Azanta and Sobi enter distribution agreement to make Nimoral® available in Eastern Europe and Russia

2013-12-09

Hellerup, Denmark, December 9, 2013. Azanta A/S, a Danish specialty pharmaceutical company and Swedish Orphan Biovitrum AB (publ) (Sobi) have entered an exclusive distribution agreement for Sobi to provide Azanta's product Nimoral in Eastern Europe and Russia as well as certain parts of Scandinavia. Under the terms of the agreement, Sobi will make the product available under named patient programs.

Nimoral (nimorazole) is Azanta's proprietary cancer product in pivotal Phase III development. Nimoral is a radiosensitizer that enhances the effect of radiotherapy in head and neck cancer patients, and the product is being made available under named patient programs throughout the world.

Dr. Claus Møller, Chief Executive Officer of Azanta, commented: "The agreement with Sobi allows us to make Nimoral available in Eastern Europe, Russia and a string of other countries, to doctors who are trying to optimize the effect of radiation therapy in head and neck cancer. We are pleased to sign the agreement with Sobi, whom we believe will be an excellent partner for Azanta in this special pharmaceutical niche."

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About Nimoral

For many cancers, radiotherapy is the main choice of treatment. The effectiveness of radiotherapy treatment depends on various factors, including the ability of the irradiation to kill the cancer cells. When cancer cells are oxygen deprived (hypoxic), they are less prone to die upon irradiation. Nimoral mimics oxygen in rendering cancer cells more responsive to radiotherapy. The active ingredient, nimorazole, has been used in routine clinical practice (according to DAHANCA guideline) in Denmark and Norway for more than two decades. Use of this product in treatment practice by oncologists requires a compassionate use license from the local/national health authorities.

Nimoral for the treatment of head and neck cancer patients undergoing radiotherapy received orphan designation by EMA in 2011. A number of phase III trials with Nimoral are either on-going or being planned for near term initiation. Nimoral is proprietary to Azanta, who is responsible for the world-wide development.

About Azanta A/S

Azanta A/S is a privately owned specialty pharma company primarily operating within oncology, women´s health and addiction medicine. The vision of Azanta A/S is to become an international market leader within specialty pharma products and innovative pharmaceutical products. Azanta A/S currently markets or makes available a string of specialty pharma products, including Nimoral, a hypoxic radiosensitizer for the treatment of head and neck cancer patients undergoing primary radiotherapy and Zybrestat, a vascular disrupting agent used for anaplastic thyroid cancer. In addition, Azanta A/S has a portfolio of low risk development projects for commercialization within the near future.

For further information, please visit www.azanta.com.

Contact Azanta:

Claus Møller

Tel: + 45 - 70 25 95 45

Fax: + 45 - 70 25 95 46

Email: info@azanta.com

Azanta A/S, Gearhalsvej 1, DK-2500 Valby, Denmark, Phone +45 7025 9545, Fax: +45 7025 9546, Mail: info@azanta.com

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