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A patent approval in Canada for VAL001 fits well with the ongoing exit process, as North America is an important market for VAL001
CEO Johan Drott
With the progress since we started the exit process, especially in the last few months, we want to increase our capacity and strengthen our negotiating position, why Partner International with an established brand and network is a natural choice
CEO Johan Drott
We are very pleased to be representing Respiratorius. VAL001 is a very exciting breakthrough cancer therapeutic and we expect significant response from the industry. The excellent Phase I/II clinical trial results show the strong potential VAL001 has for Diffuse Large B-Cell Lymphoma.”
President and CEO, Joanne Ball-Gautschi, Partner International
EMA's advice, that the next step is to directly initiate a Phase III study instead of first carrying out a Phase II study, means a repositioning for VAL001 and likely a reduction in development costs.
CEO Johan Drott
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
CEO Johan Drott
It is very honorable that the article was accepted after such a quick review which indicates great interest in our results.
Kristina Drott
The results of the clinical study are good, and I am still positive for major comparative studies
Kristina Drott, MD, PhD
The new patent approval in Europe further strengthens the commercial value of RESP3000 and confirms that we have a strong patent application
Johan Drott, CEO and President Respiratorius AB
A new patent approval in the Japan further strengthens patent protection for RESP3000, which is essential in all negotiations
CEO Johan Drott
A new patent approval in the US further strengthens patent protection for RESP3000 on the single most important market
CEO Johan Drott
A patent approval in Australia complements previous approvals in the United States and Israel and provides additional commercial value to the project
Johan Drott CEO
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Canada grants patent for VAL001

The Canadian Intellectual Property Office (CIPO) 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 Canada until 2031. Previously the patent has been granted in Europe, US, Japan and Korea under equivalent conditions. The patent applies to a combination of a HDAC inhibitor and a steroid for pre-treatment before chemotherapy (R-CHOP) in the treatment of diffuse

Agreement for negotiation and sale for VAL001

Respiratorius has signed an agreement with Partner International Inc. to complete the exit of VAL001. The assignment for Partner International is to work with already identified candidates as well as seek additional stakeholders to reach an agreement as soon as possible.Since the start of the VAL001 exit process, the clinical study has been completed with strong results and we have received additional patent approvals that give a excellent patent position with approved patents in Europe, the USA, Japan and Korea. Furthermore, the European Medicines Agency (EMA) has, in scientific advice,

EMA recommends Phase III study for VAL001

The European Medicines Agency (EMA) recommends, following scientific advice, that Respiratorius conduct a Phase III study as the next step in the clinical development of VAL001.EMA's Scientific Advice Working Party (SAWP) assesses in the feedback from a scientific advice meeting regarding clinical strategy that VAL001 is qualified for a direct start of a phase III study and that inclusion of approximately 700 patients should be satisfactory for such a study to be able to constitute the basis for market approval. Prior to the start of a Phase III study, with the new dedicated formulation,

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

Scientific Publication on Clinical Studies of VAL001

Respiratorius announces that the high-ranking scientific journal of the American Society of Hematology – Blood Advances, accepted the manuscript "Valproate in Combination with Rituximab and CHOP as First Line Therapy in Diffuse Large B-cell Lymphoma (VALFRID)" for immediate publication.The scientific article summarizes the implementation and results of the study. The key results from the Phase I / IIa stuies are presented briefly: · •      Potential synergistic effect with Rituximab as VAL001 increases the levels of the surface protein CD20. · •      Overall Survival Analysis for

Respiratorius presents positive results from clinical studies of VAL001

Respiratorius reports positive results from clinical phase I/IIa studies of VAL001.The key results from the Phase I / IIa studies are presented briefly: · •       Published scientific results from the Phase I study show a 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

FDA Grants Orphan Drug Designation for VAL001

Respiratorius AB has been granted Orphan Drug Designation by US Food and Drug Administration (FDA) for valproic acid for the treatment of Diffuse Large B-cell Lymphoma.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, and constitute 30% of patients diagnosed with this type of cancer. Annually diagnosed approximately 20 000 people in the US

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