Company highlights

Build a global leader in oncology focused on orphan diseases, supported by an advanced product pipeline:

  • Breakthrough, highly innovative products in diseases with strong unmet medical need
  • Advanced programs with results expected in the short/medium term (2014-2016)
  • Potential company changers with large sales potential (up to €800 M)


Partnerships are key to Onxeo’s growth strategy.

Onxeo has a successful experience in licensing deals with pharmaceutical companies around the world.

Onxeo is highly interested in collaborative opportunities – co-development, out-licensing and in-licensing – to develop relationships with partners.

Partnering priorities focused on our orphan oncology products

Livatag®Doxorubicin Transdrug™ – A nanoformulated doxorubicin, innovative therapy targeting survival in hepatocelullar carcinoma (HCC)

  • International Phase III trial ongoing: 100% of patients enrolled out of the 390 planned
  • Worldwide Industrial Protection until 2036
  • Orphan status in both Europe and US, Fast Track in the US
  • Significant commercial opportunity with potential sales up to €700-800 million

Beleodaq® – belinostat – A histone deacetylase inhibitor (HDACi) for patients with refractory or relapsed peripheral T-cell lymphoma (PTCL)

  • Positive International Phase II trial (BELIEF Study) showing efficacy and favorable safety profile
  • NDA obtained in July 2014 from the FDA for this indication (accelerated registration program)
  • Already licensed in North America, South America, and India
  • Long Term IP until at least 2026
  • Orphan status in both Europe and US
  • Significant opportunities in PTCL and other oncology indications

AsiDNA™The first-in-class siDNA (signal-interfering DNA)

  • A first-in-human Phase I trial in patients with metastatic melanoma demonstrated the safety of local administration of the product (DRIIM trial; NCT01469455). Now planning to initiate the development of the product by the systemic route
  • Protection by 6 patent families until 2036
  • Significant opportunities in monotherapy and combination, in various types of cancers

Validive® - Clonidine Lauriad® - A mucoadhesive anti-inflammatory tablet to prevent severe oral mucositis in head & neck cancer patients

  • Positive Phase II final results (Q4 2014). Onxeo is seeking for a partner to further co-develop Validive®
  • Strong IP in the US, Europe and Japan until 2029
  • Orphan status in Europe, Fast Track in the US
  • Significant commercial opportunity with potential sales up to €200 million to €400 million

Out-licensing opportunities for our registered/marketed products:

Sitavig® – Acyclovir Lauriad® – One day treatment for herpes labialis – Approved in EU/USAlready licensed in the US, in Italy, Brazil, South Korea and Israel.

Oravig®/Loramyc® – Miconazole Lauriad® – For oropharyngeal candidiasis treatment – Approved in EU/USAlready licensed in North America, EU, Japan, China, South Korea, Malaysia, Taiwan and Singapore


Onxeo is committed to build up its portfolio of innovative products through in-licensing deals. We are looking for early stage compounds – with at least POC in human – or more advanced projects, in the field of orphan oncology.

Last modified on January 30, 2017.