PARIS--(BUSINESS WIRE)--Regulatory News:
Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ Copenhagen: ONXEO), (“Onxeo” or the “Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, today announced the sale of two historical products Sitavig® and Loramyc®1 to Vectans Pharma, a private pharmaceutical company which develops and markets innovative therapeutics in oral pathologies.
Under this agreement, Onxeo will assign to Vectans Pharma all assets relating to the two products – notably patents, regulatory authorizations and outstanding contracts – and will receive an upfront payment of €4 million, as well as a potential earn-out payment based on the cumulated worldwide commercial performance of the products.
In addition, Onxeo will receive most of the expected milestone payments from existing partners, related to predefined regulatory or commercial performance events expected over the next 3 years.
Sitavig® and Loramyc are the two first products developed and registered in Europe and the US by Onxeo R&D teams for the treatment of labial herpes and oropharyngeal candidiasis respectively. These products have already been licensed to several international distributors and have reached various development stages depending on the country, from ongoing registration activities to market authorization and commercialization.
“We are extremely pleased with this transaction as these products constitute a solid foundation to build our portfolio of innovative specialty products in oral pathologies upon,” stated Jean Theron, President of Vectans Pharma. Loramyc® and Sitavig® represent valuable assets that address patients’ needs in two oral diseases for which these convenient products bring significant advantages”.
While these two products, commercialized or under approval in several key countries around the world, illustrate Onxeo’s undeniable development experience and skills, they are no longer at the heart of the Company’s strategy dedicated to the development of innovative drugs in orphan oncology. Vectans Pharma, in turn, specializes in commercialization of drugs for oral pathologies, and is therefore ideally positioned to harvest the full potential of these products.
“This transaction marks the completion of our Company’s strategic transformation initiated few years ago focusing on innovative orphan oncology drugs development. We will now be able to concentrate all our resources on the development of our diversified product pipeline in this high-potential therapeutic area.” concluded Judith Greciet, Chief Executive Officer of Onxeo.
For this transaction, Onxeo was advised by the Altana Law Firm, represented by Jean-Nicolas Soret (partner), Fabien Pouchot (counsel) and Vincent Guilaine (associate). Vectans Pharma was advised by Raphael Financial Advisory represented by Benoit Perrin d’Arloz and by the Almain Law Firm represented by Edgard Nguyen (partner).
About Onxeo
Onxeo is a biotechnology company developing innovative drugs for the treatment of orphan diseases in oncology, driven by high therapeutic demand in one of the fastest growing segments of the pharmaceutical industry.
Onxeo’s objective is to become a major international player in the field of rare cancers. Its growth strategy is founded on the development of innovative, effective, and safe drugs based on breakthrough technologies that can make a real difference in the treatment of orphan oncology diseases and considerably improve the quality of life of patients affected by rare or resistant cancers.
Onxeo’s comprehensive portfolio features a broad orphan oncology pipeline, with 3 major products in several on-going preclinical and clinical programs, alone or in combination for various cancer indications:
- Livatag® (Doxorubicin Transdrug™): Currently evaluated in the treatment of Hepatocellular carcinoma (HCC, also called primary liver cancer) in a phase III trial, ReLive. ReLive is a randomized, international trial designed to demonstrate the efficacy and the safety of Livatag® compared to the best available treatment chosen by the physician in 390 patients with advanced HCC after failure or intolerance to sorafenib.
- Beleodaq® (belinostat): FDA conditional approved in the US in 2014 under the agency’s accelerated approval program as a second-line treatment for patients with peripheral T-cell lymphoma (PTCL) and currently marketed by Onxeo’s partner in the US, Spectrum Pharmaceuticals; belinostat in combination with other anti-cancer agents is currently in development in first-line treatment for patients with PTCL (BelCHOP) and in solid tumors.
- AsiDNATM: The first-in-class siDNA (signal-interfering DNA) which has successfully undergone a proof-of-concept Phase I trial with a local administration in metastatic melanoma. The Company is currently pursuing preclinical programs to demonstrate AsiDNA activity with a systemic administration
The Company is headquartered in Paris, France with offices in Copenhagen and in New York, and has approximately 60 employees. Onxeo is listed on Euronext in Paris, France and Nasdaq Copenhagen, Denmark (Ticker: ONXEO, ISIN Code: FR0010095596).
Learn more by visiting www.onxeo.com
About Vectans Pharma
Vectans Pharma is an international pharmaceutical company based in Paris, France, which develops and markets innovative therapeutics addressing unmet medical needs in Oral Pathology. Vectans Pharma is committed to continued growth through acquisitions, in-licensing of new products and forming mutually beneficial business partnerships. Vectans Pharma is backed by a management team and board members with deep industry experience and has a proven track record of commercial, regulatory, CMC, medical affairs and market access achievements.
Vectans Pharma core competencies are:
- Re-launch or repositioning of existing products
- Launch of
innovative niche products
- Acquisition and integration capabilities
-
Licensing of strategic products
- International Market Access
(Europe and Emerging Markets)
Forward looking statements
This communication expressly or implicitly contains certain forward-looking statements concerning Onxeo and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Onxeo to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Onxeo is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of Onxeo to differ from those contained in the forward-looking statements, please refer to the section 5.5.1.4 “Risk Factors” ("Facteurs de Risque") of the 2016 reference document filed with the Autorité des marchés financiers on April 24, 2017 under number D.17-0423, which is available on the Autorité des marchés financiers website (www.amf-france.org) or on the Company’s website (www.onxeo.com).1 Loramyc® is also known as Oravig® in the US and China, and Oravi® in Japan - Sitavig® is also known as Labiriad® in Italy. For more information on these products please refer to Onxeo’s 2016 registration document – par. 4.2.3.2 and 4.2.3.3.
