US and Korea grants patents for VAL001

US Patent and Trademark Office (USPTO) and Korean Intellectual Property Office (KIPO) has announced the intent to grant Respiratorius patent for VAL001, "A Pharmaceutical Composition Comprising a HDAC inhibitor and a steroid and the use thereof."

After the formal fees have been paid, the patent will be granted, which will give Respiratorius market exclusivity in the United States and Korea until 2031. Previously the patent has been granted in Europe and Japan under equivalent conditions.

The patent applies to a combination of a HDAC inhibitor and a steroid for pretreatment before chemotherapy (R-CHOP) in the treatment of diffuse large B-cell lymphoma (DLBCL), a lymphoma which annually affects about 60,000 people in the United States and Europe. DLBCL is the most common type of Non-Hodgkin's lymphoma, which comprises 30% of diagnosed patients in the EU.

In Q2 2018, a phase I/IIa study of VAL00, in combination with R-CHOP, was completed with the following results:

• Potential synergistic effect with Rituximab as VAL001 increases the levels of the surface protein CD20.
• Overall Survival Analysis for 32 patients treated with VAL001 and R-CHOP shows that 1-year survival is 100% and 2-year survival is 96.8%. Comparative data from a matched reference population of 330 patients from The Swedish lymphoma registry treated with R-CHOP alone provides 1-year survival of 89.6% and 2-year survival of 81.7%. This shows a statistically assured survival benefit (p = 0.034) for patients treated with VAL001 and R-CHOP compared to those treated between 2000–2015 with R-CHOP alone.

In summary, the study shows a statistically-guaranteed survival benefit (p = 0.034) for patients treated between year 2000 and 2015 with VAL001 and R-CHOP compared to those treated with R-CHOP alone.

As previously communicated, VAL001 has received Orphan Drug Designation in Europe and the United States, giving market exclusivity for 10 and 7 years from market approval.

"A patent approval in the US and Korea for VAL001 is of strength and with excellent timing for the ongoing exit-process as US is the single most important market for VAL001. The patent approval complements previously granted Orphan Drug Designation and further strengthens our market position" comments CEO Johan Drott.

This information is information that Respiratorius AB (Publ) is required to disclose under the EU Market Abuse Regulation. The information was provided by the above contact person for publication on August 8, 2018.

Johan Drott
President Respiratorius AB
+46 709-22 41 40
johan.drott@respiratorius.com

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

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