Danish Biotech Company Azanta Gets Orphan Drug Approval By The Eu Commission

By Author: Karen Mudde
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For years, Danish head and neck cancer patients have had their chances of overcoming their cancer therapy improved by an add-on treatment to radiotherapy.

For years, Danish head and neck cancer patients have had their chances of overcoming their cancer therapy improved by an add-on treatment to radiotherapy. Danish biotech company Azanta has now received Orphan Drug Designation, which will facilitate the dissemination of the treatment for the benefit of a wide range of patients both in Europe and the rest of the world.

The EU Commission has granted the so-called Orphan Drug Status to the specialty pharma company Azanta’s treatment Nimorazole, which is used for head and neck cancer. This new status means that Azanta can benefit from ten years of market exclusivity in the European market and other special terms to facilitate the further development and export of treatment.

"We are very pleased to have received this special status. Azanta will exploit the advantages associated with this to develop the treatment and realize the commercial potential that no one else had seen. This is an important step towards ...
... better treatment of patients with head and neck cancer”, says Chief Executive Officer of Azanta Claus Møller.

The number of patients in Denmark who will be receiving the treatment is about 700 per year. Converted to a European scale, it means that there are approximately 50,000 patients in Europe, who can ultimately benefit from the treatment. This implies a market potential for Azanta approximately of DKK 600 million in Europe alone.

Limited focus on rare diseases

Orphan Drug is the term for products targeting orphan diseases where there are so few patients that under normal circumstances it would not pay off to develop and market the drugs. The EU grants Orphan Drug Status to treatments for diseases that affect fewer than 5 in 10,000 people.

Achieving the Orphan Drug Status means that many more patients suffering from these rare diseases, will receive better treatment as this treatment is now being made available in more countries.

"Because of limited commercial potential, investments are rarely targeting rare diseases such as head and neck cancer. Azanta has chosen to focus on the narrow needs of the niches by prioritizing the development of Orphan Drugs. Nimorazole is one of these products that Azanta now focuses on exporting to a number of markets in and outside the EU, "says Chief Executive Officer of Azanta Claus Møller.

Treatment improve the effect of radiotherapy

The treatment was originally developed by a group of Danish researchers, led by Professor Jens Overgaard from Aarhus University Hospital, and is used today in combination with radiation therapy. The treatment works by making cancer cells more sensitive to radiation, thereby increasing the efficacy of radiotherapy.

"The treatment increases patients' chance of recovery by about 20 percent," says Jens Overgaard.

Facts

About the commercial potential

• The treatment is very affordable compared to other new cancer drugs. A full treatment cycle with the product costs approximately DKK 12,000.

• The number of patients in Denmark who will be receiving the treatment is about 700 per year. The treatment rates in the rest of the Western World will most likely be in the same order of magnitude. All in all, it means that there are approximately 50,000 patients in Europe per annum, which can ultimately benefit from the treatment.

• This implies a market potential for the product of approximately DKK 600 million in Europe alone, assuming the product achieves a market penetration comparable to what is seen on the Danish market.

• For the North American market patient numbers in the same order of magnitude are expected.
Resource: http://www.azanta.com/