Approval in sight, Perceptive, OrbiMed double down on Foamix's antibiotic foam to the tune of $64M
In anticipation of a long-awaited — and somewhat delayed — date with the FDA on its topical dermatology drugs, Foamix has returned to its biggest shareholders to stack up resources for the commercial stretch ahead.
The $64 million financing investment from Perceptive Advisors and OrbiMed break down to two main parts. A credit agreement covers up to $50 million in term loans, $15 million of which would be provided at closing; the other $20 million and $15 million are contingent on regulatory and revenue milestones, respectively. Perceptive has also signed up to purchase $14 million worth of Foamix’s shares, which is listed on the Nasdaq currently at $2.14 a pop.
“As we manage the transition of Foamix to becoming a fully integrated commercial organization it is important that the Company is financed appropriately,” CEO David Domzalski said in a statement. “Combined with our current cash position, we believe these initial investments, along with future access to capital which this transaction provides, will allow us to fund the commercial launches for FMX101 and FMX103, pending FDA approval.”
FMX101 and FMX103 are both foam formulations of the antibiotic minocycline but concocted at different concentrations for acne and rosacea, respectively.
The Israeli biotech had originally lined up two Phase III studies for the lead drug, FMX101, back in 2017, but ended up with mixed results that forced a third late-stage trial. The drug cleared that test on inflammatory lesion reduction and IGA treatment success, securing for Foamix a PDUFA date of October 20.
The NDA submission for FMX103, which hit the co-primary endpoints in both trials, is in the “final stages of preparation.”
At the end of last quarter, Foamix reported that it expected to last through mid-2020 with its cash and cash equivalents of $82.9 million. The new funding should extend the runway for some time to come.