Partnership and Early Access Program for Antisense

Melbourne biotech Antisense Therapeutics (ASX:ANP) has announced an Early Access Program (EAP) for its multiple sclerosis (MS) therapy ATL1102 in the European Union, as well as a partnership with a US-based company to develop its growth disorder treatment ATL1103.

The company recently signed a global agreement with Amsterdam-based expanded access provider myTomorrows to implement an EAP in selected countries within the EU, including the four major pharmaceutical markets in that territory, in Q4 2015. EAPs allow biopharma companies to provide eligible patients with ethical access to investigational medicines for unmet medical needs within the scope of the existing early-access legislation.

ATL1102 is directed to the target VLA-4 (Very Late Antigen-4) for the treatment of MS - a lifelong chronic disease that progressively destroys the central nervous system. The drug was shown to reduce MS brain lesions in a phase II clinical trial, with the data published in the medical journal Neurology.

myTomorrows will perform the EAP activities as its own cost, including relevant data collection and the seeking of the EAP approvals. The company will receive a share of EAP-related revenue and, 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 for those countries where an EAP has been established.

Antisense separately announced a partnership with pharmaceutical company Cortendo to progress development of ATL1103, a therapy to treat growth disorders such as acromegaly. Acromegaly leads to excessive growth of hands, feet, face and internal organs and can be fatal.

The agreement provides Cortendo with development and commercialisation rights to ATL1103 for endrocrinology applications. Cortendo will provide Antisense with an initial upfront payment of $6.2 million; additional payments, contingent on achieving development and commercialisation milestones, may total up to $131 million over the lifetime of the agreement. There is also the potential for royalty payments based on sales performance.

Cortendo will be responsible for the ongoing clinical development of ATL1103 in endrocrinology applications and will fund the associated future development, regulatory and drug manufacture costs. Antisense will retain commercialisation rights in endrocrinology applications in A/NZ and will also retain worldwide rights for other ATL1103 indications. The company may also utilise ANT1103 data generated by Corntendo in pursuing these other indications.

Antisense (ASX:ANP) shares closed 13.64% higher at $0.125 on Thursday (28/5).