Attached files

file filename
8-K - SUCAMPO PHARMACEUTICALS, INC. 8-K - Sucampo Pharmaceuticals, Inc.a50477466.htm

Exhibit 99.1

GRAPHIC

Cary J. Claiborne, CFOStanley G. Miele, SVP, Sales & MarketingSilvia Taylor, SVP, IR, PR & Corporate CommunicationsNovember 14, 2012


GRAPHIC

This presentation contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, future financial and operating results, and other statements that are not historical facts.  The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo’s ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the US and internationally and the exposure to litigation and/or regulatory actions.No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect Sucampo’s business, particularly those mentioned in the risk factors and cautionary statements in Sucampo’s Form 10-K for the year ended Dec. 31, 2011, which the Company incorporates by reference.Forward-Looking Statements


GRAPHIC

Sucampo Snapshot:  Prostone Pioneers Commercial-stage, global biopharmaceutical company  2 FDA-approved drugs based on our proprietary prostone technologyAMITIZA® (lubiprostone) in gastroenterology marketRESCULA® (unoprostone isopropyl) in ophthalmology marketProstone pioneersTherapeutic potential 1st identified by Sucampo’s founders, Drs Ryuji Ueno and Sachiko Kuno Sucampo MissionTo develop and commercialize prostone-based medicines to meet the     major unmet medical needs of patients on a global basis ® Registered trademark of Sucampo


GRAPHIC

Sucampo Has Pioneered the Field of Prostones Prostones:Functional fatty acids naturally occuring in the human bodyIon-channel activatorsPhysiological mediators of restoration of cellular homeostasis and tissue regeneration Clinical safety profile of prostones is excellent, as demonstrated by the clinical safety record of AMITIZA in GI and RESCULA in ophthalmologyClinical potential of prostones is broad and applicable to various therapeutic fields beyond GI and ophthalmology Sucampo is the only company developing and commercializing prostone compounds globally See Reference 1


GRAPHIC

Proprietary Platform Technology: Sucampo’s Prostones Are Highly Potent Ion-Channel Activators  AMITIZA  RESCULA  Fluid Secretion  Barrier Repair and Mucosal Protection  Anti-Inflammatory Activity  ClC-2-Chloride Channel Activation  BK-Potassium Channel Activation  Prevents neuronal cell death  Smooth Muscle Relaxation  Nerve Stabilization  Prostones  See Reference 1


GRAPHIC

Global AMITIZA Approvals and Regulatory Filings  JapanCC (2012)2  UKCIC (2012)OIC (target filing 4Q12-1Q13)  USCIC (2006)IBS-C (2008)OIC sNDA1 Priority Review (2013)  SwitzerlandCIC (2009)OIC (target filing 4Q12-1Q13) (Gp:) AMITIZA has been used for >6 y with 6 million prescriptions by patients suffering from chronic idiopathic constipation and irritable bowel syndrome with constipation  $10M milestone from Takeda upon first OIC sale$15M milestone from Abbott Japan upon first sale  See Reference 1


GRAPHIC

Sucampo: Leader in Gastrointestinal Disease Medication Development Chronic Idiopathic Constipation (CIC)Affects ~14%-16% of adult population globally33M in US (14%),2 41M in EU 5 (16%),2 15M in Japan (14.3%)3 – CCAccounts for 92,000 hospitalizations/yr in US4Severe constipation is associated with increased cardiovascular risk in women5,6Irritable Bowel Syndrome (IBS)Affects ~15% of adult population globally, 1/3 of whom have IBS with constipation (IBS-C)712M in US, 11M in EU7,8, 3M in Japan7,9 Direct and indirect costs of IBS care in US: $20 billion/yr7Patients with IBS consume >50% more healthcare resources than those without IBS10 See References 2-10


GRAPHIC

AMITIZA Users Are the Most Satisfied With Their Treatment and Twice as Satisfied as MiraLAX Users  AMITIZA also has highest persistency rate in category  See Reference 11


GRAPHIC

Long-term Efficacy Positive Long-term Treatment Response: Phase 3 Studies of AMITIZA 8 µg BID in IBS-C  Month  0  5  10  15  20  25  30  35  40  Treatment Responders, % (Gp:) 1 (Gp:) 2 (Gp:) 3 (Gp:) 4 (Gp:) 5 (Gp:) 6 (Gp:) 7 (Gp:) 8 (Gp:) 9 (Gp:) 10 (Gp:) 11 (Gp:) 12   See Reference 1


GRAPHIC

 TRx: +7%  Dollars: +12% Positive Clinical Experience Translating to Consumption Growth: $291M on Annualized Basis  See Reference 12  AMITIZA has 1-2% share of ~250M units for Constipation


GRAPHIC

AMITIZA Has Time-Tested Safety Profile and Positive Clinical Experience Valued by Physicians See Reference 1


