Antisense Therapeutics and myTomorrows ATL1102 Early Access Program for
Patients with Multiple Sclerosis
Antisense Therapeutics Limited (“ANP” or “the Company”) is pleased to announce that it has signed a
global agreement with innovative expanded access provider myTomorrows (Amsterdam, The
Netherlands) to implement an Early Access Program (EAP) for ATL1102 for the treatment of Multiple
Sclerosis (MS). This program will initially be established in selected countries within the European Union
(EU) including the 4 major pharmaceutical markets in that territory.
Early Access Programs allow biopharmaceutical companies to provide eligible patients with ethical
access to investigational medicines for unmet medical needs within the scope of the existing early
access legislation. Access is provided in response to physician requests where other treatments have
been unsuccessful and no alternative or appropriate treatment options are available to these patients.
MS is a life-long, chronic disease that progressively destroys the central nervous system (CNS). It
affects approximately 400,000 people in Europe and more than 1 million worldwide. A significant
number of patients fail to be adequately treated with current medicines due to efficacy, safety or
tolerance related issues.
ATL1102 is directed to the target VLA-4 (Very Late Antigen– 4) for the treatment of MS. The drug was
shown to reduce MS brain lesions in a Phase II clinical trial with the data published in the medical
journal Neurology (Limmroth, V. et al Neurology September 19, 2014).
Subject to myTomorrows receiving the requisite regulatory approvals and support for the ATL1102 EAP
program, ANP expects to provide ATL1102 to MS treatment centers in the EU at prices that are
comparable to current medicines used to treat MS. Initially the focus will be on those major European
countries where the drug would qualify for use.
The Company plans to access an existing source of ATL1102 material for use in the EAP that, assuming
it is of suitable quality (to be confirmed through appropriate retesting), could potentially be available
in the 4th quarter 2015 for the commencement of the EAP.
Under the EAP agreement, myTomorrows will perform at their cost the EAP activities including relevant
data collection and the seeking of the EAP approvals. myTomorrows are to receive a share of EAP
related revenue less the cost of drug and associated pass through costs including those to Isis
Pharmaceuticals from whom ANP in-licensed ATL1102.
Separate to this EAP agreement, ANP is seeking a partner for the on-going clinical development and
potential commercialisation of ATL1102. In the event of future licensing revenue and sales of ATL1102,
myTomorrows will also be entitled to a percentage of such sales and licensing revenue received by
ANP as compensation for the services provided, but only in those countries where an EAP had been
established.
Antisense Therapeutics’ CEO and Managing Director Mark Diamond said
"Antisense Therapeutics is pleased to establish this Early Access Program for ATL1102 that may help
the lives of those suffering from MS by providing an alternate treatment option. We look forward to
working with treating physicians and myTomorrows to make ATL1102 available to the European
medical community”.
myTomorrows’ Chief Business Officer, Govert Schouten, said
“myTomorrows is an innovative early access provider with a rapid, proactive and patient-centric
Internet-based platform to facilitate reimbursed early access to drugs like ATL1102 in the treatment
of MS. We have developed a core expertise in this field having implemented and conducted global
Early Access Programs and, relevant to ATL1102, having previously managed CNS-focused EAP’s. This
is an exciting opportunity that we believe fits well with the aims of the EAP legislation and so we look
forward to making ATL1102 available for MS patients in need of new therapeutic options.”
Contact Information:
Website: www.antisense.com.au
About Antisense Therapeutics Limited
Antisense Therapeutics Limited is an Australian publicly listed biopharmaceutical drug discovery and development company.
Its mission is to create, develop and commercialise second generation antisense pharmaceuticals for large unmet markets.
Antisense Therapeutics has 4 products in its development pipeline that it has in-licensed from Isis Pharmaceuticals Inc. (ISIS),
a world leader in antisense drug development and commercialisation - ATL1102 (injection) which has successfully completed
a Phase II efficacy and safety trial in patients with relapsing-remitting multiple sclerosis (RRMS), ATL1103 drug designed to
block GHr production which in a Phase II clinical trial reduced blood IGF-1 levels in patients with the growth disorder
acromegaly, ATL1102 (inhaled) which is at the pre-clinical research stage as a potential treatment for asthma and ATL1101
a second-generation antisense drug at the pre-clinical stage being investigated as a potential treatment for cancer.
