paolo colombo, ceo [email protected] plumestars srl
TRANSCRIPT
2. There are 7.000 Rare Diseases in the world 25-30 M Americans live with a rare disease.
To cure these diseases orphan medicines are required.
The BIG IDEA!
To develop novel medicines to cure rare diseases by repurposing known drugs in innovative delivery systems.
3. Problem / Market Opportunity
• Mesothelioma (MPM) is a very aggressive pleura or peritoneum rare cancer.
• Over 43.000 people die every year worldwide for MPM.
• Patients have 12 months survival after diagnosis.
• PlumeSTARS has the opportunity to enter the market of MPM medicines thank to the EMA/FDA orphan designation of its novel product for local delivery of the anticancer cisplatin.
4. Solution (Hyalcis)
Hyalcis is a novel designed orphan medicinal product, consisting in a biodegradable film loaded with cisplatin, for loco-regional drug delivery. The film is implanted in thorax during surgery for primary tumor resection, with the objective to prevent or delay the local metastases of MPM.
PlumestarsS.r.l.|StradaInzani1,43125-Parma
DESCRIPTIONOFTHEPRODUCT
ThemedicinalproductobtainedtheEMAorphanmedicinedesignationin2017.EMAgavealsotheprotocolassistanceforthepreparationoftheregistrationdossier.Theapplicationfor
orphandrughasbeensenttoFDA.
Theproductunderdevelopmentisathinandflexiblepolymericfilm,sufficientlyresistanttobeappliedintrapleuralorinotherdistricts,adheringtothemesothelialorepithelialsurfaces.Forexample,theinvitroreleaseofcisplatinfromthefilmresultedprolongedforatleastthreedays,inreleaseconditionswheretheentirefilmwasimmersedinthedissolutionmedium.Invivo,acontinuousreleaseformorethan10dayscouldbeextractedfromtheplasmalevelcurveobtainedinPKstudyonasheepmodel.Thisprolongationprovidedhighlocalconcentrationsofdrug,where the residual tumour could be present. Therefore,hyaluronate-cisplatinfilm(HA-CisPt)isanovelcisplatindeliverysystem.Hyaluronicacid(HA),aphysiologicalcomponentofthe
extracellularmatrix,isabiocompatiblepolymer.
MAINADVANTAGES
Preclinicalstudiesonratsshowedthathyaluronatefilmsloadedwithcisplatinweresignificantlymoreeffectiveinreducingtumourrecurrenceandassuringhigherandprolongedplasmaticdrugconcentrationsthancisplatinsolution,withoutincreasingsystemictoxicity.
SubsequentpreclinicalstudiesconductedonSardiniansheepshowedthatpolymericfilmsapplicationinthepleuralcavitywaseasyandhomogenoustoplaceinthoraciccavityofthesheep.Plasmaticdrugconcentrationwasmuchhigherafterpolymericfilmstreatmentthandrugsolutionafter7-9days.
TECHNOLOGYKEYWORDSPolymericFilm,Drugdelivery,Loco-regionalAdministration,HyaluronicAcid,MalignantPleuralMesothelioma
CURRENTSTAGEOFDEVELOPMENTPreclinicalstudiesalreadybedone-TestedinlaboratoryTECHNICALANDSCIENTIFICPUBLICATIONSIntrapleuralpolymericfilmscontainingcisplatinformalignantpleuralmesotheliomainarattumourmodel:apreliminarystudy,EuropeanJournalofCardio-thoracicSurgery37(2010)557—565.
