The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY...

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The AsthmaCo. June 2013

Transcript of The AsthmaCo. June 2013. $8.9B Problem in Asthma SALBUTAMOL (a.k.a. Albuterol) is the ONLY...

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.

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.

$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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.