orexo to acquire biolipox building a specialty pharma
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Orexo to acquire Biolipox, building a specialty pharma company driven by innovation Update October 25, 2007 Page 1 Page 1 Agenda Biolipox product overview Transaction rationale The combined company Strategy Products


  1. Orexo to acquire Biolipox, building a specialty pharma company driven by innovation Update October 25, 2007 Page 1 Page 1

  2. Agenda • Biolipox product overview • Transaction rationale • The combined company – Strategy – Products • The transaction Page 2

  3. Biolipox in brief Commercialization Development Discovery • Focus in respiratory and inflammatory pain • Cutting-edge highly innovative pipeline • Portfolio transformation into commercial partnerships • Innovative liposomal drug delivery technology • EUR 250m partnership with Boehringer Ingelheim Page 3

  4. Biolipox product portfolio Broad and Innovative product pipeline Product Indication PC Phase I Phase II Phase III NDA Market Partner(s) Ongoing BLX-NLA Rhinitis BLX-LSAID Asthma BLX-914 COPD/Asthma Initiate partnering 09’ BLX-2477 Asthma Ongoing BLX-MPI Inflam Pain BLX-CLI Asthma NLA & Steroid Rhinitis Page 4

  5. BLX-NLA (Nasal Ceterizine) Rhinitis • Product New treatment for the management of rhinitis. • description On demand treatment for allergy • Respiratory rhinitis market USD 7 bn* Market potential • NLA sales potential appr USD 300 mill • Direct competitor to Azelastine Nasal Spray (US, MedPointe and Meda) Competitive • Azelastine (appr USD 200 mill) ac counts for appr 80% of Medpointe sales landscape • Azelastine compliance hampered by taste • Good clinical efficacy Target • Fast onset to action and better compliance compared to Azelastine competitive • Faster onset of action compared to Ceterizine tablets advantage • No sedation compared to Ceterizine tablets • Partnering discussions ongoing Partnerships Development • Liposomal drug delivery / Phase II status * IMS Page 5

  6. BLX-NLA Ceterizine Nasal Spray description • Target Product Profile – Full effect (similar to market leading oral antihistamine) – No sedation (as effective as oral antihistamines at lower plasma levels) – Fast onset (< 5-10 min) – Taste masking irritant effects (liposomal formulation) • Perennial rhinitis (line extension) – Targeting all patients with rhinitis • Combination with nasal steroid – The rhinitis therapy with optimal therapeutic coverage – Targeting patients with moderate to severe rhinitis Targeting all rhinitis patients Page 6

  7. BLX-NLA Development - Phase II Study 6 4 Symptom Score *** *** • Total Nasal Score (max 9) at 10 minutes after allergen 2 challenge 0 Placebo NLA Cetirizine tablet Similar efficacy as cetirizine tablets Page 7

  8. BLX-NLA Development - Phase II Study 6 6 * 4 Symptom Score Symptom Score 4 *** *** *** 2 2 0 0 Placebo NLA Cetirizine Placebo Budesonide Budesonide tablet 64 µg 256 µg Similar efficacy as a nasal steroid Source: Annals of Allergy, Asthma & Immunology Vol 85, 2000 Page 8

  9. BLX-NLA Development - Phase II Study n=35 6 ** ** 5 α 2 -macroglobulin (µg/mL) • Results: Sustained 4 “Morning Effect” 3 2 1 0 Placebo NLA (bid) Cetirizine (qd) NLA Nasal Spray: Superior morning effect Page 9

  10. BLX-NLA Development - Phase II Study results 0,9 0,8 0,7 α 2 -macroglobulin (ug/mL) 0,6 ** 0,5 * * 0,4 0,3 0,2 0,1 0 Baseline 5 15 25 55 Time (min) Placebo NLA NLA Nasal Spray – full effect after 5 min Page 10

  11. Need for new asthma and COPD therapies Singulair sales 1998-2006 (global) USD bn • Respiratory market USD 17 bill 3.5 • Current leukotriene receptor 3.0 antagonists have lower efficacy than inhaled corticosteroids 2.5 • Aversion to steroids 2.0 1.5 • Singulair was launched on the major markets in 1998 with great success 1.0 • Need for improved therapy 0.5 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 Source: Medtrack Great demand for novel, non-steroidal anti-inflammatory drugs for asthma and COPD Page 11

  12. BLX-914– COPD and Asthma Product • New treatment for the management of COPD and asthma description • Respiratory market USD +17 bn* Market potential • Products on the market: Spiriva, Advair and Spirocort Competitive • Products in development: Several PDE4 inhibitors in development but with a landscape non-competitive safety profile and lack of good clinical efficacy Target • Good clinical efficacy competitive • Excellent tolerability advantage • Acquiring from Inflazyme Pharmaceuticals Partnerships • To be partnered following clinical Phase II Development • First Phase II results in the end of 2008 status * IMS Page 12

