to API Result: Industry will likely be dominated by a handful of global players plus many small, focused players

8 LEAGUE TABLES ARE CONSTANTLY SHIFTING

LEAGUE TABLES ARE CONSTANTLY SHIFTING

Source: TS Research

9 COPING STRATEGIES: GEOGRAPHIC DIVERSIFICATION: EUROPE

COPING STRATEGIES: GEOGRAPHIC DIVERSIFICATION: EUROPE

Recent Examples Barr-Pliva Mylan-Merck Generics Hospira-Mayne DRL-Betapharm Matrix-Docpharma Ranbaxy-Terapia Aurobindo-Milpharm Alkem close to buying two firms in UK and Germany Pros Counterweight to the U.S. market Some markets still focused on branded generic Rapid growth of pharma industry in E. Europe and Russia Cons Some markets as competitive as U.S. Generic uptake high at the expense of margins

10 COPING STRATEGIES: GEOGRAPHIC DIVERSIFACTION: JAPAN

COPING STRATEGIES: GEOGRAPHIC DIVERSIFACTION: JAPAN

Pros Japanese generics market seen as having a tremendous growth potential Currently 5% by value, 17% by volume Cons Some still skeptical about actual market potential Difficult for foreign companies to do it alone Acquisitions, JVs, and marketing agreements provide ready access to: Manufacturing Marketing Distribution relationships

11 COPING STRATEGIES: GEOGRAPHIC DIVERSIFACTION: JAPAN

COPING STRATEGIES: GEOGRAPHIC DIVERSIFACTION: JAPAN

Acquisitions Zydus Cadila acquired a 100% stake in Nihon Universal Yakuhin in April 2007 Joint Ventures In November 2005, Ranbaxy increased equity stake in Nippon Chemiphar from 10% to 50% Marketing Agreements In August 2005, Lupin entered into a long-term marketing agreement with Kyowa Pharmaceutical In March 2006, Hospira-Taiyo agreement to sell each other’s injection agents Additional companies to watch Continued speculation that Teva will eventually acquire a Japanese firm Rumors that one of the three large generics (Nichi-iko, Sawai, Towa) will come under part ownership by a large multinational Torrent Pharma opened a fully-owned subsidiary in Yokohama in April 2006 Dr. Reddy's considering setting up an office in Tokyo or Osaka

12 COPING STRATEGIES: BACKWARD INTEGRATION INTO API

COPING STRATEGIES: BACKWARD INTEGRATION INTO API

Recent examples Mylan-Matrix Barr-Pliva Pros More control over cost and access to API Decreasing number of established API manufacturers still independent due to M&A Different parts of the value chain may make money in different products Faster response times Cons No one plant can make all APIs required by a typical generic Making just enough for captive use often not economical Other dose companies wary of buying API from a competitor

13 COPING STRATEGIES: MOVING MANUFACTURING AND R&D TO LOWER-COST

COPING STRATEGIES: MOVING MANUFACTURING AND R&D TO LOWER-COST

COUNTRIES

Applies to both API and dose Examples Sandoz – multiple units in India Teva – scientists in Faridabad, acquired Regent Drugs (JK) Apotex – manufacturing and R&D facilities in Bangalore Ratiopharm – R&D center in Goa Stada – production sites in Russia, Vietnam (50:50 JV) and China Perrigo – JV in China for ibuprofen Actavis – API development facility and CRO in India Pros Abundance of scientists Cost savings Cons Language barriers Potential for intellectual property theft Quality control

14 COPING STRATEGIES: ALLIANCES WITH COMPANIES IN LOWER-COST COUNTRIES

COPING STRATEGIES: ALLIANCES WITH COMPANIES IN LOWER-COST COUNTRIES

Applies to both API and dose Manufacturing Examples Alpharma-Shasun 2005 agreement for 10 finished dose products and undisclosed number of APIs Actavis-Orchid 2007 agreement involving 9 cephs in Europe Development, manufacturing, and distribution agreement for 10 non-cephs in the U.S. Pros Cost savings Access to a diverse talent pool Cons Longer response time to changes in market dynamics Potential delays due to regulatory issues Potential loss of IP Challenges with managing long-distance relationships

15 COPING STRATEGIES: SOURCING API FROM LOWER-COST COUNTRIES

COPING STRATEGIES: SOURCING API FROM LOWER-COST COUNTRIES

Examples Teva, Apotex, Watson has been sourcing from India for years Indian companies increasingly sourcing out of China Pros Cost savings Many qualified API sources to choose from Cons Many API sources with limited track record FDA inspections more lax overseas? Language barrier QA costs Potential shortages due to stricter enforcement of local environmental laws

16 COPING STRATEGIES: SOURCING API FROM LOWER-COST COUNTRIES (cont)

COPING STRATEGIES: SOURCING API FROM LOWER-COST COUNTRIES (cont)

