Generics and Biogenerics

RESEARCH AND DEVELOPMENT OF GENERIC DRUG S Trends and R&D Impact i n Global Pharma Arena PharmaCon 2007 Dubrovnik, May 23 , 2007 Dr Aleksandar Danilovski Head of Global API R&D

Disclaimer This presentation expresses the opinion of the speaker and does not necessarily reflect the views or policies of PLIVA/Barr. All information pertaining to this presentation is from publications.

[object Object],[object Object],[object Object],[object Object],[object Object],Presentation Outline

1928 “Kaštel” d.d. moves to Zagreb ,[object Object],[object Object],[object Object],[object Object],PLIVA Zagreb Prilaz baruna Filipovića PLIVA Zagreb Avenija grada Vukovara Legacy PLIVA 85 Years Dedicated to Health

1936 First organized research activities initiated in “Kaštel” in collaboration with Professor Vladimir Prelog (later Nobel Prize laureate for chemistry) New R&D Building opened in October 2002 V. Prelog opens first PLIVA R&D (1952) V. Prelog teaching in Zagreb (1936) Legacy PLIVA 70 Years of Continuous Scientific Activities

Barr Group  Barr & PLIVA Combination Global Generic Pharmaceutical Company ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

200 5 Total Market Revenues Rx Drug 200 5 Revenues ($B) ~$230B ~$120B France Germany Italy Spain UK Sources: IMS Health; Marakon Associates -- Excludes some branded generics units Pharmaceutical Market Emerging Markets Growth Rates

R&D innovation draught ,[object Object],[object Object],[object Object],Business Performance Big Pharma Protection Strategies are Constantly Evolving

Business Performance (cnt’d) Generics Outpace Big Pharma

Generic Pharma Trends EU Generics Market Shares

BRAND GENERIC Gx+ & BioGx 1.Chemistry 1.Chemistry 1.Chemistry/Biochemistry 2.Manufacturing 2.Manufacturing 2.Manufacturing 3.Controls 3.Controls 3.Controls 4.Labeling 4.Labeling 4.Labeling 5.Testing 5.Testing 5.Testing 6.Preclinical Dev. 6.N/A 6.Preclinical Dev. (abridged) 7.Clinical Dev. 7.Bioequivalance 7.Clinical Dev. (abridged) What are Generic Drugs?? First Definition Quality Safety/Efficacy GENERIC drug INNOVATOR drug bioequivalence efficacy & safety quality, efficacy, safety quality

Generic Pharma Trends (cnt’d) Most Analyst Expect a Decline

What are Generic Drugs?? Second Definition GENERIC drug Basic Patent Expired INNOVATOR drug Basic Patent Not-Expired GENERIC drug INNOVATOR drug bioequivalence efficacy & safety quality, efficacy, safety quality

[object Object],[object Object],Getting a Patent What is a Patent?? NOVEL NON OBVIOUS APPLICABLE three criteria for patentability

Pharmaceutical Patents What can be Patented (Subject Matter)?? … USE(s) method-of-use dose, route of application, … PROCESS(es) synthesis, crystallization pharmaceutical technology,. PRODUCT(s) solid-state forms (“polymorphism”) drug product (“formulation”), dosage form,… drug substance (“basic patent”) TIME

i PrOH chlatrate Dihydrate PLIVA? ? Amorphous form Crystalline with non- crystalline water Stable mono-hydrate Monohydrate with residual solvents Unstable mono-hydrate Ethanolate Stable anhydrous form Anhydrous solvates New crystalline hydrate (di?) (pilars) RELATED PATENTS (14) September 2001 SOLID-STATE FORMS RELATED PATENTS (30) (Sept. 2001 - Oct. 2005) PURITY ANHY- DROUS MONO- HYDRATE SOLVATES DIHYDRATE PLIVA Stabilized by antioxidant Impurities High purity mono-hydrate Improved stability in impermeable Al containers Tetragonal anhydrous (cryst. ) Stable mono-hydrate Mono with lower hygr. by compaction Ethanolate Azi-hydrates 1,2-propylene-glycol clathrates 2 Novel iPr-solvates Propanolate 1pat. +1appl. Sesquihydr. & monoclinic & ortho-rhombic solv. 5 appl. Monoclinic solvates & Process for dihydrate Single step process for dihydrate Process for non-hygroscopic dihydrate Process for dihydrate (t-BuOH) Dihydrate polymorphs Amorphous via Ortho- rhombic solvates Granted Improved process for monohydrate Anhydrous (by azeotr. dest. - 2 appl. Ethanolate formulation Azi from Cryst. DHL & EtOH/water Degradation products Pfizer Ercros Apotex TEVA Hanmi Chimica Sintetica TEVA Lab. Silanes Wockhardt Pfizer Biochemie Alembic ADAMED Astur Pharma Sandoz Alembic Jubilant Hanmi Chemi Spa.

Atorvastatin Example (exp.2010) Status in 2005 - 557 patent families Second Example ATORVASTATIN (Lipitor ® ) 1 basic 39+36 polymorphs (salts) + processes 91 drug product (formulation); pharmaceutical technology 390 methods-of-use, dosing regimes, …

Proven solid-state expertise: from patents to commercial products PLIVA Generic R&D Know-How Generic Drugs are NOT COPIES!!!

Generic Pharma Differentiation Approaches  M&A Consolidation

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Generic Pharma Differentiation Approaches  R&D is the Future!!

Being First is Everything ! !! ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],KSF ! Generic Pharma Key Success Factors (KSF)

Origin Paradigm Pharmaceutical Sciences Molecule Size “ Small” “ Big” Molecule Synthesis “ Chem” “ Biotech” “ Traditional” drugs (chemistry) “ Recombinant” drugs (molecular biology & biotechnology) pharmacy

PLIVA R&D (Zagreb site only) Resources Breakdown in Dec.2006 (total of 186 scientists) FBF; 41; 22% PMF; 60; 31% FKIT; 39; 21% PBF; 27; 15% Medicina; 5; 3% Veterina; 2; 1% FER; 2; 1% Ostali HR; 5; 3% Ostali svijet; 5; 3%

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Strategy for Success The Best R&D Paradigm

Thank You! “ As soon as you find the key to success, somebody always changes the lock” Tracey Ullman

Generics and Biogenerics

Recommandé

Recommandé

Contenu connexe

Tendances

Tendances (20)

En vedette

En vedette (19)

Similaire à Generics and Biogenerics

Similaire à Generics and Biogenerics (20)

Plus de inemet

Plus de inemet (20)

Dernier

Dernier (20)

Generics and Biogenerics