Click here to close now.

SYS-CON MEDIA Authors: Carmen Gonzalez, Liz McMillan, Pat Romanski, Marty Puranik, Marco Meinardi

News Feed Item

Recordati Licenses Graspa(R) From Erytech in Europe

MILANO, ITALY -- (Marketwire) -- 11/23/12 -- Recordati announces that its subsidiary Orphan Europe and Erytech Pharma, a late development stage French biopharmaceutical company focused on orphan oncology and rare diseases, have entered into an agreement granting Orphan Europe the exclusive rights for the commercialization and distribution of Graspa® for the treatment of Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) in Europe. Graspa®, human erythrocytes encapsulating L-asparaginase, for the treatment of hematological malignancies, is currently in pivotal Phase II/III clinical trial for ALL and will enter a Phase IIb trial in AML in Europe. The product has obtained an orphan drug designation in Europe and the USA for ALL.

Graspa® is a new formulation of L-asparaginase with a safer and broader range of clinical use than existing forms due to the entrapment and protection of the enzyme inside homologous red blood cells. The added value of Graspa® (by encapsulating L-asparaginase in red blood cells) relates to its ability to overcome existing limitations associated with conventional L- asparaginase via longer efficacy, better compliance, reduced doses and a better safety profile. Graspa® is intended to satisfy the unmet medical needs of frail patients, patients suffering relapses and other patient groups for whom the current treatments are not suitable.

Marco Liguori CEO of Orphan Europe is delighted with this new partnership "The Orphan Europe team has considerable experience in the orphan drug field and the special requirements of rare diseases. We are committed and prepared to ensure that these treatments become available for patients in Europe rapidly".

"We are very pleased to announce this agreement with Orphan Europe (Recordati Group)" said Pierre-Olivier Goineau, Chief Executive Officer of Erytech. "We believe we have found a partner that is uniquely positioned to ensure market access and commercial success of our lead product in ALL, and to advance the product in AML. Erytech will manufacture the product. This agreement is a major milestone for Erytech, and a clear recognition of the potential of our technology. It will allow us to focus on our developments in the US in solid tumors and in other rare disease indications".

About Orphan Europe Orphan Europe was founded in 1990 and acquired by Recordati in 2007. For the past two decades Orphan Europe has developed and marketed orphan drugs for patients with rare diseases. In 2000 orphan drugs were defined by the European Drug Regulation as a treatment for a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons. The parameters involved in the development of an orphan drug are very different from the development of conventional drugs, for example there is a limited number of patients and a scarcity of expertise. Therefore Orphan Europe's approach is based on combined efforts between the company, patients and the medical community with the overall aim to improve the life of affected persons. Orphan Europe has also built the Orphan Europe Academy with the aim to further the understanding of rare diseases and provide a forum for sharing knowledge and developing new ideas.

About Erytech Erytech Pharma SA is a late-stage French biopharmaceutical company developing medicinal products for orphan oncology and rare diseases. The company's proprietary core technology is based on the use of human red blood cells (RBCs) to improve the pharmacokinetic (PK) and pharmacodynamic (PD) properties of therapeutic molecules. Erytech has established a cGMP approved manufacturing facility that can meet the demand for Graspa® products in Europe. The company is expanding the use of its technology in oncology to Acute Myeloid Leukemia and solid tumors, and outside oncology in enzyme replacement therapy, immunology and haematology indications.

Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of over 3,200, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in the main European countries, in Central and Eastern Europe, and in Turkey. A field force of around 1,700 medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses from companies which do not have a European presence. Recordati is committed to the research and development of new drug entities within the cardiovascular and urogenital therapeutic areas and of treatments for rare diseases. Consolidated revenue for 2011 was EUR 762.0 million, operating income was EUR 163.5 million and net income was EUR 116.4 million.

Statements contained in this release, other than historical facts, are "forward- looking statements" (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are based on currently available information, on current best estimates, and on assumptions believed to be reasonable. This information, these estimates and assumptions may prove to be incomplete or erroneous, and involve numerous risks and uncertainties, beyond the Company's control. Hence, actual results may differ materially from those expressed or implied by such forward-looking statements. All mentions and descriptions of Recordati products are intended solely as information on the general nature of the company's activities and are not intended to indicate the advisability of administering any product in any particular instance

RECORDATI LICENSES GRASPA® FROM ERYTECH IN EUROPE: http://hugin.info/143644/R/1660193/537599.pdf

This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: RECORDATI via Thomson Reuters ONE [HUG#1660193]


For more information:

Erytech Pharma:
Caroline Carmagnol, ALIZE RP
Tel.: +33 142 688 643 // +33 664 189 959
Email Contact

