SUDA LTD ANNUAL GENERAL MEETING CHAIRMAN’S … · 2013-11-12 · by healthcare regulatory authorities in the world’s major territories. ... They have offered to assist us in raising

ASX Release No. 665 12 November 2013 Page 1 of 4

ACN 090 987 250

ASX Release

SUDA LTD ANNUAL GENERAL MEETING

CHAIRMAN’S STATEMENT

PERTH, AUSTRALIA - 12 November 2013: The following statement was made at today's Annual General Meeting by SUDA LTD’s (ASX: SUD) Executive Chairman and Chief Executive Officer, Stephen Carter:

Over the past three years we have reshaped SUDA into a leading oro-mucosal drug delivery company, underpinned by a fast-growing medical supplies subsidiary. We are now well positioned to drive the business forward, having achieved some key milestones in the period since the end of the financial year, as follows:

• The final ArTiMist™ Phase III results confirmed the product’s superiority to intravenous quinine for the treatment of severe malaria in children and we have opened a dialogue with the global organisation, Medicines for Malaria Venture;

• As announced today, we have restructured the ownership of the ArTiMist™ project as a key prerequisite for commercialisation via a trade sale or global partnership.

• We completed the acquisition of the NovaDel assets, which include a broad patent portfolio and clinical-stage oral sprays for migraine, nausea, erectile dysfunction, hypertension and anxiety;

• We appointed an experienced Chief Business Officer, Nick Woolf, to drive business development activities;

• Also as announced today, we have retained Torreya Insights, a subsidiary of New York based Torreya Partners, which is a leading firm for strategic advice in the commercialisation of life-science technology and drug candidates; and

• Our subsidiary, Westcoast, achieved a greater than 200% increase in revenue in the first quarter of FY2014 versus the prior comparable period, having secured a number of new contracts and strategic alliances.

The foundations are now set for an exciting period of growth as we work towards some key value inflection points over the next 12 to 18 months.

We are building a pharmaceutical business based on reformulated products using our proprietary intellectual property, which is able to provide major cost, functional and effectual advantages over competitors, thereby securing patient demand.

Each of our development products addresses an unmet market need with a substantial

For

per

sona

l use

onl

y


market size and uses well-characterised molecules that have been approved and accepted by healthcare regulatory authorities in the world’s major territories.

Our commercial strategy is to add value to each programme through to a stage where we can secure licensing or collaborative partnerships or alternatively an outright sale of the asset.

ArTiMist™ remains our lead product. It is the world’s first sub-lingual spray for the treatment of p. falciparum severe paediatric malaria. The active pharmaceutical ingredient in ArTiMist™ is artemether, which is a widely used anti-malarial and is currently administered by infusion or orally in a tablet form.

The final results from the ART004 Phase III trial in 150 patients across multiple sites in Africa confirmed that ArTiMist™ was convincingly superior to the current gold standard, being intravenous quinine treatment. We are now making good progress towards the completion of the Common Technical Document (CTD). This comprehensive report will form the basis of applications for marketing approval and will be an important partnering tool as we seek to monetize ArTiMist™.

In September 2013, we had an encouraging dialogue with the global partnership, Medicines for Malaria Venture. They have offered to assist us in raising the profile of ArTiMist™ with global funds and groups such as the World Health Organisation.

As a next step, we are establishing a Scientific Advisory Board (SAB) of key opinion leaders in the field of malaria. The SAB will provide invaluable advice as the Company works to expand the potential of the product from a first-line treatment of severe malaria to include use in the pre-referral setting, which is when a child first develops a fever or has other danger signs associated with severe malaria. In addition, we believe that the involvement of highly respected academics and clinicians will assist to further raise the profile of ArTiMist™ in the global malaria community. We will announce the members of the SAB in due course.

We announced today the reorganisation of our collaboration with ProtoPharma Ltd for ArTiMist™. Previously, our rights, as a Licensee, were limited primarily to the treatment of children in Africa, India, Asia and the Pacific region. There was also a royalty obligation on product sales payable to ProtoPharma.

