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Posted: Wed Feb 20, 2008 10:22 am Post subject: ATL1102
I guess this is a vote of confidence for ATL1102 from Teva. The phase 2a trial is scheduled to report results around the middle of this year.
Antisense Therapeutics Ltd Licenses ATL1102 to Teva Pharmaceutical
February 20, 2008 - Antisense Therapeutics announced on February 11, 2008 that the Company had entered into an exclusive, world-wide license agreement with Teva to develop and commercialize ATL1102, a drug discovered by Isis Pharmaceuticals Inc. and licensed to ANP.
Under the terms of the agreement, ANP will receive an initial US$2 million 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 US$100 million 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 US$2 million 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 recognized 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 commercialization.
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).
Ah, the irony. The company that leaked a report during the FDA hearings into Tysabri (which purportedly showed that Tysabri gives you the immune system of somebody with full blown AIDS) has now invested in a drug that basically does the same thing as Tysabri (i.e. inhibits VLA-4). It wouldn't surprised me if Teva launched an interferon at this rate.
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