Orphan Europe Recordati Group
Samantha Parker, Director of External Affairs and Rare Disease
Partnerships,
Tel: +33 1 47739529
Email Contact


For further information:

Recordati website:
www.recordati.com

Investor Relations
Media Relations
Marianne Tatschke
Ketchum Pleon
(39)0248787393

Cristina Risciotti,
(39)0262411919
Email Contact
e-mail: Email Contact

Marzia Ongaretti,
(39)0262411915,
Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impac...
Advanced Persistent Threats (APTs) are increasing at an unprecedented rate. The threat landscape of today is drastically different than just a few years ago. Attacks are much more organized and sophisticated. They are harder to detect and even harder to anticipate. In the foreseeable future it's going to get a whole lot harder. Everything you know today will change. Keeping up with this changing landscape is already a daunting task. Your organization needs to use the latest tools, methods and ex...
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
Disruptive macro trends in technology are impacting and dramatically changing the "art of the possible" relative to supply chain management practices through the innovative use of IoT, cloud, machine learning and Big Data to enable connected ecosystems of engagement. Enterprise informatics can now move beyond point solutions that merely monitor the past and implement integrated enterprise fabrics that enable end-to-end supply chain visibility to improve customer service delivery and optimize sup...
Wearable devices have come of age. The primary applications of wearables so far have been "the Quantified Self" or the tracking of one's fitness and health status. We propose the evolution of wearables into social and emotional communication devices. Our BE(tm) sensor uses light to visualize the skin conductance response. Our sensors are very inexpensive and can be massively distributed to audiences or groups of any size, in order to gauge reactions to performances, video, or any kind of present...
Hadoop as a Service (as offered by handful of niche vendors now) is a cloud computing solution that makes medium and large-scale data processing accessible, easy, fast and inexpensive. In his session at Big Data Expo, Kumar Ramamurthy, Vice President and Chief Technologist, EIM & Big Data, at Virtusa, will discuss how this is achieved by eliminating the operational challenges of running Hadoop, so one can focus on business growth. The fragmented Hadoop distribution world and various PaaS soluti...
Even as cloud and managed services grow increasingly central to business strategy and performance, challenges remain. The biggest sticking point for companies seeking to capitalize on the cloud is data security. Keeping data safe is an issue in any computing environment, and it has been a focus since the earliest days of the cloud revolution. Understandably so: a lot can go wrong when you allow valuable information to live outside the firewall. Recent revelations about government snooping, along...
The Workspace-as-a-Service (WaaS) market will grow to $6.4B by 2018. In his session at 16th Cloud Expo, Seth Bostock, CEO of IndependenceIT, will begin by walking the audience through the evolution of Workspace as-a-Service, where it is now vs. where it going. To look beyond the desktop we must understand exactly what WaaS is, who the users are, and where it is going in the future. IT departments, ISVs and service providers must look to workflow and automation capabilities to adapt to growing ...
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures...
Business and IT leaders today need better application delivery capabilities to support critical new innovation. But how often do you hear objections to improving application delivery like, “I can harden it against attack, but not on this timeline”; “I can make it better, but it will cost more”; “I can deliver faster, but not with these specs”; or “I can stay strong on cost control, but quality will suffer”? In the new application economy, these tradeoffs are no longer acceptable. Customers will ...
Red Hat has launched the Red Hat Cloud Innovation Practice, a new global team of experts that will assist companies with more quickly on-ramping to the cloud. They will do this by providing solutions and services such as validated designs with reference architectures and agile methodology consulting, training, and support. The Red Hat Cloud Innovation Practice is born out of the integration of technology and engineering expertise gained through the company’s 2014 acquisitions of leading Ceph s...
The free version of KEMP Technologies' LoadMaster™ application load balancer is now available for unlimited use, making it easy for IT developers and open source technology users to benefit from all the features of a full commercial-grade product at no cost. It can be downloaded at FreeLoadBalancer.com. Load balancing, security and traffic optimization are all key enablers for application performance and functionality. Without these, application services will not perform as expected or have the...
As organizations shift toward IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection &E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his session at 16th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Partnerships, will disc...
VictorOps is making on-call suck less with the only collaborative alert management platform on the market. With easy on-call scheduling management, a real-time incident timeline that gives you contextual relevance around your alerts and powerful reporting features that make post-mortems more effective, VictorOps helps your IT/DevOps team solve problems faster.
Skytap Inc., has appointed David Frost as vice president of professional services. David joins Skytap from Deloitte Consulting where he served as Managing Director leading SAP, Cloud, and Advanced Technology Services. At Skytap, David will head the company's professional services organization, and spearhead a new consulting practice that will guide IT organizations through the adoption of DevOps best practices. David's appointment comes on the heels of Skytap's recent $35 million Series D fundin...