GRAPHIC

Opioid-Induced Constipation: Increase Potential Pool for AMITIZA and Strengthen Efficacy Positioning  Moderate-severe OIC affects ~2.0M-2.5M patientsCurrently no approved oral product for OIC Most common reason for discontinuation of opioid therapyOIC patients are viewed as “difficult to treat” and are dissatisfiedPCPs welcome 1 medicine indicated for multiple causes of constipationAMITIZA does not act on opiate receptors or inhibit analgesic activity of opioid therapyMu-opioid-receptor agonist compounds under development may have cardiac safety concerns  See Reference 13-16  FDA priority review action date: late January 2013


GRAPHIC

Summary and Outlook for AMITIZA Well positioned to serve expanding population of patients with CIC and IBS-CContinue growth in US:  over 6 million prescriptions used over past 6 yrs, with favorable benefit-risk profileNear-term goalsSeek approval for OIC indication in US and submit labeling applications for OIC abroadExpand global approvals and launches for AMITIZA worldwideDevelop and seek approval for AMITIZA in pediatric constipationCurrently unmet medical need; no approved prescription medicationsDevelop liquid formulation of AMITIZA for long-term care marketEvaluate potential of AMITIZA for new indications, such as mixed irritable bowel syndrome


GRAPHIC

OphthalmologyGlaucoma is a group of ocular diseases with various causes that ultimately are associated with a progressive optic neuropathy leading to loss of visionAge-related disease:Second leading cause of bilateral blindness worldwideWill affect an estimated 79.6 million people worldwide by 202018Reduction in intra-ocular pressure (IOP) is currently the only modifiable risk factor for patients with glaucoma and ocular hypertension  See References 17-18 Sucampo Is an Emerging Player in Ophthalmology:  RESCULA


GRAPHIC

US Glaucoma Market Overview  The US glaucoma market is 29.2M TRx’s224-5M potential patients21,22,2467% of the market is generic2380% of TRx’s are by eye specialists23~$3B:  US sales volume (2012)~$1B:  Japan sales volume (2011)Compliance and adherence are unmet needs50% of new patients drop off therapy within one year of initiationProstaglandins are inflammatory agents which depolarize cell membranes#1 reason for discontinuation of prostaglandins is hyperemia20,24  See References 19-24


GRAPHIC

Over Past 3 Years, Category TRx Volume in US Has Increased 7% From 27.3M to 29.2M  See Reference 25


GRAPHIC

In patients with primary open angle glaucoma or ocular hypertension, RESCULAReduces IOP throughout the day, alone or in combinationHas an excellent systemic safety profile and an established and ocular safety profileMOA:  ion channel activator promotes aqueous humor outflow through the trabecular meshworkClinically meaningful results:  glaucoma and intraocular hypertension RECULA has an alternate route to IOP Reduction  BK channel  Hyperpolarization  Relaxation of TM  Increases in outflow via  conventional pathway  TM, trabecular meshwork.See Reference 1  Opportunity for new option:  differentiated product with a novel mechanism of action


GRAPHIC

RESCULA: Only Nonprostaglandin That Lowers IOP Throughout Day (12 h) With Excellent Systemic Safety Profile  See References 23, 26-28


GRAPHIC

RESCULA US Launch Overview  RESCULA was FDA-approved (2000) for the lowering of intraocular pressure (IOP) in primary open-angle glaucoma (POAG) and ocular hypertension (OH) in patients who are intolerant of or insufficiently responsive to other IOP-lowering medicationssNDA Approval and Label update:  reflect current scientific understanding of mechanism of action and be approved for first-line treatmentSucampo plans to launch RESCULA in US upon sNDA approval


GRAPHIC

Sucampo’s Clinical Pipeline (Gp:) Successfully completed (Gp:) Approval pending (Gp:) Projected start or submission


GRAPHIC

Key Facts


GRAPHIC

Key Value Drivers (Gp:)  Filed OIC sNDA: 3Q 2012 OIC filing accepted by FDA for priority review Decision in Takeda arbitration resolved dispute (Gp:) US   AMITIZA (Gp:)  Approved in Japan for CC: 2Q 2012 Await pricing decision: Nov ‘12 Launch: 4Q 2013 ($15M milestone upon first sale) (Gp:) Japan  (Gp:) Approved in UK for CIC: 3Q 2012Launch 1Q 2013Submit for regulatory approval of OIC (Gp:) EU  (Gp:)  Reached agreement on reimbursement priceBegin active marketing 1Q 2013Submit for regulatory approval of OIC (Gp:) Switzerland   RESCULA (Gp:) Obtain approval of sNDA (updated label) Launch:  shortly after approval of sNDA (Gp:) US  (Gp:) Completed (Gp:) In Process


