Fennec announced some bad news this morning. Their NDA submission for Pedmark has been pushed back by 9-12 months to “late 2019 to early 2020”. The NDA timing was initially expected in Q1 2019. The reasoning for this delay falls on manufacturing.
Avista, the manufacturer that was initially making Pedmark, was recently acquired by leading pharma manufacturer Cambrex (CMB). As a result, Fennec, a small batch producer, had to transition to another facility for commercial scale manufacturing. The good news is that Cambrex has commercial scale manufacturing capabilities and a proven track record of prior successful FDA launches.
Generally, NDA submissions require that a company submit long-term manufacturing stability data (up to 6 months). This is the reason for Fennec’s NDA delay: Fennec will need to show that the new manufacturing facility can produce a stable commercial batch of Pedmark.
The remainder of Fennec’s NDA, including clinical data, is going as planned. The company ended 2018 with $22.8M in cash, along with a $12.5M debt facility. We anticipate the 2019 burn to be roughly ~$7M. Fennec's cash balance and debt facility will be sufficient to fund Fennec’s planned commercial launch.
Although the unexpected setback pushes the timeline back by 9-12 months, the thesis around Fennec has not changed. We’re going to be patient and hold our position. We expect Pedmark to be commercially available by 2H 2020.
Disclosure: PropThink contributors are LONG FENC
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