BioBusiness Biopharmaceutical Ingredients Recombinant albumins & albumin fusion Dermot Pearson, Strategic Product Director, NZ Biopharma

Transcription

1 BioBusiness Biopharmaceutical Ingredients Recombinant albumins & albumin fusion Dermot Pearson, Strategic Product Director, NZ Biopharma

2 2 Novozymes solutions dedicated to the biopharmaceutical industry Formulation and drug delivery Recombumin HyaCare albucult albufuse Purification Downstream processing Protein A Discovery AMP Plectasin Development Protein expression albufuse Yeast expression technology Cell culture products LONG R 3 IGF-I CellPrime Fermentation Protein expression and manufacturing Cell culture products LONG R 3 IGF-I CellPrime

3 3 8/9/2009 Albumin is the most abundant protein in plasma It acts to balance the osmotic pressure of blood and as a carrier of fatty acids and metal ions Human serum albumin (HSA) manufactured since the 1940s for therapeutic use Availability at an affordable price and in large quantities Good functionality it is compatible with most protein drugs and viruses and generally stabilizes them well Good safety record, stable, and easy to use BUT perceived significant risk profile due to source, and supply can be variable Novozymes supplies two versions of recombinant albumin (ralbumin) Recombumin and albucult Recombinant (animal-free, GMP) and sustainable supply

4 4 4 8/9/2009 Recombumin World s first and only commercially available, animalfree, GMP-manufactured, recombinant human albumin used in an FDA- and EMEAapproved parenteral product

5 5 8/9/2009 Uses of ralbumin Stabilizer for protein drugs & vaccines Chemical linking agent for peptides Biocoating agent for medical devices Microsphere used as an artificial platelet IVF media component Surgical wound healing gel/glue/sealant ingredient

6 6 8/9/2009 Chemical coupling to albumin for targeted delivery Drug Affinity Complex (DAC) synthetically made construct Chemical reaction Albumin supplied by Chemical coupling takes place after manufacture of separate components Albumin-drug conjugate

7 7 8/9/2009 Albufuse technology delivers improved drugs Albufused drug remains in the body longer and therefore is active for longer Reduces dose size and therefore potential drug toxicity Reduces number of injections (from twice daily to weekly or twoweekly) Improves patient t compliance with medication regime Can reduce cost of healthcare delivery Reduces amount of drug manufactured COGS savings

8 8 8/9/2009 Albufusion keeps drug levels in the zone Therapeutic level Toxicity level Albumin-X fusion X native protein T herapeut tic index Efficacy Region Days 16

9 9 8/9/2009 Biological coupling (fusion) to albumin for targeted delivery Fusion molecule produced by yeast as it grows in the fermentor as a fully formed albumin + active protein entity no separate coupling step in the manufacturing process Albumin Active protein/peptide

10 10 8/9/2009 Applications Segment/product Formulation Recombumin and albucult Application Albumin used as an excipient for improved stabilization of peptides, proteins, and vaccines Drug delivery Recombumin and albucult Albumin chemical linkage to improve half-life of peptides Albumin nanoparticles for sustained release of peptides and small molecules (sirna) Medical devices Recombumin and albucult Ingredient in the manufacture of a variety of different types of devices Half-life extension passive delivery albufuse Use of albufuse for improved half-life of peptides and proteins

11 11 8/9/2009 Our products and technologies are critical in several drugs that improve quality of life Syncria- & Exendin- Type II diabetes: Recombumin and albufuse extend GLP-1 drug half-life MMR-II Childhood vaccine: uses Recombumin in its manufacture Albuferon Hepatitis C: albufuse used to extend the half-life of interferon 2 alpha Other developmental activities Formulation of a well-known cosmetic toxin product and of a variety of vaccines Active customer programs in development of cancer, anti-inflammatory, and regenerative medicine drugs Partnerships with other large pharma players using albufuse technology

12 12 8/9/2009 Key benefits address market needs Improved patient compliance and convenience and reduced cost of healthcare Functional superiority over competitive alternatives Improved toxicity profile or activity period for drug Regulatory agency friendly GMP, animal free Manufactured exclusively for biopharma use Available from recognized supplier assuring long-term security of supply

13 13 8/9/2009 Fits with Novozymes technology Both biopharma offerings use expertise complementing the R&D and production capabilities that Novozymes has used to establish global leadership in enzymes Protein expression Protein engineering g Large-scale biomanufacturing High throughput screening

14 14 8/9/2009 Why is Novozymes uniquely positioned in the biopharmaceutical market? Functional offerings delivering needed benefits Proven manufacturing technology and expertise to deliver Global reputation as a reliable supplier

15 15 8/9/2009 Use of ralbumin may give specific drug improvement benefits not achievable with chemical excipients Liquid formulations of protein drugs and vaccines for selfadministration or more convenient supply chain storage temperatures Formulation of monoclonal antibodies

16 16 8/9/2009 Physicians' top reason for choosing drug Ease of self-administration Source: Baxter research from US Drug Delivery Frost & Sullivan 2008

17 17 8/9/2009 albufuse technology offers significant advantages not available from competitive alternatives such as PEGylation Clinical efficacy demonstrated Attractive COGS Ease of manufacture Licenses for expression in yeast and fusion available from Novozymes

18 Forward-looking statements This presentation and its related comments contain forward- looking statements, including financial expectations. Forward-looking statements are by their very nature associated with risks and uncertainties that may cause actual results to differ materially from expectations. The uncertainties may include unexpected developments in the international currency exchange and securities markets, market- driven price decreases for Novozymes products and the introduction of competing products within Novozymes core areas.

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