GRAPHIC

Appendix


GRAPHIC

AMITIZA: Effective 1st-Line Therapy for CIC and IBS-C  No gender restriction in CIC Approved for use in women with IBS-C in US Rapid onset in CIC: 57%-63% of patients respond within 24 hr No black box warning Proven long-term safety profile in CIC and IBS-C No serious safety concerns have arisen in post marketing use of AMITIZA Safety in clinical-use setting has been a problem for other CIC and IBS-C medications, leading to withdrawal of marketing applicationsLabeled risk-benefit ratio for AMITIZA is well supported by post marketing safety profile from over 6 million prescriptions over 6 yrs No limitation on duration of use in US, Japan, and Switzerland  See Reference 1


GRAPHIC

Terms of Sucampo’s AMITIZA Agreements  Takeda AgreementTakeda shall promote, market, and sell AMITIZA in US and CanadaSucampo’s tiered royalty rate: 18%-26% of annual net salesSucampo earned $20M in upfront and $130M in development milestone payments as of 6/30/12Sucampo received $106M in reimbursement for R&D expenses from TakedaAbbott Japan AgreementAbbott Japan shall promote, market, and sell AMITIZA in JapanSucampo will sell product to Abbott Japan at discount to Abbott Japan’s approved reimbursement priceSucampo earned $10M in upfront and $12.5M in development milestone payments as of 6/30/12Sucampo expected to earn $15M milestone payment on 1st commercial sale in Japan by Abbott Japan in 4Q12


GRAPHIC

RESCULA 0.12% Has Been Shown to Maintain IOP in Patients Intolerant of Prostaglandins   Changes over time in intra-ocular pressure (N = 23)ANOVA revealed no significant change (P = 0.41)  Intra-ocular pressure, mm Hg  24  22  18  16  10  14  12  Before Switch  M1  M2  M6  M9  Y1  Follow-up period  IOP change in 23 eyes switched to RESCULA after mean 8 mo on prostaglandins, with mean initial IOP of 24.7 mm Hg and 17.2 mm Hg at treatment switch   See Reference 29


GRAPHIC

AMITIZA Mechanism of Action: ClC-2 Ion-Channel Activation and Fluid Secretion  Highly selective activation of ClC-2 channels in intestinal lumen  Chloride efflux followed by passive efflux of sodium into small intestine  Enhanced intestinal fluid secretion without alteration of serum electrolyte levels  See Reference 1


GRAPHIC

AMITIZA Mechanism of Action: Restores ClC-2-Mediated Barrier  Disease, injury, stress, or medications such as NSAIDs can damage epithelial barrier  Disorganized tight junctions and resulting intestinal permeability may be involved in pathogenesis of IBS  ClC-2 activation by AMITIZA enhances restoration of tight junctions and reduces intestinal permeability caused by stress or ischemia  Cl–  Apical membrane  Intracellular  Extracellular  Tight junction  Basolateral membrane  CIC-2 Channel  Prostone binding site  See Reference 1


GRAPHIC

AMITIZA Safety Profile: Clinical Trials in Patients With CIC or IBS-C  Nausea rated as mild-moderate by 89% and 96% of CIC and IBS-C patients, respectively, who experienced nausea >93% of patients reporting nausea experienced only 1 event over course of treatment with AMITIZAIn placebo-controlled, 12-wk IBS-C trials, diarrhea reported by 7% of AMITIZA patients vs 4% of placebo patientsIn IBS-C exposure up to 1 yr, dropout due to diarrhea accounted for <2% of patients  AMITIZA has excellent tolerability and safety profile as demonstrated in clinical studies  See References 1, 30


GRAPHIC

AMITIZA Postmarketing Safety  No serious safety concerns have arisen in postmarketing use of AMITIZASafety in clinical-use setting has been a problem for other CIC and IBS-C medications, leading to withdrawal of marketing applicationsLabeled risk-benefit ratio for AMITIZA is well supported by postmarketing safety profile from 6 million prescriptions over 6 yr  See Reference 1


GRAPHIC

Substantial Abdominal Pain Improvement in IBS-C Patients Reporting at Least Severe Abdominal Pain at Baseline*  *LOCF analysis; †P value from CMH test.See Reference 31


GRAPHIC

Unoprostone – BK Channels – Trabecular Outflow   Aqueous humorFormed in ciliary processes from arterial bloodSecreted to posterior chamberReaches anterior chamber by crossing pupil  BK channels are found in the trabecular meshwork (TM)2Unoprostone reduces IOPActivation of BK channels hyperpolarizes the cell and leads to relaxation of the TMResulting in increased outflow via conventional pathway (through the TM)  See Reference 18  Anterior Chamber


