UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): November 14, 2012
Sucampo Pharmaceuticals, Inc. |
(Exact Name of Registrant as Specified in Charter) |
Delaware |
001-33609 |
30-0520478 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
4520 East-West Highway, 3rd Floor Bethesda, Maryland |
20814 |
(Address of Principal Executive Offices) | (Zip Code) |
Registrant’s
telephone number, including area code: (301) 961-3400
(Former Name or Former Address, if Changed Since Last Report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
⃞ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
⃞ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01. Regulation FD Disclosure.
On November 14, 2012, Sucampo Pharmaceuticals, Inc. (“the Company”) will make a corporate update presentation with one-on-one meetings in San Francisco, California. On November 15, 2012, the Company will make the same corporate update presentation at an investor conference in Phoenix, Arizona at the 2012 Credit Suisse Healthcare Conference. Both meetings will include written communication comprised of slides. The slides from the presentation are being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 and Exhibit 99.1 to this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
99.1 The corporate update presentation slides dated November 14, 2012.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
SUCAMPO PHARMACEUTICALS, INC. |
||||
|
|||||
Date: | November 14, 2012 | By: |
|
/s/ Thomas J. Knapp |
|
|
Name: |
Thomas J. Knapp |
|||
|
Title: |
EVP, Chief Legal Officer and Corporate Secretary |
Exhibit 99.1
Cary J. Claiborne, CFOStanley G. Miele, SVP, Sales & MarketingSilvia Taylor, SVP, IR, PR & Corporate CommunicationsNovember 14, 2012
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
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
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
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
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
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
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
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
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
AMITIZA Has Time-Tested Safety Profile and Positive Clinical Experience Valued by Physicians See Reference 1
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
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
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
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
Over Past 3 Years, Category TRx Volume in US Has Increased 7% From 27.3M to 29.2M See Reference 25
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
RESCULA: Only Nonprostaglandin That Lowers IOP Throughout Day (12 h) With Excellent Systemic Safety Profile See References 23, 26-28
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
Sucampo’s Clinical Pipeline (Gp:) Successfully completed (Gp:) Approval pending (Gp:) Projected start or submission
Key Facts
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
Appendix
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Cary J. Claiborne, CFO Stanley G. Miele, SVP, Sales & Marketing Silvia Taylor, SVP, IR, PR & Corporate Communications November 14, 2012