Market success

The estimated global market for Nalox potentially exceeds $1 billion. The untapped demand is significant, since many patients remain untreated. It is generally recognised that there is a need for new efficacious and safe
topical treatments.

But Moberg Derma saw the potential to address this unmet need without having to resort to new compound development. It did this by acquiring two patents on a novel combination of compounds with well‑established use being developed by dermatologists at Göteborg’s Sahlgrenska University Hospital.

Mr Wolpert, a business entrepreneur and former strategy developer with McKinsey, tells PRIME: ‘We decided to focus on innovative products — not compounds. We take proven molecules that are associated with lower risk and that have a shorter time to market. We are committed to this model, but we are open to looking at new delivery modes or combinations of compounds.’

This approach allows the company to be closer to both the market and clinicians, and to gauge the benefits in terms of the efficiency and safety that patients require. ‘We can always do more in our interactions with consumers and patients,’ he says.

Moberg Derma does not position itself at the beauty end of the cosmetic medicines industry, but rather provides products that are health-related and that make a difference to patients. ‘Our products bring medical-type benefits, and they may sit on the borderlines of medical technology, pharma and cosmetic medicine.’

So far, the market has approved. ‘Nalox has done better than we would have expected,’ says Mr Wolpert, adding: ‘We have been overwhelmed by the reception of the market. It was launched in the Nordic countries in late 2010, and within the first two quarters of beginning marketing, we had expanded the market by 400–500%.’

Nalox has successfully filled this niche for a number of reasons, says Mr Wolpert. It is a simple product, with no safety issues, and, as a topical product, has no risk of side-effects. Loceryl, the traditional market leader, is a lacquer. Systemic treatments are based on terbinafine, itraconazole, fluconazole and griseofulvin. ‘But why have a tablet to treat nails?’ asks Mr Wolpert. The market preference is moving to topical presentations, but nail lacquers do not have sufficient efficacy.

The product has a keratolytic effect, which can be likened to a gentle chemical peel. By softening up and carefully loosening the damaged layer of the nail, the topical application gives a smoother nail surface, reduces discoloration and improves the nail’s appearance. Nalox adds and binds moisture in the nail, restoring the moisture balance, giving the nails a healthier appearance.

The safety and efficacy of Nalox have been demonstrated in five clinical trials of more than 600 patients. After 2 weeks, 77% of users reported improvements, rising to 90% after 8 weeks. The product is less expensive than Loceryl, at SKr299/$24.99, but is selling some 140000 units per quarter. It has a market target of 100 million patients in the Western world, and a peak sales potential of $100 million, the CEO believes.

The Nordic market success has showed that the product has proven itself in a demanding market. The next challenge will be to see that success replicated in other markets. But markets are different, and so are competitors, he cautions.

Nevertheless, the foundations for further success were laid during a hectic period in 2011, when Moberg Derma achieved a small cap share listing on NASDAQ OMX at the Nordic Exchange Stockholm, and scored a number of major deals.

Building on position

In November 2011, the company extended its license agreement with Meda to Russia, Turkey and other countries in eastern Europe. Two months prior to that, it gave Meda exclusive rights to market and sell Nalox in several major markets in Europe, including Germany, France, Spain and the UK. The launches are scheduled to start during the first half of 2012.

Meda paid SKr50 million for European exclusivity rights, of which SKr21 million was up-front and the rest in milestone payments. This payment, in combination with the rapid growth, helped Moberg Derma turn in a first-time quarterly operating profit in Q3 2011, and in Q4 first net profit, of SKr4.4 million, on sales of Skr56 million in calendar 2011 (reported on 9 February 2012). The goal is to be cash‑flow positive and generate an annual operating profit from 2013.

In Italy, Moberg Derma partnered in late 2011 with Menarini, which will sell Nalox as YouDerm Emtrix. The company is now also present in Australia, and the ongoing expansion of its coverage means that, within a short time, it has extended its market reach from 25 million people in the Nordic territories to some 1 billion globally.

To build its position further, Moberg Derma uses feedback from its network of distribution partners and brings groups of dermatologists together. It also works with specialists at the Karolinska Institute in Sweden, where the
company was founded, the Sahlgrenska University Hospital, and with German and US dermatologists. Additionally, in the US, its product is being carried by the pharmacy chains CVS, Rite Aid and Walgreens, other than Walmart.

Moberg Derma also aims to educate the market and distributors by ensuring scientific staff are present at meetings, and by engaging with local opinion‑formers. For instance, in February 2012 Moberg Derma presented at the New York School of Podiatry, and in March will do so at the American Academy of Dermatologists (AAD) meeting.