Validive®

Onxeo Grants Exclusive Worldwide License of Validive® developed for the treatment of oral severe mucositis to Monopar Therapeutics

Agreement includes substantial milestone payments up to $108m as well as escalating royalties on future sales Monopar Therapeutics will drive and fund all remaining development, regulatory and commercialization activities Paris (France), September 13, 2017 – 8:00 am CEST – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (“Onxeo” or the “Company”), a clinical-stage biotechnology company specializing in the development of innovative…read more →

Onxeo Announces Data Demonstrating High Patient Compliance and Acceptability of Validive® for Treatment of Severe Oral Mucositis — Onxeo offentliggør data, der viser et højt niveau af ordinationsoverholdelse og en god sikkerhedsprofil for Validive® til behandling af svær oral mucositis

Results Presented in Oral ePoster Presentation at ASTRO Annual Meeting 2015 Paris (France), Copenhagen (Denmark) – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, announced compliance and patient acceptability results from a global Phase 2 clinical trial demonstrating daily treatment application of Validive® (Clonidine Lauriad®), a mucoadhesive buccal tablet for…read more →

Onxeo Validive® Abstract Accepted for Oral Presentation at ASTRO Annual Meeting 2015 — Abstract for Onxeo Validive® accepteret til mundtlig præsentation ved ASTRO’s årsmøde 2015

Paris (France), Copenhagen (Denmark) – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced that an abstract supporting the clinical evaluation of Validive® (Clonidine Lauriad®), a mucoadhesive buccal tablet developed for the prevention and treatment of chemo-radioation therapy-induced severe oral mucositis (SOM) in patients with head and neck cancer,…read more →

Validive® at the MASCC/ISOO International Symposium: Oral presentation of Phase II trial results and meeting with its International Advisory Board – Data om Validive® på MASCC/ISOO International Symposium: Mundtlig præsentation af resultater fra fase II-studiet og møde med det internationale ekspertudvalg

Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, has presented Validive® (clonidine Lauriad®) Phase II clinical trial results at the MASCC/ISOO International Symposium which took place in Copenhagen from June 25 to June 27, 2015 and on this occasion, held a meeting of its Advisory Board to discuss  design of…read more →

Onxeo consolidates its industrial property with a US patent protecting Validive® until 2029 – Onxeo styrker sine immaterielle rettigheder med et amerikansk patent til beskyttelse af Validive® frem til 2029

Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced the allowance by the US Patent and Trademark  Office (USPTO) of a patent covering its product Validive® until September 2029. Validive® is based on Onxeo’s mucoadhesive technology Lauriad® and has obtained positive Phase II results last year in the prevention…read more →

Onxeo Announces Final Data from Completed Phase II Trial of Validive® for the Prevention of Severe Oral Mucositis in Head and Neck Cancer Patients – Onxeo offentliggør endelige data fra gennemført fase II-studie med Validive® til forebyggelse af svær oral mucositis hos patienter med hoved-halskræft

Data confirm Validive® efficacy and safety; Provide basis for planned Phase 3 Trial Full results to be presented at ASCO Annual Meeting 2015 on Saturday, May 30 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced the final data from its global Phase II clinical trial of Validive® (clonidine…read more →

Oral presentation of Phase II trial results of Validive® at the MASCC/ISOO International Symposium – Mundtlig præsentation af resultater fra fase II-studiet med Validive® på MASCC/ISOO International Symposium

Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced that Validive® (clonidine Lauriad®) phase II clinical trial results have been accepted for an oral presentation at the MASCC/ISOO International Symposium taking place in Copenhagen from June 25 to June 27, 2015. The MASCC/ISOO Annual meeting is dedicated to supportive…read more →

Phase II trial results of Validive® presented at the ASCO Conference – Fase II forsøgsresultater præsenteret på ASCO-konferencen

Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced that Validive® (clonidine Lauriad®) phase II clinical trial results have been accepted for a poster presentation at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO). The ASCO annual meeting is a major event in the field…read more →

ONXEO consolidates its Intellectual Property with the grant of new patent protection of Validive® in Japan until 2029 – ONXEO styrker sine immaterielle rettigheder med tildelingen af ny patentbeskyttelse af Validive® i Japan frem til 2029

Onxeo S.A. (Euronext Paris, NASDAQ OMX Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced the grant of Validive® patent by the Japanese Patent Office. Validive® is based on Onxeo mucoadhesive technology Lauriad® and is currently entering phase III in the prevention of severe oral mucositis in patients treated for a head and neck…read more →

Positive Phase II preliminary results of Validive® for the prevention of Severe Oral Mucositis in Head and Neck cancer patients

Positive Phase II preliminary results of Validive® For the prevention of Severe Oral Mucositis in Head and Neck cancer patients • Significant reduction of incidence of severe mucositis • Improved oral mucositis related symptoms and decreased adverse events related to radiotherapy • Good Safety profile • Strong Compliance to treatment Trial Advisory Board validated data as supportive to enter into…read more →

BioAlliance Pharma announces major achievements on Validive®: Enrollment completion in the international Phase II trial with Validive® in severe oral mucositis, Presentation of preclinical data at the next ASCO annual meeting

BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company specialized in the development of drugs in orphan oncology diseases, today announced the completion of enrollment in the Phase II clinical trial with Validive® (clonidine Lauriad®) in the prevention and treatment of severe oral mucositis induced by radiotherapy and/or chemotherapy in head and neck cancer patients. This large and robust…read more →

Quarterly information as of March 31, 2014

BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company specialized in the development of drugs in orphan oncology diseases, today published a summary of the key events of the first quarter of 2014, as well as its consolidated revenues for the quarter. Key orphan oncology programs Validive® and Livatag® have successfully reached important milestones during the first quarter of…read more →

BioAlliance Pharma collaborates with Penn Pharma on the industrial development of Validive®

BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company specialized in the development of drugs in orphan oncology diseases, announced today an agreement with Penn Pharma to manufacture Validive®, currently in a late phase II trial for the prevention and treatment of severe oral mucositis induced by radiotherapy and/or chemotherapy in head and neck cancer patients. Penn Pharma is…read more →

FDA grants Validive® (clonidine Lauriad®) with a Fast Track Designation for the prevention and treatment of oral mucositis induced by anticancer treatments

BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company dedicated to the development of orphan oncology, announced today that Validive® (clonidine Lauriad®) received a Fast Track designation from the U.S. Food and Drug Administration (FDA) for the prevention and treatment of oral mucositis induced by radiotherapy and/or chemotherapy in cancer patients. The Fast Track procedure is designed to facilitate…read more →

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