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Oxford Signs Potential $1B Collaboration with Menarini

By Nuala Moran
Staff Writer

LONDON – Oxford BioTherapeutics Ltd. (OBT) has landed a "transformational" deal with Menarini, in which the Italian pharma company is to invest €800 million (US$1 billion) in a portfolio of five antibody and antibody-conjugate drugs discovered by OBT.

Under the collaboration, Menarini will be responsible for the manufacture and clinical development of each product, with OBT providing proprietary cancer targets, antibody generation and drug conjugation technologies.

Products will be jointly developed to Phase II proof of concept, at which point OBT will have rights to commercialize the antibodies in North America and Japan, while Menarini will hold rights to markets in Europe, the Commonwealth of Independent States, Asia and Latin America.

"This is a pretty big deal for us, providing nondilutive funding for our pipeline," said Christian Rohlff, CEO of OBT. "When you look at the position of the biotech industry today, you can't IPO, you can't raise money, so how do you grow a company? You need deals like this, where there is a fair partnership that leaves something on the table for both sides," he told BioWorld International.

Although pharma is cutting more early stage deals, those do not typically provide the same level of give and take.

"Big pharma wants worldwide rights, and wants to backload payments in the form of royalties on products, eight to 10 years down the line. We can't wait that long," Rohlff said.

In the agreement, Menarini will fund all development to Phase II proof of concept. Abingdon, UK-based OBT will be entitled to development milestones and will have control in Phase II over how to raise more money to take products forward.

"So, this gives us a path to market. There will be flexibility about further development, for example, finding a partner in Japan," Rohlff said. "The deal puts it into our reach to become a product company in our own right."

Rohlff noted the move to get involved at such an early stage of development marks a "sea change" for Menarini, which usually in-licenses more advanced programs. The advantage of doing the deal with OBT is that the company represents a one-stop shop, having a proteomics target discovery platform and the rights to use some of industry's leading antibody generation and drug conjugation technologies.

"We are pleased they have come to us: Menarini has good expertise is oncology, inhouse antibody manufacturing and fill and finish capacity, and the marketing infrastructure to take products to patients," Rohlff said.

The cancers to be targeted by the alliance were not disclosed, but Rohlff said they will be a mixture of hematological and solid tumors, addressed both by naked antibodies and antibody-drug conjugates.

OBT's clinical development unit, set up in March in Basel, Switzerland, under the leadership of former Novartis AG executive Esteban Pombo-Villar, chief operating officer of OBT, will play a central role in supporting the new collaboration with Florence, Italy-based Menarini.

Although it has development alliances with GlaxoSmithKline plc and Sanofi SA, the agreement is the first big-ticket deal for OBT since its formation in 2004 around the Oxford Genome Anatomy Project, a proteomics database built up by Oxford GlycoSciences plc.

The database integrates clinical, tissue, genomic and proteomic data on human disease, enabling OBT to single out proteins that are markedly overexpressed in cancer but are not present in healthy tissue. Those tumor-specific antigens mark out the tumor for destruction by antibodies.

For antibody generation, OBT has rights to Amgen Inc.'s XenoMouse platform and to the Medarex platform, which is owned by Bristol-Myers Squibb Co., while for antibody-drug conjugation, the company can call on technology from Seattle Genetics Inc. or BioWa Inc.

In May 2009, OBT entered its first significant deal, a potential $370 million pact with GSK, under which the pharma company is developing antibodies against cancer targets identified by OBT.