Under the new agreement with ProtoPharma, all of the intellectual property and global rights in relation to ArTiMist™ will be owned by a new legal entity, called Malaria Research Company Pty Ltd (MRC). SUDA will control the new entity and will own 80% of MRC with ProtoPharma owning the balance. There will be no royalty obligations to either company and, importantly, all territorial rights to ArTiMist™ for the entire field of malaria will be consolidated into MRC.

We believe that this new structure is an excellent outcome for our shareholders and ensures that the ArTiMist™ asset is optimally positioned for a global partnership or a trade sale to the pharmaceutical industry.

For

per

sona

l use

onl

y


In August 2013, we finalised the purchase of the NovaDel assets. This acquisition cements our position as a world leader in the field of oro-mucosal drug delivery. The oral mucosa is the highly absorptive lining of the mouth and there are real advantages compared to tablets and other modes of drug administration from using the oral mucosa to reach the systemic blood circulation. These advantages include: faster onset of action; lower dose levels due to increased bioavailability of the drug by avoiding first pass metabolism in the liver; and enhanced patient compliance and convenience, particularly in situations where the patient is vomiting or has difficulty swallowing.

Our patented technology essentially covers the delivery of over 300 active pharmaceuticals as liquid formulations to the oral cavity in the form of a mist that covers the oral mucosal membranes. The technology is compatible with, and patented for, use in either pump (ie: air-activated) or aerosol (ie: propellant-driven) spray systems, and can be provided in either multi-dose or unit containers based on the medical need and marketing requirements for each product.

We have an extensive portfolio of intellectual property and patents with patent life on some extending to 2031. There is clinical data on a number of products and we have chosen to focus on five opportunities in the first instance. We have named these development-stage products as SUD-001 through to SUD-005 in our pipeline. Our recently re-launched website describes our oro-mucosal technology platform and has pages on each of our pipeline products. These proprietary therapeutic products are for the treatment of the following disorders: migraine headache, chemotherapy-induced nausea and vomiting, erectile dysfunction, pulmonary arterial hypertension and pre-procedure anxiety.

Each product is a low-risk reformulation of a widely used drug and, in each case, the market opportunity is substantial. Like ArTiMist™, our new products potentially offer important advantages such as quicker onset of action; lower doses; and enhanced patient convenience, particularly for those with difficulty swallowing

As we achieve our commercialisation goals for these products, we will look to add additional opportunities to the pipeline based on our patent estate. To assist us with our strategic partnering and asset sales, we announced yesterday that we have retained Torreya Insights, which is the consultancy arm of Torreya Partners, an internationally renowned advisory company for pharmaceutical licensing and trade sales. Torreya has offices in New York and London and has carried out over 500 transactions in the healthcare sector.

Initially, Torreya will work with us to secure deals for ArTiMist™ and for SUD-001 for the treatment of migraine headaches. Over the next few months, we will finalise the diligence materials, which will include primary market research intended to demonstrate the market potential and likely pricing and reimbursement levels for each product.

We expect to commence an outreach initiative to the pharmaceutical industry in the first half of CY2014 for both ArTiMist™ and the migraine product. Our plan is to conduct bidding processes with the objective of executing strategic deals within six to nine months of the initial outreach. By working with a leading advisory firm like Torreya, we believe that we have access to the necessary experience to ensure that we secure the best value for

For

per

sona

l use

onl

y


these breakthrough proprietary products in the shortest time period.

In summary, we have established a deep pipeline of oral sprays based on our oro-mucosal drug delivery platform. ArTiMist™ and our newly acquired drug candidates have already caught the attention of pharmaceutical companies looking for products in the respective therapeutic areas.

In addition, our fully owned subsidiary, Westcoast, which provides medical supplies, is experiencing rapid revenue growth. First quarter FY2014 revenue was $3.3 million (>200% increase) with a net profit of $720,000 for the period. Whilst we can expect some month to month and seasonal fluctuations in both revenue and net profit, the positive trend continues. Revenue for the month of October 2013 climbed to approximately $1.3 million, generating an estimated net profit of $220,000. In our view, Westcoast has entered a new era in its operations and we are delighted that it is contributing to the financial sustainability of SUDA.

