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news.Antisense Therapeutics (ANP), an Australian biopharmaceutical drug discovery and development company, has received notification from Teva Pharmaceutical Industries Ltd (Teva), the licensee of ANP’s drug ATL1102, of Teva’s decision to discontinue further clinical development of ATL1102 and to end the license agreement.
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Teva advised ANP that after performing certain steps in the development process, ATL1102 was determined to no longer be in line with Teva’s preferred product profile. ANP understands that business considerations or factors contributing to Teva’s decision include issues with one of the long-term toxicological studies that may require repeat of the study, lengthening the development time and time to market of the drug in light of the competitive landscape.
ANP wil now evaluate its options with respect to further development of ATL1102 with key stakeholders including Isis Pharmaceuticals, ANP’s technology collaboration partner and the original developer of ATL1102.
Similarly, Isis believes that the quality of the Phase 2 trial results warrant consideration of the further development of ATL1102 and discussions are currently underway between the parties on possible paths forward.
ANP plans to move forward as quickly as possible with this evaluation, however a timeline for its completion cannot be advised at this point until the company has fully analysed and assessed its options with respect to ATL1102 and once details of the license termination are finalised.
In addition to the review of ATL1102, the company continues development of its pipeline projects including ATL1103 for abnormal growth and sight disorders and ATL1101 for prostate cancer.
Previously ANP has reported the successful conduct of toxicology studies of ATL1103 and its intention to move this compound forward into clinical trials proposed for 2nd half of 2010. Isis is currently completing manufacture of clinical supplies of ATL1103 for this study.
With respect to ATL1101 for prostate cancer, ANP has generated preclinical data confirming the drug’s effectiveness in suppressing human prostate cancer tumour growth in animal models. The company remains in discussions with interested parties with regard to the further development of the drug.