11 February 2008
• ATL1102 licensed to Teva Pharmaceutical Industries Ltd
• ANP to complete current Phase IIa trial, results due mid-year
• Teva to fund and perform all future development of ATL1102 beyond the current trial
Antisense Therapeutics Ltd. (ASX:ANP) is pleased to announce that it has entered an exclusive, world-wide license agreement with Teva Pharmaceutical Industries Ltd. (Teva), a top 20 global pharmaceutical company, to develop and commercialise ATL1102, a drug discovered by Isis Pharmaceuticals Inc. (Nasdaq: ISIS) and licensed to ANP.
Under the terms of the agreement, ANP will receive an initial $US2m up-front payment. ANP also has the potential to receive payments related to the continued clinical development of ATL1102 for MS upon certain future development milestones, with more significant milestone payments for entry into the market, and sales targets in particular territories. The License includes potential milestone payments of up to $US100m for the MS indication which is contingent upon completion of R&D,
successful commercialization and meeting certain sales milestones and bears inherent risks as does all pharmaceutical R&D. Teva would fund and perform all future development of ATL1102 beyond the current trial, should they decide to continue beyond that point.
If ANP fails to meet a particular development milestone regarding completion of the current ongoing, fully enrolled Phase IIa study by the agreed date in mid 2008, Teva may terminate the agreement and receive a $US2m termination fee.
Royalties are payable on net sales of ATL1102 are in the low double digit range and are tiered according to annual net sales achieved.
The agreement also provides an option for Teva to in-license ATL1102 as an aerosol drug for asthma.
Under a separate Collaboration and License Agreement between ANP and Isis Pharmaceuticals Inc., ANP pays Isis one third of sublicense fees and milestone payments received from Teva as well as a percentage of any royalties ANP receives.
ANP’s Managing Director Mark Diamond said, “We are delighted to have signed this significant licensing deal with one of the world’s leading pharmaceutical companies. Clinical stage deals such as this are subject to very stringent selection criteria and we are particularly pleased that Teva has recognised the drug’s commercial potential. Teva is a company with tremendous expertise in developing drugs, and is our partner of choice.”
ANP will continue to manage and fund the current Phase IIa clinical trial in relapsing-remitting MS patients, which is on track for completion of dosing, unblinding of the clinical trial, and reporting of results in mid 2008.
Antisense Therapeutics makes no representations with respect to the outcome of the Phase IIa trial and, like all other clinical trials in pharmaceutical R&D, there are inherent risks in terms of clinical outcomes, efficacy, cost and timeframes. As such, no assurance can be given that ANP’s drug development efforts will translate to successful commercialisation.
Background Information
ATL1102 is a second generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4), and is currently in
Phase IIa clinical trials as a treatment for MS. In inflammation, white blood cells (leukocytes) move out of the bloodstream
into the inflamed tissue, for example, the 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 halting progression of the disease. VLA-4 is a clinically
validated target in the treatment of MS. Antisense inhibition of VLA-4 has demonstrated positive effects in a number of
animal models of inflammatory disease including MS (Myers et al. J Neuroimmunol 160, p12-24, 2005).
Multiple sclerosis is a life long chronic disease of the central nervous system which is believed to affect as many as 2.5
million people worldwide. Global drug sales for MS exceeded US$5 billion in 2005 and are expected to grow with the
introduction of novel treatment options. There remains a high demand for more effective and better tolerated treatments.
Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and
development company. Its mission is to create, develop and commercialise antisense pharmaceuticals for large unmet
markets. ANP has two drugs in development and two drugs in pre-clinical research. Its lead drug, ATL1102, is in the
advanced stages of a Phase IIa trial as a potential treatment of multiple sclerosis.
Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) is exploiting its expertise in RNA to discover and develop novel drugs for its
product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has
18 drugs in development. Isis' drug development programs are focused on treating cardiovascular and metabolic diseases.
Isis' partners are developing drugs for a wide variety of diseases. Ibis Biosciences, Inc., Isis' wholly owned subsidiary, is
developing and commercializing the Ibis T5000™ Biosensor System, a revolutionary system to identify infectious organisms.
Isis is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development and
commercialization of microRNA therapeutics. As an innovator in RNA-based drug discovery and development, Isis is the
owner or exclusive licensee of over 1,500 issued patents worldwide. Additional information about Isis is available at
http://www.isispharm.com.
For more information:
Website: www.antisense.com.au
Managing Director – Mark Diamond +61 3 9827 8999
Investor Relations – Market Connect Pty. Ltd. (Simon Watkin) +61 3 9863 7797 or 0413 153 272
