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Agreements

Date: 2015-05-20

Type of information: Development agreement

Compound: Traumakine® - FP-1201 (human recombinant interferon-beta 1a)

Company: Faron Pharmaceuticals (Finland) China Medical Systems Holding Limited (China) A&B Ltd (China)

Therapeutic area: Lung diseases - Respiratory diseases

Type agreement:

development

commercialisation

Action mechanism:

protein. FP-1201 is a human recombinant interferon-beta 1a. In acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), the predominant patho-physiological result is increased vascular leakage, which has been shown to be due to the lack of adenosine, an end product of AMP degradation by 5’-nucleotidase (CD73). Adenosine acts to enhance endothelial barrier function via adenosine receptor activation. Therefore, any biological substance, which acts to increase adenosine level, will reduce vascular leakage and be of benefit in ALI/ARDS patients. Such substances are type I interferons, and especially the interferon-beta (IFN-beta). IFN-beta has been shown to up-regulate 5’-nucleotidase (also known as a CD73 molecule and expressed abundantly by normal endothelial cells) and prevent ALI in animal models (Kiss et al. (2007) Eur. J. Immunol. 37:3334).

Disease: acute respiratory distress syndrome (ARDS)

Details:

* On May 20, 2015, Faron Pharmaceuticals announced that it has entered into strategic agreements with China Medical Systems Holding Limited  and A&B Ltd for the development and commercialization of Traumakine® for the treatment of moderate to severe acute respiratory distress syndrome (ARDS). CMS, a fast growing pharmaceutical company listed on the Hong Kong Stock Exchange has acquired exclusive assets and rights for the development and commercialisation of Traumakine in China, Hong Kong, Macao and Taiwan (the “Territory”). A&B Ltd., an investment and development company based in Hong Kong and owned by Dr. Lam, CEO of CMS, makes a simultaneous strategic €5 million equity investment in Faron. Dr. Huaizheng Peng, Head of International Business at CMS, will join the Faron Board.

Traumakine® is entering a pan-European Phase III trial in 2015 and has the potential to be the first pharmaceutical treatment of moderate to severe acute respiratory distress syndrome, a condition that kills 35-45% of ICU patients despite ventilation assisted supportive therapies1. Positive results from the phase 2 clinical trial carried out in the UK demonstrated more than 80% reduction in mortality in the Traumakine treatment group1. Following a successful pan-European Phase III trial of Traumakine in Europe, market authorization and licenses are expected to be obtained for the development and commercialization in the Territory. All further development costs in the Territory will be covered by A&B Ltd.

This is the second agreement Faron has entered for the development and commercialisation of Traumakine in Asia. In 2011, Faron also entered into an agreement with Japanese pharmaceutical company Maruishi, which has licensed the rights to develop and commercialise Traumakine® in Japan.

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