  13. BLX-2477 (Eoxin) – Asthma and COPD • Product New treatment concept for the management of asthma, COPD and other description inflammatory diseases. First in class and highly innovative • Respiratory market USD +17 bn* Market potential Competitive • Singulair, Advair and Spirocort landscape • Good clinical efficacy due to superior anti-inflammatory efficacy compared to Target Singulair and comparable to steroids. Superior anti inflammatory efficacy competitive compared to Singulair • advantage Good clinical efficacy • Excellent tolerability • Partnerships Partnering discussions initiated Development • Planning start of Phase I in 2008 status * IMS Page 13

  14. BLX-MPI: Challenging the COX-2 inhibitors COX-2 sales 1999-2005 (global) • Rapid sales surge after launch USD bn 6 • Concerns over 5 cardiovascular safety in 2001 4 • VIOXX withdrawn worldwide in Oct 2004 due 3 to increased risk of CV 2 events 1 0 1999 2000 2001 2002 2003 2004 2005 NA Source: Com pany data Room to exploit gap in the market Page 14

  15. BLX-MPI– Inflammatory Pain • Selective PGE2 inhibitor Product • Targeting the medical need in inflammatory pain description • Filling the gap in the market following the COX2 limitations • Inflammatory pain USD 5 bn++* Market potential • NSAIDS Competitive • COX2 inhibitors landscape • Target Good safety profile • competitive No CV/GI side effects • advantage Good clinical efficacy • Partnerships Partnered with Boehringer Ingelheim (B-I) Development • Preclinical status * IMS 2005 Page 15

  16. EUR 250m partnership with B-I Total value of EUR 250m+ royalties • Research collaboration for 3 years, signed in 2005 • B-I responsible for all development costs • Co-promotion rights in the Nordic and Baltic countries • Next milestone expected in 2008 • Page 16

  17. Agenda • Biolipox product overview • Transaction rationale • The combined company – Strategy – Products • The transaction Page 17

  18. A combination with clear industrial logic � Several late stage products � Innovative product portfolio � Broader product portfolio � Development capabilities � Earlier portfolio with partnering � Significant news and deal flow opportunities → cash and quids � Formulation & CMC capability � CMC & Chemistry capability � Emphasis on development – not discovery � Drug delivery platform � Drug delivery platform � Innovative technology base � Marketing & Sales � Clinical capability � State of the art product � Deal dependent � Big Pharma partnership development process � Narrowly traded � 52 employees � Cost synergies � Subcritical market cap � Deal dependent � 74 employees � Larger market cap � New facilities � Enhanced liquidity � Broader/international owner base � Improved M&A ability Page 18

  19. Agenda • Biolipox product overview • Transaction rationale • The combined company – Strategy – Products • The transaction Page 19

  20. Orexo’s combined product pipeline Product Indication PC Phase I Phase II Phase III NDA Market Partner(s) Rapinyl Acute Pain Sublinox Insomnia Ongoing Ongoing OX-17 Gerd Ongoing BLX-NLA Rhinitis BLX-LSAID Asthma BLX-914 COPD/Asthma Initiate partnering 09’ Ox-19 Incontinence OX-40 Migraine BLX-2477 Asthma Ongoing BLX-MPI Inflam Pain BLX-CLI Asthma Ongoing OX-30 Pain OX-23 Pain NLA & Steroid Rhinitis Orexo Biolipox Page 20

  21. Portfolio optimization SUBJECT TO PRODUCT DEALS DEVELOPMENT EVALUATION Cash inflow $$$ FOCUS • OX19 – Incontinence • Rapinyl √ • OX40 – Migraine • Sublinox • OX30 – Pain/Abuse resist • OX23 – Pain ongoing • OX17 • OX17 – GERD • BLX - LSAID ongoing • BLX NLA • BLX 914 – COPD / Asthma ongoing • MPI √ • BLX –CLI ongoing • BLX –2477 ongoing = Biolipox projects Page 21

  22. Anticipated news flow 2008 Short term cash generating and pipeline value enhancing • business development Distribution deal Rapinyl Asia and RoW √ – EU approval and launch of Rapinyl – Partnering agreement OX-17 – NLA Nasal Spray partnering agreement – Partnering agreement Sublinox – Partnering agreement dual effect respiratory drug and EOXIN inhibitor – Product development • FDA filing of Sublinox – EU approval and launch of Rapinyl – FDA filing of Rapinyl in the US – Initiation Phase II PDE4 inhibitor in asthma and COPD – Initiation Phase I EOXIN inhibitor in asthma – First Phase II data PDE4 inhibitor – Phase I data EOXIN inhibitor in asthma – Page 22

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