Welcome to your weekly digest of approaching regulatory and clinical readouts.
This week brings the PDUFA date for Valeant Pharmaceuticals' efinaconazole in fungal nail infection (onychomycosis). The topical project boasts improved cure rates over approved topical drugs and has few side effects. While the more effective agents are taken orally and have a shorter treatment duration they do carry increased side effects.
However, the onychomycosis market is crowded with generics and OTC agents, so Valeant needs to prove that efinaconazole can carve out a niche.
The FDA's decision on May 26 will decide the future for the company’s third-biggest growth driver; efinaconazole's 2018 sales are forecast to reach $144m, according to EvaluatePharma. Deutsche Bank analysts say onychomycosis affects 35 million people in the US.
Two phase III trials were conducted in a total of 1,655 patients aged 18 to 70 with mild to moderate onychomycosis, defined as 20-50% of the area of the target nail. Their primary endpoint was the complete cure rate at week 52. In the two studies, patients treated with the drug had complete cure rates of 17.8% and 15.2% compared with 3.3% and 5.5%, respectively, in those given placebo.
Adverse events were mild and transient and were similar between treatment groups. Local site reactions occurred in 2% of those treated with efinaconazole.
Topical agents are normally used front line before the oral, systemic therapies. Analysts at JP Morgan note that complete cure rates for currently approved topical agents are below 10%.
Meanwhile, the analysts say that cure rates for oral agents such as Lamisil, Sporanox and Onmel are 40%, 14% and 21% respectively. Side effects with oral agents include headaches, rash and drug interactions, and they can affect liver enzyme function.
Oral agents will likely remain the most widely used therapies for onychomycosis, due to dosing convenience, shorter duration of therapy and patient compliance. However, the analysts see efinaconazole as a best-in-class topical therapy with $200m+ in peak sales potential.
Valeant announced earlier this month that the launch of efinaconazole would not occur until after September owing to an arbitration hearing. It is in a breach of contract dispute with Anacor Pharmaceuticals, whose own topical agent tavaborole is a year behind efinaconazole. Anacor had used Valeant’s Dow division for development services relating to tavaborole.
Despite this Valeant has a sales force in place through last year's acquisition of Pedinol Pharmacal and Medicis, with plans to market the drug through both podiatry and dermatology platforms. Efinaconazole will have to compete with a highly crowded and genericised market, and Valeant will need to tout the drug's efficacy and safety strong points for the product to gain traction.
|Phase III trials||IDs|
|Topical application of efinaconazole or placebo once a day for 48 weeks||NCT01007708, NCT01008033|
All information is sourced to analyst notes and the EvaluatePharma Calendar of Events tool.