The Company is now positioned to commercialise its pipeline through strategic transactions and has prioritised ArTiMist™ and SUD-001 for migraine headaches over the next 12 to 18 months. Our excellent team will continue to work hard to achieve these goals.

Finally, I greatly appreciate the ongoing support of all of our shareholders and the commitment and dedication of our Board members and I look forward to SUDA’s next phase of value creation.

Further information: STEPHEN CARTER EXECUTIVE CHAIRMAN SUDA LTD Tel: +61 8 6142 5555 [email protected] NOTES TO EDITORS:

About SUDA LTD SUDA LTD (ASX: SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using novel formulations of existing off-patent pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (ie: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA’s most advanced product is a novel sub-lingual treatment, ArTiMist™, for severe malaria in children. In a Phase III trial, ArTiMist™ was shown to be superior to intravenous quinine. Other development stage products include orals sprays for the treatment of migraine headache, erectile dysfunction and chemotherapy-induced nausea and vomiting.

For

per

sona

l use

onl

y

AGM: 12 November 2013

1

1

Drug delivery through the oral mucosa ANNUAL GENERAL MEETING

Stephen Carter -‐ ExecuBve Chairman & CEO

12 November 2013

Level 1, Unit 12, 55 Howe Street Osborne Park, Western Australia 6017 PO Box 1719 Osborne Park BC, WA 6916 (T) +61 8 6142 5555 (F) +61 8 9443 8858 (E) [email protected]

2

KEY MILESTONES SINCE FY2013 YEAR END

v  Final ArTiMist™ Phase III results confirmed superiority to standard of care in severe malaria

Ø  Opened dialogue with the global organizaBon, Medicines for Malaria Venture

v  Restructured ArTiMist™ collaboraBon with ProtoPharma Ltd

Ø  Global IP and commercial rights owned by a Suda-‐controlled enBty

Ø  FacilitaBng a trade sale or global partnership

v  Completed acquisiBon of NovaDel oro-‐mucosal assets

Ø  Clinical-‐stage oral sprays for migraine, nausea, erecBle dysfuncBon, hypertension and anxiety

v  Appointed experienced Chief Business Officer to oversee business development

Ø  Retained a leading advisory firm in life-‐science transacBons

v  Westcoast subsidiary achieved >200% increase in revenue in 1Q FY2014

Ø  This represents a new era for Westcoast

For

per

sona

l use

onl

y


2

3

STRATEGY FOR ORO-‐MUCOSAL PLATFORM

v  Reformulate off-‐patent pharmaceuBcals into high-‐value patentable oral sprays

v  Demonstrate meaningful advantages over standard of care in proof-‐of-‐concept small trials

v  Collaborate or trade sale of asset to Pharma for registraBon and markeBng

v  AnBcipate first major deals in CY2014

“Our oral sprays poten/ally offer improved

efficacy and a be8er outcome for pa/ents”

4

ARTIMIST™ ANTI-‐MALARIAL SPRAY

v  ArTiMist™ sublingual artemether for children with severe malaria

v  Completed Phase III trial versus intravenous quinine in August 2013

Ø  150 children from mulBple sites in Africa

Ø  Conducted to highest standards for use in worldwide regulatory submissions

v  Primary endpoints were achieved showing superiority to quinine

v  Finalising regulatory documentaBon for markeBng applicaBons

Thompson Reuters idenBfied ArTiMist™ as one of the

world’s Top-‐5 most promising Phase III drugs in 2011

For

per

sona

l use

onl

y


3

5

ARTIMIST™ MOVING TO COMMERCIALISATION

v  Opened dialogue with Medicines for Malaria Venture

v  Establishing ScienBfic Advisory Board to advise on expanding product potenBal

v  Raising the profile of ArTiMist™ with global malaria community

v  Restructured collaboraBon with ProtoPharma to include all IP and global rights

v  Suda will control new enBty Malaria Research Pty Ltd

v  Assets opBmally posiBoned for global partnership or trade sale

“ArTiMist™ has huge poten/al as an early interven/onal treatment for children with

severe malaria”