5. Hyalcis Benefits • Efficacy: reduction of local tumor metastases • Liver and renal toxicity lower than IV administration • Applicability to other drugs or other treatable cancers
No treatment Hyalcis
Operated Rat Chest Conditions
6. Competition/ Barriers to entry
Chemotherapy
+Surgery Radiotherapy
Intracavitary
chemotherapy Hyalcis
Efficacy
Fair
Proven in humans
Low
Palliative
Medium
Drug solution tested, marginal
effect
Highest
Demonstrated in animal, not yet in
humans
Toxicity
High
Proven severe harmful effects
n/a
High
Similar to IV therapy
Low
Demonstrated in animal
Safety & Effectiveness
Low
Heavy, complex treatment
Low
Radiations effects
Low
Potential fluid leakage
High
Precise and accurate
application
No other products for loco-regional treatment of MPM
7. Go To Market Strategy
Customers: thoracic surgery hospital depts; pharma companies. Market type: niche market of high economic and social value. Market size and value: 40,000 treatable cases worldwide potential market value of 1.200 M€, per year. Target market share: 25% in the third year from product registration.
Exclusive market after registration: 10 ys in EU and 7 ys in US
8. Roadmap
Studies and preliminary composition
of films
2007-2010
1st preclinical study on rats
2010
2nd preclinical study on
larger animals (sheep)
2012
Orphan medicinal
designation approved by
EMA
2016
Orphan medicinal
designation approved by
FDA
2017
EU Program, SME
Instrument Phase 1, financed
2019
Past milestones
9. Business Model
1. Find Investor to register Hyalcis directly in EU and USA and then sell the product to pharmaceutical company or hospital
2. Find a pharma industrial partner to license or sell the product on the base of lump sum and royalties on the market.
Two strategies:
10. Financial Overview
10M€ cumulated
revenues in the
first 3 years after
product
registration.
Year 1 2 3 4 5
Costs
Preclinical and clinical studies €120.000 €80.000 €0 €0 €0
Pharmaceutical studies €50.000 €50.000 €0 €0 €0
Industrialization and registration €1.500.000 €50.000 €50.000 €50.000
Investment in marketing €25.000 €50.000 €52.500 €60.375 €75.469
Fixed expenses €300.000 €900.000 €945.000 €1.086.750 €1.358.438
Variable Costs €0 €0 €5.000.000 €15.000.000 €25.000.000
Revenues
Revenues €0 €0 €10.000.000 €30.000.000 €50.000.000
Unit sales # 0 0 2.000 6.000 10.000
Cash flow (EBITDA)
Cash flow -€495.000 -€2.580.000 €3.952.500 €13.802.875 €23.516.094
Cumulative Cash Flow -€495.000 -€3.075.000 €877.500 €14.680.375 €38.196.469
Actualized cash flow
Discounted Cash Flow -€478.261 -€2.408.458 €3.564.929 €12.028.408 €19.799.920
Discounted Cumulative Cash Flow -€478.261 -€2.870.545 €791.455 €12.793.099 €32.160.402
Jobs created (PlumeStars only) 3 2 5 5 5
Net Present Value (*) €32.506.538
Internal Return Rate (IRR) 179% (*) Based on EBITDA, excluding taxes and dividends.
Financial table submitted to EU to apply for
SME Instrument Phase 1
11. Who we are
Paolo Colombo
The Headmaster, CEO
Fabio Borella
The Hipmaster
Eride
Quarta The Hacker
The pharmaceutical technology researchers of PLU are world recognized and patent owners in medicines constructed on drug delivery technology.
Laura
Monica The Hustler and Communication
12. The Ask & Use of Funds
• Investors
• Partners for development and marketing
• Researchers for new products’ discovery
Funding requirement: ~ 3M€ investment to bring the product to market: - 2.5 M€ for pharmaceutical, pre-clinical and clinical studies. - 0.9 M€ for industrialization and registration dossier preparation. - 100 K€ for initial marketing.
Paolo Colombo, Pharm D.; PhD; CEO
Eride Quarta, Pharm D.; PhD Student;
Temporary Lab at Biopharmanet –TEC, University of Parma
c/o Department of Food & Drug,
Parco Area delle Scienze 27/A , 43125 Parma (Italy).
+39 320 43 44 670; +39 0521 905086
http://plumestars.com