As far as I can see, there was an initial license agreement signed between UWA and AVI Biopharma (now Sarepta) in November 2008 following a period of collaboration. I’d observe that wasn’t a great time for getting funding or licensing deals. The license agreement gave rights to AVI to a patent application related to the use of ASOs to treat DMD - the patent application, “Antisense Oligonucleotides for Inducing Exon Skipping and Methods of Use Thereof”. By the time this agreement was signed, AVI was already conducting a Phase 1 trial of AVI 4658 (Exondys51). AVI also lays claim to having previously conducted various preclinical studies and opening an IND for AVI 4658.
In April 2013, Sarepta and UWA entered into an amended and restated license agreement. The terms allowed for up to US$6 million to be paid in development and regulatory milestones relating to EXONDYS 51 and up to five additional product candidates. At the end of 2018, US$2.0 million of the US$6.0 million milestone payments had been made. Sarepta was also required to pay up to US$20.0 million in sales milestones as well as a low-single-digit percentage royalty on net sales of 10 products covered by issued patents licensed from UWA during the term of this agreement. However, there was an alternative option for Sarepta to purchase future royalties upfront for US$30.0 million, prior to the First Amendment of the license agreement.
This First Amendment occurred in June 2016 (a few months prior to Exondys51 receiving FDA approval). Sarepta this time made an upfront payment of US$7.0 million to UWA. Under the terms of the First Amendment, UWA waived rights to certain royalties and amended the timing of certain other royalty payments under the 2013 license agreement, including lowering the one-off royalty payment due upon exercise of the option to purchase future royalties upfront to US$23 million. The US$20.0 million sales milestone payments provision remained unchanged.
What I take out of this is that UWA handed over their work at a very early stage of development for ultimately a very modest reward. I suspect there have been lessons learned; hence the current PYC plan to first progress its tech into the clinic for therapeutic validation.
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