Hikma Pharmaceuticals PLC · LSE:HIK
Hikma Pharmaceuticals — Technical Presentation (2007)
13 slides from Hikma Pharmaceuticals's technical presentation, Jan 1, 2007
Slide 1: Injectable Pharmaceuticals New Product Development
INJECTABLE PHARMACEUTICALS New Product Development Rosa Bispo New Product Development Manager
Slide 2: This document, which has been issued by Hikma Pharmaceuticals PLC (the “Company”), comprises the
z This document, which has been issued by Hikma Pharmaceuticals PLC (the “Company”), comprises the written materials/slides for a presentation. This document and its contents are confidential and may not be reproduced, redistributed or passed on, directly or indirectly, to any other person or publis
Slide 3: Agenda
Agenda z New products development process z Pending approvals z Annual targets 2
Slide 4: Product identification is demand-driven and strategic
Product identification is demand-driven and strategic z Co-ordinated centrally by business development in Jordan z Selection of products according to: z IMS data and proper market research in the different countries z Wish list from the different markets z Initial list is sent to z API Department z
Slide 5: Rigorous product development process
Rigorous product development process z Analytical methods development z Formulation development z Manufacturing parameters evaluation/determination z Packaging system evaluation/determination z Preliminary stability study z A Product Development Report is generated and sent to Manufacturing Departme
Slide 6: Scale up and submission batches filling
Scale up and submission batches filling z Manufacturing process is designed by fitting the product requirements (as per the Development Report) to the operational available conditions z Validation/Qualification of manufacturing equipment is performed to cover the new product needs z Submission/Stabi
Slide 7: Submission to authorities
Submission to authorities z Samples from the submission batches are tested as per the Stability Protocol z Submission files are prepared as per the authorities requirements (CTD or ANDA), collecting information from several sources: z QC/Stability (3 or 6 months Accelerated Conditions) z QC/Product
Slide 8: Follow up on deficiency letters and product approval
Follow up on deficiency letters and product approval z Submitted file is reviewed by the authorities. z During the revision process, questions (deficiencies letters) are raised by the authorities z To answer the questions the following might be needed: z Simple explanation z Additional validation z
Slide 9: From origination to production in 3-5 years
From origination to production in 3 to 5 years •Development Process •Operational feasibility •Products Identification •API supply •New Lists of products per (Tentative List) •Patent Expiry market for the next 3 years (2-6 months) (1 month) •Validation of manufacturing •Analytical Methods dev. •File
Slide 10: 21 ANDAs pending approval in the US
21 ANDA’s pending approval in the US Therapeutic category Number ANDA’s pending Market size ($ million) Antibacterial (Cephalosporin) 3 624 Antibacterial 3 75 Cardiovascular 5 51 Anesthetic (Benzodiazepine) 1 62 Anti-inflammatory and immunosuppressant 2 7 (Glucocorticoid) Antihistaminic 1 44 Analges
Slide 11: 9 Marketing authorizations pending approval - EU
9 Marketing authorizations pending approval - EU Therapeutic category Number of marketing Market size (€ millions) authorizations pending (Germany, Austria, Benelux, Portugal & Italy) Antibacterial 1 51 Antiemetic 1 13 Antiepileptic 1 2 Cardiovascular 3 15 Antihistaminic 1 0.3 Benzodiazepine antagon
Slide 12: 6 New products pending approval - MENA
6 New products pending approval - MENA Therapeutic category Number of products pending Market size Reliable market data unavailable for the MENA region Antihistaminic 1 Cardiovascular 3 Anti-inflammatory and 1 immunosuppressant (Glucocorticoid) Antibacterial 1 z 50 products are approved and marketed
Slide 13: Focus on continued pipeline development
Focus on continued pipeline development z Annual Target z 10 ANDA’s - USA z 4 CTD’s - in at least 5 EU countries z 12 Dossiers – in at least 3 MENA region countries 12
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