+33

Change from 2006

+7

+2

+4

-1

+2

Source: Newport Strategies Horizon Global ™

17 COPING STRATEGIES: FOCUS ON NICHE PRODUCTS

COPING STRATEGIES: FOCUS ON NICHE PRODUCTS

Examples Ranbaxy, DRL eyeing Bradley Pharmaceuticals (dermatology) Pros Less competition Margins in difficult formulations likely to remain higher Inhaled products, certain injectables, controlled release Cons Even $20M products attracting interest If multiple generics get involved, may not recoup investment Costly barriers to entry for certain products

18 COPING STRATEGIES: INNOVATION

COPING STRATEGIES: INNOVATION

New formulations Andrx – Altoprev (controlled-release lovastatin) Ranbaxy – Riomet (metformin oral solution) New molecules Best known examples: Pliva – Zithromax (azithromycin), Teva – Copaxone (glatiramer) Ranbaxy expects to be the first Indian pharma co to launch a new NCE (exp. 2011) Pros Potential for big returns during patent and exclusivity period Cons Original R&D very expensive and risky: It may take 1000s of failures before a successful NCE Possible reimbursement issues and higher marketing costs for “generic plus” products

19 COPING STRATEGIES: PARAGRAPH IV PATENT CHALLENGES

COPING STRATEGIES: PARAGRAPH IV PATENT CHALLENGES

Pros Generic companies can make a considerable amount of money during the 180-day exclusivity period First-to-market generic company often maintains a big market share even after the end of the exclusivity Cons Expensive and risky Authorized generics and shared exclusivity reduce the potential payoff from the initial 180 days

20 PARAGRAPH IV PATENT CHALLENGES

PARAGRAPH IV PATENT CHALLENGES

As of September 7, 2007, challenges on products encompassing 341 unique brand names 282 unique molecules or molecule combinations 48 unique dose forms In 2006, 27 molecules (or new combinations) first were exposed to patent challenges So far in 2007, 17 molecules (or combinations) have seen their first patent challenges

Source: FDA, Newport Strategies Horizon Global ™

21 TOP 10 COMPANIES BY NUMBER OF PATENT CHALLENGES

TOP 10 COMPANIES BY NUMBER OF PATENT CHALLENGES

Source: Newport Strategies Horizon Global ™

22 IMPORTANCE OF API IN PATENT CHALLENGES

IMPORTANCE OF API IN PATENT CHALLENGES

Risk of supplier failure is high for companies involved with patent challenges Even one day of delay can cost the company FTF status Risk is also high for API manufacturers Generics may settle with innovators or do deals with other generics who use other API sources If dose company is backward integrated into API, may switch to internal API source when convenient If development starts too early, product may be withdrawn from market Backward integration into API may provide crucial advantages Coordinated API and dose development Coordinated regulatory submissions Speedy addressing of any issues Improved knowledge of polymorphs

23 INDIAN COMPANIES (*) ARE CLEARLY BASING THEIR PARAGRPH IV STRATEGY ON

INDIAN COMPANIES (*) ARE CLEARLY BASING THEIR PARAGRPH IV STRATEGY ON

BACKWARD INTEGRATION

Source: Newport Strategies Horizon Global ™

24 COPING STRATEGIES: SOPHISTICATED PRODUCT SELECTION

COPING STRATEGIES: SOPHISTICATED PRODUCT SELECTION

Companies need to pick products for development very carefully It is not enough to look at sales data!

Data Needs during Product Selection

Sales Dose Form and Strength Patents, Patent Challenges Labeling Chemistry, Synthesis Data Exclusivity Market Exclusivity

Approvals API Sources Company Data Manufacturing Capabilities Bioequivalence Stability

Pharmacodynamics Toxicity Country Regulations Pack Pricing Reimbursement

25 COPING STRATEGIES: SOPHISTICATED PARTNER SELECTION

COPING STRATEGIES: SOPHISTICATED PARTNER SELECTION

Companies need to pick partners and acquisition targets carefully

Data Needs during Partner Selection

Product portfolio Product pipeline Geographic reach Financials Regulatory experience Manufacturing capabilities

Patent portfolio Patent challenge experience Approvals Backward/forward integration Current alliances Location

26 TOOLS TO TH RESCUE

TOOLS TO TH RESCUE

Access global market, intellectual property and product info Predict key data in advance (e.g. competitiveness, generic launch date) Flexible, fast searching across multiple, exacting criteria Identify early, viable source of API supply and backup sources Spot in- and out-licensing capabilities Identify potential partner companies with multiple, exacting criteria Keep a watchful eye on potential acquisition targets and track competitors

27 THANK YOU

THANK YOU

Kate Kuhrt Newport Strategies Thomson Reuters 215 Commercial Street Portland, Maine 04101 USA + 1 (207) 871-9700 x26 kaire.kuhrt@thomsonreuters.com

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