Sosei Group Corporation

Transcription

1 Sosei Group Corporation Shinichi Tamura President and CEO

2 Sosei History - Background Incorporated in Japan in 1990 and traded initially as a technology transfer company In 1999 switched to biopharmaceutical development company Floated on MOTHERS index of TSE (JP:4565) in 2004 raising >$100m Acquired Arakis Ltd in 2005 at ~$200m Group companies Sosei Group Corporation, Sosei Co. Ltd. and Sosei R&D

3 Sosei Vision and Goals/Events Sosei Vision To become a significant global biopharmaceutical company that originated in Japan To quickly adapt to the changing environment Events and Goals ERS presentation of QVA149 (13-15 Sept 09) NDA of SOH-075 (Sept 09) P3 start of QVA149 (4Q09) Approval of SOH-075 (by 1Q11) NDA of NVA237/QVA149 (2011) Partnering of other assets (?) In-licensing late stage compounds (?)

4 Sosei Pipeline Territory Products Indication Phase II Pre-clinical Phase I Phase III Phase IIa Phase IIb Regulatory Approval NVA237 Worldwide COPD QVA149 1 Worldwide COPD Japan, Australia SOH Emergency contraceptive SD118 Worldwide( -) 3 Neuropathic pain AD 452 Worldwide Malaria 1 QVA149 is a combination of NVA237 and Novartis long-acting beta agonist, indacaterol 2 NorLevo 3 Excluding Japan and some other Asian territories

5 NVA237/QVA149 Status/Plan Long Acting Muscarinic Antagonist (LAMA) Originally launched in 60s for GI disorder, but reprofiled for COPD Out-licensed to Novartis and all development costs borne by them For achieving pre-agreed clinical, regulatory and commercial targets, Sosei receives up to $187.5m milestones, plus royalties on product sales NVA237 (monotherapy) - Novartis started Phase III trial in June Potential first line therapy for COPD - Confirmed superior efficacies to current treatment QVA149 (combination with LABA) - Novartis expect to start Phase III in 4Q Phase II data to be presented at ERS (13-15 Sept 2009) - Potential to be best-in-class and blockbuster product Novartis expect to file NDA of both products in 2011

6 SOH-075 Current Status Levonorgestrel (NorLevo ) for emergency contraception Typical drug-lag product for Japan (listed in WHO essential drug) Phase III Clinical Trial (Completed in 2008) Study was designed to evaluate the safety and prevented pregnancy rate in Japanese adult female subjects who require emergency contraception No serious adverse events were reported during the study In 62 of 63 subjects pregnancy was successfully prevented, which is same as the results of studies undertaken abroad Development Schedule NDA submission by the end of September 2009 Approval expected in early 2011 Partnering Binding heads of terms in place with Aska Pharmaceutical

7 Partnering Candidates SD118* Neuropathic pain Ph I completed AD923 Cancer breakthrough pain Ph III AD337* Fibromyalgia, etc. Ph IIa completed SD726 Lower back pain, etc. Pre-clinical SD208 Psoriasis Pre-clinical SD281 Ulcerative colitis Research DRP-049* Fibrosis Research Only ones with * will be covered.

8 SD118 - Background Candidate for Neuropathic pain treatment SD118 was licensed from a Japanese Pharma having previously been developed as far as Phase III but stalled due to lack of efficacy SD118 was re-profiled using Sosei s Drug Re-profiling Platform (DRP ) In-vivo efficacy models conducted with DRP partner NeuroSolutions Ltd. Completed two Phase I studies (SAD & MAD) in the UK with supporting CMC and safety work 8

9 SD118 - Efficacy PWT (g) dosing D-2 D-1 D0 D7 D14 1hr 2hr 4hr 6hr Time after dosing vehicle GBP100mg/kg 0.3mg/kg SD118 3mg/kg SD118 10mg/kg SD118 30mg/kg SD118 n=8 or more animals per group *,,, =, P<0.05, 0.01 and respectively versus vehicle by ANOVA In the CCI model of neuropathic pain SD118 is as effective as gabapentin, with a longer duration of action and numerically superior efficacy 9

10 SD118 - Pharmacology summary Favourable profile in neuropathic pain models - Modest effects in models of inflammatory pain suggest strongly that neuropathic pain is the correct disease segment to target Inhibits ectopic discharge of neuropathic pain neurones in vivo No effect on baseline (normal) nocioception No tolerance on repeated dosing Possibly working via a novel mechanism of action Overall, the preclinical and pharmacological profile is at least equivalent (in some cases superior) to Gabapentin, and legacy and current clinical studies suggests a superior tolerability profile 10

11 AD 337 in Fibromyalgia Single isomer of proven analgesics, SNRI + Dopamine RI FMS (muscular pain, fatigue and depression/anxiety) AD 337 is potent analgesics and has demonstrated a broad pharmacological profile beneficial for fibromyalgia It has shown comparable pre-clinical pharmacology to drugs which have promising results in FMS Its pre-clinical pharmacology offers a number of potential ways to differentiate AD 337 from other products in development: - Efficacy in Acute and Chronic Pain - Possible reduced potential for drug-drug interaction in a condition where polypharmacy is common provides differentiated side effect profile (other members of class suffer from black box warnings for liver toxicity) - Long patent life potential compared to pregabalin, duloxetine, milnacipran ~$500m sales potential

12 AD337 - Fibromyalgia Impact Questionnaire The p-value at week 1 is significant (0.012) The p-value at week 4 is not statistically significant (0.216) (Primary Endpoint) Mean Baseline scores = 68 (AD 337), 65 (placebo) Subscales of FIQ (Physical impairment/feel good/work done/pain)

13 DRP Anti-fibrotic agent Originally developed for hyperlipidemia, but stalled due to lack of efficacy. Identified from Sosei s DRP project Inhibitory effect of TGF-β signal transduction, and pre-clinical data supports utility for the treatment of fibrotic disorders. Sosei has world wide exclusive rights of IP, development and marketing. Since Originator terminated the Development of DRP-049 after Phase IIa study due to lack of efficacy not safety problem, a commercial partner: - can construct a low risk development strategy from its safety profile, and - can construct a rapid development plan from many existing data.

14 DRP New Finding in vivo: Bleomycin-induced pulmonary fibrosis in mice DRP-049 significantly reduced the change induced by Bleomycin in lung morphology No bleomycin + bleomycin Vehicle DRP-049 NAC Hematoxylin-eosin staining 40x magnification This model is widely used experimental model of human pulmonary fibrosis. This model replicates many of the features of human pulmonary fibrosis, including excess deposition of extracellular matrix components, such as collagen, elastic fibers and proteoglycans. Fibrotic cytokines, TGF-β in particular, play important roles in the process of collagen faulty expression in lung tissue

15 Contacts SD118, DRP049 Akira Tsunashima SVP of Business Development, Sosei Co. Ltd. T. +81(0) E. AD923, AD337, SD726, SD208, SD281 AD923, AD337, SD726, SD208, SD281 Michael Murray Managing Director, Sosei R&D Ltd. T. +44(0) E.