Exciting times await Danish MC2 Therapeutics after the US Food and Drug Agency (FDA) approved the company's cream for treatment of plaque psoriasis, Wynzora.
The cream is MC2 Therapeutics' first approved product and it opens the door to the US market for the Danish firm – something CEO Jesper J. Lange and his team have long prepared for.
"We expected a 'yes' as our clinical trials yielded really good data and, in my opinion, we've filed a detailed application and had good collaboration with the FDA. That said, it's very nice to have it all sorted," Lange says.
Recently, MC2 Therapeutics also filed for approval of Wynzora in the EU and expects to receive an answer next year.
Will carry out commercialization alone
MC2 Therapeutics has prepared for the US launch more or less since the company received positive phase III result with Wynzora one and a half years ago. Since then, the company has been busy preparing and initiating dialog with payers, physicians, and other actors in the US health system.
According to the plan, the company will initiate the US launch later this year. As something rather uncommon for a small biotech firm, MC2 Therapeutics will be solely responsible for the sales process.
"We decided to be solely responsible for the sales when we saw the good phase III data that exceeded our expectations. When you have such a good product, it's a great opportunity to build a new global pharma company. So, this is what we have to execute on now," Lange says.
He does not want to give details about how much sales personnel MC2 Therapeutics will employ or how much money the company will invest in a US-based organization. But he is confident that his company can handle the task.
"We're entering a pretty well-defined market segment. About 3,500 dermatologists carry out approximately 80 percent of the prescriptions, and we think we can address them with a relatively small sales force – we follow a well-known go-to-market model," the CEO says.
The most important element of MC2 Therapeutics' sales pitch is the company's data from the phase III clinical trial that compared its product to Leo Pharma's well-established treatment Taclonex.
"In the US, it's not common to make these kinds of head-to-head studies that compare your treatment to branded products. We've already received positive responses from the payers and the dermatologists so we expect to be in a good position," Lange says.
Opens for new investors
Although Lange cannot give many details regarding the upcoming launch and the US organization yet, he does reveal that the company needs to raise more money.
So far, MC2 Therapeutics has been funded by private investors such as Mads Clausen, the son of Danfoss' founder, and the former owner of Radiometer, Johan Schrøder, and his family.
"Our current owners have been with us since the beginning and have shown a lot of support and professionalism. They will continue to support the company but, that being said, it might be a good time for the company to get one or two new investors on board. I believe it will be a strength for the company and the opportunities we’re facing," Lange says.
He will focus on finding investors who are willing to support the company in its decision to build up a new pharmaceutical group instead of looking into a quick sale opportunity or an IPO.
"With the US approval and the application submission to EMA, we expand the field of potential investors. It means that larger funds, pension funds, and others, who want to see products marketed and commercialized, might want to invest," explains the CEO.
More investments are also important as MC2 Therapeutics is not only aiming to gain footing in the US and commercialize only one product. The company has more candidates in the pipeline for other inflammatory diseases, and the development of those products should be able to continue at unchanged pace regardless of how many resources the MC2 Therapeutics will invest in the US launch.
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