Extending the business base
The development pipeline includes a second-generation fungal nail product with fungicidal, keratolytic and emollient properties, MOB-015. In December 2011, Moberg Derma completed the recruitment of 237 patients with onychomycosis to participate in a phase II study. Final results from this phase are expected by the end of 2012.
Data analysed by the company in early February showed, however, that there appeared to be a low probability that the final results from the study will be sufficient for out‑licensing the project. Further studies will probably be required before continuing to phase III, the company now believes. ‘We will get additional data and seek to identify possible product improvements,’ says Mr Wolpert.
As to the formulation technology of MOB-015, it facilitates high concentrations of a fungicidal substance to be transported in and through the nail tissue. In pre‑clinical studies on human nails, significantly higher concentrations of the antifungal substance have been detected, compared with the concentrations measured in the nail with successful oral treatment. Like Nalox, as MOB-015 is applied locally, the side-effects associated with oral treatment are avoided.
‘MOB-015 has the potential to be the future market leader for the treatment of nail fungus,’ says Mr Wolpert. He tells PRIME: ‘The product is expected to be a prescription product in certain markets, as regards positioning, and will likely compete in the same markets as Nalox, but it is early days yet.’
MOB-015 will be delayed from its original launch timing, which was estimated to be 2017. A pipeline actinic keratosis (AK), genital warts and basal cell cancer product, Limtop, is likely to hit the market in 2017. Moberg Derma was recently granted SKr4 million by the funder Vinnova for the development of Limtop with a goal to initiate clinical studies in the first half of 2012. Vinnova aims to support local small and medium enterprises (SMEs) in Sweden. Pre-clinical results show that Limtop has a far greater capacity than existing preparations when it comes to transporting the active substance to the target tissue in the skin.
Conclusions
Elsewhere, now in an expansion phase, Moberg Derma has plans to ramp up staffing, and has begun by appointing a new vice president of pharmaceutical innovation and development, Lena Pereswetoff-Morath, who was formerly in a similar position at Orexo.
‘She will help us maximise the tremendous opportunities for the innovation we are targeting. Not new molecules — patients don’t care about that particularly. But we want to make full use of the products in all respects, including packaging, formulation and delivery,’ says the CEO.
Even with growth products, SMEs have to work hard to be noticed. ‘We’re too small for many investors, so we need to get them to understand the company and how it differs from a biotech or a pharma.’
He says: ‘Moberg Derma is not high risk, but we have learnt that you have to be constantly on your toes and be adaptable. We have changed our plans constantly. You have to be ready to do that. And we have learned a lot from the market. Over time our development performance will be judged. Maybe when we’ve completed 10–20 projects.’
As to the future, ‘we are very optimistic about Nalox, and additionally have strong partners in place. The first product’s success has created a platform to develop the company — including developing products internally as well as licensing in or acquiring external assets.’