6

ORO-‐MUCOSAL DELIVERY – BETTER PATIENT EXPERIENCE

v  Finalised purchase of NovaDel assets

v  Oral mucosa is the lining of the mouth, richly supplied by blood vessels

v  Oral cavity is ideal for systemic therapy, avoids metabolism in the gut

v  Unique advantages of oral sprays versus tablets Ø  Faster onset of acBon Ø  ReducBon in dose level and dose variability Ø  Enhanced paBent convenience Ø  Avoids the need to swallow or be taken with water1,2

1.  >40% of adults experience difficulBes swallowing 2.  >50% of children (6 to 11 years) have problems swallowing tablets

For

per

sona

l use

onl

y


4

7

EXTENSIVE PATENT ESTATE

v  MulBple patent families & more pending, covering:

Ø  300 high-‐usage exisBng drugs formulated into oral sprays

Ø  Technology for producing ‘micro-‐mist’ formulaBon

Ø  Pump (air-‐acBvated) & aerosol (propellant-‐driven) sprays

Ø  MulB-‐dose or single-‐unit containers

v  Patent term of certain families extends to 2031

8

Product AcBve Ingredient

Market Size

MarkeBng Approval Clinical Pre-‐

clinical

Malaria ArBMist™ >$500m

Migraine headache SUD-‐001 $3.2bn

Pre-‐procedural anxiety SUD-‐005 $170m

Chemotherapy induced nausea & vomiBng SUD-‐002 $2.5bn

ErecBle dysfuncBon SUD-‐003 DuroMist™

$4.1bn

Pulmonary arterial hypertension SUD-‐004 $2.7bn

Artemether

Sumatriptan

Midazolam

Ondansetron

Sildenafil

Sildenafil

LOW-‐RISK PIPELINE TARGETING LARGE MARKETS

For

per

sona

l use

onl

y


5

9

EVENT ANTICIPATED TIMING

Finalise ArTiMist™ regulatory documenta?on H1 CY2014

Conduct primary research on market opportuni?es H1 CY2014

Ini?ate outreach to Pharma industry H1 CY2014

ArTiMist™ trade sale or out-‐licensing deal H2 CY2014

First major oro-‐mucosal out-‐licensing deal H2 CY2014

COMMERCIALISATION GOALS v  Appointed leading life sciences advisory firm, Torreya, to assist with

strategic partnering and asset sales

“We have established a deep pipeline of oral sprays based on our oro-‐mucosal drug delivery plaDorm”

10

WESTCOAST SURGICAL – RAPID GROWTH

v  Wholly-‐owned subsidiary is a sales and logisBcs operaBon for medical devices and consumables based in Western Australia

v  Experiencing rapid revenue growth from recent contract in August 2013

v  1Q FY2014 revenue of $3.3 million, >200% increase from PCP

v  1Q FY2014 net profit of $720,000 compared to a loss in the PCP

“Westcoast has entered a new era in its operaBons. Our posiBve cash flow will contribute significantly to the financial sustainability of our parent, Suda Ltd” F

or p

erso

nal u

se o

nly


6

11

SUMMARY

v  World-‐leading proprietary technology for reformulaBng drugs into high-‐value oral sprays

v  Breakthrough anB-‐malarial spray progressing towards commercialisaBon

v  Pipeline of oral sprays offering superior profiles (eg: faster onset) than standard of care

v  TargeBng large markets with short Bmelines for development

v  Rapid value creaBon through collaboraBons or trade sales, anBcipated in next 12-‐18 months

For

per

sona

l use

onl

y

Documents

SUDA LTD ANNUAL GENERAL MEETING CHAIRMAN’S … · 2013-11-12 · by healthcare regulatory authorities in the world’s major territories. ... They have offered to assist us in raising