Acne is seen as a trivial disorder by some, but with around 50 million sufferers in the US any product that can beat current therapies has a shot at a large market. Topical antimicrobials, used in mild cases, have modest efficacy, while more severely affected patients receive oral antibiotics, which come with a risk of side effects.
The Israeli company Foamix Pharmaceuticals (NASDAQ:FOMX) believes that it has a solution with FMX101, a foam version of the antibiotic minocycline that is due to report phase III results next year. “We haven’t seen any drug-related systemic side effects in any of our studies,” its chief executive, Dov Tamarkin, tells EP Vantage.
A topical antibiotic could also have the edge in an era where antibiotic resistance is a major worry. And FMX101 might even get to work more quickly than oral minocycline, which is sold by Valeant (NYSE:VRX) under the brand name Solodyn. In phase II, patients treated with Foamix’s project had a statistically significant, over 50% reduction in inflammatory lesions after three weeks.
“With Solodyn it takes 12 weeks to achieve a 44% reduction in lesions. Remember this is not a head-to-head comparison, but it gives you an idea,” says Mr Tamarkin.
There is already a topical version of the antibiotic dapsone in the form of Allergan’s (NYSE:AGN) Aczone gel but, until now, creating a topical version of minocycline has proven challenging because “the molecule is extremely unstable, it degrades in the presence of water, alcohol, surfactant, polymers – almost anything used in topical formulations.”
Mr Tamarkin will not say how Foamix solved this problem, except that “it took us three years and 12 patents”. He claims that the company’s intellectual property is strong and that no other groups are developing similar foams – a medium that he says makes the drug more effective.
Spot the difference
Foamix is taking aim at the moderate to severe end of the acne spectrum, which affects around 10 million people in the US. Two identical 450-patient phase III trials of ’101 are due to report topline results in the first half of 2017 – the primary endpoints are severity of disease according to the investigator global assessment, and the number of inflammatory lesions.
If data are positive the company could file an NDA soon afterwards, and hopes for approval by the end of 2018. Although small, Foamix plans to go it alone in the US. “In the US acne patients go directly to the dermatologist; there are around 15,000 dermatologists altogether and 5,000 write most of the scripts. To target 5,000 dermatologists requires a salesforce of 50-75 reps, which is not huge,” Mr Tamarkin says.
Cowen analysts believe that ’101 could have peak sales of $500m or more, citing rapid uptake of two more conventional topical therapies, Allergan’s Aczone and Galderma/Nestlé’s Epiduo, “both of which we believe will ultimately prove inferior to FMX101”, they wrote.
But as well as going up against these products and the might of Valeant, Foamix might have to watch out for new kids on the block like Dermira, whose acne gel DRM01 looked promising in phase II (Dermira’s acne drug hits the spot in phase II, May 11, 2016).
In Europe Foamix wants to find a partner for ’101. Here the company could be helped by its existing connections – it already has collaborations in place with Bayer (OTCPK:BAYRY), Allergan, Merz and Mylan (NASDAQ:MYL). The deal with Bayer covers Finacea, a foam version of azelaic acid that the German group markets for mild to moderate rosacea.
Mr Tamarkin declined to give more details on the products involved in the partnerships with Allergan, Merz and Mylan: “All I can say is that they’re in advanced stages of development.”
The chief executive believes that Finacea is complementary to the group’s own rosacea candidate, FMX103, which recently reported positive phase II results in moderate to severe disease (Snippet roundup: Wins for AcelRx, Foamix and SGLT2 developers, September 16, 2016).
Foamix hopes to go into phase III “as soon as practicable” with ’103, which also has minocycline as its active ingredient but at a lower dose than ’101. The phase II trial of ’103 found a significant improvement at both doses studied, 1.5% and 3%. As for phase III, “we have a good feeling about dose, we think it’ll be the 1.5%”, says Mr Tamarkin.
Royalties from Finacea, which totaled $752,000 in the second quarter, along with a recently announced $57m equity raise, will give Foamix sufficient cash to complete development of both ’101 and ’103, the chief executive believes.
The group is also working on another minocycline foam, FMX102, which is in phase II for impetigo, and FDX104, a doxycycline foam in phase II for the management of the acne-like rash induced by EGFR inhibitor anticancer drugs.
With Valeant still incapacitated, one potential Foamix buyer seems to be out of the picture. But the company no doubt hopes that others will be interested if ’101 succeeds in phase III.
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