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and eventual commercial use. Alnylam said in today’s statement that it has its own manufacturing facility that meets common Good Manufacturing Practices required by regulators. Alnylam said it plans to use that manufacturing space to produce the ALN-TTR02 batches it will need for the beginning of pivotal clinical trials, which are expected to start by the end of 2013.
“With this restructuring of our Tekmira relationship, we are gaining independence in our LNP (lipid-nanoparticle ) manufacturing and decreasing the milestone and royalty burdens on several of our LNP-based products. Further, the companies have created clarity around the overall patent estate for LNP-based products, while ensuring Alnylam’s full access to use this technology for our products in the future. Of course, we are also pleased to put this legal matter behind us and continue our focus on advancing RNAi therapeutics through clinical trials with the goal of bringing them to the market where we can make an impact in the lives of patients and their caregivers,” said Barry Greene, Alnylam’s president and chief operating officer, in a statement.
Alnylam said it will take a $65 million hit from the settlement in its fourth-quarter financial report, which means that it expects to close the year with $215 million in cash. The company plans to discuss the settlement with shareholders on a conference call at 8 am ET/5 am PT tomorrow (Tuesday Nov. 13).
Tekmira has also agreed to settle separate litigation with AlCana Technologies, a fellow Vancouver, BC-based company that has sought to improve upon RNAi delivery technologies. Tekmira said in today’s statement that it expects to enter into a cross license agreement with AlCana, and that AlCana has agreed not to compete in the RNAi field for five years. Tekmira accused AlCana in its litigation of being “an instrument of Alnylam.”