ATL1102 Early Access Program Presentation
Released
Released
Announcement PDF
Antisense Therapeutics
ATL1102 for Multiple Sclerosis
Early Access Program
Forward Looking Statements
This presentation contains forward-looking statements regarding the Company’s
business and the therapeutic and commercial potential of its technologies and products
in development. Any statement describing the Company’s goals, expectations,
intentions or beliefs is a forward-looking statement and should be considered an at-risk
statement. Such statements are subject to certain risks and uncertainties, particularly
those risks or uncertainties inherent in the process of developing technology and in the
process of discovering, developing and commercializing drugs that can be proven to be
safe and effective for use as human therapeutics, and in the endeavor of building a
business around such products and services. Actual results could differ materially from
those discussed in this presentation. Factors that could cause or contribute to such
differences include, but are not limited to, those discussed in the Antisense
Therapeutics Limited Annual Report for the year ended 30 June 2014 and the report for
Half Year ending 31 December 2014, copies of which are available from the Company
or at www.antisense.com.au.
THIS PRESENTATION IS FOR THE AUSTRALIAN MARKET ONLY
This presentation has been prepared in connection with the obligations of
Antisense Therapeutics under Listing Rules of the Australian Securities Exchange.
Early Access Program (EAP)
EAP offers patients access to new non-registered pharmaceuticals
•
Products may be provided to patients with a life threatening or debilitating disease
where no alternative or appropriate therapy exists
•
> 1,000,000 patients annually in Europe alone are left without treatment options with
only a small percentage able to access new therapies via clinical trials1
•
Can charge for drug access in certain markets
•
Product must have been in Phase 2 trials or later and have shown evidence of
efficacy
EAP Pricing
•
Pricing set by the Sponsor (ANP) at comparable price to registered products
•
MS treatment costs in Europe range from A$25,000–$33,000 per patient per year2
1 Estimated by myTomorrows
2 Pricing for Tysabri, Gilenya, & Tecfidera -Toumi M and Jadot G in J. Market Access and Health Policy 2014, 2: 23932
EAP in Europe for ATL1102
MS Market
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400,000 people with MS in Europe and more than 1,000,000 world wide
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Significant number of patients do not properly respond to existing therapies suggesting a
pool of possible candidates for use of ATL1102 under the EAP conditions
EAP Establishment for ATL1102
•
Partnering Agreement signed with EAP specialists myTomorrows
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myTomorrows to perform EAP activities at their cost including data collection and seeking
EAP approvals initially in Europe in those markets where drug use is reimbursed
•
ANP to provide ATL1102 product for use in the EAP
• Arrangements being established to source ATL1102 from existing 3rd party supplies (2 batches) for
potential use in the EAP
• Proposal to initially source one batch of ATL1102 to commence the EAP
• Subject to this first batch of material being confirmed (through retesting) as of suitable quality for use
in the EAP, the quantity of material is expected to be sufficient for one year’s treatment for over 150
patients at the 200mg/week dose
• Material could be available as early as 4’Q’15 for use in the EAP
• Possible cash flow positive income
myTomorrows
PROVIDING EARLY ACCESS TO DRUGS IN DEVELOPMENT
myTomorrows is creating freedom of choice for physicians and patients with unmet
medical needs by offering earlier access to medicines that show promising results
during clinical trials, but are not officially registered yet. With the support of their
doctors, patients who suffer from cancer, a neurological disorder, a rare disease or
a severe depression, can have earlier access to such medicines. myTomorrows
identifies innovative drugs, informs physicians and patients and facilitates requests
for access to these drugs in development via a world-wide Internet-based platform.
For more information about myTomorrows, please visit the website
www.mytomorrows.com.
ATL1102
Multiple Sclerosis
ATL1102 for Multiple Sclerosis
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Multiple Sclerosis (MS) is a chronic, progressive, and
debilitating autoimmune disease that affects central
nervous system, brain and spinal cord
•
Global sales for MS drugs in 2013 were US$14 Billion
•
ATL1102 is an antisense inhibitor of VLA-4 protein a
clinically validated target in MS
•
Successful Phase II trial completed in patients with
Relapsing Remitting-MS
• Met primary end point after only two months of dosing
reducing the cumulative number of new active brain
lesions by 54.4% (p=0.01) compared to placebo
Phase II trial results published in Neurology
Project Status: ATL1102 for MS
• US and EU patent allowances extending patent protection to 2029
• Positive response received from FDA on Pre-IND assessment for a Phase IIb trial
• Phase IIa trial results published in the Journal of the American Academy of Neurology
• Engaged in the process to attract a pharmaceutical company partner to undertake the
Phase IIb trial
• Early Access Program now established initially for use of ATL1102 in Europe
Antisense Therapeutics
Mark Diamond, CEO
+61 (3) 9827 8999
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