the asthmaco. june 2013. $8.9b problem in asthma salbutamol (a.k.a. albuterol) is the only...
TRANSCRIPT
![Page 1: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/1.jpg)
The AsthmaCo.June 2013
![Page 2: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/2.jpg)
$8.9B Problem in Asthma
SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via same B-adrenergic pathway $1.6B sales, 4th most prescribed, 15th highest selling GENERIC worldwide
When Salbutamol doesn’t work… 3.9M Emergency Department visits / yr TREATED WITH SALBUTAMOL AGAIN! – no other options exist $2.1B: 85% sent home after 3 hrs $6.8B: 15% take up 1.8M hospital bed-days >10,000 deaths worldwide
WHAT IS NEEDED: NEW Short-Acting Bronchodilator, with NEW mechanism of action
![Page 3: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/3.jpg)
Canadian Asthma ResearchLeads to New Drug Discovery
NEW mechanism of action
Mucous plugs Drugs can’t get to where they are needed
![Page 4: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/4.jpg)
New Treatment: S-1226TM
Perflubron mixed with CO2-enriched air Short-Acting Bronchodilator Constituents are well described, safe Constituents have previously been
approved by FDA, EMA, etc…
NEW mechanism of action
Superior to Salbutamol!
Perflubron
CO2
Circulaire II
S-1226TM
![Page 5: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/5.jpg)
Faster Than Salbutamol
0 secondtreatment
2 secondstreatment
3 secondstreatment
1 secondtreatment
4 secondstreatment
Pre-MCh Post-MCh
www.SolAeroMed.com/S-1226
Tissue dye
![Page 6: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/6.jpg)
More Potent and Longer-Lasting than Salbutamol
Immediately 10 minutes 20 minutes0
10
20
30
40
50
60
No treatment
Salbutamol
S-1226™ (12%)
Time After Treatment Cessation
% O
peni
ng o
f Air
way
s
![Page 7: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/7.jpg)
Patented in Major Markets
Issued in US and Europe Pending in other jurisdictions Claims:
Composition of matter and method to treat Monotherapy and in combination
![Page 8: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/8.jpg)
MarketsEmergency Department: “preceding salbutamol for acute
asthma exacerbation” Estimated at $190M Peak Sales Less than 10% COGS – approximately $13/unit
Personal rescue device Estimated at up to $2.9B Peak Sales
Combination drug Estimated at $2B - $4B Peak Sales
![Page 9: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/9.jpg)
Partners
Proprietary nebulizer
Exclusive Perflubron supply (marketed as Perflubronc® by Origen Biomedical)
Phase I Clinical Trial
Phase IIa Clinical Trial
Development Partner Candidates
??
![Page 10: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/10.jpg)
TeamManagement
Experienced in the business, and top scientists
Board of DirectorsExtremely successful at growing and selling respiratory medicine
companies
AdvisorsHighly networked, experienced
![Page 11: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/11.jpg)
2008-2012 2013 2014 2015 2016 2017-Nonclinical ResearchDrug Screening ✓Compare vs Salbutamol ✓Find Optimal Dose ✓
ManufacturingBuild Prototype ✓Secure Suppliers ✓Minimize COGS ✓Large-Scale
Clinical DevelopmentReceive NOL ✓Phase I Phase IIa Phase IIb Phase III
MarketingSecure Marketing Partner Marketing Clearance Launch
US VCs &Partn
ers
Corporate Development
EXIT - Acquisition
CorpOff.inUS
- July 2013 - CTA@Boston Award
Prototype Proof of Concept Market Test Exit
![Page 12: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/12.jpg)
US Expansion Interest expressed by:
Boston Harbor Angels, Lead: Bill McPhee Mass Medical Angels, Lead: Frank Bobe Launchpad, Lead: Eduardo Pontoriero
Office in Cambridge, MA Canadian Technology Accelerator
Selected in a highly competitive application process
Cambridge Innovation Center Office
Other MIT VMS, Lead: Jerome Smith Keiretsu Forum, Lead: Thealzel Lee
![Page 13: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/13.jpg)
S-1226™ is De-RiskedAnimal Studies
Pre-clinical Phase I Phase IIa Phase IIb Phase III Approval
Regulatory Approval
Statistically Significant
Data
Controlled Human Efficacy
Toxicity
Proof of Concept &
Animal Studies
Risk
Manufacturing
Real World Efficacy
Manufacturing - 510(k)
Efficacy – sheep, humans
Toxicity – past studies
S-1226™
![Page 14: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/14.jpg)
Future Partnerships
We are seeking additional strategic partnerships to help fund, develop, and commercialize S-1226™
![Page 15: The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY short-acting bronchodilator – several “me toos” - all act via](https://reader035.vdocuments.mx/reader035/viewer/2022081514/56649c9c5503460f9495b9e6/html5/thumbnails/15.jpg)