Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), an innovative company specialized in the development of orphan oncology therapeutics, today announced it has entered into an exclusive license agreement with Pint Pharma for the commercialization of Beleodaq® (belinostat), Onxeo’s pan-HDAC inhibitor for PTCL (peripheral T-cell lymphoma), in key South American countries.
Beleodaq® is approved in the US, and has been marketed by Spectrum Pharmaceuticals since July 2014 as a 2nd-line treatment for PTCL.
Pint Pharma is a private specialty pharma company well experienced in commercializing orphan drugs and highly specialized products in South American healthcare markets.
Under the terms of the agreement, Pint Pharma will register, commercialize, and promote Beleodaq® in seven countries: Argentina, Brazil, Chile, Colombia, Ecuador, Peru, and Venezuela.
Onxeo will receive an upfront payment from Pint Pharma, regulatory and commercial milestone as well as double-digit royalties on the net sales of Beleodaq® in these territories, representing a deal value of over USD 20 million.
“We are extremely pleased to announce this exclusive licensing agreement for Beleodaq®, and to have Pint Pharma as a strategic partner in South America. This is the second Beleodaq® licensing agreement, demonstrating our product’s commercial potential as well as its clinical value. We look forward to a close collaboration with Pint Pharma as we leverage their team’s strong expertise in this region to provide access to our treatment to a greater number of PTCL patients,” commented Judith Greciet, CEO of Onxeo.
While initiating the regulatory procedures to obtain market approval, Pint Pharma also plans to make Beleodaq® available to PTCL patients through Early Access Programs (EAPs) in eligible countries by the end of 2016.
“This collaboration agreement with Onxeo is a great opportunity for us to expand our hematology franchise and strengthen our leadership position in the South American oncology market. We are thrilled to be working with Onxeo, a company that shares our values and commitment to making innovative therapeutics available to patients suffering from rare diseases,” commented David Muñoz, CEO of Pint Pharma.
About Early Access Programs
Early Access programs, also known as Named Patient Program (NPP) or compassionate use, is a mechanism that enables patients with unmet medical need to be provided with access to a medicine, prior to the medicine being commercially available in that country. NPPs can take different forms, and are generally initiated by healthcare professionals contacting the manufacturer or distributor of a medicine to ask about access for their patient.
About Pint Pharma
Pint Pharma is a private specialty pharma company which benefits from specialized leaders with extensive experience in the pharmaceutical sector and whom are based strategically throughout Latin America and Europe. Pint Pharma has also a long track record of developing strong relationships with global pharmaceutical and healthcare companies. Pint Pharma has the ambition to become a leading Latin American company delivering innovative treatments to patients with cancers, rare diseases and genetic disorders.
Onxeo is a leading developer of orphan oncology drugs. The Company is focused on developing innovative therapeutics for rare cancers, one of the fastest growing markets in the healthcare industry with high, unmet medical needs. Onxeo’s vision is to become a global leader and pioneer in oncology, with a focus on orphan or rare cancers, by developing advanced, effective, and safe therapeutics designed to improve the lives of patients. Onxeo’s comprehensive portfolio features a broad orphan oncology pipeline, with four independent programs in various stages of clinical development, including Onxeo’s first approved orphan oncology drug, Beleodaq®. The Company is headquartered in Paris, France and has approximately 50 employees. Onxeo is listed on Euronext in Paris, France (Ticker: ONXEO, ISIN Code: FR0010095596) and Nasdaq Copenhagen, Denmark (Ticker: ONXEO).
Onxeo’s orphan oncology products are:
- Livatag® (Doxorubicin Transdrug™): Currently being evaluated in a Phase III trial (ReLive) in patients with hepatocellular carcinoma (primary liver cancer); and in combination with other cancer agents in first-line HCC
- Beleodaq® (belinostat): FDA-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 cancer agents is currently in development in first-line treatment for patients with PTCL (BelCHOP) and in other solid tumors
- AsiDNA: The first-in-class siDNA (signal-interfering DNA) which has successfully undergone a proof-of-concept Phase I trial in metastatic melanoma
- Validive® (Clonidine Lauriad®): Positive final results from a Phase II trial in head and neck cancer patients with severe oral mucositis
In addition, Onxeo has successfully developed and registered two non-cancer products, which are currently being commercialized in the U.S. and Europe.
Learn more by visiting www.onxeo.com.
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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 Risk Factors ("Facteurs de Risque") section of the 2015 Reference Document filed with the AMF on April 29, 2016, which is available on the AMF website (http://www.amf-france.org) or on the company’s website (www.onxeo.com).
Judith Greciet, CEO
Nicolas Fellmann, CFO
+33 1 45 58 76 00
Caroline Carmagnol /Florence Portejoie – Alize RP (France)
+33 6 64 18 99 59 / +33 6 47 38 90 04
Kirsten Thomas / Lee Roth – The Ruth Group (U.S.)
+1 508 280 6592 / +1 646 536 7012