About myTomorrows
MyTomorrows is an online platform that 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. For more information about myTomorrows, please visit the website
www.mytomorrows.com.
ATL1102 background Information
ATL1102 is a second generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4). In inflammation,
white blood cells (leukocytes) move out of the bloodstream into the inflamed tissue, for example, the Central Nervous System
(CNS) in MS, and the lung airways in asthma. The inhibition of VLA-4 may prevent white blood cells from entering sites of
inflammation, thereby slowing progression of the disease. Antisense inhibition of VLA-4 expression has demonstrated activity
in a number of animal models of inflammatory disease including asthma and MS with the MS animal data having been
published in a peer reviewed scientific journal. ATL1102 was shown by the Company to reduce MS lesions in a Phase II clinical
trial in RRMS patients and the data has been published (Limmroth, V. et al Neurology, 2014; 83(20): 1780-1788).
[/SIZE][/FONT][/SIZE][/FONT]
Early access pogram slide presentation-
http://www.asx.com.au/asxpdf/20150527/pdf/42ytkk65s7dzn4.pdf
Scientific Paper-ATL1102 Phase II MS trial results published in NEUROLOGY
http://www.asx.com.au/asxpdf/20140922/pdf/42sc4g2kv2283m.pdf
Toxicology results
http://www.asx.com.au/asxpdf/2014040...1zsbxgmlpd.pdf
Hadnt seen any of this posted on here so I thought you guys might find it informative! Theaccess program is due o start 2nd 1/4 next year so hopefully providing another option for sufferers particulary for those with the jc virus.
The vla4 target s exactly the same target as Tysabri but without the chance of contracting pml due to a differing method of action where the immune system is less compromised.
Regards.
Looking.
Patients with Multiple Sclerosis
Antisense Therapeutics Limited (“ANP” or “the Company”) is pleased to announce that it has signed a
global agreement with innovative expanded access provider myTomorrows (Amsterdam, The
Netherlands) to implement an Early Access Program (EAP) for ATL1102 for the treatment of Multiple
Sclerosis (MS). This program will initially be established in selected countries within the European Union
(EU) including the 4 major pharmaceutical markets in that territory.
Early Access Programs allow biopharmaceutical companies to provide eligible patients with ethical
access to investigational medicines for unmet medical needs within the scope of the existing early
access legislation. Access is provided in response to physician requests where other treatments have
been unsuccessful and no alternative or appropriate treatment options are available to these patients.
MS is a life-long, chronic disease that progressively destroys the central nervous system (CNS). It
affects approximately 400,000 people in Europe and more than 1 million worldwide. A significant
number of patients fail to be adequately treated with current medicines due to efficacy, safety or
tolerance related issues.
ATL1102 is directed to the target VLA-4 (Very Late Antigen– 4) for the treatment of MS. The drug was
shown to reduce MS brain lesions in a Phase II clinical trial with the data published in the medical
journal Neurology (Limmroth, V. et al Neurology September 19, 2014).
Subject to myTomorrows receiving the requisite regulatory approvals and support for the ATL1102 EAP
program, ANP expects to provide ATL1102 to MS treatment centers in the EU at prices that are
comparable to current medicines used to treat MS. Initially the focus will be on those major European
countries where the drug would qualify for use.
The Company plans to access an existing source of ATL1102 material for use in the EAP that, assuming
it is of suitable quality (to be confirmed through appropriate retesting), could potentially be available
in the 4th quarter 2015 for the commencement of the EAP.
Under the EAP agreement, myTomorrows will perform at their cost the EAP activities including relevant
data collection and the seeking of the EAP approvals. myTomorrows are to receive a share of EAP
related revenue less the cost of drug and associated pass through costs including those to Isis
Pharmaceuticals from whom ANP in-licensed ATL1102.
