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Post# of 251306
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Alias Born 12/29/2003

Re: DewDiligence post# 205425

Tuesday, 10/25/2016 10:03:49 AM

Tuesday, October 25, 2016 10:03:49 AM

Post# of 251306
Was curious about its provenance.
IND 24 years ago.
Magainin became Genaera. Macrochem acquired it. Then Access Oncology bought Macrochem, gave up, handed it back to a liquidating trust. A who's who of failed biotechs. Asset bought out of bankruptcy presumably for peanuts and flipped into an IPO. Amazing the stock had run up so much even with this history spelled out in the S1.

History of Locilex™

In August 1992, the prior sponsor of Locilex™, Magainin, submitted an initial IND for the prior formulation of Locilex™ to study broad spectrum anti-infective activity for the treatment of superficial and complicated dermatological infections. Another IND was submitted in November 1993 to cover a new indication for the treatment of DFI. In the late 1990s, the prior sponsor tested the prior formulation of Locilex™, with over 1,000 human subjects exposed without safety concerns, to such prior formulation of Locilex™, including 835 evaluable patients in two Phase 3 clinical trials. The Phase 3 trial results showed that such prior formulation of topical Locilex™ had an approximate 80% response rate measured as resolution or improvement in infection in patients who under today's standards would be considered to have Mild or Moderate DFI. See "– Clinical Development Strategy – Phase 3 Clinical Trial Results: Studies 303 and 304" above.

The FDA Advisory Committee reviewing Locilex™ at the time unanimously approved the safety of the product, but did not approve its efficacy and recommended an additional Phase 3 placebo controlled trial. In its 1999 non-approvable letter, the FDA identified certain cGMP manufacturing deficiencies, namely stability and quality control issues, and questions regarding the comparability of the product used in the Phase 3 program versus that which was produced at commercial scale. We believe that these hurdles and a lack of financing ultimately caused Magainin (later renamed Genaera Corporation) to deprioritize the product within their product pipeline. MacroChem Corporation (or MacroChem) licensed the technology in late 2007, after several years of attempting to remediate the manufacturing deficiencies. In February 2009, MacroChem was acquired by Access Pharmaceuticals, Inc. (or Access), which focused on oncology and oncology supportive care product candidates. Rights to Locilex™ reverted to Genaera Liquidating Trust (established to sell the drug related assets of Genaera Corporation in liquidation) when Access failed to start a Phase 3 trial by the two-year anniversary of the effective date of the license agreement, triggering a termination right for Genaera Liquidating Trust in December 2009.

In April 2010, we acquired the worldwide rights to pexiganan, the API in Locilex™, and the prior formulation of the product and all related assets after participating in a public auction for our product conducted by Genaera Liquidating Trust. During the period between the FDA non-approval letter received in July 1999 and the second half of 2006, SmithKline Beecham Corporation (now part of GlaxoSmithKline plc) held the exclusive distribution rights to Locilex™ in the U.S.

In March 2011, we exercised our exclusive option to buy out the downstream, success-based milestones and royalty obligations related to Locilex™ and currently own 100% of our product candidate.

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