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2016-11-21

Respiratorius: The European Commission Grants VAL001 Orphan Drug Designation for the Treatment of Diffuse Large B-cell Lymphoma

Respiratorius AB (publ.) has received Orphan Drug Designation for its
drug candidate VAL001 following a decision by the European
Commission. VAL001 will at product launch be included in the EU
Community Register of Orphan Medicinal Products.

VAL001 is a combination of a HDAC inhibitor (valproic acid) and a
steroid (prednisone) and referred to as a pretreatment before
chemotherapy (R-CHOP), for the treatment of diffuse large B-cell
lymphoma (DLBCL). DLBCL is an aggressive form of lymphoma, and the
most common type of non-Hodgkin lymphoma, which constitute 30% of the
patients diagnosed with this type of cancer. DLBCL annually affects
about 60 000 people in the United States and Europe. The forecast for
the 5-year survival with standard treatment is estimated at 60-70%.

A clinical phase I/IIa study of VAL001 is on-going, in which all
included patients have been treated, at Skåne Oncology Clinic, SUS
Lund/Malmö, Oncology Clinic at the University Hospital in Uppsala and
at the Cancer Centre, University Hospital in Umeå. In the study,
VAL001 is given as pretreatment prior to chemotherapy with the
addition of rituximab (R-CHOP), in the treatment of DLBCL. Results of
the interim analysis of the phase I/IIa study is showing that VAL001
combined with R-CHOP is significantly better than the reference group
which consisted of a matched population of the Swedish lymphoma
registry, which is only treated with R-CHOP, for both 1-year survival
(95% significance) and 2-year survival (90% significance).

About Orphan Drug Designation

To obtain orphan drug designation in the EU, the new investigational
drug product drug must be intended for the diagnosis, prevention or
treatment of a life-threatening or chronically debilitating condition
affecting no more than 5 in 10 000 persons in the EU and for which no
satisfactory treatments exist or, where they do exist, where the new
medicine will be of great benefit to those suffering from this
condition. It can also be granted if a new product is not expected to
provide a sufficient return to justify the investment in the
development of a new drug.

In short, by obtaining orphan drug designation Respiratorius will
obtain market exclusivity for ten years in the EU, from the date of
marketing approval. In addition, Respiratorius will receive free
consultation and scientific advice on contact with the European
Medicinal Agency, which among other things includes support for
designing clinical trial protocols and reduced costs for regulatory
applications for the commercialization.

For further information, please contact:

Johan Drott
President Respiratorius
+46 709-22 41 40
johan.drott@respiratorius.com
Christer Fåhraeus
Chairman Respiratorius
+46 705-60 90 00
christer.fahraeus@respiratorius.com

Respiratorius AB (publ) is developing drug candidates with the goal to
launch drugs for common diseases like cancer, chronic obstructive
pulmonary disease (COPD) and severe asthma. In addition, the company
portfolio also holds a project for improved diagnosis of certain
cardiovascular diseases.

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http://news.cision.com/respiratorius/r/the-european-commission-grants-va...
http://mb.cision.com/Main/10477/2127261/593000.pdf

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