Quo vadis Pharma industry. Vladimír Král, 2015

Transcription

1 Quo vadis Pharma industry Vladimír Král, 2015

2 Steady flow of NCEs and lines extensions in the last years NBE New Combo + New Dosage Form + Vaccines NCE Ø 55 1 Graul, A. I. et al Drugs News Perspect. 2010, 23, 7-36; Graul, A. I. et al Drugs of Today 2012, 48, (and previous issues of the same series) Average Between 2000 and 2011 a steady flow of new products entered the global markets 1 An average of 26 New Chemical Entities (NCEs) and 21 New combinations / Dosage Forms / Vaccines were launched by originators Current Phase II + III developments will maintain this flow of new launches in the next years. Out of this pool the development pipeline for Sanofi Gx is and will be generated 2

3 Leading Therapeutic Areas in 2015 Oncology, Antivirals, Autoimmune products are expected to grow strongly Source: IMS, Therapy Forecaster Diseases of old age will continue to be significant drivers of demand to 2015 Autoimmune, multiple sclerosis, antivirals (hep C) Note: OTC and biologicals included 3

4 Well-stocked pipelines ~130 approvals of NCEs and NCs expected in next 4-5 years 15% 44% 80% 100% 138 The current originator pipelines comprise around 370 new small molecules and combinations. Based on the average probability rate of development projects to enter the market, we would expect more then 130 new products to be launched in the next 4 to 5 years. There is an upside potential for 2016 as currently undisclosed Phase II candidates might reach the market. Current pool (2013) Originator average success rate to enter the market* Expected # of molecules which will get approval ( ) comment Source: EvaluatePharma *Biotechnology Industry Organization: Biomed tracker (Success rates) Phase II Approval 15% Phase III Approval 44% Filed Approval 80% 4

5 60 Number of NCEs and biologics reached their first market contrast agents dental Poisoning+drug abuse renal-urologic gastrointestinal ophthalmic immunologic dermatologic pulmonary+antiallergy antiarthritic metabolic drugs endocrine drugs hematologic CVS CNS Antineoplastic Anti-Infective line extensions (new formulations, new indications, and/or new combinations), 17 vaccines

6 2012 was a good year with 36 NCE launches 23 small molecules, 7 biologics, 1 diagnostic and 5 vaccine Small mol Biologic New active substances launched worlwide Split by Indication NCE

7 Big Pharma comparison, Fresh index

8 Peak sales in excess of $5 billion by 2018 Pfizer's Prevnar (approved in 2000) and Celgene's Revlimid (approved in 2006). In this sense, Merck & Co.'s diabetes treatment Januvia (which generated sales of $5.7 billion in 2013), which was launched in the US in 2006, The chart above includes Biogen Idec's multiple sclerosis treatment Tecfidera and the anticipated approval of Gilead Sciences' hepatitis C treatment sofosbuvir in late 2013

9 Zentiva development 3 Pharmaceutical development sites 1 API development site H 2, PtO 2, MeO + MeOH, 12 h MeO O H 2N NH H 2NO 2S MeO 13 HSO 3Cl, CH 2Cl 2, then NH 3 aq. MeO NHAc 12 Ac 2O, 4-6 h NHAc H 2, 3% Pd/C, HCl/AcOH MeO NH % HCl aq., then K 2CO 3 aq. H 2NO 2S MeO NH 2 6 O Br O 8 Na 2CO 3, DMF, then HCl/EtOH H 2NO 2S MeO O NH 2 O Cl - Sanofi-aventis technology global resources

10 How we do it

11 Entry to market opening the door for us. closing it for the others

12 Own IP for safe market entry Market entry door is closing fast. NCE lunched product patent protection period (monopoly) generic market API Pharma

13 Integrated development process API API Morphology Pre- Formulation 13 Physical chem. Formulation BES/CT Registration

14 Solid state innovative platform Cocrystal strategy can be used as part of formulation to improve typical parameters: solubility, dissolution rate, absorption Closer collaboration between Academia, and Pharma PE and Formulation Departments can lead to stronger IP. Cocrystal Formulation Strategies

15

16

17 Future of NTE in Pharma industry

18

19

20 Growth strategies for Zentiva: product differentiation Supergenerics (value-added generics or Gx+) recognized as an opportunity: Shorter development timelines compared to NCEs Less complex clinical development Patent protection and market exclusivity Differen tiation Focus on drug delivery Oral DDS. Modified release Injectable depots Device related supergenerics Innovative drug combination

21 Drug Delivery Technology: Revolutionizing Cancer Therapies

22 F-mAb Better pharmacokinetic properties than origin mab Ease of producing in large quantitiest Low cost. Possibility optimization of their properties (binding affinity, rapid clearance from circulation) by genetic modification Accomplishment of optimal size for tumor targeting (55 kda)

23 Therapeutic, diagnostic and preventive monoclonal antibodies

24 Usebility of F-mAb High potential for cancer and neurodegenerative diseases Crossing of blood-brain barrier Bilocation of target receptors Combination with radionuclide, drugs, toxins Target elements of nanoparticles

25 Monoclonal antibody fragments approved in the US Generic (brand) names Description Indication of 1 st approval Date of 1 st approval Sponsor abciximab (Reopro) Anti-GPIIb/IIIa chimeric Fab Clot prevention in angioplasty 12/22/94 Centocor ranibizumab (Lucentis) Anti-VEGF-A humanized Fab Macular degeneration 06/30/06 Genentech certolizumab pegol (Cimzia) Anti-TNFalpha pegylated humanized Fab Moderate to severe Crohn disease 04/22/08 UCB

26

27 Measuring Productivity R&D Productivity = Number of Approvals R&D Send 27

28 Peptide Targeted for Intestinal Absorption Peptide Targeted for Intestinal Absorption NAME OF PRESENTATION 28

29 Drug repositioning: a new path to address unmet clinical needs

30 Cooperation with BIOCEV Drug repositioning, the process of finding new indications for existing drugs, presents a promising avenue for identifying better and safer treatments without the full cost or time required for de novo drug development. Proposed therapeutic area: Medications for rare and neglected diseases. Substantial percentage of rare diseases if not all 8000 rare diseases might be treatable with drugs in the current pharmacopeia. BIOCEV/Medical School: focus on rare disease indentification and treatment, mitochondrial disease (pediatric clinic)

31 Conclusion: Still chance to catch a big fish