Oxford BioTherapeutics and Menarini Progress Enhanced Antibody for Acute Myeloid Leukemia as First Clinical Development Candidate in $1 Billion Oncology Investment Alliance

OXFORD, England and BERLIN CHEMIE/MENARINI, Germany, December 9, 2013 /PRNewswire/ --

Oxford BioTherapeutics (OBT) and Berlin-Chemie (Menarini Group) announce today that they have designated a novel enhanced antibody targeting acute myeloid leukemia (AML) as the first clinical development candidate under the companies' strategic oncology collaboration. The companies have initiated formal regulatory enabling studies to support an application for a clinical phase I trial in AML patients in H2 2014.

OBT and Menarini established their strategic partnership in October 2012, covering the development and commercialization of five of OBT's proprietary antibody-based cancer therapies.  Under the collaboration, Menarini contributes manufacturing, regulatory, pre-clinical, clinical and expertise, supported by investment of up to $1.1 billion. Futhermore Menarini is responsible for the clinical development, first up to the clinical proof of concept study, then to the full development and regulatory approval in its territories: Europe, Asia, and Latin America, while OBT is responsible for full development, approval and commercialization in North America and Japan.

The first of the partnership's programs to progress into clinical development is an engineered antibody designed to induce antibody-dependent cellular cytotoxicity (ADCC) in AML and related hematological cancers. This first-in-class therapeutic incorporates BioWa ADCC-enhancing technology and has completed the in vitro/ex vivo proof-of-concept, demonstrating efficacy, and exploratory toxicology testing. The manufacturing process has been transferred and scaled-up at Menarini Biotech. Further regulatory pre-clinical studies and ex vivo experiments on AML blasts are now underway by Menarini.

"We welcome the achievement of this strategic milestone in our partnership with Menarini," said Dr Christian Rohlff, Oxford BioTherapeutics' CEO and Founder. "This is an important first step in accelerating the clinical development of our pipeline of novel antibody-based cancer therapeutics. As a leading international pharmaceutical company, Menarini has a growing presence in the cancer research field, and we look forward to progressing additional oncology programs as part of our alliance."

"The aim of the partnership between the Menarini Group and OBT", declared Andrew Slade, CEO of Menarini Biotech, "is to focus on cancer research where the available treatments are not very effective. The study of antibodies, that is biological drugs, capable of attacking and destroying the blasts, the carcinogenic cells responsible for this type of leukaemia, is one of the areas our research groups are concentrating on. The first result of our researchers has arrived after a year of intense work, in the form of a monoclonal antibody which shows a remarkable ability to identify the target cells and induce their elimination."

About Oxford BioTherapeutics

Oxford BioTherapeutics is an international biotechnology company developing a range of antibody-based cancer drugs, built on its OGAP® oncology targeting technology.  The OGAP® system incorporates one of the world's largest proprietary proteomic databases, with data on 7,500 cancer cell membrane proteins providing unique, highly-qualified therapeutic targets.  Oxford BioTherapeutics has established collaborations with leading antibody and antibody enhancement companies to build an in-house pipeline of therapies against a number of these novel targets.  The company is based in Oxford, UK and San Jose, CA, and has a strong management team with significant experience of developing antibody-based therapies.  Oxford BioTherapeutics has completed a number of funding rounds, and is supported by a syndicate of specialist venture capital investors.  For more information please visit http://www.oxfordbiotherapeutics.com.

About Menarini Group

The Menarini Group is the first Italian pharmaceutical company in the world, 16th in Europe out of 5,180 companies, and 38th company in the world out of 18,237 companies*, with a turnover of more than 3 billion Euro and nearly 17,000 employees.  The Menarini Group has always pursued two strategic objectives: Research and Internationalisation.  It is present in the most important therapeutic areas including: cardiovascular products, gastroenterology products, antibiotics/respiratory products, drugs used in diabetology, anti-inflammatory agents/analgesics.  It has a strong presence across Europe and in the major countries of Asia, Africa, Central and South America.  Its products are available to patients in more than 100 countries.

For more information about Menarini, please visit:  http://www.menarini.com/

Contacts
Dr Christian Rohlff
CEO
Oxford BioTherapeutics
+44(0)1235-861770
christian.r@oxfordbiotherapeutics.com

David Dible / Sita Shah
Citigate Dewe Rogerson
+44(0)207-638-9571
david.dible@citigatedr.co.uk

Valeria Speroni Cardi
Head of Menarini Group Press Office
Menarini
0039-055-56801
pressoffice@menarini.com