Separate to this EAP agreement, ANP is seeking a partner for the on-going clinical development and
potential commercialisation of ATL1102. In the event of future licensing revenue and sales of ATL1102,
myTomorrows will also be entitled to a percentage of such sales and licensing revenue received by
ANP as compensation for the services provided, but only in those countries where an EAP had been
established.
Antisense Therapeutics’ CEO and Managing Director Mark Diamond said
"Antisense Therapeutics is pleased to establish this Early Access Program for ATL1102 that may help
the lives of those suffering from MS by providing an alternate treatment option. We look forward to
working with treating physicians and myTomorrows to make ATL1102 available to the European
medical community”.
myTomorrows’ Chief Business Officer, Govert Schouten, said
“myTomorrows is an innovative early access provider with a rapid, proactive and patient-centric
Internet-based platform to facilitate reimbursed early access to drugs like ATL1102 in the treatment
of MS. We have developed a core expertise in this field having implemented and conducted global
Early Access Programs and, relevant to ATL1102, having previously managed CNS-focused EAP’s. This
is an exciting opportunity that we believe fits well with the aims of the EAP legislation and so we look
forward to making ATL1102 available for MS patients in need of new therapeutic options.”
Contact Information:
Website: www.antisense.com.au
About Antisense Therapeutics Limited
Antisense Therapeutics Limited is an Australian publicly listed biopharmaceutical drug discovery and development company.
Its mission is to create, develop and commercialise second generation antisense pharmaceuticals for large unmet markets.
Antisense Therapeutics has 4 products in its development pipeline that it has in-licensed from Isis Pharmaceuticals Inc. (ISIS),
a world leader in antisense drug development and commercialisation - ATL1102 (injection) which has successfully completed
a Phase II efficacy and safety trial in patients with relapsing-remitting multiple sclerosis (RRMS), ATL1103 drug designed to
block GHr production which in a Phase II clinical trial reduced blood IGF-1 levels in patients with the growth disorder
acromegaly, ATL1102 (inhaled) which is at the pre-clinical research stage as a potential treatment for asthma and ATL1101
a second-generation antisense drug at the pre-clinical stage being investigated as a potential treatment for cancer.
About myTomorrows
MyTomorrows is an online platform that 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. For more information about myTomorrows, please visit the website
www.mytomorrows.com.
ATL1102 background Information
ATL1102 is a second generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4). In inflammation,
white blood cells (leukocytes) move out of the bloodstream into the inflamed tissue, for example, the Central Nervous System
(CNS) in MS, and the lung airways in asthma. The inhibition of VLA-4 may prevent white blood cells from entering sites of
inflammation, thereby slowing progression of the disease. Antisense inhibition of VLA-4 expression has demonstrated activity
in a number of animal models of inflammatory disease including asthma and MS with the MS animal data having been
published in a peer reviewed scientific journal. ATL1102 was shown by the Company to reduce MS lesions in a Phase II clinical
trial in RRMS patients and the data has been published (Limmroth, V. et al Neurology, 2014; 83(20): 1780-1788).
[/SIZE][/FONT][/SIZE][/FONT]
Early access pogram slide presentation-
http://www.asx.com.au/asxpdf/20150527/pdf/42ytkk65s7dzn4.pdf
Scientific Paper-ATL1102 Phase II MS trial results published in NEUROLOGY
http://www.asx.com.au/asxpdf/20140922/pdf/42sc4g2kv2283m.pdf
Toxicology results
http://www.asx.com.au/asxpdf/2014040...1zsbxgmlpd.pdf
Hadnt seen any of this posted on here so I thought you guys might find it informative! Theaccess program is due o start 2nd 1/4 next year so hopefully providing another option for sufferers particulary for those with the jc virus.
The vla4 target s exactly the same target as Tysabri but without the chance of contracting pml due to a differing method of action where the immune system is less compromised.
Regards.
Looking.
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