GRAPHIC

Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, Chief Scientific Officer, and Co-FounderR-Tech Ueno, LTD, Co-Founder MD and Ph.D. (Medicinal Chemistry) from Keio University; Ph.D. (Pharmacology) from Osaka UniversityCary J. Claiborne, Chief Financial OfficerNew Generation Biofuels, CEO, CFO, Director Osiris Therapeutics, CFO Constellation Energy Group, VP Financial Planning Senior leadership positions with General Electric (15 years), MCI and Home DepotStanley G. Miele, President, Sucampo Pharma Americas, LLC and Senior Vice President, Sales and Marketing, Sucampo Pharmaceuticals, Inc.Abbott Laboratories Millennium Pharmaceuticals (COR Therapeutics) Greg Deener, Senior Vice President, Marketing Strategy and ImplementationGTx, Inc.GlaxoSmithKlineThomas J. Knapp, Executive Vice President, Chief Legal Officer and SecretaryNorthWestern Corporation, General Counsel and Corporate Secretary BoeingOther executive experience includes FDA/Center for Drug Evaluation and Research, Procter & Gamble, Pfizer, MedImmune, Allergan, Alcon and GlaxoSmithKline Management


GRAPHIC

US Patent No. Expires Type of patent 5,284,858 2014 Composition of matter 6,414,016 2020 Therapeutic use (treating conditions including constipation) 6,583.174 2020 Composition of matter 7,064,148 2022 Therapeutic use (treating conditions including constipation) 7,417,067 2020 Composition of matter 7,795,312 2024 Therapeutic use (treating conditions including IBS) 8,026,393 2027 Formulation 8,071,613 2020 Method for relieving constipation in IBS-C 8,088,934 2021 Composition of matter 8,097,649 2020 Composition of matter 8,097,653 2022 Therapeutic use (treating constipation) 8,114,890 2020 Composition of matter 4,332,316 2020 Composition of matter 4,332,353 2022 Therapeutic use 4,684,334 2021 Therapeutic use (treating conditions including constipation) 4,783,794 2027 Composition of matter 4,786,866 2022 Therapeutic use (treating constipation)   .    Issued Lubiprostone Patents  *For Orange Book-listed patents concerning lubiprostone, see for example: http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021908&Product_No=001&table1=OB_Rx


GRAPHIC

Japanese Patent No. Expires Type of patent 4,332,316 2020 Composition of matter 4,332,353 2022 Therapeutic use 4,684,334 2021 Therapeutic use (treating conditions including constipation) 4,783,794 2027 Composition of matter 4,786,866 2022 Therapeutic use (treating constipation) 4,852,229 2022 Therapeutic use (treating constipation) 4,889,219 2023 Therapeutic use (treating constipation) European Patent No. Expires Type of Patent 1,220,849 2020 Composition of matter 1,315,485 2021 Therapeutic use (treating constipation) 1,392,318 2022 Therapeutic use 1,426,361 2020 Composition of matter 1,443,938 2022 Therapeutic use (treating constipation)   .    Issued Lubiprostone Patents  *For Orange Book-listed patents concerning lubiprostone, see for example: http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021908&Product_No=001&table1=OB_Rx


GRAPHIC

References  Sucampo data on file.Suares et al. Am J Gastroenterol. 2011Kantar Health Epi database http://epidb.khapps.jpLembo et al. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease. 2010Salmoirago-Blotcher et al. Am J Med. 2011Talley et al. Am J Gastroenterol. 2001Saito et al. Am J Gastroenterol. 2002Muller-Lissner S et al. Digestion. 2001Kubo et al. Neurogastroenterol Motil. 2011Hulisz D. J Manag Care Pharm. 2004Sucampo data on file – Physician ATUIMS MAT July 2012 compared with MAT July 2011IMS HealthVerispan PDDAPhysician InterviewsClearView AnalysisRESCULA Package InsertQuigley et al. Br J Ophthalmol 2006 Mar;90(3):252-7American Academy of Ophthalmology


GRAPHIC

References Cont.  Friedman et al. Prevalence of Open-Angle Glaucoma Among Adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):532-8July 2011-June 2012 MATTY IMS NPS DataJuly 2011-June 2012 MATTY IMS NPA DataCatalina Presentation 2011Input from KOLsIMS NPA data, MATTY June 2009 to MATTY June 2012Timoptic Prescribing Information; 2005. Merck & Co. Inc., Whitehouse Station, NJAlphagan-P Prescribing Information. 2005. Allergan Inc, Irvine, CAAzopt Prescribing information. 2000–2009. Alcon Laboratories Inc, Fort Worth, TXGoseki T et al. Jpn. J Clin Ophthalmol. 2006;60:1227-30AMITIZA Package Inserts (US and UK) Joswick et al. Digestive Disease Week, 2012


GRAPHIC

Cary J. Claiborne, CFO Stanley G. Miele, SVP, Sales & Marketing Silvia Taylor, SVP, IR, PR & Corporate Communications November 14, 2012